WorldWideScience

Sample records for oncology group phase

  1. Phase II Radiation therapy oncology group trial of weekly paclitaxel and conventional external beam radiation therapy for supratentorial glioblastoma multiforme

    International Nuclear Information System (INIS)

    Langer, Corey J.; Ruffer, James; Rhodes, Harker; Paulus, Rebecca; Murray, Kevin; Movsas, Benjamin; Curran, Walter

    2001-01-01

    Purpose: Fractionated external beam radiotherapy (EBRT) ± carmustine (BCNU) is the standard of care for patients with glioblastoma multiforme (GBM), but survival results remain poor. Preclinical studies indicate synergy between RT and paclitaxel (TAX) in astrocytoma cell lines. Phase I studies in GBM have demonstrated a maximum tolerated dose for TAX of 225 mg/m 2 /3 h/week x 6, during EBRT, with no exacerbation of typical RT-induced toxicities. The Radiation Therapy Oncology Group (RTOG) therefore mounted a Phase II study to determine the feasibility and efficacy of conventional EBRT and concurrent weekly TAX at its MTD. Patients and Methods: Sixty-two patients with histologic diagnosis of GBM were enrolled from 8/16/96 through 3/21/97 in a multi-institutional Phase II trial of EBRT and TAX 225 mg/m 2 /3 h (1-3 h before EBRT), administered the first treatment day of each RT week. Total EBRT dose was 60 Gy (200 cGy/fraction), 5 days per week. A smaller treatment field, to include gross disease plus a margin only, was used after 46 Gy. Results: Sixty-one patients (98%) were evaluable. Median age was 55 years (range, 28-78). Seventy-four percent were ≥50 years. Recursive partitioning analysis (RPA) Classes III, IV, V, VI included 10 (17%), 21 (34%), 25 (41%), and 5 (8%) patients, respectively. Gross total resection was performed in only 16%. There was no Grade 3 or 4 neutropenia or thrombocytopenia. Hypersensitivity reactions precluding further use of TAX occurred in 4 patients. There were 2 instances of late neurotoxicity (4% Grade 3 or 4). Ninety-one percent of patients received treatment per protocol. Seventy-seven percent completed prescribed treatment (6 weeks). Of 35 patients with measurable disease, CR/PR was observed in 23%, MR in 17%, and SD in 43%. Seventeen percent demonstrated progression at first follow-up. Median potential follow-up time is 20 months. Median survival is 9.7 months, with median survivals for RPA classes III, IV, V, and VI of 16.3, 10

  2. Phase II trial of cisplatin in advanced or recurrent cancer of the vagina: a Gynecologic Oncology Group Study.

    Science.gov (United States)

    Thigpen, J T; Blessing, J A; Homesley, H D; Berek, J S; Creasman, W T

    1986-01-01

    Twenty-six patients with advanced or recurrent cancer of the vagina no longer amenable to control with surgery and/or radiotherapy were entered into a phase II study of cisplatin 50 mg/m2 intravenously every 3 weeks. Two were deemed ineligible because of a primary site of origin other than vagina. Two were deemed inevaluable, one because of the lack of measurable disease and the other because she never received drug. The remaining 22 included a variety of histologies (16 squamous cell carcinomas, 2 adenosquamous carcinomas, 1 clear cell carcinoma, 1 leiomyosarcoma, and 2 carcinomas not otherwise specified). One complete responder was observed among the 16 patients with squamous cell carcinoma. Adverse effects were tolerable and were essentially those reported in other series. These results suggest that cisplatin has insignificant activity in advanced or recurrent squamous cell carcinoma of the vagina at least at the dose and schedule tested. No comment can be made regarding the activity of cisplatin in other histologies.

  3. Phase I/II Study of Radiofrequency Ablation for Malignant Renal Tumors: Japan Interventional Radiology in Oncology Study Group 0701

    Energy Technology Data Exchange (ETDEWEB)

    Mimura, Hidefumi, E-mail: mimura@marianna-u.ac.jp [St. Marianna University School of Medicine, Department of Radiology (Japan); Arai, Yasuaki, E-mail: arai-y3111@mvh.biglobe.ne.jp [National Cancer Center Hospital, Department of Diagnostic Radiology (Japan); Yamakado, Koichiro, E-mail: yama@clin.medic.mie-u.ac.jp [Mie University School of Medicine, Department of Interventional Radiology (Japan); Sone, Miyuki, E-mail: msone@me.com; Takeuchi, Yoshito, E-mail: yotake62@qg8.so-net.ne.jp [National Cancer Center Hospital, Department of Diagnostic Radiology (Japan); Miki, Tsuneharu, E-mail: tmiki@koto.kpu-m.ac.jp [Kyoto Prefectural University of Medicine, Department of Urology (Japan); Gobara, Hideo, E-mail: gobara@cc.okayama-u.ac.jp [Okayama University Medical School, Department of Radiology (Japan); Sakuhara, Yusuke, E-mail: yusaku@med.hokudai.ac.jp [Hokkaido University School of Medicine, Department of Diagnostic and Interventional Radiology (Japan); Yamamoto, Takanobu, E-mail: tyamamot@tcc.pref.tochigi.lg.jp [Tochigi Cancer Center, Department of Radiology (Japan); Sato, Yozo, E-mail: ysato@aichi-cc.jp [Aichi Cancer Center Hospital, Department of Diagnostic and Interventional Radiology (Japan); Kanazawa, Susumu, E-mail: susumu@cc.okayama-u.ac.jp [Okayama University Medical School, Department of Radiology (Japan)

    2016-05-15

    PurposeThis multicenter phase I/II study evaluated the safety, feasibility, and initial efficacy of radiofrequency ablation (RFA) for small malignant renal tumors.MethodsThirty-three patients were enrolled in the study. A single session of RFA was performed in patients with a renal tumor of 1–3 cm in greatest diameter, with the exception of lesions adjacent to the renal hilum. The primary endpoint was the safety of renal RFA, and the secondary endpoints were its feasibility and initial efficacy for local control, as well as the incidence and grade of adverse events. Clinical efficacy was evaluated by CT scans within 1 week and at a further 4 weeks after the procedure using the criteria adapted from the Response Evaluation Criteria in Solid Tumors.ResultsThe RFA procedure was completed in 100 % (95 % confidence interval [CI] 89–100 %) of all 33 patients. There were no severe adverse events (0 % [95 % CI 0–11 %]). Among the 33 patients, a complete response, partial response, progressive disease, and stable disease were seen in 28 (85 %), 0 (0 %), one (3 %), and one (3 %) patient(s), respectively, with a tumor response rate of 85 % [95 % CI 68–95 %]). Three patients (9 %), including one ineligible patient (3 %), were not evaluable. Out of 30 evaluable patients, a complete response was achieved in 28 (93 %).ConclusionThe current multicenter trial revealed that RFA is a safe, feasible, and effective treatment for small malignant renal tumors in patients who are not candidates for surgery.

  4. Phase I/II Study of Radiofrequency Ablation for Malignant Renal Tumors: Japan Interventional Radiology in Oncology Study Group 0701

    International Nuclear Information System (INIS)

    Mimura, Hidefumi; Arai, Yasuaki; Yamakado, Koichiro; Sone, Miyuki; Takeuchi, Yoshito; Miki, Tsuneharu; Gobara, Hideo; Sakuhara, Yusuke; Yamamoto, Takanobu; Sato, Yozo; Kanazawa, Susumu

    2016-01-01

    PurposeThis multicenter phase I/II study evaluated the safety, feasibility, and initial efficacy of radiofrequency ablation (RFA) for small malignant renal tumors.MethodsThirty-three patients were enrolled in the study. A single session of RFA was performed in patients with a renal tumor of 1–3 cm in greatest diameter, with the exception of lesions adjacent to the renal hilum. The primary endpoint was the safety of renal RFA, and the secondary endpoints were its feasibility and initial efficacy for local control, as well as the incidence and grade of adverse events. Clinical efficacy was evaluated by CT scans within 1 week and at a further 4 weeks after the procedure using the criteria adapted from the Response Evaluation Criteria in Solid Tumors.ResultsThe RFA procedure was completed in 100 % (95 % confidence interval [CI] 89–100 %) of all 33 patients. There were no severe adverse events (0 % [95 % CI 0–11 %]). Among the 33 patients, a complete response, partial response, progressive disease, and stable disease were seen in 28 (85 %), 0 (0 %), one (3 %), and one (3 %) patient(s), respectively, with a tumor response rate of 85 % [95 % CI 68–95 %]). Three patients (9 %), including one ineligible patient (3 %), were not evaluable. Out of 30 evaluable patients, a complete response was achieved in 28 (93 %).ConclusionThe current multicenter trial revealed that RFA is a safe, feasible, and effective treatment for small malignant renal tumors in patients who are not candidates for surgery.

  5. Misonidazole and unconventional radiation in advanced squamous cell carcinoma of the esophagus: a phase II study of the Radiation Therapy Oncology Group

    International Nuclear Information System (INIS)

    Ydrach, A.A.; Marcial, V.A.; Parsons, J.; Concannon, J.; Asbell, S.O.; George, F.

    1982-01-01

    This is a report on Radiation Therapy Oncology Group (RTOG) Protocol78-32, a Phase I/II prospective study aimed at determining tolerance, tumor response, and survival of squamous cell carcinoma of the esophagus treated with unorthodox fractionation radiotherapy combined with misonidazole. Misonidazole was administered by mouth 4 to 6 hr prior to radiation, at a dose of 1.0 to 1.25 Gm/.m 2 ; blood levels were measured at about 4 hr after intake of the drug and reported in micrograms/ml. Radiotherapy was administered at 4 to 6 hr post-misonidazole dose and given with 400 rad fractions, alternating 2 or 3 times/week, up to 4,800 rad. A total of 43 patients were entered; 26 are evaluated for survival at 1 year post accession. Thirty patients (88%) received the planned radiation course. Twenty-eight patients (78%) received the planned misonidazole dosage. Tumor response, evaluated in 18 patients, showed a complete regression (C.R.) in only 2 patients (11%); and partial response (P.R.) in 6 patients (33%). Eight patients (44%) showed no tumor response to planned therapy. Toxicity was acceptable and in 38 evaluated patients only 4 reported (11%) nausea and vomiting, 7 reported mild paresthesias (18%). The median survival was only five months. In 26 patients evaluated for 1 year survival determination, only 1 survived (3.8%) this period. In view of the poor tumor response and low survival observed, we do not recommend that this particular fractionation regimen with misonidazole be used in a Phase III randomized trial in squamous cell carcinoma of the esophagus

  6. Safety and efficacy of high-dose tamoxifen and sulindac for desmoid tumor in children: results of a Children's Oncology Group (COG) phase II study.

    Science.gov (United States)

    Skapek, Stephen X; Anderson, James R; Hill, D Ashley; Henry, David; Spunt, Sheri L; Meyer, William; Kao, Simon; Hoffer, Fredric A; Grier, Holcombe E; Hawkins, Douglas S; Raney, R Beverly

    2013-07-01

    Desmoid fibromatosis (desmoid tumor, DT) is a soft tissue neoplasm prone to recurrence despite complete surgical resection. Numerous small retrospective reports suggest that non-cytotoxic chemotherapy using tamoxifen and sulindac may be effective for DT. We evaluated the safety and efficacy of tamoxifen and sulindac in a prospective phase II study within the Children's Oncology Group. Eligible patients were <19 years of age who had measurable DT that was recurrent or not amenable to surgery or radiation. The primary objective was to estimate progression-free survival (PFS). Patients received tamoxifen and sulindac daily for 12 months or until disease progression or intolerable toxicity occurred. Response was assessed by magnetic resonance imaging. Fifty-nine eligible patients were enrolled from 2004 to 2009; 78% were 10-18 years old. Twenty-two (38%) were previously untreated; 15 (41%) of the remaining 37 enrolling with recurrent DT had prior systemic chemotherapy and six (16%) had prior radiation. No life-threatening toxicity was reported. Twelve (40%) of 30 females developed ovarian cysts, which were asymptomatic in 11 cases. Ten patients completed therapy without disease progression or discontinuing treatment. Responses included four partial and one complete (5/59, 8%). The estimated 2-year PFS and survival rates were 36% (95% confidence interval: 0.23-0.48) and 96%, respectively. All three deaths were due to progressive DT. Tamoxifen and sulindac caused few serious side effects in children with DT, although ovarian cysts were common. However, the combination showed relatively little activity as measured by response and PFS rates. Copyright © 2012 Wiley Periodicals, Inc.

  7. Safety and Efficacy of High-Dose Tamoxifen and Sulindac for Desmoid Tumor in Children: Results of a Children’s Oncology Group (COG) Phase II Study

    Science.gov (United States)

    Skapek, Stephen X.; Anderson, James R.; Hill, D. Ashley; Henry, David; Spunt, Sheri L.; Meyer, William; Kao, Simon; Hoffer, Fredric A.; Grier, Holcombe E.; Hawkins, Douglas S.; Raney, R. Beverly

    2015-01-01

    Background Desmoid fibromatosis (desmoid tumor, DT) is a soft tissue neoplasm prone to recurrence despite complete surgical resection. Numerous small retrospective reports suggest that non-cytotoxic chemotherapy using tamoxifen and sulindac may be effective for DT. We evaluated the safety and efficacy of tamoxifen and sulindac in a prospective phase II study within the Children’s Oncology Group. Procedures Eligible patients were <19 years of age who had measurable DT that was recurrent or not amenable to surgery or radiation. The primary objective was to estimate progression-free survival (PFS). Patients received tamoxifen and sulindac daily for 12 months or until disease progression or intolerable toxicity occurred. Response was assessed by magnetic resonance imaging. Results Fifty-nine eligible patients were enrolled from 2004 to 2009; 78% were 10–18 years old. Twenty-two (38%) were previously untreated; 15 (41%) of the remaining 37 enrolling with recurrent DT had prior systemic chemotherapy and six (16%) had prior radiation. No life-threatening toxicity was reported. Twelve (40%) of 30 females developed ovarian cysts, which were asymptomatic in 11 cases. Ten patients completed therapy without disease progression or discontinuing treatment. Responses included four partial and one complete (5/59, 8%). The estimated 2-year PFS and survival rates were 36% (95% confidence interval: 0.23–0.48) and 96%, respectively. All three deaths were due to progressive DT. Conclusions Tamoxifen and sulindac caused few serious side effects in children with DT, although ovarian cysts were common. However, the combination showed relatively little activity as measured by response and PFS rates. PMID:23281268

  8. Phase 2 Study of Temozolomide-Based Chemoradiation Therapy for High-Risk Low-Grade Gliomas: Preliminary Results of Radiation Therapy Oncology Group 0424

    Energy Technology Data Exchange (ETDEWEB)

    Fisher, Barbara J., E-mail: barbara.fisher@lhsc.on.ca [London Regional Cancer Program, London, Ontario (Canada); Hu, Chen [Radiation Therapy Oncology Group-Statistical Center, Philadelphia, Pennsylvania (United States); Macdonald, David R. [London Regional Cancer Program, London, Ontario (Canada); Lesser, Glenn J. [Wake Forest University Baptist Medical Center, Winston-Salem, North Carolina (United States); Coons, Stephen W. [Barrow Neurological Institute, Phoenix, Arizona (United States); Brachman, David G. [Arizona Oncology Services Foundation, Phoenix, Arizona (United States); Ryu, Samuel [Henry Ford Hospital, Detroit, Michigan (United States); Werner-Wasik, Maria [Thomas Jefferson University Hospital Center, Philadelphia, Pennsylvania (United States); Bahary, Jean-Paul [Centre Hospitalier de l' Université de Montréal-Notre Dame, Montreal, Quebec (Canada); Liu, Junfeng [GCE Solutions, Inc., Bloomington, Illinois (United States); Chakravarti, Arnab [The Ohio State University, The James, Columbus, Ohio (United States); Mehta, Minesh [University of Maryland Medical Systems, Baltimore, Maryland (United States)

    2015-03-01

    Purpose: Radiation Therapy Oncology Group (RTOG) 0424 was a phase 2 study of a high-risk low-grade glioma (LGG) population who were treated with temozolomide (TMZ) and radiation therapy (RT), and outcomes were compared to those of historical controls. This study was designed to detect a 43% increase in median survival time (MST) from 40.5 to 57.9 months and a 20% improvement in 3-year overall survival (OS) rate from 54% to 65% at a 10% significance level (1-sided) and 96% power. Methods and Materials: Patients with LGGs with 3 or more risk factors for recurrence (age ≥40 years, astrocytoma histology, bihemispherical tumor, preoperative tumor diameter of ≥6 cm, or a preoperative neurological function status of >1) were treated with RT (54 Gy in 30 fractions) and concurrent and adjuvant TMZ. Results: From 2005 to 2009, 129 evaluable patients (75 males and 54 females) were accrued. Median age was 49 years; 91% had a Zubrod score of 0 or 1; and 69%, 25%, and 6% of patients had 3, 4, and 5 risk factors, respectively. Patients had median and minimum follow-up examinations of 4.1 years and 3 years, respectively. The 3-year OS rate was 73.1% (95% confidence interval: 65.3%-80.8%), which was significantly improved compared to that of prespecified historical control values (P<.001). Median survival time has not yet been reached. Three-year progression-free survival was 59.2%. Grades 3 and 4 adverse events occurred in 43% and 10% of patients, respectively. One patient died of herpes encephalitis. Conclusions: The 3-year OS rate of 73.1% for RTOG 0424 high-risk LGG patients is higher than that reported for historical controls (P<.001) and the study-hypothesized rate of 65%.

  9. A randomized phase III study of accelerated hyperfractionation versus standard in patients with unresected brain metastases: a report of the radiation therapy oncology group (RTOG) 9104

    International Nuclear Information System (INIS)

    Murray, Kevin J.; Scott, Charles; Greenberg, Harvey M.; Emami, Bahman; Seider, Michael; Vora, Nayana L.; Olson, Craig; Whitton, Anthony; Movsas, Benjamin; Curran, Walter

    1997-01-01

    Purpose: To compare 1-year survival and acute toxicity rates between an accelerated hyperfractionated (AH) radiotherapy (1.6 Gy b.i.d.) to a total dose of 54.4 Gy vs. an accelerated fractionation (AF) of 30 Gy in 10 daily fractions in patients with unresected brain metastasis. Methods and Materials: The Radiation Therapy Oncology Group (RTOG) accrued 445 patients to a Phase III comparison of accelerated hyperfractionation vs. standard fractionation from 1991 through 1995. All patients had histologic proof of malignancy at the primary site. Brain metastasis were measurable by CT or MRI scan and all patients had a Karnofsky performance score (KPS) of at least 70 and a neurologic function classification of 1 or 2. For AH, 32 Gy in 20 fractions over 10 treatment days (1.6 Gy twice daily) was delivered to the whole brain. A boost of 22.4 Gy in 14 fractions was delivered to each lesion with a 2-cm margin. Results: The average age in both groups was 60 years; nearly two-thirds of all patients had lung primaries. Of the 429 eligible and analyzable patients, the median survival time was 4.5 months in both arms. The 1-year survival rate was 19% in the AF arm vs. 16% in the AH arm. No difference in median or 1-year survival was observed among patients with solitary metastasis between treatment arms. Recursive partitioning analysis (RPA) classes have previously been identified and patients with a KPS of 70 or more, a controlled primary tumor, less than 65 years of age, and brain metastases only (RPA class I), had a 1-year survival of 35% in the AF arm vs. 25% in the AH arm (p = 0.95). In a multivariate model, only age, KPS, extent of metastatic disease (intracranial metastases only vs. intra- and extracranial metastases), and status of primary (controlled vs. uncontrolled) were statistically significant (at p < 0.05). Treatment assignment was not statistically significant. Overall Grade III or IV toxicity was equivalent in both arms, and one fatal toxicity at 44 days secondary

  10. Radiation Therapy Oncology Group clinical trials with misonidazole

    International Nuclear Information System (INIS)

    Wasserman, T.H.; Stetz, J.; Phillips, T.L.

    1981-01-01

    This paper presents a review of the progressive clinical trials of the hypoxic cell radiosensitizer, misonidazole, in the Radiation Therapy Oncology Group (RTOG). Presentation is made of all the schemas of the recently completed and currently active RTOG Phase II and Phase III studies. Detailed information is provided on the clinical toxicity of the Phase II trials, specifically regarding neurotoxicity. With limitations in drug total dose, a variety of dose schedules have proven to be tolerable, with a moderate incidence of nausea and vomiting and mild peripheral neuropathy or central neuropathy. No other organ toxicity has been seen, specifically no liver, renal or bone marrow toxicities. An additional Phase III malignant glioma trial in the Brain Tumor Study Group is described

  11. Racial Differences in CYP3A4 Genotype and Survival Among Men Treated on Radiation Therapy Oncology Group (RTOG) 9202: A Phase III Randomized Trial

    International Nuclear Information System (INIS)

    Roach, Mack; Silvio, Michelle de; Rebbick, Timothy; Grignon, David; Rotman, Marvin; Wolkov, Harvey; Fisher, Barbara; Hanks, Gerald; Shipley, William U.; Pollack, Alan; Sandler, Howard; Watkins-Bruner, Deborah Ph.D.

    2007-01-01

    Purpose: Inherited genotypes may explain the inferior outcomes of African American (AA) men with prostate cancer. To understand how variation in CYP3A4 correlated with outcomes, a retrospective examination of the CYP3A4*1B genotype was performed on men treated with Radiation Therapy Oncology Group (RTOG) 92-02. Methods and Materials: From 1,514 cases, we evaluated 56 (28.4%) of 197 AA and 54 (4.3%) of 1,274 European American (EA) patients. All patients received goserelin and flutamide for 2 months before and during RT (STAD-RT) ± 24 months of goserelin (long-term androgen deprivation plus radiation [LTAD-RT]). Events studied included overall survival and biochemical progression using American Society for Therapeutic Radiology and Oncology consensus guidelines. Results: There were no differences in outcome in patients in with or without CYP3A4 data. There was an association between race and CYP3A4 polymorphisms with 75% of EAs having the Wild Type compared to only 25% of AA men (p <0.0001). There was no association between CYP3A4 classification or race and survival or progression. Conclusions: The samples analyzed support previously reported observations about the distribution of CYP3A4*1B genotype by race, but race was not associated with poorer outcome. However, patient numbers were limited, and selection bias cannot be completely ruled out

  12. A pediatric phase 1 trial of vorinostat and temozolomide in relapsed or refractory primary brain or spinal cord tumors: a Children's Oncology Group phase 1 consortium study.

    Science.gov (United States)

    Hummel, Trent R; Wagner, Lars; Ahern, Charlotte; Fouladi, Maryam; Reid, Joel M; McGovern, Renee M; Ames, Matthew M; Gilbertson, Richard J; Horton, Terzah; Ingle, Ashish M; Weigel, Brenda; Blaney, Susan M

    2013-09-01

    We conducted a pediatric phase I study to estimate the maximum tolerated dose (MTD), dose-limiting toxicities (DLT), and pharmacokinetic properties of vorinostat, a histone deacetylase (HDAC) inhibitor, when given in combination with temozolomide in children with refractory or recurrent CNS malignancies. Vorinostat, followed by temozolomide approximately 1 hour later, was orally administered, once daily, for 5 consecutive days every 28 days at three dose levels using the rolling six design. Studies of histone accumulation in peripheral blood mononuclear cells were performed on Day 1 at 0, 6, and 24 hours after vorinostat dosing. Vorinostat pharmacokinetics (PK) and serum MGMT promoter status were also assessed. Nineteen eligible patients were enrolled and 18 patients were evaluable for toxicity. There were no DLTs observed at dose level 1 or 2. DLTs occurred in four patients at dose level 3: thrombocytopenia (4), neutropenia (3), and leucopenia (1). Non-dose limiting grade 3 or 4 toxicities related to protocol therapy were also hematologic and included neutropenia, lymphopenia, thrombocytopenia, anemia, and leucopenia. Three patients exhibited stable disease and one patient had a partial response. There was no clear relationship between vorinostat dosage and drug exposure over the dose range studied. Accumulation of acetylated H3 histone in PBMC was observed after administration of vorinostat. Five-day cycles of vorinostat in combination with temozolomide are well tolerated in children with recurrent CNS malignancies with myelosuppression as the DLT. The recommended phase II combination doses are vorinostat, 300 mg/m(2) /day and temozolomide, 150 mg/m(2) /day. Copyright © 2013 Wiley Periodicals, Inc.

  13. Acute symptoms, not rectally administered sucralfate, predict for late radiation proctitis: longer term follow-up of a phase III trial--Trans-Tasman Radiation Oncology Group.

    Science.gov (United States)

    O'Brien, Peter C; Franklin, C Ian; Poulsen, Michael G; Joseph, David J; Spry, Nigel S; Denham, James W

    2002-10-01

    To assess the potential for sucralfate administered rectally to reduce the risk of late rectal morbidity in patients undergoing nonconformal radiotherapy (RT) for carcinoma of the prostate and to study the variables potentially contributing to late rectal morbidity and particularly to explore the relationship between acute and late toxicity. Eighty-six patients with localized prostate carcinoma were randomized in a double-blind, placebo-controlled study to a daily enema of 3 g of sucralfate in a 15-mL suspension or the same suspension without sucralfate. The enema began the first day of RT and was continued for 2 weeks after treatment completion. The primary end point of the study was acute Radiation Therapy Oncology Group (RTOG)/European Organization for Research and Treatment of Cancer (EORTC) toxicity; however, the patients were followed for an additional 5 years on a 6-month basis. The evaluation included late RTOG/EORTC toxicity and a patient self-assessment questionnaire. With a median follow-up of 5 years, the Kaplan-Meier probability of late Grade 2 RTOG/EORTC toxicity was 12% (95% confidence interval [CI] 2-22%) for placebo and 5% (95% CI 0-12%) for sucralfate (p = 0.26). The probability of late rectal bleeding was 59% (95% CI 45-73%) for placebo and 54% (95% CI 40-68%) for sucralfate. No statistically significant difference was found between the treatment arms for the peak incidence of any of the other patient self-assessment variables. Cox proportional hazards modeling indicated acute RTOG/EORTC toxicity of Grade 2 or greater was associated with a hazard ratio of 2.74 (95% CI 1.31-5.73) for the development of late toxicity of Grade 1 or greater. Substituting the patient self-assessment variables for acute RTOG/EORTC toxicity revealed that rectal pain of a moderate or severe grade during RT was the best predictor of the subsequent development of late toxicity, with a hazard ratio of 3.44 (95% CI 1.68-7). The results of this study do not support the use of

  14. Acute symptoms, not rectally administered sucralfate, predict for late radiation proctitis: longer term follow-up of a phase III trial--Trans-Tasman Radiation Oncology Group

    International Nuclear Information System (INIS)

    O'Brien, Peter C.; Franklin, C. Ian; Poulsen, Michael G.; Joseph, David J.; Spry, Nigel S.; Denham, James W.

    2002-01-01

    Purpose: To assess the potential for sucralfate administered rectally to reduce the risk of late rectal morbidity in patients undergoing nonconformal radiotherapy (RT) for carcinoma of the prostate and to study the variables potentially contributing to late rectal morbidity and particularly to explore the relationship between acute and late toxicity. Methods and Materials: Eighty-six patients with localized prostate carcinoma were randomized in a double-blind, placebo-controlled study to a daily enema of 3 g of sucralfate in a 15-mL suspension or the same suspension without sucralfate. The enema began the first day of RT and was continued for 2 weeks after treatment completion. The primary end point of the study was acute Radiation Therapy Oncology Group (RTOG)/European Organization for Research and Treatment of Cancer (EORTC) toxicity; however, the patients were followed for an additional 5 years on a 6-month basis. The evaluation included late RTOG/EORTC toxicity and a patient self-assessment questionnaire. Results: With a median follow-up of 5 years, the Kaplan-Meier probability of late Grade 2 RTOG/EORTC toxicity was 12% (95% confidence interval [CI] 2-22%) for placebo and 5% (95% CI 0-12%) for sucralfate (p=0.26). The probability of late rectal bleeding was 59% (95% CI 45-73%) for placebo and 54% (95% CI 40-68%) for sucralfate. No statistically significant difference was found between the treatment arms for the peak incidence of any of the other patient self-assessment variables. Cox proportional hazards modeling indicated acute RTOG/EORTC toxicity of Grade 2 or greater was associated with a hazard ratio of 2.74 (95% CI 1.31-5.73) for the development of late toxicity of Grade 1 or greater. Substituting the patient self-assessment variables for acute RTOG/EORTC toxicity revealed that rectal pain of a moderate or severe grade during RT was the best predictor of the subsequent development of late toxicity, with a hazard ratio of 3.44 (95% CI 1.68-7). Conclusion

  15. Children's Oncology Group's 2013 blueprint for research: acute myeloid leukemia.

    Science.gov (United States)

    Gamis, Alan S; Alonzo, Todd A; Perentesis, John P; Meshinchi, Soheil

    2013-06-01

    For the 365 children diagnosed with acute myeloid leukemia in the US annually, 5-year survival for patients on COG trials with low, intermediate, and high risk disease is 83%, 62%, and 23%, respectively. Recent advances include improved therapeutic stratification, improved survival with dose intensification, and further elucidation of the heterogeneity specific to childhood AML. These discoveries now guide current strategy incorporating targeted agents to pathways specific to childhood AML as well as evaluating methods to increase the sensitivity of the leukemic stem cell, first in Phase II feasibility trials followed by Phase III efficacy trials of the most promising agents. Acute myeloid leukemia in children, though with similar subgroups to adults, remains uniquely different based upon quite different prevalence of subtypes as well as overall response to therapy. The Children's Oncology Group's research agenda builds upon earlier efforts to better elucidate the leukemogenic steps distinct to childhood AML in order to more scientifically develop and test novel therapeutic approaches to the treatment and ultimate cure for children with this disorder. Pediatr Blood Cancer 2013; 60: 964-971. © 2012 Wiley Periodicals, Inc. Copyright © 2012 Wiley Periodicals, Inc.

  16. Prospective randomized phase II study of FOLFIRI versus FOLFOX7 in advanced gastric adenocarcinoma: a Chinese Western Cooperative Gastrointestinal Oncology Group Study.

    Science.gov (United States)

    Li, Qiu; Wen, Feng; Zhou, Chengya; Qiu, Meng; Liu, Jiyan; Chen, Jing; Yi, Cheng; Li, Zhiping; Luo, Deyun; Xu, Feng; Cai, Xiaohong; Bi, Feng

    2017-11-17

    Until now, no standard chemotherapy has been widely accepted for advanced gastric cancer (GC). The current research aimed to compare folinic acid, fluorouracil with irinotecan (mFOLFIRI) or with oxaliplatin (mFOLFOX7) as first-line treatments in patients with locally advanced GC in an open, randomized, phase II study. Previously untreated metastatic or recurrent GC patients with measurable disease received mFOLFIRI (arm A) or mFOLFOX7 (arm B) every 2 weeks. The defined second-line treatment was mFOLFOX7 for arm A and mFOLFIRI for arm B. Primary endpoint was progression-free survival (PFS), and secondary endpoints were overall survival (OS), disease control rate (DCR) and toxicity. The evaluable population consisted of 128 patients (54 in arm A; 74 in arm B). Median PFS of arm A was 2.9 months (m) (95% confidence interval, CI , 1.9 to 4.1 m) versus 4.1 m (95% CI , 3.2 to 4.8 m) for arm B ( p = 0.109). Median OS was 9.9 months (95% CI , 6.0 to 13.5 m) for arm A versus 12.0 m for arm B (95% CI , 10.3 to 13.7m; p = 0.431). DCRs for arm A and arm B were 59.3% and 66.3%, respectively ( p = 0.850). In subgroup analysis of the patients who completed both treatment lines per protocol, the median first-line PFS was 2.1 m for the mFOLFIRI/mFOLFOX7arm versus 8.0 m for the mFOLFOX7/mFOLFIRI arm ( p = 0.053), and the median second-line PFS values were 1.2 m versus 5.1 m ( p = 0.287). Total PFS and OS were 8.1m and 11.0 m for the mFOLFIRI/mFOLFOX7 group compared with 12.2m and 20.2 m for the mFOLFOX7/mFOLFIRI group ( p = 0.008, p = 0.030). Both regimens were well-tolerated with acceptable and manageable toxicities. Hence, there was no significant difference in the PFS or DCR. However, mFOLFOX7 followed by mFOLFIRI might have a better OS.

  17. Group consensus peer review in radiation oncology: commitment to quality.

    Science.gov (United States)

    Duggar, W Neil; Bhandari, Rahul; Yang, Chunli Claus; Vijayakumar, Srinivasan

    2018-03-27

    Peer review, especially prospective peer review, has been supported by professional organizations as an important element in optimal Radiation Oncology practice based on its demonstration of efficacy at detecting and preventing errors prior to patient treatment. Implementation of peer review is not without barriers, but solutions do exist to mitigate or eliminate some of those barriers. Peer review practice at our institution involves three key elements: new patient conference, treatment planning conference, and chart rounds. The treatment planning conference is an adaptation of the group consensus peer review model from radiology which utilizes a group of peers reviewing each treatment plan prior to implementation. The peer group in radiation oncology includes Radiation Oncologists, Physician Residents, Medical Physicists, Dosimetrists, and Therapists. Thus, technical and clinical aspects of each plan are evaluated simultaneously. Though peer review is held in high regard in Radiation Oncology, many barriers commonly exist preventing optimal implementation such as time intensiveness, repetition, and distraction from clinic time with patients. Through the use of automated review tools and commitment by individuals and administration in regards to staffing, scheduling, and responsibilities, these barriers have been mitigated to implement this Group Consensus Peer Review model into a Radiation Oncology Clinic. A Group Consensus Peer Review model has been implemented with strategies to address common barriers to effective and efficient peer review.

  18. A Phase 2 Trial of Radiation Therapy With Concurrent Paclitaxel Chemotherapy After Surgery in Patients With High-Risk Endometrial Cancer: A Korean Gynecologic Oncologic Group Study

    International Nuclear Information System (INIS)

    Cho, Hanbyoul; Nam, Byung-Ho; Kim, Seok Mo; Cho, Chi-Heum; Kim, Byoung Gie; Ryu, Hee-Sug; Kang, Soon Beom; Kim, Jae-Hoon

    2014-01-01

    Purpose: A phase 2 study was completed by the Korean Gynecologic Oncologic Group to evaluate the efficacy and toxicity of concurrent chemoradiation with weekly paclitaxel in patients with high-risk endometrial cancer. Methods and Materials: Pathologic requirements included endometrial endometrioid adenocarcinoma stages III and IV. Radiation therapy consisted of a total dose of 4500 to 5040 cGy in 5 fractions per week for 6 weeks. Paclitaxel 60 mg/m 2 was administered once weekly for 5 weeks during radiation therapy. Results: Fifty-seven patients were enrolled between January 2006 and March 2008. The median follow-up time was 60.0 months (95% confidence interval [CI], 51.0-58.2). All grade 3/4 toxicities were hematologic and usually self-limited. There was no life-threatening toxicity. The cumulative incidence of intrapelvic recurrence sites was 1.9% (1/52), and the cumulative incidence of extrapelvic recurrence sites was 34.6% (18/52). The estimated 5-year disease-free and overall survival rates were 63.5% (95% CI, 50.4-76.5) and 82.7% (95% CI, 72.4-92.9), respectively. Conclusions: Concurrent chemoradiation with weekly paclitaxel is well tolerated and seems to be effective for high-risk endometrioid endometrial cancers. This approach appears reasonable to be tested for efficacy in a prospective, randomized controlled study

  19. A Phase 2 Trial of Radiation Therapy With Concurrent Paclitaxel Chemotherapy After Surgery in Patients With High-Risk Endometrial Cancer: A Korean Gynecologic Oncologic Group Study

    Energy Technology Data Exchange (ETDEWEB)

    Cho, Hanbyoul [Department of Obstetrics and Gynecology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul (Korea, Republic of); Institute of Women' s Life Medical Science, Yonsei University College of Medicine, Seoul (Korea, Republic of); Nam, Byung-Ho [Cancer Biostatistics Branch, Research Institute for National Cancer Control and Evaluation, National Cancer Center, Goyang (Korea, Republic of); Kim, Seok Mo [Department of Obstetrics and Gynecology, Chonnam National University School of Medicine, Gwangju (Korea, Republic of); Cho, Chi-Heum [Department of Obstetrics and Gynecology, Keimyung University School of Medicine, Daegu (Korea, Republic of); Kim, Byoung Gie [Department of Obstetrics and Gynecology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul (Korea, Republic of); Ryu, Hee-Sug [Department of Obstetrics and Gynecology, Ajou University School of Medicine, Suwon (Korea, Republic of); Kang, Soon Beom [Department of Obstetrics and Gynecology, Konkuk University School of Medicine, Seoul (Korea, Republic of); Kim, Jae-Hoon, E-mail: jaehoonkim@yuhs.ac [Department of Obstetrics and Gynecology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul (Korea, Republic of); Institute of Women' s Life Medical Science, Yonsei University College of Medicine, Seoul (Korea, Republic of)

    2014-09-01

    Purpose: A phase 2 study was completed by the Korean Gynecologic Oncologic Group to evaluate the efficacy and toxicity of concurrent chemoradiation with weekly paclitaxel in patients with high-risk endometrial cancer. Methods and Materials: Pathologic requirements included endometrial endometrioid adenocarcinoma stages III and IV. Radiation therapy consisted of a total dose of 4500 to 5040 cGy in 5 fractions per week for 6 weeks. Paclitaxel 60 mg/m{sup 2} was administered once weekly for 5 weeks during radiation therapy. Results: Fifty-seven patients were enrolled between January 2006 and March 2008. The median follow-up time was 60.0 months (95% confidence interval [CI], 51.0-58.2). All grade 3/4 toxicities were hematologic and usually self-limited. There was no life-threatening toxicity. The cumulative incidence of intrapelvic recurrence sites was 1.9% (1/52), and the cumulative incidence of extrapelvic recurrence sites was 34.6% (18/52). The estimated 5-year disease-free and overall survival rates were 63.5% (95% CI, 50.4-76.5) and 82.7% (95% CI, 72.4-92.9), respectively. Conclusions: Concurrent chemoradiation with weekly paclitaxel is well tolerated and seems to be effective for high-risk endometrioid endometrial cancers. This approach appears reasonable to be tested for efficacy in a prospective, randomized controlled study.

  20. A randomized phase II study of carboplatin plus pegylated liposomal doxorubicin versus carboplatin plus paclitaxel in platinum sensitive ovarian cancer patients: a Hellenic Cooperative Oncology Group study

    Directory of Open Access Journals (Sweden)

    Briasoulis Evangelos

    2010-01-01

    Full Text Available Abstract Background Platinum-based combinations are the standard second-line treatment for platinum-sensitive ovarian cancer (OC. This randomized phase II study was undertaken in order to compare the combination of carboplatin and pegylated liposomal doxorubicin (LD with carboplatin and paclitaxel (CP in this setting. Methods Patients with histologically confirmed recurrent OC, at the time of or more than 6 months after platinum-based chemotherapy, were randomized to six cycles of CP (carboplatin AUC5 + paclitaxel 175 mg/m2, d1q21 or CLD (carboplatin AUC5 + pegylated LD 45 mg/m2, d1q28. Results A total of 189 eligible patients (CP 96, CLD 93, with a median age of 63 years, median Performance Status (PS 0 and a median platinum free interval (PFI of 16.5 months, entered the study. Discontinuation due to toxicity was higher in the CP patients (13.5% versus 3%, P = 0.016. The overall response rate was similar: CP 58% versus CLD 51%, P = 0.309 (Complete Response; CR 34% versus 23% and there was no statistical difference in time-to-progression (TTP or overall survival (OS; TTP 10.8 months CP versus 11.8 CLD, P = 0.904; OS 29.4 months CP versus 24.7 CLD, P = 0.454. No toxic deaths were recorded. Neutropenia was the most commonly seen severe toxicity (CP 30% versus CLD 35%. More frequent in CLD were severe thrombocytopenia (11% versus 2%, P = 0.016, skin toxicity and Palmar-plantar erythrodysesthesia (PPE grade 1-2 (38% versus 9%, PP = 0.029, 20% versus 5%, P = 0.003. PS and PFI were independent prognostic factors for TTP and OS. Conclusions The combination of pegylated LD with carboplatin is effective, showing less neurotoxicity and alopecia than paclitaxel-carboplatin. It thus warrants a further phase III evaluation as an alternative treatment option for platinum-sensitive OC patients. Trial Registration Australian New Zealand Clinical Trials Registry: ACTRN12609000436279

  1. Outcome of Children With Metastatic Medulloblastoma Treated With Carboplatin During Craniospinal Radiotherapy: A Children's Oncology Group Phase I/II Study

    Science.gov (United States)

    Jakacki, Regina I.; Burger, Peter C.; Zhou, Tianni; Holmes, Emiko J.; Kocak, Mehmet; Onar, Arzu; Goldwein, Joel; Mehta, Minesh; Packer, Roger J.; Tarbell, Nancy; Fitz, Charles; Vezina, Gilbert; Hilden, Joanne; Pollack, Ian F.

    2012-01-01

    Purpose We evaluated the feasibility of administering carboplatin as a radiosensitizer during craniospinal radiation therapy (CSRT) to patients with high-risk medulloblastomas (MBs) and supratentorial primitive neuroectodermal tumors, and we report the outcome in the subset with metastatic (M+) MB. Patients and Methods After surgery, patients received 36 Gy CSRT with boosts to sites of disease. During radiation, patients received 15 to 30 doses of carboplatin (30-45 mg/m2/dose), along with vincristine (VCR) once per week for 6 weeks. Patients on regimen A received 6 months of maintenance chemotherapy (MC) with cyclophosphamide and VCR. Once the recommended phase II dose (RP2D) of carboplatin was determined, cisplatin was added to the MC (regimen B). Results In all, 161 eligible patients (median age, 8.7 years; range, 3.1 to 21.6 years) were enrolled. Myelosuppression was dose limiting and 35 mg/m2/dose × 30 was determined to be the RP2D of carboplatin. Twenty-nine (36%) of 81 patients with M+ MB had diffuse anaplasia. Four patients were taken off study within 11 months of completing radiotherapy for presumed metastatic progression and are long-term survivors following palliative chemotherapy. Excluding these four patients, 5-year overall survival ± SE and progression-free survival ± SE for M+ patients treated at the RP2D on regimen A was 82% ± 9% and 71% ± 11% versus 68% ± 10% and 59% ± 10% on regimen B (P = .36). There was no difference in survival by M stage. Anaplasia was a negative predictor of outcome. Conclusion The use of carboplatin as a radiosensitizer is a promising strategy for patients with M+ MB. Early progression should be confirmed by biopsy. PMID:22665539

  2. Cetuximab as second-line therapy in patients with metastatic esophageal adenocarcinoma: A phase II Southwest Oncology Group Study (S0415)

    Science.gov (United States)

    Gold, Philip J.; Goldman, Bryan; Iqbal, Syma; Leichman, Lawrence P.; Zhang, Wu; Lenz, Heinz-Josef; Blanke, Charles D.

    2010-01-01

    Introduction Esophageal adenocarcinomas commonly express the Epidermal Growth Factor Receptor (EGFR). This trial assessed the six month overall survival probability in metastatic esophageal cancer patients treated with cetuximab as second line therapy. Methods This was a multicenter, open-label phase II study of single agent cetuximab for metastatic esophageal adenocarcinoma patients who failed one prior chemotherapy regimen. Adequate organ function and Zubrod performance status of 0-2 were required. Patients received cetuximab 400mg/m2 IV on week one, and 250 mg/m2 IV weekly thereafter. The primary objective was to determine 6 month overall survival. Secondary endpoints included progression-free survival, response rate, and toxicity. Tumor tissue was collected for correlative studies. Results Sixty-three patients were registered, with 8 ineligible or never treated. Fifty-five eligible patients (male=49, female=6; median age=61.2 years [range 30.7-88.5]) were enrolled. Twenty patients survived > 6 months for a 6-month overall survival rate of 36% (95% CI: 24%, 50%). The median overall survival was 4.0 months (95% CI: 3.2, 5.9). Median progression-free survival was 1.8 months (95% CI: 1.7, 1.9). One partial response and 2 unconfirmed partial responses were observed. Two patients experienced grade 4 fatigue. There was one treatment-related death due to pneumonitis. Germline polymorphisms of EGFR, EGF, IL-8, COX-2, VEGF, CCND1, NRP1 and Kras mutational status were not associated with response or survival. Conclusions The 6-month overall survival rate of 36% observed on this study failed to meet the primary survival objective. Thus, cetuximab alone cannot be recommended in the second-line treatment of metastatic esophageal cancer. PMID:20631636

  3. Efficacy and tolerability of concurrent weekly low dose cisplatin during radiation treatment of localised muscle invasive bladder transitional cell carcinoma: A report of two sequential Phase II studies from the Trans Tasman Radiation Oncology Group

    International Nuclear Information System (INIS)

    Gogna, Nirdosh Kumar; Matthews, John H.L.; Turner, Sandra L.; Mameghan, Heidi; Duchesne, Gillian M.; Spry, Nigel; Berry, Martin P.; Keller, Jacqui; Tripcony, Lee

    2006-01-01

    Background and purpose: To determine the feasibility, toxicity, and clinical effectiveness of concurrent weekly cisplatin chemotherapy in conjunction with definitive radiation in the treatment of localised muscle invasive bladder cancer. Patients and methods: In January 1997 the Trans Tasman Radiation Oncology Group embarked on a Phase II study (TROG 97.01) of weekly cisplatin (35 mg/m 2 x 7 doses) plus radiation to a dose of 63 Gy over 7 weeks. Following an interim toxicity analysis, the dose intensity of cisplatin was reduced to 6 cycles and the radiation schedule changed to 64 Gy over 6.5 weeks leading to the second study (TROG 99.06). A total of 113 patients were enrolled. Results: Acute grade 3 urinary toxicity occurred in 23% of the patients. Acute grade 4 pelvic toxicity was not seen. Thirty-eight patients (33%) experienced grade 3 or 4 cisplatin related toxicities with 15 patients (12%) requiring significant dose modification. The reduced dose intensity in Study 99.06 improved tolerability. Incidence of significant late morbidity was low (6%). Seventy-nine patients (70%) achieved complete remission at the 6 month cystoscopic assessment. Local invasive recurrence was seen in 11 of the 79 patients (14%). In 18 patients (16%) isolated superficial TCC/CIS were detected (6 months and beyond).The local control rate was 45% with a functional bladder being retained in 69 of the 113 patients (61%). RFS and DSS at 5 years were 33% and 50%, respectively. Conclusion: Our two sequential Phase II studies have shown that concurrent chemoradiation using weekly cisplatin in the management of localised invasive bladder TCC is feasible and reasonably well tolerated. This approach is currently being investigated further in a randomised study

  4. A Phase II feasibility study of oral etoposide given concurrently with radiotherapy followed by dose intensive adjuvant chemotherapy for children with newly diagnosed high-risk medulloblastoma (protocol POG 9631): A report from the Children's Oncology Group.

    Science.gov (United States)

    Esbenshade, Adam J; Kocak, Mehmet; Hershon, Linda; Rousseau, Pierre; Decarie, Jean-Claude; Shaw, Susan; Burger, Peter; Friedman, Henry S; Gajjar, Amar; Moghrabi, Albert

    2017-06-01

    Children with high-risk medulloblastoma historically have had a poor prognosis. The Children's Oncology Group completed a Phase II study using oral etoposide given with radiotherapy followed by intensive chemotherapy. Patients enrolled in the study had high-risk disease defined as ≥1.5 cm 2 of residual disease postsurgery or definite evidence of central nervous metastasis. All patients underwent surgery followed by radiotherapy. During radiation, the patients received oral etoposide (21 days on, 7 off) at an initial dose of 50 mg/m 2 per day (treatment 1), which was reduced to 35 mg/m 2 per day (treatment 2) due to toxicity. After radiotherapy, the patients received chemotherapy with three cycles of cisplatin and oral etoposide, followed by eight courses of cyclophosphamide and vincristine. Between November 1998 and October 2002, 53 patients were accrued; 15 received treatment 1 and 38 treatment 2. Forty-seven patients (89%) were eligible. Response to radiation was excellent, with 19 (40.4%) showing complete response, 24 (51.1%) partial response, and four (8.5%) no recorded response. The overall 2- and 5-year progression-free survival (PFS) was 76.6 ± 6% and 70.2 ± 7%, respectively. The 2- and 5-year overall survival (OS) was 80.9 ± 6% and 76.6 ± 6%, respectively. Clinical response postradiation and PFS/OS were not significantly different between the treatment groups. There was a trend toward a difference in 5-year PFS between those without and with metastatic disease (P = 0.072). Oral etoposide was tolerable at 35 mg/m 2 (21 days on and 7 days off) when given during full-dose irradiation in patients with high-risk medulloblastoma with encouraging survival data. © 2016 Wiley Periodicals, Inc.

  5. Dispositional Optimism and Therapeutic Expectations in Early Phase Oncology Trials

    Science.gov (United States)

    Jansen, Lynn A.; Mahadevan, Daruka; Appelbaum, Paul S.; Klein, William MP; Weinstein, Neil D.; Mori, Motomi; Daffé, Racky; Sulmasy, Daniel P.

    2016-01-01

    Purpose Prior research has identified unrealistic optimism as a bias that might impair informed consent among patient-subjects in early phase oncology trials. Optimism, however, is not a unitary construct – it can also be defined as a general disposition, or what is called dispositional optimism. We assessed whether dispositional optimism would be related to high expectations for personal therapeutic benefit reported by patient-subjects in these trials but not to the therapeutic misconception. We also assessed how dispositional optimism related to unrealistic optimism. Methods Patient-subjects completed questionnaires designed to measure expectations for therapeutic benefit, dispositional optimism, unrealistic optimism, and the therapeutic misconception. Results Dispositional optimism was significantly associated with higher expectations for personal therapeutic benefit (Spearman r=0.333, poptimism was weakly associated with unrealistic optimism (Spearman r=0.215, p=0.005). In multivariate analysis, both dispositional optimism (p=0.02) and unrealistic optimism (poptimism (p=.0001), but not dispositional optimism, was independently associated with the therapeutic misconception. Conclusion High expectations for therapeutic benefit among patient-subjects in early phase oncology trials should not be assumed to result from misunderstanding of specific information about the trials. Our data reveal that these expectations are associated with either a dispositionally positive outlook on life or biased expectations about specific aspects of trial participation. Not all manifestations of optimism are the same, and different types of optimism likely have different consequences for informed consent in early phase oncology research. PMID:26882017

  6. Children's Oncology Group's 2013 blueprint for research: behavioral science.

    Science.gov (United States)

    Noll, Robert B; Patel, Sunita K; Embry, Leanne; Hardy, Kristina K; Pelletier, Wendy; Annett, Robert D; Patenaude, Andrea; Lown, E Anne; Sands, Stephen A; Barakat, Lamia P

    2013-06-01

    Behavioral science has long played a central role in pediatric oncology clinical service and research. Early work focused on symptom relief related to side effects of chemotherapy and pain management related to invasive medical procedures. As survival rates improved, the focused has shifted to examination of the psychosocial impact, during and after treatment, of pediatric cancer and its treatment on children and their families. The success of the clinical trials networks related to survivorship highlights an even more critical role in numerous domains of psychosocial research and care. Within the cooperative group setting, the field of behavioral science includes psychologists, social workers, physicians, nurses, and parent advisors. The research agenda of this group of experts needs to focus on utilization of psychometrically robust measures to evaluate the impact of treatment on children with cancer and their families during and after treatment ends. Over the next 5 years, the field of behavioral science will need to develop and implement initiatives to expand use of standardized neurocognitive and behavior batteries; increase assessment of neurocognition using technology; early identification of at-risk children/families; establish standards for evidence-based psychosocial care; and leverage linkages with the broader behavioral health pediatric oncology community to translate empirically supported research clinical trials care to practice. Copyright © 2012 Wiley Periodicals, Inc.

  7. A Phase II Comparative Study of Gross Tumor Volume Definition With or Without PET/CT Fusion in Dosimetric Planning for Non–Small-Cell Lung Cancer (NSCLC): Primary Analysis of Radiation Therapy Oncology Group (RTOG) 0515

    International Nuclear Information System (INIS)

    Bradley, Jeffrey; Bae, Kyounghwa; Choi, Noah; Forster, Ken; Siegel, Barry A.; Brunetti, Jacqueline; Purdy, James; Faria, Sergio; Vu, Toni; Thorstad, Wade; Choy, Hak

    2012-01-01

    Background: Radiation Therapy Oncology Group (RTOG) 0515 is a Phase II prospective trial designed to quantify the impact of positron emission tomography (PET)/computed tomography (CT) compared with CT alone on radiation treatment plans (RTPs) and to determine the rate of elective nodal failure for PET/CT-derived volumes. Methods: Each enrolled patient underwent definitive radiation therapy for non–small-cell lung cancer (≥60 Gy) and had two RTP datasets generated: gross tumor volume (GTV) derived with CT alone and with PET/CT. Patients received treatment using the PET/CT-derived plan. The primary end point, the impact of PET/CT fusion on treatment plans was measured by differences of the following variables for each patient: GTV, number of involved nodes, nodal station, mean lung dose (MLD), volume of lung exceeding 20 Gy (V20), and mean esophageal dose (MED). Regional failure rate was a secondary end point. The nonparametric Wilcoxon matched-pairs signed-ranks test was used with Bonferroni adjustment for an overall significance level of 0.05. Results: RTOG 0515 accrued 52 patients, 47 of whom are evaluable. The follow-up time for all patients is 12.9 months (2.7–22.2). Tumor staging was as follows: II = 6%; IIIA = 40%; and IIIB = 54%. The GTV was statistically significantly smaller for PET/CT-derived volumes (98.7 vs. 86.2 mL; p < 0.0001). MLDs for PET/CT plans were slightly lower (19 vs. 17.8 Gy; p = 0.06). There was no significant difference in the number of involved nodes (2.1 vs. 2.4), V20 (32% vs. 30.8%), or MED (28.7 vs. 27.1 Gy). Nodal contours were altered by PET/CT for 51% of patients. One patient (2%) has developed an elective nodal failure. Conclusions: PET/CT-derived tumor volumes were smaller than those derived by CT alone. PET/CT changed nodal GTV contours in 51% of patients. The elective nodal failure rate for GTVs derived by PET/CT is quite low, supporting the RTOG standard of limiting the target volume to the primary tumor and involved nodes.

  8. A Phase 3 Trial of 2 Years of Androgen Suppression and Radiation Therapy With or Without Adjuvant Chemotherapy for High-Risk Prostate Cancer: Final Results of Radiation Therapy Oncology Group Phase 3 Randomized Trial NRG Oncology RTOG 9902

    Energy Technology Data Exchange (ETDEWEB)

    Rosenthal, Seth A., E-mail: rosents@sutterhealth.org [Radiation Oncology, Sutter Cancer Centers, Roseville, California (United States); Hunt, Daniel [NRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania (United States); Sartor, A. Oliver [Tulane University Medical Center, New Orleans, Louisiana (United States); Pienta, Kenneth J. [Johns Hopkins School of Medicine, Baltimore, Maryland (United States); Gomella, Leonard [Thomas Jefferson University Hospital, Philadelphia, Pennsylvania (United States); Grignon, David [Indiana University, Bloomington, Indiana (United States); Rajan, Raghu [McGill University, Montreal, Quebec (Canada); Kerlin, Kevin J. [Community Clinical Oncology Program, Southeast Cancer Control Consortium, Inc, Winston-Salem, North Carolina (United States); Jones, Christopher U. [Radiation Oncology, Sutter Cancer Centers, Roseville, California (United States); Radiological Associates of Sacramento, Sacramento, California (United States); Dobelbower, Michael [University of Alabama at Birmingham Medical Center, Birmingham, Alabama (United States); Shipley, William U. [Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts (United States); Zeitzer, Kenneth [Albert Einstein Medical Center, Bronx, New York (United States); Hamstra, Daniel A. [University of Michigan Medical Center, Ann Arbor, Michigan (United States); Donavanik, Viroon [Christiana Care Health Services, Inc, Wilmington, Delaware (United States); Rotman, Marvin [State University of New York Health Science Center–Brooklyn, Brooklyn, New York (United States); Hartford, Alan C. [Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire (United States); Michalski, Jeffrey [Washington University, St. Louis, Missouri (United States); Seider, Michael [Akron City Hospital, Akron, Ohio (United States); Kim, Harold [Wayne State University, Detroit, Michigan (United States); and others

    2015-10-01

    Purpose: Long-term (LT) androgen suppression (AS) with radiation therapy (RT) is a standard treatment of high-risk, localized prostate cancer (PCa). Radiation Therapy Oncology Group 9902 was a randomized trial testing the hypothesis that adjuvant combination chemotherapy (CT) with paclitaxel, estramustine, and oral etoposide plus LT AS plus RT would improve overall survival (OS). Methods and Materials: Patients with high-risk PCa (prostate-specific antigen 20-100 ng/mL and Gleason score [GS] ≥7 or clinical stage ≥T2 and GS ≥8) were randomized to RT and AS (AS + RT) alone or with adjuvant CT (AS + RT + CT). CT was given as four 21-day cycles, delivered beginning 28 days after 70.2 Gy of RT. AS was given as luteinizing hormone-releasing hormone for 24 months, beginning 2 months before RT plus an oral antiandrogen for 4 months before and during RT. The study was designed based on a 6% improvement in OS from 79% to 85% at 5 years, with 90% power and a 2-sided alpha of 0.05. Results: A total of 397 patients (380 eligible) were randomized. The patients had high-risk PCa, 68% with GS 8 to 10 and 34% T3 to T4 tumors, and median prostate-specific antigen of 22.6 ng/mL. The median follow-up period was 9.2 years. The trial closed early because of excess thromboembolic toxicity in the CT arm. The 10-year results for all randomized patients revealed no significant difference between the AS + RT and AS + RT + CT arms in OS (65% vs 63%; P=.81), biochemical failure (58% vs 54%; P=.82), local progression (11% vs 7%; P=.09), distant metastases (16% vs 14%; P=.42), or disease-free survival (22% vs 26%; P=.61). Conclusions: NRG Oncology RTOG 9902 showed no significant differences in OS, biochemical failure, local progression, distant metastases, or disease-free survival with the addition of adjuvant CT to LT AS + RT. The trial results provide valuable data regarding the natural history of high-risk PCa treated with LT AS + RT and have implications for

  9. Oncology

    International Nuclear Information System (INIS)

    1998-01-01

    This paper collects some scientific research works on nuclear medicine developed in Ecuador. The main topics are: Brain metastases, computed tomography assessment; Therapeutic challenge in brain metastases, chemotherapy, surgery or radiotherapy; Neurocysticercosis and oncogenesis; Neurologic complications of radiation and chemotherapy; Cerebral perfusion gammagraphy in neurology and neurosurgery; Neuro- oncologic surgical patient anesthesic management; Pain management in neuro- oncology; Treatment of metastatic lesions of the spine, surgically decompression vs radiation therapy alone; Neuroimagining in spinal metastases

  10. Pretreatment quality of life predicts for locoregional control in head and neck cancer patients : A radiation therapy oncology group analysis

    NARCIS (Netherlands)

    Siddiqui, Farzan; Pajak, Thomas F.; Watkins-Bruner, Deborah; Konski, Andre A.; Coyne, James C.; Gwede, Clement K.; Garden, Adam S.; Spencer, Sharon A.; Jones, Christopher; Movsas, Benjamin

    2008-01-01

    Purpose: To analyze the prospectively collected health-related quality-of-life (HRQOL) data from patients enrolled in two Radiation Therapy Oncology Group randomized Phase III head and neck cancer trials (90-03 and 91-11) to assess their value as an independent prognostic factor for locoregional

  11. Immunotherapy Response Assessment in Neuro-Oncology (iRANO): A Report of the RANO Working Group

    Science.gov (United States)

    Okada, Hideho; Weller, Michael; Huang, Raymond; Finocchiaro, Gaetano; Gilbert, Mark R.; Wick, Wolfgang; Ellingson, Benjamin M.; Hashimoto, Naoya; Pollack, Ian F.; Brandes, Alba A.; Franceschi, Enrico; Herold-Mende, Christel; Nayak, Lakshmi; Panigrahy, Ashok; Pope, Whitney B.; Prins, Robert; Sampson, John H.; Wen, Patrick Y.; Reardon, David A.

    2015-01-01

    Immunotherapy represents a promising area of therapy among neuro-oncology patients. However, early phase studies reveal unique challenges associated with assessment of radiological changes reflecting delayed responses or therapy-induced inflammation. Clinical benefit, including long-term survival and tumor regression, can still occur following initial apparent progression or appearance of new lesions. Refinement of response assessment criteria for neuro-oncology patients undergoing immunotherapy is therefore warranted. A multinational and multidisciplinary panel of neuro-oncology immunotherapy experts describes immunotherapy response assessment for neuro-oncology (iRANO) criteria that are based on guidance for determination of tumor progression outlined by the immune-related response criteria (irRC) and the response assessment in neuro-oncology (RANO) working group. Among patients who demonstrate imaging findings meeting RANO criteria for progressive disease (PD) within six months of initiating immunotherapy including the development of new lesions, confirmation of radiographic progression on follow-up imaging is recommended provided that the patient is not significantly worse clinically. The proposed criteria also include guidelines for use of corticosteroids. The role of advanced imaging techniques and measurement of clinical benefit endpoints including neurologic and immunologic functions are reviewed. The iRANO guidelines put forth herein will evolve successively to improve their utility as further experience from immunotherapy trials in neuro-oncology accumulate. PMID:26545842

  12. Dummy Run of Quality Assurance Program in a Phase 3 Randomized Trial Investigating the Role of Internal Mammary Lymph Node Irradiation in Breast Cancer Patients: Korean Radiation Oncology Group 08-06 Study

    International Nuclear Information System (INIS)

    Chung, Yoonsun; Kim, Jun Won; Shin, Kyung Hwan; Kim, Su Ssan; Ahn, Sung-Ja; Park, Won; Lee, Hyung-Sik; Kim, Dong Won; Lee, Kyu Chan; Suh, Hyun Suk; Kim, Jin Hee; Shin, Hyun Soo; Kim, Yong Bae; Suh, Chang-Ok

    2015-01-01

    Purpose: The Korean Radiation Oncology Group (KROG) 08-06 study protocol allowed radiation therapy (RT) technique to include or exclude breast cancer patients from receiving radiation therapy to the internal mammary lymph node (IMN). The purpose of this study was to assess dosimetric differences between the 2 groups and potential influence on clinical outcome by a dummy run procedure. Methods and Materials: All participating institutions were asked to produce RT plans without irradiation (Arm 1) and with irradiation to the IMN (Arm 2) for 1 breast-conservation treatment case (breast-conserving surgery [BCS]) and 1 mastectomy case (modified radical mastectomy [MRM]) whose computed tomography images were provided. We assessed interinstitutional variations in IMN delineation and evaluated the dose-volume histograms of the IMN and normal organs. A reference IMN was delineated by an expert panel group based on the study guidelines. Also, we analyzed the potential influence of actual dose variation observed in this study on patient survival. Results: Although physicians intended to exclude the IMN within the RT field, the data showed almost 59.0% of the prescribed dose was delivered to the IMN in Arm 1. However, the mean doses covering the IMN in Arm 1 and Arm 2 were significantly different for both cases (P<.001). Due to the probability of overdose in Arm 1, the estimated gain in 7-year disease-free survival rate would be reduced from 10% to 7.9% for BCS cases and 7.1% for MRM cases. The radiation doses to the ipsilateral lung, heart, and coronary artery were lower in Arm 1 than in Arm 2. Conclusions: Although this dummy run study indicated that a substantial dose was delivered to the IMN, even in the nonirradiation group, the dose differences between the 2 groups were statistically significant. However, this dosimetric profile should be studied further with actual patient samples and be taken into consideration when analyzing clinical outcomes according to IMN

  13. Dummy Run of Quality Assurance Program in a Phase 3 Randomized Trial Investigating the Role of Internal Mammary Lymph Node Irradiation in Breast Cancer Patients: Korean Radiation Oncology Group 08-06 Study

    Energy Technology Data Exchange (ETDEWEB)

    Chung, Yoonsun [Department of Radiation Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul (Korea, Republic of); Kim, Jun Won [Department of Radiation Oncology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul (Korea, Republic of); Shin, Kyung Hwan [Department of Radiation Oncology, Proton Therapy Center, Research Institute and Hospital, National Cancer Center, Goyang (Korea, Republic of); Kim, Su Ssan [Department of Radiation Oncology, Asan Medical Center, University of Ulsan, College of Medicine, Seoul (Korea, Republic of); Ahn, Sung-Ja [Department of Radiation Oncology, Chonnam National University Medical School, Gwangju (Korea, Republic of); Park, Won [Department of Radiation Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul (Korea, Republic of); Lee, Hyung-Sik [Department of Radiation Oncology, Dong-A University Hospital, Dong-A University School of Medicine, Busan (Korea, Republic of); Kim, Dong Won [Department of Radiation Oncology, Pusan National University Hospital, Pusan National University School of Medicine, Busan (Korea, Republic of); Lee, Kyu Chan [Department of Radiation Oncology, Gachon University Gil Medical Center, Incheon (Korea, Republic of); Suh, Hyun Suk [Department of Radiation Oncology, Ewha Womans University Mokdong Hospital, Seoul (Korea, Republic of); Kim, Jin Hee [Department of Radiation Oncology, Dongsan Medical Center, Keimyung University School of Medicine, Daegu (Korea, Republic of); Shin, Hyun Soo [Department of Radiation Oncology, Bundang CHA Hospital, School of Medicine, CHA University, Seongnam (Korea, Republic of); Kim, Yong Bae, E-mail: ybkim3@yuhs.ac [Department of Radiation Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul (Korea, Republic of); Suh, Chang-Ok [Department of Radiation Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul (Korea, Republic of)

    2015-02-01

    Purpose: The Korean Radiation Oncology Group (KROG) 08-06 study protocol allowed radiation therapy (RT) technique to include or exclude breast cancer patients from receiving radiation therapy to the internal mammary lymph node (IMN). The purpose of this study was to assess dosimetric differences between the 2 groups and potential influence on clinical outcome by a dummy run procedure. Methods and Materials: All participating institutions were asked to produce RT plans without irradiation (Arm 1) and with irradiation to the IMN (Arm 2) for 1 breast-conservation treatment case (breast-conserving surgery [BCS]) and 1 mastectomy case (modified radical mastectomy [MRM]) whose computed tomography images were provided. We assessed interinstitutional variations in IMN delineation and evaluated the dose-volume histograms of the IMN and normal organs. A reference IMN was delineated by an expert panel group based on the study guidelines. Also, we analyzed the potential influence of actual dose variation observed in this study on patient survival. Results: Although physicians intended to exclude the IMN within the RT field, the data showed almost 59.0% of the prescribed dose was delivered to the IMN in Arm 1. However, the mean doses covering the IMN in Arm 1 and Arm 2 were significantly different for both cases (P<.001). Due to the probability of overdose in Arm 1, the estimated gain in 7-year disease-free survival rate would be reduced from 10% to 7.9% for BCS cases and 7.1% for MRM cases. The radiation doses to the ipsilateral lung, heart, and coronary artery were lower in Arm 1 than in Arm 2. Conclusions: Although this dummy run study indicated that a substantial dose was delivered to the IMN, even in the nonirradiation group, the dose differences between the 2 groups were statistically significant. However, this dosimetric profile should be studied further with actual patient samples and be taken into consideration when analyzing clinical outcomes according to IMN

  14. Histopathologic grading of medulloblastomas: a Pediatric Oncology Group study.

    Science.gov (United States)

    Eberhart, Charles G; Kepner, James L; Goldthwaite, Patricia T; Kun, Larry E; Duffner, Patricia K; Friedman, Henry S; Strother, Douglas R; Burger, Peter C

    2002-01-15

    Medulloblastomas are small cell embryonal tumors of the cerebellum found predominantly in children, only slightly more than half of whom survive. Predicting favorable outcome has been difficult, and improved stratification clearly is required to avoid both undertreatment and overtreatment. Patients currently are staged clinically, but no pathologic staging system is in use. Two rare subtypes at extreme ends of the histologic spectrum, i.e., medulloblastomas with extensive nodularity and large cell/anaplastic medulloblastomas, are associated with better and worse clinical outcomes, respectively. However, there is little data about correlations between histologic features and clinical outcome for most patients with medulloblastomas that fall between these histologic extremes of nodularity and anaplasia. Therefore, the authors evaluated the clinical effects of increasing anaplasia and nodularity in a large group of children with medulloblastomas, hypothesizing that increasing nodularity would predict better clinical outcomes and that increasing anaplasia would presage less favorable results. Medulloblastomas from 330 Pediatric Oncology Group patients were evaluated histologically with respect to extent of nodularity, presence of desmoplasia, grade of anaplasia, and extent of anaplasia. Pathologic and clinical data were then compared using Kaplan-Meier and log-rank analyses. Increasing grade of anaplasia and extent of anaplasia were associated strongly with progressively worse clinical outcomes (P anaplasia (moderate or severe) was identified in 24% of medulloblastoma specimens. Neither increasing degrees of nodularity nor desmoplasia were associated significantly with longer survival. Moderate anaplasia and severe anaplasia were associated with aggressive clinical behavior in patients with medulloblastomas and were detected in a significant number of specimens (24%). Pathologic grading of medulloblastomas with respect to anaplasia may be of clinical utility.

  15. Merging Children's Oncology Group Data with an External Administrative Database Using Indirect Patient Identifiers: A Report from the Children's Oncology Group.

    Directory of Open Access Journals (Sweden)

    Yimei Li

    Full Text Available Clinical trials data from National Cancer Institute (NCI-funded cooperative oncology group trials could be enhanced by merging with external data sources. Merging without direct patient identifiers would provide additional patient privacy protections. We sought to develop and validate a matching algorithm that uses only indirect patient identifiers.We merged the data from two Phase III Children's Oncology Group (COG trials for de novo acute myeloid leukemia (AML with the Pediatric Health Information Systems (PHIS. We developed a stepwise matching algorithm that used indirect identifiers including treatment site, gender, birth year, birth month, enrollment year and enrollment month. Results from the stepwise algorithm were compared against the direct merge method that used date of birth, treatment site, and gender. The indirect merge algorithm was developed on AAML0531 and validated on AAML1031.Of 415 patients enrolled on the AAML0531 trial at PHIS centers, we successfully matched 378 (91.1% patients using the indirect stepwise algorithm. Comparison to the direct merge result suggested that 362 (95.7% matches identified by the indirect merge algorithm were concordant with the direct merge result. When validating the indirect stepwise algorithm using the AAML1031 trial, we successfully matched 157 out of 165 patients (95.2% and 150 (95.5% of the indirectly merged matches were concordant with the directly merged matches.These data demonstrate that patients enrolled on COG clinical trials can be successfully merged with PHIS administrative data using a stepwise algorithm based on indirect patient identifiers. The merged data sets can be used as a platform for comparative effectiveness and cost effectiveness studies.

  16. Assessment Tools for Peripheral Neuropathy in Pediatric Oncology: A Systematic Review From the Children's Oncology Group.

    Science.gov (United States)

    Smolik, Suzanne; Arland, Lesley; Hensley, Mary Ann; Schissel, Debra; Shepperd, Barbara; Thomas, Kristin; Rodgers, Cheryl

    Peripheral neuropathy is a known side effect of several chemotherapy agents, including vinca alkaloids and platinum-based chemotherapy. Early recognition and monitoring of this side effect is an important role of the pediatric oncology nurse. There are a variety of peripheral neuropathy assessment tools currently in use, but the usefulness of these tools in identifying and grading neuropathy in children varies, and there is currently no standardized tool in place to evaluate peripheral neuropathy in pediatric oncology. A systematic review was performed to identify the peripheral neuropathy assessment tools that best evaluate the early onset and progression of peripheral neuropathy in pediatric patients receiving vincristine. Because of the limited information available in pediatric oncology, this review was extended to any pediatric patient with neuropathy. A total of 8 studies were included in the evidence synthesis. Based on available evidence, the pediatric-modified Total Neuropathy Scale (ped-m TNS) and the Total Neuropathy Score-pediatric version (TNS-PV) are recommended for the assessment of vincristine-induced peripheral neuropathy in children 6 years of age and older. In addition, several studies demonstrated that subjective symptoms alone are not adequate to assess for vincristine-induced peripheral neuropathy. Nursing assessment of peripheral neuropathy should be an integral and regular part of patient care throughout the course of chemotherapy treatment.

  17. [An art education programme for groups in the psycho-oncological after-care].

    Science.gov (United States)

    Geue, Kristina; Buttstädt, Marianne; Richter, Robert; Böhler, Ursula; Singer, Susanne

    2011-03-01

    In this paper the formal and contentual structure of the outpatient art education programme for oncological patients is presented. The group intervention was comprised of 22 separate sessions. The course consisted of 3 phases. The first unit helped to foster mutual understanding and to learn various experimental drawing techniques using a given topic. The second unit merged into the shaping of personal thoughts and feelings with the aim of encouraging self-perception and reflection. The aim in the third phase is to create a personal book. The effects of the intervention for the participants were examined in studies. The art therapist as well as the supervisor sees development of better coping strategies, contact with other patients and enhancement of scope of action through the regular activities as main effects. Participants reported the enlargement of means of expression, emotional stabilization, coping with illness, personal growth and contacts with other patients as meanings. This art education course enlarges the field of psycho-oncological interventions in outpatient care with a low-treshhold and resource-oriented creative programme. © Georg Thieme Verlag KG Stuttgart · New York.

  18. Standard thoracic radiotherapy with or without concurrent daily low-dose carboplatin in elderly patients with locally advanced non-small cell lung cancer. A phase III trial of the Japan Clinical Oncology Group (JCOG9812)

    International Nuclear Information System (INIS)

    Atagi, Shinji; Kawahara, Masaaki; Tamura, Tomohide

    2005-01-01

    The purpose of this study was to evaluate whether radiotherapy with carboplatin would result in longer survival than radiotherapy alone in elderly patients with unresectable stage III non-small cell lung cancer (NSCLC). Eligible patients were 71 years of age or older with unresectable stage III NSCLC. Patients were randomly assigned to the radiotherapy alone (RT) arm, irradiation with 60 Gy; or the chemoradiotherapy (CRT) arm, the same radiotherapy and additional concurrent use of carboplatin 30 mg/m 2 per fraction up to the first 20 fractions. This study was terminated early when 46 patients were registered from November 1999 to February 2001. Four patients (one in the RT arm, three in the CRT arm) were considered to have died due to treatment-related causes. The Japan Clinical Oncology Group (JCOG) Radiotherapy Committee assessed these treatment-related deaths (TRDs) and the compliance with radiotherapy in this trial. They found that 60% of the cases corresponded to protocol deviation and 7% were protocol violation in dose constraint to the normal lung, two of whom died due to radiation pneumonitis. As to the effectiveness for the 46 patients enrolled, the median survival time was 428 days [95% confidence interval (CI)=212-680 days]in the RT arm versus 554 days (95% CI=331 to not estimable) in the CRT arm. Due to the early termination of this study, the effectiveness of concurrent use of carboplatin remains unclear. We're-planned and started a study with an active quality control program which was developed by the JCOG Radiotherapy Committee. (author)

  19. The impact of concurrent granulocyte macrophage-colony stimulating factor on radiation-induced mucositis in head and neck cancer patients: A double-blind placebo-controlled prospective Phase III study by Radiation Therapy Oncology Group 9901

    International Nuclear Information System (INIS)

    Ryu, Janice K.; Swann, Suzanne; LeVeque, Francis; Scarantino, Charles W.; Johnson, Darlene J.; Chen, Allan; Fortin, Andre; Pollock, JonDavid; Kim, Harold; Ang, Kian K.

    2007-01-01

    Purpose: Based on early clinical evidence of potential mucosal protection by granulocyte-macrophage colony stimulating factor (GM-CSF), the Radiation Therapy Oncology Group conducted a double-blind, placebo-controlled, randomized study to test the efficacy and safety of GM-CSF in reducing the severity and duration of mucosal injury and pain (mucositis) associated with curative radiotherapy (RT) in head-and-neck cancer patients. Methods and Materials: Eligible patients included those with head-and-neck cancer with radiation ports encompassing >50% of oral cavity and/or oropharynx. Standard RT ports were used to cover the primary tumor and regional lymphatics at risk in standard fractionation to 60-70 Gy. Concurrent cisplatin chemotherapy was allowed. Patients were randomized to receive subcutaneous injection of GM-CSF 250 μg/m 2 or placebo 3 times a week. Mucosal reaction was assessed during the course of RT using the National Cancer Institute Common Toxicity Criteria and the protocol-specific scoring system. Results: Between October 2000 and September 2002, 130 patients from 36 institutions were accrued. Nine patients (7%) were excluded from the analysis, 3 as a result of drug unavailability. More than 80% of the patients participated in the quality-of-life endpoint of this study. The GM-CSF did not cause any increase in toxicity compared with placebo. There was no statistically significant difference in the average mean mucositis score in the GM-CSF and placebo arms by a t test (p = 0.4006). Conclusion: This placebo-controlled, randomized study demonstrated no significant effect of GM-CSF given concurrently compared with placebo in reducing the severity or duration of RT-induced mucositis in patients undergoing definitive RT for head-and-neck cancer

  20. Acute toxicity and cost analysis of a phase III randomized trial of accelerated and conventional radiotherapy for squamous carcinoma of the head and neck: a trans- tasman radiation oncology group study

    International Nuclear Information System (INIS)

    Poulsen, M.; Williamson, S.; Tripcony, L.; Spry, N.; Peters, L.; Penniment, M.; Lamb, D.; Krawitz, H.

    1999-01-01

    The primary purpose of the present analysis was to assess the feasibility and acute toxicity of a pure accelerated fractionation regimen in a cooperative group setting. This analysis included the first 320 patients entered on to the Trans-Tasman Radiation Oncology Group (TROG) randomized controlled trial which compared accelerated radiotherapy (ART) with conventional radiotherapy (CRT) in stage lIl and IV squamous cell carcinoma (SCC) of the head and neck. Patients were randomized to either 59.4 Gy in 33 fractions over 24 days (ART) or to 70 Gy 35 fractions over 49 days (CRT) after being stratified for site and stage. Accrual began in 1991 and the trial was closed on 3 April 1998 with the targeted 350 patients. The 3-year survival for the whole group was 54%, and the 3-year disease-free survival was 41%. Toxicity data were available on 303 patients (148 ART; 155 CRT). Mucosal toxicity was worse in the accelerated grup, and it peaked ∼ 3 weeks earlier than the conventional grup. Skin toxicity was equivalent but occurred ∼ 7 days earlier in the accelerated grup. Acute effects in both grups healed completely. Hospitalization was more common in the ART grup (71 vs 52 patients; P=0.01) but the total bed days in hospital was not greatly different (1707 bed days for ART and 1607 bed days for CRT). Patients were more likely to require nasogastric (NG) feeding in the ART grup (49 vs 33 patients; P = 0.02). There were 1157 NG feeding days for ART and 1154 NG feeding days for CRT. The average cost of radiation treatment per patient including hospitalisation, NG feeding and accommodation was $11 750 in the ART grup and $11 587 in the CRT grup. The accelerated grup has been shown to be a tolerable, practical and cost-equivalent regimen. The assessment of the therapeutic ratio of this accelerated protocol (ART) will be determined when the analysis of late effects and loco-regional control is made when the data are more mature. Copyright (1999) Blackwell Science Pty Ltd

  1. American Association of Physicists in Medicine Task Group 263: Standardizing Nomenclatures in Radiation Oncology.

    Science.gov (United States)

    Mayo, Charles S; Moran, Jean M; Bosch, Walter; Xiao, Ying; McNutt, Todd; Popple, Richard; Michalski, Jeff; Feng, Mary; Marks, Lawrence B; Fuller, Clifton D; Yorke, Ellen; Palta, Jatinder; Gabriel, Peter E; Molineu, Andrea; Matuszak, Martha M; Covington, Elizabeth; Masi, Kathryn; Richardson, Susan L; Ritter, Timothy; Morgas, Tomasz; Flampouri, Stella; Santanam, Lakshmi; Moore, Joseph A; Purdie, Thomas G; Miller, Robert C; Hurkmans, Coen; Adams, Judy; Jackie Wu, Qing-Rong; Fox, Colleen J; Siochi, Ramon Alfredo; Brown, Norman L; Verbakel, Wilko; Archambault, Yves; Chmura, Steven J; Dekker, Andre L; Eagle, Don G; Fitzgerald, Thomas J; Hong, Theodore; Kapoor, Rishabh; Lansing, Beth; Jolly, Shruti; Napolitano, Mary E; Percy, James; Rose, Mark S; Siddiqui, Salim; Schadt, Christof; Simon, William E; Straube, William L; St James, Sara T; Ulin, Kenneth; Yom, Sue S; Yock, Torunn I

    2018-03-15

    A substantial barrier to the single- and multi-institutional aggregation of data to supporting clinical trials, practice quality improvement efforts, and development of big data analytics resource systems is the lack of standardized nomenclatures for expressing dosimetric data. To address this issue, the American Association of Physicists in Medicine (AAPM) Task Group 263 was charged with providing nomenclature guidelines and values in radiation oncology for use in clinical trials, data-pooling initiatives, population-based studies, and routine clinical care by standardizing: (1) structure names across image processing and treatment planning system platforms; (2) nomenclature for dosimetric data (eg, dose-volume histogram [DVH]-based metrics); (3) templates for clinical trial groups and users of an initial subset of software platforms to facilitate adoption of the standards; (4) formalism for nomenclature schema, which can accommodate the addition of other structures defined in the future. A multisociety, multidisciplinary, multinational group of 57 members representing stake holders ranging from large academic centers to community clinics and vendors was assembled, including physicists, physicians, dosimetrists, and vendors. The stakeholder groups represented in the membership included the AAPM, American Society for Radiation Oncology (ASTRO), NRG Oncology, European Society for Radiation Oncology (ESTRO), Radiation Therapy Oncology Group (RTOG), Children's Oncology Group (COG), Integrating Healthcare Enterprise in Radiation Oncology (IHE-RO), and Digital Imaging and Communications in Medicine working group (DICOM WG); A nomenclature system for target and organ at risk volumes and DVH nomenclature was developed and piloted to demonstrate viability across a range of clinics and within the framework of clinical trials. The final report was approved by AAPM in October 2017. The approval process included review by 8 AAPM committees, with additional review by ASTRO

  2. Randomized Phase III Trial to Test Accelerated Versus Standard Fractionation in Combination With Concurrent Cisplatin for Head and Neck Carcinomas in the Radiation Therapy Oncology Group 0129 Trial: Long-Term Report of Efficacy and Toxicity

    Science.gov (United States)

    Nguyen-Tan, Phuc Felix; Zhang, Qiang; Ang, K. Kian; Weber, Randal S.; Rosenthal, David I.; Soulieres, Denis; Kim, Harold; Silverman, Craig; Raben, Adam; Galloway, Thomas J.; Fortin, André; Gore, Elizabeth; Westra, William H.; Chung, Christine H.; Jordan, Richard C.; Gillison, Maura L.; List, Marcie; Le, Quynh-Thu

    2014-01-01

    Purpose We tested the efficacy and toxicity of cisplatin plus accelerated fractionation with a concomitant boost (AFX-C) versus standard fractionation (SFX) in locally advanced head and neck carcinoma (LA-HNC). Patients and Methods Patients had stage III to IV carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx. Radiation therapy schedules were 70 Gy in 35 fractions over 7 weeks (SFX) or 72 Gy in 42 fractions over 6 weeks (AFX-C). Cisplatin doses were 100 mg/m2 once every 3 weeks for two (AFX-C) or three (SFX) cycles. Toxicities were scored by using National Cancer Institute Common Toxicity Criteria 2.0 and the Radiation Therapy Oncology Group/European Organisation for Research and Treatment of Cancer criteria. Overall survival (OS) and progression-free survival (PFS) rates were estimated by using the Kaplan-Meier method and were compared by using the one-sided log-rank test. Locoregional failure (LRF) and distant metastasis (DM) rates were estimated by using the cumulative incidence method and Gray's test. Results In all, 721 of 743 patients were analyzable (361, SFX; 360, AFX-C). At a median follow-up of 7.9 years (range, 0.3 to 10.1 years) for 355 surviving patients, no differences were observed in OS (hazard ratio [HR], 0.96; 95% CI, 0.79 to 1.18; P = .37; 8-year survival, 48% v 48%), PFS (HR, 1.02; 95% CI, 0.84 to 1.24; P = .52; 8-year estimate, 42% v 41%), LRF (HR, 1.08; 95% CI, 0.84 to 1.38; P = .78; 8-year estimate, 37% v 39%), or DM (HR, 0.83; 95% CI, 0.56 to 1.24; P = .16; 8-year estimate, 15% v 13%). For oropharyngeal cancer, p16-positive patients had better OS than p16-negative patients (HR, 0.30; 95% CI, 0.21 to 0.42; P < .001; 8-year survival, 70.9% v 30.2%). There were no statistically significant differences in the grade 3 to 5 acute or late toxicities between the two arms and p-16 status. Conclusion When combined with cisplatin, AFX-C neither improved outcome nor increased late toxicity in patients with LA-HNC. Long-term high survival

  3. Influence of a sampling review process for radiation oncology quality assurance in cooperative group clinical trials -- results of the Radiation Therapy Oncology Group (RTOG) analysis

    International Nuclear Information System (INIS)

    Martin, Linda A.; Krall, John M.; Curran, Walter J.; Leibel, Steven A.; Cox, James D.

    1995-01-01

    The Radiation Therapy Oncology Group (RTOG) designed a random sampling process and observed its influence upon radiotherapy review mechanisms in cooperative group clinical trials. The method of sampling cases for review was modeled from sampling techniques commonly used in pharmaceutical quality assurance programs, and applied to the initial (on-study) review of protocol cases. 'In control' (IC) status is defined for a given facility as the ability to meet minimum compliance standards. Upon achieving IC status, activation of the sampling process was linked to the rate of continued patient accrual for each participating institution in a given protocol. The sampling design specified that ≥ 30% cases not in compliance would be detected with 80% power. A total of 458 cases was analyzed for initial review findings in four RTOG Phase III protocols. Initial review findings were compared with retrospective (final) review results. Of the 458 cases analyzed, 370 underwent initial review at on-study, while 88 did not require review as they were enrolled from institutions that had demonstrated protocol compliance. In the group that had both initial and final review, (345(370)) (93%) were found to have followed the protocol or had a minor variation. Of the exempted cases, (79(88)) (90%) were found to be per protocol or a minor variant. The sampling process proved itself to be cost-effective and resulted in a noticeable reduction in the workload, thus providing an improved approach to resource allocation for the group. Continued evaluation of the sampling mechanism is appropriate as study designs and participants vary over time, and as more data become available to study. Further investigation of individual protocol compliance is appropriate to identify problems specific to new trial investigations

  4. Phase 3 Oncology Clinical Trials in South Africa: Experimentation or Therapeutic Misconception?

    Science.gov (United States)

    Malan, Tina; Moodley, Keymanthri

    2016-02-01

    Although clinical research in oncology is vital to improve current understanding of cancer and to validate new treatment options, voluntary informed consent is a critical component. Oncology research participants are a particularly vulnerable population; hence, therapeutic misconception often leads to ethical and legal challenges. We conducted a qualitative study administering semi-structured questionnaires on 29 adult, Phase 3, oncology clinical trial participants at three different private oncology clinical trial sites in South Africa. A descriptive content analysis was performed to identify perceptions of these participants regarding Phase 3 clinical trials. We found that most participants provided consent to be included in the trial for self-benefit. More than half of the participants had a poor understanding of Phase 3 clinical trials, and almost half the participants believed the clinical trial did not pose any significant risk to them. The word "hope" was used frequently by participants, displaying clear optimism with regard to the clinical trial and its outcome. This indicated that therapeutic misconception does occur in the South African oncology research setting and has the potential to lead to underestimation of the risks of a Phase 3 clinical trial. Emphasizing the experimental nature of a clinical trial during the consent process is critical to address therapeutic misconception in oncology research. © The Author(s) 2016.

  5. Stakeholder perspectives on the use of positron emission tomography in phase III oncology trials in the UK.

    Science.gov (United States)

    Rojas-Anaya, Hector; Skogen, Karoline; Miles, Kenneth Alan

    2012-06-01

    To identify factors that influence the use of PET in phase III oncology trials in the UK by evaluating stakeholder perspectives. A wide range of UK PET research stakeholders with a potential interest in the use of PET in phase III trials were identified and invited to participate. These UK PET research stakeholders were consulted using a semistructured questionnaire on their personal experience with and involvement in PET research, the role of PET in phase III oncology clinical trials and on the promotion of UK PET research and unmet clinical needs in oncology. Responses were analysed quantitatively and by qualitative content analysis of free-text responses. A total of 118 responses were received from a wide range of stakeholders representing several professional groups and working environments. Of these respondents, 49 (42%) were using PET in their research. There was the general perception that using PET in clinical research is beneficial in oncology. The two major barriers identified were poor availability of PET and perceived difficulties in funding of excess treatment costs (75% of respondents). Other factors included limited coverage of PET in training, uncertainty about developing imaging protocols or the status of tracers other than 18F-fluorodeoxyglucose, and low awareness of the role of PET in patient selection for therapeutic trials. Patient concerns about radiation were not perceived as a research barrier. Interventions that improve the availability and funding pathways for PET research scans and that increase researcher awareness could help promote the use of PET for phase III oncology trials in the UK.

  6. Successful Integration of Cooperative Groups: The Origin of the Children's Oncology Group.

    Science.gov (United States)

    Reaman, Gregory H

    2012-01-01

    In March 2000, the four legacy pediatric cooperative groups officially merged to become the Children's Oncology Group (COG). This was accomplished by the ratification of a new constitution by the respective executive committees and voting membership of the four legacy groups. The actual merger was preceded by a 12 to 18 month period of planning, negotiation, and transition, overseen by a Transition Committee of select executive leadership under the direction of the four current chairs of the existing pediatric groups. Despite the constant threat of budget reductions and questions related to the judicious use of National Cancer Institute (NCI) funds to support four pediatric groups when "children constitute only 3% of the US cancer problem," the decision to unify was initiated and driven internally. The merger was envisioned as an opportunity to create efficiency by reducing duplicative systems and processes, which was becoming increasingly apparent as more planned clinical trials required intergroup collaboration. It was also recognized that such intergroup efforts would become more of a reality as clinical trial paradigms were built on risk-adjusted approaches. Clinically, biologically, and molecularly defined homogeneous subgroups of patients were of insufficient sample size within each group to design and conduct studies within a reasonable time frame. In essence, this merger was motivated by an overwhelming sense of necessity to preserve our mission of defining and delivering compassionate and state-of-the-art care through scientific discovery. The merger process itself was challenging, time consuming, not supported by any supplemental funding, and at times painful. What has emerged as a result is the largest pediatric cancer research organization in the world. Accomplishments in epidemiology, biology, translational science, and improved clinical outcomes for some pediatric cancers would have never been achieved without the merger. The very fact that outcome

  7. Radiation oncology training in the United States: report from the Radiation Oncology Resident Training Working Group organized by the Society of Chairman of Academic Radiation Oncology Programs (SCAROP)

    International Nuclear Information System (INIS)

    1999-01-01

    Purpose: In response to the major changes occurring in healthcare, medical education, and cancer research, SCAROP addressed issues related to post-graduate education that could enhance existing programs and complement the present system. Methods and Materials: SCAROP brought together a Working Group with a broad range of representatives organized in subcommittees to address: training, curriculum, and model building. Results: The Working Group emphasized the importance of training physicians with the necessary clinical, scientific, and analytical skills, and the need to provide expert radiation oncology services to patients throughout the United States. Opportunities currently exist for graduates in academic medicine, although there may be limited time and financial resources available to support academic pursuits. Conclusions: In the face of diminishing resources for training and education and the increased scope of knowledge required, a number of models for resident training are considered that can provide flexibility to complement the present system. This report is intended to initiate dialogue among the organizations responsible for radiation oncology resident education so that resident training can continually evolve to meet the needs of cancer patients and take advantage of opportunities for progress through innovative cancer care and research

  8. Quality of reporting in oncology phase II trials: A 5-year assessment through systematic review.

    Science.gov (United States)

    Langrand-Escure, Julien; Rivoirard, Romain; Oriol, Mathieu; Tinquaut, Fabien; Rancoule, Chloé; Chauvin, Frank; Magné, Nicolas; Bourmaud, Aurélie

    2017-01-01

    Phase II clinical trials are a cornerstone of the development in experimental treatments They work as a "filter" for phase III trials confirmation. Surprisingly the attrition ratio in Phase III trials in oncology is significantly higher than in any other medical specialty. This suggests phase II trials in oncology fail to achieve their goal. Objective The present study aims at estimating the quality of reporting in published oncology phase II clinical trials. A literature review was conducted among all phase II and phase II/III clinical trials published during a 5-year period (2010-2015). All articles electronically published by three randomly-selected oncology journals with Impact-Factors>4 were included: Journal of Clinical Oncology, Annals of Oncology and British Journal of Cancer. Quality of reporting was assessed using the Key Methodological Score. 557 articles were included. 315 trials were single-arm studies (56.6%), 193 (34.6%) were randomized and 49 (8.8%) were non-randomized multiple-arm studies. The Methodological Score was equal to 0 (lowest level), 1, 2, 3 (highest level) respectively for 22 (3.9%), 119 (21.4%), 270 (48.5%) and 146 (26.2%) articles. The primary end point is almost systematically reported (90.5%), while sample size calculation is missing in 66% of the articles. 3 variables were independently associated with reporting of a high standard: presence of statistical design (p-value <0.001), multicenter trial (p-value = 0.012), per-protocol analysis (p-value <0.001). Screening was mainly performed by a sole author. The Key Methodological Score was based on only 3 items, making grey zones difficult to translate. This literature review highlights the existence of gaps concerning the quality of reporting. It therefore raised the question of the suitability of the methodology as well as the quality of these trials, reporting being incomplete in the corresponding articles.

  9. Randomized phase III study comparing best supportive care to biafine as a prophylactic agent for radiation-induced skin toxicity for women undergoing breast irradiation: Radiation therapy oncology group (RTOG) 97-13

    International Nuclear Information System (INIS)

    Fisher, J.; Scott, Charles; Stevens, Randy; Marconi, Barbara; Champion, Lorraine; Freedman, Gary M.; Asrari, Fariba; Pilepich, M.V.; Gagnon, James D.; Wong, Gene

    2000-01-01

    Purpose: To determine if Biafine compared to Best Supportive Care (BSC) is effective in minimizing or preventing radiation-induced dermatitis in women undergoing breast irradiation. Methods and Materials: Patients were randomized between Biafine (n = 83) vs. BSC (n = 89). The institutions identified preference for BSC at the time of randomization. A no-treatment arm was allowed (16% received no treatment). Patients were instructed to apply randomized product three times a day, but not within 4 h of their daily RT session. Application began following their first radiation treatment and continued 2 weeks postradiation. Skin dermatitis was scored weekly utilizing the RTOG and ONS (Oncology Nursing Society) skin toxicity scales, a weekly patient satisfaction and quality-of-life questionnaire. Results: Using the RTOG toxicity scale there was no overall difference for maximum dermatitis during RT between Biafine and BSC (p = 0.77). There was no difference in maximum toxicity by arm or breast size. There was an interaction between breast size and toxicity, with large-breasted women exhibiting more toxicity. Large-breasted women receiving Biafine were more likely to have no toxicity 6 weeks post RT. Conclusion: There was no overall difference between BSC and Biafine in the prevention, time to, or duration of radiation-induced dermatitis.

  10. A Phase II Study of Preradiotherapy Chemotherapy Followed by Hyperfractionated Radiotherapy for Newly Diagnosed High-Risk Medulloblastoma/Primitive Neuroectodermal Tumor: A Report From the Children's Oncology Group (CCG 9931)

    International Nuclear Information System (INIS)

    Allen, Jeffrey; Donahue, Bernadine; Mehta, Minesh; Miller, Douglas C.; Rorke, Lucy B.; Jakacki, Regina; Robertson, Patricia; Sposto, Richard; Holmes, Emi; Vezina, Gilbert; Muraszko, Karin; Puccetti, Diane; Prados, Michael; Chan, K.-W.

    2009-01-01

    Purpose: To verify feasibility and monitor progression-free survival and overall survival in children with high-risk medulloblastoma and noncerebellar primitive neuroectodermal tumors (PNETs) treated in a Phase II study with preradiotherapy chemotherapy (CHT) followed by high-dose, hyperfractionated craniospinal radiotherapy (CSRT). Methods and Materials: Eligibility criteria included age >3 years at diagnosis, medulloblastoma with either high M stage and/or >1.5 cm 2 postoperative residual disease, and all patients with noncerebellar PNET. Treatment was initiated with five alternating monthly cycles of CHT (A [cisplatin, cyclophosphamide, etoposide, and vincristine], B [carboplatin and etoposide], A, B, and A) followed by hyperfractionated CSRT (40 Gy) with a boost to the primary tumor (72 Gy) given in twice-daily 1-Gy fractions. Results: The valid study group consisted of 124 patients whose median age at diagnosis was 7.8 years. Eighty-four patients (68%) completed the entire protocol according to study guidelines (within 9 months), and the median time to complete CSRT was 1.6 months. Major reasons for failure to complete CHT included progressive disease (17%) and toxic death (2.4%). The 5-year progression-free survival and overall survival rates were 43% ± 5% and 52% ± 5%, respectively. No significant differences were detected in subset analysis related to response to CHT, site of primary tumor, postoperative residual disease, or M stage. Conclusions: The feasibility of this intensive multimodality protocol was confirmed, and response to pre-RT CHT did not impact on survival. Survival data from this protocol can not be compared with data from other studies, given the protocol design.

  11. Postgraduate Training in Clinical Oncology. Report on a WHO Working Group (The Hague, The Netherlands, December 6-8, 1978).

    Science.gov (United States)

    World Health Organization, Copenhagen (Denmark). Regional Office for Europe.

    The 1978 report of the Working Group of Postgraduate Training in Clinical Oncology, convened by the World Health Organization (WHO) Regional Office for Europe in collaboration with the government of The Netherlands, is presented. The groups analyzed models of postgraduate training in clinical oncology and evaluated their suitability in relation to…

  12. Radiation Therapy Oncology Group 0247: A Randomized Phase II Study of Neoadjuvant Capecitabine and Irinotecan or Capecitabine and Oxaliplatin With Concurrent Radiotherapy for Patients With Locally Advanced Rectal Cancer

    International Nuclear Information System (INIS)

    Wong, Stuart J.; Winter, Kathryn; Meropol, Neal J.; Anne, Pramila Rani; Kachnic, Lisa; Rashid, Asif; Watson, James C.; Mitchell, Edith; Pollock, Jondavid; Lee, Robert Jeffrey; Haddock, Michael; Erickson, Beth A.; Willett, Christopher G.

    2012-01-01

    Purpose: To evaluate the rate of pathologic complete response (pCR) and the toxicity of two neoadjuvant chemoradiotherapy (chemoRT) regimens for Stage T3-T4 rectal cancer in a randomized Phase II study. Methods and Materials: Patients with Stage T3 or T4 rectal cancer of 2 /d Mondays through Friday) and irinotecan (50 mg/m 2 weekly in four doses) (Arm 1) or concurrent capecitabine (1,650 mg/m 2 /d Monday through Friday) and oxaliplatin (50 mg/m 2 weekly in five doses) (Arm 2). Surgery was performed 4–8 weeks after chemoRT, and adjuvant chemotherapy 4–6 weeks after surgery. The primary endpoint was the pCR rate, requiring 48 evaluable patients per arm. Results: A total of 146 patients were enrolled. The protocol chemotherapy was modified because of excessive gastrointestinal toxicity after treatment of 35 patients; 96 were assessed for the primary endpoint—the final regimen described above. The patient characteristics were similar for both arms. After chemoRT, the rate of tumor downstaging was 52% and 60% and the rate of nodal downstaging (excluding N0 patients) was 46% and 40%, for Arms 1 and 2, respectively. The pCR rate for Arm 1 was 10% and for Arm 2 was 21%. For Arm 1 and 2, the preoperative chemoRT rate of Grade 3-4 hematologic toxicity was 9% and 4% and the rate of Grade 3-4 nonhematologic toxicity was 26% and 27%, respectively. Conclusions: Preoperative chemoRT with capecitabine plus oxaliplatin for distal rectal cancer has significant clinical activity (10 of 48 pCRs) and acceptable toxicity. This regimen is currently being evaluated in a Phase III randomized trial (National Surgical Adjuvant Breast and Bowel Project R04).

  13. There is no role for hyperfractionated radiotherapy in the management of children with newly diagnosed diffuse intrinsic brainstem tumors: results of a pediatric oncology group phase III trial comparing conventional vs. hyperfractionated radiotherapy

    International Nuclear Information System (INIS)

    Mandell, Lynda R.; Kadota, Richard; Freeman, Carolyn; Douglass, Edwin C.; Fontanesi, James; Cohen, Michael E.; Kovnar, Edward; Burger, Peter; Sanford, Robert A.; Kepner, James; Friedman, Henry; Kun, Larry E.

    1999-01-01

    Purpose: In June 1992, POG began accrual to a phase III study, POG-9239, designed to compare the time to disease progression, overall survival, and toxicities observed in children with newly diagnosed brainstem tumor treated with 100 mg/m 2 of infusional cisplatin and randomized to either conventional vs. hyperfractionated radiotherapy. Methods and Materials: Patients eligible for study were those between 3 and 21 years of age with previously untreated tumors arising in the pons. Histologic confirmation of diagnosis was not mandatory, provided that the clinical and MRI scan findings were typical for a diffusely infiltrating pontine lesion. Treatment consisted of a six-week course of local field radiotherapy with either once a day treatment of 180 cGy per fraction to a total dose of 5400 cGy (arm 1) or a twice a day regimen of 117 cGy per fraction to a total dose of 7020 cGy (the second of the three hyperfractionated dose escalation levels of POG-8495) (arm 2). Because of previously reported poor results with conventional radiotherapy alone, cisplatin was included as a potential radiosensitizer in an attempt to improve progression-free and ultimate survival rates. Based on results of the phase I cisplatin dose escalation trial, POG-9139, 100 mg/m 2 was chosen for this trial and was delivered by continuous infusion over a 120-hour period, beginning on the first day of radiotherapy and repeated during weeks 3 and 5. One hundred thirty eligible patients were treated on protocol, 66 on arm 1 and 64 on arm 2. Results: The results we report are from time of diagnosis through October 1997. For patients treated on arm 1, the median time to disease progression (defined as time to off study) was 6 months (range 2-15 months) and the median time to death 8.5 months (range 3-24 months); survival at 1 year was 30.9% and at 2 years, 7.1%. For patients treated on arm 2, the corresponding values were 5 months (range 1-12 months) and 8 months (range 1-23 months), with 1- and 2-year

  14. Is it time to rethink the role of hyperfractionated radiotherapy in the management of children with newly-diagnosed brainstem glioma?: Results of a Pediatric Oncology Group Phase III trial comparing conventional VS. hyperfractionated radiotherapy

    International Nuclear Information System (INIS)

    Mandell, L.; Kadota, R.; Douglass, E.C.; Fontanesi, J.; Freeman, C.; Cohen, M.; Kovnar, E.; Burger, P.; Sanford, R.A.; Kepner, J.; Friedman, H.; Kun, L.

    1997-01-01

    Purposes/Objective: In June 1992, POG began accrual to a Phase III study, POG 9239, designed to compare the time to disease progression, overall survival, and toxicities observed in children with newly diagnosed brainstem glioma treated with 100 mg/m 2 of infusional Cisplatin and randomized to either conventional vs. hyperfractionated radiotherapy. The trial was closed in March 1996, having achieved its accrual goal. Materials and Methods: Patients (pts) eligible for study were those between 3 and 21 years of age with previously untreated tumors arising in the pons. Histologic confirmation of diagnosis was not mandatory, provided that the clinical and MRI scan findings were typical for diffusely infiltrating pontine glioma. Treatment (Rx) consisted of a six-week course of local field radiotherapy with either once a day treatment (Rx 1) of 180 cGy per fraction to a total dose of 5400 cGy or a twice a day regimen (Rx 2) of 117 cGy per fraction to a total dose of 7020 cGy (the second of the three hyperfractionated dose escalation levels of POG 8495). Because of previously reported poor results with conventional radiotherapy alone, Cisplatin was included as a potential radiosensitizer in an attempt to improve progression-free and ultimate survival rates. Based on results of the Phase I Cisplatin dose escalation trial, POG 9139, 100 mg/m 2 was chosen for this trial and was delivered by continuous infusion over a 120-hour period, beginning on the first day of radiotherapy and repeated during Weeks 3 and 5. Of the 132 pts accrued to the study, 94 are eligible for review based upon time since entry, 47 in each Rx arm. In Rx 1, there were 23 males and 24 females, ranging in age from 40 to 161 mo (median, 77 mo); in Rx 2, there were 20 males and 27 females, ranging in age from 41 to 212 mo (median, 77 mo). As of 4/18/96, the study coordinator had not yet verified eligibility and assessed the evaluability of the remaining pts. Results: All results are from time of diagnosis

  15. Phase II study of oral capsular 4-hydroxyphenylretinamide (4-HPR/fenretinide) in pediatric patients with refractory or recurrent neuroblastoma: A report from the Children’s Oncology Group NSC #374551; IND# 40294

    Science.gov (United States)

    Villablanca, Judith G.; London, Wendy B.; Naranjo, Arlene; McGrady, Patrick; Ames, Matthew M.; Reid, Joel M.; McGovern, Renee M.; Buhrow, Sarah A.; Jackson, Hollie; Stranzinger, Enno; Kitchen, Brenda J.; Sondel, Paul M.; Parisi, Marguerite T.; Shulkin, Barry; Yanik, Gregory A.; Cohn, Susan L.; Reynolds, C. Patrick

    2011-01-01

    Purpose To determine the response rate to oral capsular fenretinide in children with recurrent or biopsy proven refractory high-risk neuroblastoma. Experimental Design Patients received 7 days of fenretinide: 2475 mg/m2/day divided TID (<18 years) or 1800 mg/m2/day divided BID (≥18 years) every 21 days for a maximum of 30 courses. Patients with stable or responding disease after course 30 could request additional compassionate courses. Best response by course 8 was evaluated in Stratum 1 (measurable disease on CT/MRI +/− bone marrow and/or MIBG avid sites) and Stratum 2 (bone marrow and/or MIBG avid sites only). Results Sixty-two eligible patients, median age 5 years (range 0.6–19.9), were treated in Stratum 1 (n=38) and Stratum 2 (n=24). One partial response (PR) was seen in Stratum 2 (n=24 evaluable). No responses were seen in Stratum 1 (n=35 evaluable). Prolonged stable disease (SD) was seen in 7 patients in Stratum 1 and 6 patients in Stratum 2 for 4–45+ (median 15) courses. Median time to progression was 40 days (range 17–506) for Stratum 1 and 48 days (range 17–892) for Stratum 2. Mean 4-HPR steady state trough plasma concentrations were 7.25 µM (coefficient of variation 40–56%) at day 7 course 1. Toxicities were mild and reversible. Conclusions Although neither stratum met protocol criteria for efficacy, 1 PR + 13 prolonged SD occurred in 14/59 (24%) of evaluable patients. Low bioavailability may have limited fenretinide activity. Novel fenretinide formulations with improved bioavailability are currently in pediatric Phase I studies. PMID:21908574

  16. Initial results of a phase II trial of high dose radiation therapy, 5-fluorouracil, and cisplatin for patients with anal cancer (E4292): an eastern cooperative oncology group study

    International Nuclear Information System (INIS)

    Martenson, James A.; Lipsitz, Stuart R.; Wagner, Henry; Kaplan, Edward H.; Otteman, Larry A.; Schuchter, Lynn M.; Mansour, Edward G.; Talamonti, Mark S.; Benson, Al Bowen

    1996-01-01

    Purpose: A prospective clinical trial was performed to assess the response and toxicity associated with the use of high dose radiation therapy, 5-fluorouracil, and cisplatin in patients with anal cancer. Methods and Materials: Patients with anal cancer without distant metastasis were eligible for this study. Radiation therapy consisted of 59.4 Gy in 33 fractions; a 2 week break in treatment was taken after 36 Gy had been given. A treatment of 5-fluorouracil, 1,000 mg/m 2 per day intravenously, was given for the first 4 days of radiation therapy, and cisplatin, 75 mg/m 2 intravenously, was given on day 1 of radiation therapy. A second course of 5-fluorouracil and cisplatin was given after 36 Gy of radiation, when the radiation therapy was resumed. Results: Nineteen patients entered this study and received treatment. Thirteen (68%) had a complete response, 5 (26%) had a partial response, and 1 (5%) had stable disease. The patient with stable disease and one of the patients with a partial response had complete disappearance of tumor more than 8 weeks after completion of radiation therapy. Fifteen patients had toxicity of Grade 3 or higher: the worst toxicity was Grade 3 in eight patients, Grade 4 in six patients, and Grade 5 in one patient. The most common form of toxicity of Grade 3 or higher was hematologic. The one lethal toxicity was due to pseudomembranous colitis, which was a complication of antibiotic therapy for a urinary tract infection. Conclusion: Radiation therapy, cisplatin, and 5-fluorouracil resulted in an overall response rate of 95%. Significant toxicity occurred, an indication that this regimen is near the maximal tolerated dose. A Phase III clinical trial is planned in which radiation therapy, cisplatin, and 5-fluorouracil will be used as an experimental arm

  17. Impact of liposomal doxorubicin-based adjuvant chemotherapy on autonomy in women over 70 with hormone-receptor-negative breast carcinoma: A French Geriatric Oncology Group (GERICO) phase II multicentre trial.

    Science.gov (United States)

    Brain, Etienne G C; Mertens, Cécile; Girre, Véronique; Rousseau, Frédérique; Blot, Emmanuel; Abadie, Sophie; Uwer, Lionel; Bourbouloux, Emmanuelle; Van Praagh-Doreau, Isabelle; Mourey, Loic; Kirscher, Sylvie; Laguerre, Brigitte; Fourme, Emmanuelle; Luneau, Sylvia; Genève, Jean; Debled, Marc

    2011-10-01

    Breast cancer is a disease of ageing. Functional independence in elderly patients, measured with the Katz activities of daily living (ADL) scale, predicts overall survival and the need for welfare support. Few prospective studies have examined the feasibility of adjuvant chemotherapy and its impact on autonomy in women over 70 years of age with high-risk breast cancer. This multicentre phase II trial was designed to assess the impact of adjuvant anthracycline-based chemotherapy on these patients' autonomy. In a two-stage Fleming design, women aged ≥70 years with histologically proven hormone-receptor-negative early breast cancer and a significant risk of recurrence (pN+ or "high risk" pN0) received 4 cycles of nonpegylated liposomal doxorubicin 60 mg/m(2) and cyclophosphamide 600 mg/m(2) every 3 weeks postoperatively, on an outpatient basis. The primary endpoint was the change in the ADL score during chemotherapy. Secondary endpoints include comprehensive geriatric, quality-of-life and acceptability assessments, tolerability, and long-term outcome. The results for the primary endpoint and other scales at completion of adjuvant chemotherapy are reported here, while long-term follow-up is not yet complete. Forty patients (median age 75 [70-82]) were enrolled between February 2006 and November 2007. Chemotherapy had no deleterious impact on ADL, cognition, mental status, or the frequency of comorbidities. In contrast, the number of patients at risk of malnutrition, based on the Mini Nutritional Assessment, more than doubled between baseline and the end of chemotherapy, rising from 15% to 38%. Quality-of-life deteriorated in terms of social and role functioning, likely owing to fatigue, loss of appetite, nausea and vomiting. Treatment acceptability was good. The main adverse effect was neutropenia, 15% of the patients experiencing febrile neutropenia. No cardiac toxicity or toxic deaths occurred. This study demonstrates the feasibility of an adjuvant chemotherapy

  18. Feasibility of Economic Analysis of Radiation Therapy Oncology Group (RTOG) 91-11 Using Medicare Data

    International Nuclear Information System (INIS)

    Konski, Andre; Bhargavan, Mythreyi; Owen, Jean; Paulus, Rebecca; Cooper, Jay; Forastiere, Arlene; Ang, K. Kian; Watkins-Bruner, Deborah

    2011-01-01

    Purpose: The specific aim of this analysis was to evaluate the feasibility of performing a cost-effectiveness analysis using Medicare data from patients treated on a randomized Phase III clinical trial. Methods and Materials: Cost data included Medicare Part A and Part B costs from all providers-inpatient, outpatient, skilled nursing facility, home health, hospice, and physicians-and were obtained from the Centers for Medicare and Medicaid Services for patients eligible for Medicare, treated on Radiation Therapy Oncology Group (RTOG) 9111 between 1992 and 1996. The 47-month expected discounted (annual discount rate of 3%) cost for each arm of the trial was calculated in 1996 dollars, with Kaplan-Meier sampling average estimates of survival probabilities for each month and mean monthly costs. Overall and disease-free survival was also discounted 3%/year. The analysis was performed from a payer's perspective. Incremental cost-effectiveness ratios were calculated comparing the chemotherapy arms to the radiation alone arm. Results: Of the 547 patients entered, Medicare cost data and clinical outcomes were available for 66 patients. Reasons for exclusion included no RTOG follow-up, Medicare HMO enrollment, no Medicare claims since trial entry, and trial entry after 1996. Differences existed between groups in tumor characteristics, toxicity, and survival, all which could affect resource utilization. Conclusions: Although we were able to test the methodology of economic analysis alongside a clinical trial using Medicare data, the results may be difficult to translate to the entire trial population because of non-random missing data. Methods to improve Medicare data capture and matching to clinical trial samples are required.

  19. Informed consent in oncology clinical trials: A Brown University Oncology Research Group prospective cross-sectional pilot study.

    Directory of Open Access Journals (Sweden)

    Andrew Schumacher

    Full Text Available Informed consent forms (ICFs for oncology clinical trials have grown increasingly longer and more complex. We evaluated objective understanding of critical components of informed consent among patients enrolling in contemporary trials of conventional or novel biologic/targeted therapies.We evaluated ICFs for cancer clinical trials for length and readability, and patients registered on those studies were asked to complete a validated 14-question survey assessing their understanding of key characteristics of the trial. Mean scores were compared in groups defined by trial and patient characteristics.Fifty patients, of whom half participated in trials of immunotherapy or biologic/targeted agents and half in trials of conventional therapy, completed the survey. On average, ICFs for industry-originated trials (N = 9 trials were significantly longer (P < .0001 and had lower Flesch ease-of-reading scores (P = .003 than investigator-initiated trials (N = 11. At least 80% of patients incorrectly responded to three key questions which addressed the experimental nature of their trial therapy, its purported efficacy and potential risks relative to alternative treatments. The mean objective understanding score was 76.9±8.8, but it was statistically significantly lower for patients who had not completed high school (P = .011. The scores did not differ significantly by type of cancer therapy (P = .12 or trial sponsor (P = .38.Many participants enrolled on cancer trials had poor understanding of essential elements of their trial. In order to ensure true informed consent, innovative approaches, such as expanded in-person counseling adapted to the patient's education level or cultural characteristics should be evaluated across socio-demographic groups.Clinicaltrials.gov NCT01772511.

  20. Ethics of phase 1 oncology studies: reexamining the arguments and data.

    Science.gov (United States)

    Agrawal, Manish; Emanuel, Ezekiel J

    2003-08-27

    Phase 1 oncology trials are critical to improving the treatment of cancer. Critics have raised 2 fundamental ethical challenges about phase 1 cancer research: the paucity of benefits with substantial risks and poor-quality informed consent. Despite 3 decades of controversy about phase 1 oncology research, there is little critical analysis of the arguments or of the data relevant to these questions. Existing but old data reveal that about 5% of patients in phase 1 trials experience shrinkage of their tumor, with a 0.5% mortality rate. In some notable cases, patients in phase 1 trials have been cured or sustained long-term remissions. Limited data suggest that patients in phase 1 trials may have better quality of life than comparable patients receiving supportive care. More important, the risks and benefits of phase 1 trials are not clearly worse than risk-benefit ratios used by the US Food and Drug Administration to approve chemotherapeutic agents for clinical use. The objections based on informed consent are deficiencies of disclosure, understanding, and voluntariness. The available data do not support the claim that disclosure is deficient. Although studies evaluating patient understanding have substantial methodological problems, they demonstrate that more than 70% of patients understand that they may not directly benefit even when they hope they will personally benefit. Finally, a closer look at issues of voluntariness reveals that patients with advanced cancer who participate in phase 1 research may have a different set of values than do critics and are not coerced. Overall, it appears that phase 1 oncology trials satisfy the requirement for a favorable risk-benefit ratio and that patients who enroll provide adequate informed consent.

  1. Eastern Cooperative Oncology Group and American College of Radiology Imaging Network Randomized Phase 2 Trial of Neoadjuvant Preoperative Paclitaxel/Cisplatin/Radiation Therapy (RT) or Irinotecan/Cisplatin/RT in Esophageal Adenocarcinoma: Long-Term Outcome and Implications for Trial Design

    Energy Technology Data Exchange (ETDEWEB)

    Kleinberg, Lawrence R., E-mail: kleinla@jhmi.edu [Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University, Baltimore, Maryland (United States); Catalano, Paul J. [Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, and Harvard T.H. Chan School of Public Health, Boston, Massachusetts (United States); Forastiere, Arlene A. [Department of Oncology, Johns Hopkins University, Baltimore, Maryland (United States); Keller, Steven M. [Department of Cardiovascular and Thoracic Surgery, Montefiore Medical Center, Bronx, NY (United States); Mitchel, Edith P. [Department of Medical Oncology, Thomas Jefferson University, Philadelphia, Pennsylvania (United States); Anne, Pramila Rani [Department of Radiation Oncology, Thomas Jefferson University, Philadelphia, Pennsylvania (United States); Benson, Al B. [Department of Medicine-Hematology/Oncology, Lurie Cancer Center, Northwestern University, Chicago, Illinois (United States)

    2016-03-15

    Purpose: Toxicity, pathologic complete response, and long-term outcomes are reported for the neoadjuvant therapies assessed in a randomized phase 2 Eastern Cooperative Oncology Group and American College of Radiology Imaging Network trial for operable esophageal adenocarcinoma, staged as II-IVa by endoscopy/ultrasonography (EUS). Methods and Materials: A total of 86 eligible patients began treatment. For arm A, preoperative chemotherapy was cisplatin, 30 mg/m{sup 2}, and irinotecan, 50 mg/m{sup 2}, on day 1, 8, 22, 29 during 45 Gy radiation therapy (RT), 1.8 Gy per day over 5 weeks. Adjuvant therapy was cisplatin, 30 mg/m{sup 2}, and irinotecan, 65 mg/m{sup 2} day 1, 8 every 21 days for 3 cycles. Arm B therapy was cisplatin, 30 mg/m{sup 2}, and paclitaxel, 50 mg/m{sup 2}, day 1, 8, 15, 22, 29 with RT, followed by adjuvant cisplatin, 75 mg/m{sup 2}, and paclitaxel, 175 mg/m{sup 2}, day 1 every 21 days for 3 cycles. Stratification included EUS stage and performance status. Results: In arm A, median overall survival was 35 months, and 5-, 6-, and 7-year survival rates were 46%, 39%, and 35%, respectively, whereas for arm B, they were 21 months and 27%, 27%, and 23%, respectively. Median progression- or recurrence-free survival (PFS) was 39.8 months with a 3-year PFS of 50% for arm A and 12.4 months (P=.046) with 3-year PFS of 28% for arm B. Eighty percent of the observed incidents of progression occurred within 19 months. Survival did not differ significantly by EUS and performance status strata. Conclusions: Long-term survival was similar for both arms and did not appear superior to results achieved with other standard regimens.

  2. Radiation Therapy Oncology Group Protocol 02-29: A Phase II Trial of Neoadjuvant Therapy With Concurrent Chemotherapy and Full-Dose Radiation Therapy Followed by Surgical Resection and Consolidative Therapy for Locally Advanced Non-small Cell Carcinoma of the Lung

    International Nuclear Information System (INIS)

    Suntharalingam, Mohan; Paulus, Rebecca; Edelman, Martin J.; Krasna, Mark; Burrows, Whitney; Gore, Elizabeth; Wilson, Lynn D.; Choy, Hak

    2012-01-01

    Purpose: To evaluate mediastinal nodal clearance (MNC) rates after induction chemotherapy and concurrent, full-dose radiation therapy (RT) in a phase II trimodality trial (Radiation Therapy Oncology Group protocol 0229). Patients and Methods: Patients (n=57) with stage III non-small cell lung cancer (pathologically proven N2 or N3) were eligible. Induction chemotherapy consisted of weekly carboplatin (AUC = 2.0) and paclitaxel 50 mg/m 2 . Concurrent RT was prescribed, with 50.4 Gy to the mediastinum and primary tumor and a boost of 10.8 Gy to all gross disease. The mediastinum was pathologically reassessed after completion of chemoradiation. The primary endpoint of the study was MNC, with secondary endpoints of 2-year overall survival and postoperative morbidity/mortality. Results: The grade 3/4 toxicities included hematologic 35%, gastrointestinal 14%, and pulmonary 23%. Forty-three patients (75%) were evaluable for the primary endpoint. Twenty-seven patients achieved the primary endpoint of MNC (63%). Thirty-seven patients underwent resection. There was a 14% incidence of grade 3 postoperative pulmonary complications and 1 30-day, postoperative grade 5 toxicity (3%). With a median follow-up of 24 months for all patients, the 2-year overall survival rate was 54%, and the 2-year progression-free survival rate was 33%. The 2-year overall survival rate was 75% for those who achieved nodal clearance, 52% for those with residual nodal disease, and 23% for those who were not evaluable for the primary endpoint (P=.0002). Conclusions: This multi-institutional trial confirms the ability of neoadjuvant concurrent chemoradiation with full-dose RT to sterilize known mediastinal nodal disease.

  3. Young patients', parents', and survivors' communication preferences in paediatric oncology: Results of online focus groups

    Directory of Open Access Journals (Sweden)

    Kamps Willem A

    2007-11-01

    Full Text Available Abstract Background Guidelines in paediatric oncology encourage health care providers to share relevant information with young patients and parents to enable their active participation in decision making. It is not clear to what extent this mirrors patients' and parents' preferences. This study investigated communication preferences of childhood cancer patients, parents, and survivors of childhood cancer. Methods Communication preferences were examined by means of online focus groups. Seven patients (aged 8–17, 11 parents, and 18 survivors (aged 8–17 at diagnosis participated. Recruitment took place by consecutive inclusion in two Dutch university oncological wards. Questions concerned preferences regarding interpersonal relationships, information exchange and participation in decision making. Results Participants expressed detailed and multi-faceted views regarding their needs and preferences in communication in paediatric oncology. They agreed on the importance of several interpersonal and informational aspects of communication, such as honesty, support, and the need to be fully informed. Participants generally preferred a collaborative role in medical decision making. Differences in views were found regarding the desirability of the patient's presence during consultations. Patients differed in their satisfaction with their parents' role as managers of the communication. Conclusion Young patients' preferences mainly concur with current guidelines of providing them with medical information and enabling their participation in medical decision making. Still, some variation in preferences was found, which faces health care providers with the task of balancing between the sometimes conflicting preferences of young cancer patients and their parents.

  4. Patient/Family Education for Newly Diagnosed Pediatric Oncology Patients: Consensus Recommendations from a Children’s Oncology Group Expert Panel

    Science.gov (United States)

    Landier, Wendy; Ahern, JoAnn; Barakat, Lamia P.; Bhatia, Smita; Bingen, Kristin M.; Bondurant, Patricia G.; Cohn, Susan L.; Dobrozsi, Sarah K.; Haugen, Maureen; Herring, Ruth Anne; Hooke, Mary C.; Martin, Melissa; Murphy, Kathryn; Newman, Amy R.; Rodgers, Cheryl C.; Ruccione, Kathleen S.; Sullivan, Jeneane; Weiss, Marianne; Withycombe, Janice; Yasui, Lise; Hockenberry, Marilyn

    2016-01-01

    There is a paucity of data to support evidence-based practices in the provision of patient/family education in the context of a new childhood cancer diagnosis. Since the majority of children with cancer are treated on pediatric oncology clinical trials, lack of effective patient/family education has the potential to negatively affect both patient and clinical trial outcomes. The Children’s Oncology Group Nursing Discipline convened an interprofessional expert panel from within and beyond pediatric oncology to review available and emerging evidence and develop expert consensus recommendations regarding harmonization of patient/family education practices for newly diagnosed pediatric oncology patients across institutions. Five broad principles, with associated recommendations, were identified by the panel, including recognition that (1) in pediatric oncology, patient/family education is family-centered; (2) a diagnosis of childhood cancer is overwhelming and the family needs time to process the diagnosis and develop a plan for managing ongoing life demands before they can successfully learn to care for the child; (3) patient/family education should be an interprofessional endeavor with 3 key areas of focus: (a) diagnosis/treatment, (b) psychosocial coping, and (c) care of the child; (4) patient/family education should occur across the continuum of care; and (5) a supportive environment is necessary to optimize learning. Dissemination and implementation of these recommendations will set the stage for future studies that aim to develop evidence to inform best practices, and ultimately to establish the standard of care for effective patient/family education in pediatric oncology. PMID:27385664

  5. Developing an organizing framework to guide nursing research in the Children’s Oncology Group (COG)

    Science.gov (United States)

    Kelly, Katherine Patterson; Hooke, Mary C.; Ruccione, Kathleen; Landier, Wendy; Haase, Joan

    2014-01-01

    Objectives To describe the development and application of an organizing research framework to guide COG Nursing research. Data Sources Research articles, reports and meeting minutes Conclusion An organizing research framework helps to outline research focus and articulate the scientific knowledge being produced by nurses in the pediatric cooperative group. Implication for Nursing Practice The use of an organizing framework for COG nursing research can facilitate clinical nurses’ understanding of how children and families sustain or regain optimal health when faced with a pediatric cancer diagnosis through interventions designed to promote individual and family resilience. The Children’s Oncology Group (COG) is the sole National Cancer Institute (NCI)-supported cooperative pediatric oncology clinical trials group and the largest organization in the world devoted exclusively to pediatric cancer research. It was founded in 2000 following the merger of the four legacy NCI-supported pediatric clinical trials groups (Children’s Cancer Group [CCG], Pediatric Oncology Group [POG], National Wilms Tumor Study Group, and Intergroup Rhabdomyosarcoma Study Group). The COG currently has over 200 member institutions across North America, Australia, New Zealand and Europe and a multidisciplinary membership of over 8,000 pediatric, radiation, and surgical oncologists, nurses, clinical research associates, pharmacists, behavioral scientists, pathologists, laboratory scientists, patient/parent advocates and other pediatric cancer specialists. The COG Nursing Discipline was formed from the merger of the legacy CCG and POG Nursing Committees, and current membership exceeds 2000 registered nurses. The discipline has a well-developed infrastructure that promotes nursing involvement throughout all levels of the organization, including representation on disease, protocol, scientific, executive and other administrative committees (e.g., nominating committee, data safety monitoring

  6. Fast Neutron Radiotherapy for Locally Advanced Prostate Cancer: Final Report of a Radiation Therapy Oncology Group Randomized Clinical Trial

    Energy Technology Data Exchange (ETDEWEB)

    Laramore, G. E.; Krall, J. M.; Thomas, F. J.; Russell, K. J.; Maor, M. H.; Hendrickson, F. R.; Martz, K. L.; Griffin, T. W.; Davis, L. W.

    1993-01-01

    Between June 1977 and April 1983 the Radiation Therapy Oncology Group (RTOG) sponsored a Phase III randomized trial investigating the use of fast neutron radiotherapy for patients with locally advanced (Stages C and D1) adenocarcinoma of the prostate gland. Patients were randomized to receive either conventional photon radiation or fast neutron radiation used in a mixed-beam (neutron/photon) treatment schedule. A total of 91 analyzable patients were entered into the study, and the two patient groups were balanced with respect to the major prognostic variables. Actuarial curves are presented for local/regional control and "overall" survival. Ten-year results for clinically assessed local control are 70% for the mixed-beam group versus 58% for the photon group (p = 0.03) and for survival are 46% for the mixed-beam group versus 29% for the photon group (p = 0.04). This study suggests that a regional method of treatment can influence both local tumor control and survival in patients with locally advanced adenocarcinoma of the prostate gland.

  7. Dispositional optimism and therapeutic expectations in early-phase oncology trials.

    Science.gov (United States)

    Jansen, Lynn A; Mahadevan, Daruka; Appelbaum, Paul S; Klein, William M P; Weinstein, Neil D; Mori, Motomi; Daffé, Racky; Sulmasy, Daniel P

    2016-04-15

    Prior research has identified unrealistic optimism as a bias that might impair informed consent among patient-subjects in early-phase oncology trials. However, optimism is not a unitary construct; it also can be defined as a general disposition, or what is called dispositional optimism. The authors assessed whether dispositional optimism would be related to high expectations for personal therapeutic benefit reported by patient-subjects in these trials but not to the therapeutic misconception. The authors also assessed how dispositional optimism related to unrealistic optimism. Patient-subjects completed questionnaires designed to measure expectations for therapeutic benefit, dispositional optimism, unrealistic optimism, and the therapeutic misconception. Dispositional optimism was found to be significantly associated with higher expectations for personal therapeutic benefit (Spearman rank correlation coefficient [r], 0.333; Poptimism was found to be weakly associated with unrealistic optimism (Spearman r, 0.215; P = .005). On multivariate analysis, both dispositional optimism (P = .02) and unrealistic optimism (Poptimism (P = .0001), but not dispositional optimism, was found to be independently associated with the therapeutic misconception. High expectations for therapeutic benefit among patient-subjects in early-phase oncology trials should not be assumed to result from misunderstanding of specific information regarding the trials. The data from the current study indicate that these expectations are associated with either a dispositionally positive outlook on life or biased expectations concerning specific aspects of trial participation. Not all manifestations of optimism are the same, and different types of optimism likely have different consequences for informed consent in early-phase oncology research. © 2016 American Cancer Society.

  8. Second malignancies complicating Hodgkin's disease: a Southwest Oncology Group 10-year followup

    International Nuclear Information System (INIS)

    Coltman, C.A. Jr.; Dixon, D.O.

    1982-01-01

    Thirty-two second malignancies (21 acute leukemias and 11 solid tumors) were identified among 659 patients with all stages of Hodgkin's disease treated by members of the Southwest Oncology Group. There were no leukemias and one solid tumor among 95 patients treated with radiotherapy alone. The actuarial risk of developing acute leukemia at 7 years was 6.2% for chemotherapy alone, 6.4% for combined modality, and 7.7% for salvage chemotherapy. The incidence of acute leukemia was higher (P . 0.002) among those whose treatment began at greater than or equal to 40 years of age. The actuarial risk of leukemia in that group was 20.7% at 7 years. These data are compatible with the hypothesis that chemotherapy alone, combined modality, and salvage chemotherapy have an equivalent oncogenic potential and that patients greater than or equal to 40 years of age have an enhanced susceptibility to these oncogenic stimuli

  9. Noncommutative phase spaces on Aristotle group

    Directory of Open Access Journals (Sweden)

    Ancille Ngendakumana

    2012-03-01

    Full Text Available We realize noncommutative phase spaces as coadjoint orbits of extensions of the Aristotle group in a two dimensional space. Through these constructions the momenta of the phase spaces do not commute due to the presence of a naturally introduced magnetic eld. These cases correspond to the minimal coupling of the momentum with a magnetic potential.

  10. Gynecologic Oncology Group quality assurance audits: analysis and initiatives for improvement.

    Science.gov (United States)

    Blessing, John A; Bialy, Sally A; Whitney, Charles W; Stonebraker, Bette L; Stehman, Frederick B

    2010-08-01

    The Gynecologic Oncology Group (GOG) is a multi-institution, multi-discipline Cooperative Group funded by the National Cancer Institute (NCI) to conduct clinical trials which investigate the treatment, prevention, control, quality of survivorship, and translational science of gynecologic malignancies. In 1982, the NCI initiated a program of on-site quality assurance audits of participating institutions. Each is required to be audited at least once every 3 years. In GOG, the audit mandate is the responsibility of the GOG Quality Assurance Audit Committee and it is centralized in the Statistical and Data Center (SDC). Each component (Regulatory, Investigational Drug Pharmacy, Patient Case Review) is classified as Acceptable, Acceptable, follow-up required, or Unacceptable. To determine frequently occurring deviations and develop focused innovative solutions to address them. A database was created to examine the deviations noted at the most recent audit conducted at 57 GOG parent institutions during 2004-2007. Cumulatively, this involved 687 patients and 306 protocols. The results documented commendable performance: Regulatory (39 Acceptable, 17 Acceptable, follow-up, 1 Unacceptable); Pharmacy (41 Acceptable, 3 Acceptable, follow-up, 1 Unacceptable, 12 N/A): Patient Case Review (31 Acceptable, 22 Acceptable, follow-up, 4 Unacceptable). The nature of major and lesser deviations was analyzed to create and enhance initiatives for improvement of the quality of clinical research. As a result, Group-wide proactive initiatives were undertaken, audit training sessions have emphasized recurring issues, and GOG Data Management Subcommittee agendas have provided targeted instruction and training. The analysis was based upon parent institutions only; affiliate institutions and Community Clinical Oncology Program participants were not included, although it is assumed their areas of difficulty are similar. The coordination of the GOG Quality Assurance Audit program in the SDC has

  11. Risk management of radiation therapy. Survey by north Japan radiation therapy oncology group

    International Nuclear Information System (INIS)

    Aoki, Masahiko; Abe, Yoshinao; Yamada, Shogo; Hareyama, Masato; Nakamura, Ryuji; Sugita, Tadashi; Miyano, Takashi

    2004-01-01

    A North Japan Radiation Oncology Group (NJRTOG) survey was carried out to disclose the risk management of radiation therapy. During April 2002, we sent questionnaires to radiation therapy facilities in northern Japan. There were 31 replies from 27 facilities. Many incidents and accidents were reported, including old cases. Although 60% of facilities had a risk management manual and/or risk manager, only 20% had risk management manuals for radiation therapy. Eighty five percent of radiation oncologists thought that incidents may be due to a lack of manpower. Ninety percent of radiation oncologists want to know the type of cases happened in other facilities. The risk management system is still insufficient for radiation therapy. We hope that our data will be a great help to develop risk management strategies for radiation therapy for all radiation oncologists in Japan. (author)

  12. Recommendations from the Spanish Oncology Genitourinary Group for the treatment of metastatic renal cancer.

    Science.gov (United States)

    Bellmunt, Joaquim; Calvo, Emiliano; Castellano, Daniel; Climent, Miguel Angel; Esteban, Emilio; García del Muro, Xavier; González-Larriba, José Luis; Maroto, Pablo; Trigo, José Manuel

    2009-03-01

    For almost the last two decades, interleukin-2 and interferon-alpha have been the only systemic treatment options available for metastatic renal cell carcinoma. However, in recent years, five new targeted therapies namely sunitinib, sorafenib, temsirolimus, everolimus and bevacizumab have demonstrated clinical activity in these patients. With the availability of new targeted agents that are active in this disease, there is a need to continuously update the treatment algorithm of the disease. Due to the important advances obtained, the Spanish Oncology Genitourinary Group (SOGUG) has considered it would be useful to review the current status of the disease, including the genetic and molecular biology factors involved, the current predicting models for development of metastases as well as the role of surgery, radiotherapy and systemic therapies in the early- or late management of the disease. Based on this previous work, a treatment algorithm was developed.

  13. Adolescents with Cancer in Italy: Improving Access to National Cooperative Pediatric Oncology Group (AIEOP) Centers.

    Science.gov (United States)

    Ferrari, Andrea; Rondelli, Roberto; Pession, Andrea; Mascarin, Maurizio; Buzzoni, Carlotta; Mosso, Maria Luisa; Maule, Milena; Barisone, Elena; Bertolotti, Marina; Clerici, Carlo Alfredo; Jankovic, Momcilo; Fagioli, Franca; Biondi, Andrea

    2016-06-01

    This analysis compared the numbers of patients treated at Italian pediatric oncology group (Associazione Italiana Ematologia Oncologia Pediatrica [AIEOP]) centers with the numbers of cases predicted according to the population-based registry. It considered 32,431 patients registered in the AIEOP database (1989-2012). The ratio of observed (O) to expected (E) cases was 0.79 for children (0-14 years old) and 0.15 for adolescents (15-19 years old). The proportion of adolescents increased significantly over the years, however, from 0.05 in the earliest period to 0.10, 0.18, and then 0.28 in the latest period of observation, suggesting a greater efficacy of local/national programs dedicated to adolescents. © 2016 Wiley Periodicals, Inc.

  14. Correlative Studies in Clinical Trials: A Position Statement From the International Thyroid Oncology Group.

    Science.gov (United States)

    Bible, Keith C; Cote, Gilbert J; Demeure, Michael J; Elisei, Rossella; Jhiang, Sissy; Ringel, Matthew D

    2015-12-01

    Patients with progressive thyroid cancer in distant metastatic sites represent a population with a need for new therapeutic options. Aspiring to improve the treatment of such patients, the objective of this position statement from the International Thyroid Oncology Group (ITOG) is to clarify the importance of incorporating high-quality correlative studies into clinical trials. ITOG was formed to develop and support high-quality multicenter and multidisciplinary clinical trials for patients with aggressive forms of thyroid cancer. The Correlative Sciences Committee of the ITOG focuses on the quality and types of correlative studies included in ITOG-associated clinical trials. This document represents expert consensus from ITOG regarding this issue based on extensive collective experience in clinical and translational trials informed by basic science. The Correlative Studies Committee identified an international writing group representative of diverse specialties, including basic sciences. Drafts were reviewed by all members of the writing group, the larger committee, and the ITOG board. After consideration of all comments by the writing group and modification of the document, the final document was then approved by the authors and the ITOG board. High-quality correlative studies, which include variety in the types of correlates, should be intrinsic to the design of thyroid cancer clinical trials to offer the best opportunity for each study to advance treatment for patients with advanced and progressive thyroid cancer.

  15. Understanding Effective Delivery of Patient and Family Education in Pediatric Oncology: A Systematic Review from the Children's Oncology Group

    Science.gov (United States)

    Rodgers, Cheryl C.; Laing, Catherine M.; Herring, Ruth Anne; Tena, Nancy; Leonardelli, Adrianne; Hockenberry, Marilyn; Hendricks-Ferguson, Verna

    2016-01-01

    A diagnosis of childhood cancer is a life-changing event for the entire family. Parents must not only deal with the cancer diagnosis but also acquire new knowledge and skills to safely care for their child at home. Best practices for delivery of patient/family education after a new diagnosis of childhood cancer are currently unknown. The purpose of this systematic review was to evaluate the existing body of evidence to determine the current state of knowledge regarding the delivery of education to newly diagnosed pediatric oncology patients and families. Eighty-three articles regarding educational methods, content, influencing factors, and interventions for newly diagnosed pediatric patients with cancer or other chronic illnesses were systematically identified, summarized, and appraised according to the GRADE criteria. Based on the evidence, ten recommendations for practice were identified. These recommendations address delivery methods, content, influencing factors, and educational interventions for parents and siblings. Transferring these recommendations into practice may enhance the quality of education delivered by healthcare providers, and received by patients and families following a new diagnosis of childhood cancer. PMID:27450361

  16. Current technological clinical practice in breast radiotherapy; results of a survey in EORTC-Radiation Oncology Group affiliated institutions

    NARCIS (Netherlands)

    van der Laan, Hans Paul; Hurkmans, Coen W; Kuten, Abraham; Westenberg, Helen A

    PURPOSE: To evaluate the current technological clinical practice of radiation therapy of the breast in institutions participating in the EORTC-Radiation Oncology Group (EORTC-ROG). MATERIALS AND METHODS: A survey was conducted between August 2008 and January 2009 on behalf of the Breast Working

  17. Profile of European radiotherapy departments contributing to the EORTC Radiation Oncology Group (ROG) in the 21st century

    NARCIS (Netherlands)

    Budiharto, Tom; Musat, Elena; Poortmans, Philip; Hurkmans, Coen; Monti, Angelo; Bar-Deroma, Raquel; Bernstein, Zvi; van Tienhoven, Geertjan; Collette, Laurence; Duclos, Frédéric; Davis, Bernard; Aird, Edwin

    2008-01-01

    Since 1982, the Radiation Oncology Group of the EORTC (EORTC ROG) has pursued an extensive Quality Assurance (QA) program involving all centres actively participating in its clinical research. The first step is the evaluation of the structure and of the human, technical and organisational resources

  18. A Tool for Predicting Regulatory Approval After Phase II Testing of New Oncology Compounds.

    Science.gov (United States)

    DiMasi, J A; Hermann, J C; Twyman, K; Kondru, R K; Stergiopoulos, S; Getz, K A; Rackoff, W

    2015-11-01

    We developed an algorithm (ANDI) for predicting regulatory marketing approval for new cancer drugs after phase II testing has been conducted, with the objective of providing a tool to improve drug portfolio decision-making. We examined 98 oncology drugs from the top 50 pharmaceutical companies (2006 sales) that first entered clinical development from 1999 to 2007, had been taken to at least phase II development, and had a known final outcome (research abandonment or regulatory marketing approval). Data on safety, efficacy, operational, market, and company characteristics were obtained from public sources. Logistic regression and machine-learning methods were used to provide an unbiased approach to assess overall predictability and to identify the most important individual predictors. We found that a simple four-factor model (activity, number of patients in the pivotal phase II trial, phase II duration, and a prevalence-related measure) had high sensitivity and specificity for predicting regulatory marketing approval. © 2015 American Society for Clinical Pharmacology and Therapeutics.

  19. [Nutritional support and parenteral nutrition in the oncological patient: an expert group consensus report].

    Science.gov (United States)

    Camblor-Álvarez, Miguel; Ocón-Bretón, María Julia; Luengo-Pérez, Luis Miguel; Viruzuela, Juan Antonio; Sendrós-Maroño, María José; Cervera-Peris, Mercedes; Grande, Enrique; Álvarez-Hernández, Julia; Jiménez-Fonseca, Paula

    2018-01-10

    Malnutrition is a frequent medical problem of cancer patients that negatively impacts their quality of life. To analyze and respond to different issues related to the nutritional management of cancer patients in the clinical setting. A multidisciplinary group of experts in Medical Oncology, Pharmacy, and Nutrition developed a list of topics related to the nutritional status of cancer patients, which were grouped into three blocks: Nutritional support; Parenteral nutrition (PN); and Home PN (HPN) in cancer patients. A literature search, which included articles published in Spanish, English, and French until February 2017, was carried out. The document was organized as a questionnaire with those questions that, according to the panel's criteria, could generate greater controversy or doubt. Of the 18 questions addressed, 9 focused on nutritional support: 5 were related to PN and 4 about HPN. Among the different recommendations, the panel emphasized that in the cancer patient, PN is indicated mainly when it is not possible to use the digestive tract and/or oral feeding and/or enteral nutrition is not sufficient or possible. Additionally, the objective of the HPN is to improve or maintain the nutritional status of a patient at home. This document seeks to lay down a set of recommendations and to identify key issues that may be useful for the nutritional management of cancer Patients.

  20. Double-blind, randomized phase 3 trial of low-dose 13-cis retinoic acid in the prevention of second primaries in head and neck cancer: Long-term follow-up of a trial of the Eastern Cooperative Oncology Group-ACRIN Cancer Research Group (C0590).

    Science.gov (United States)

    Bhatia, Aarti K; Lee, Ju-Whei; Pinto, Harlan A; Jacobs, Charlotte D; Limburg, Paul J; Rubin, Philip; Arusell, Robert M; Dunphy, Eamonn P; Khandekar, Janardan D; Reiner, Seth A; Baez-Diaz, Luis; Celano, Paul; Li, Shuli; Li, Yi; Burtness, Barbara A; Adams, George L; Pandya, Kishan J

    2017-12-01

    13-Cis retinoic acid (13-CRA) is a synthetic vitamin A derivative. High-dose 13-CRA in patients with squamous cell cancers of the head and neck (SCCHNs) reduces the incidence of second primary tumors (SPTs). The authors report long-term results from a phase 3 randomized trial that compared treatment with low-dose 13-CRA versus placebo for patients who had early stage SCCHN, with a focus on the development of SPTs and overall survival (OS). In total, 176 patients who received treatment for stage I/II SCCHN were randomized to receive either low-dose 13-CRA (weight-based dose of 7.5 mg or 10 mg) or placebo for 2 years. A competing-risk approach and the log-rank test were used to compare the time to SPT and OS, respectively, between groups. 13-CRA neither significantly reduced the cumulative incidence of SPT (P = .61) nor improved the time to SPT (hazard ratio [HR] for 13-CRA/placebo; 0.86; P = .61). Despite limited power, there was a trend toward improved OS for the 13-CRA arm (HR, 0.75; P = .14), particularly among patients whose index tumor was surgically excised (N = 26; HR, 0.50; P = .057) and among women (N = 39; HR, 0.44; P = .065) and never/former smokers (N = 129; HR, 0.61; P = .055), with a median follow-up of 16 years. The main 13-CRA related toxicities were dry skin and cheilitis. Treatment with low-dose 13-CRA for 2 years did not decrease the incidence of SPT; subset analysis indicates a potential survival advantage among patients who are women and never/former smokers. More targeted interventions based on clinical risk factors and molecular characterization of tumors may yield greater success in future prevention trials. Cancer 2017;123:4653-4662. © 2017 American Cancer Society. © 2017 American Cancer Society.

  1. Prognostic significance of anaplasia and angiogenesis in childhood medulloblastoma: a pediatric oncology group study.

    Science.gov (United States)

    Ozer, Erdener; Sarialioglu, Faik; Cetingoz, Riza; Yüceer, Nurullah; Cakmakci, Handan; Ozkal, Sermin; Olgun, Nur; Uysal, Kamer; Corapcioglu, Funda; Canda, Serefettin

    2004-01-01

    The purpose of this study was to investigate whether quantitative assessment of cytologic anaplasia and angiogenesis may predict the clinical prognosis in medulloblastoma and stratify the patients to avoid both undertreatment and overtreatment. Medulloblastomas from 23 patients belonging to the Pediatric Oncology Group were evaluated with respect to some prognostic variables, including histologic assessment of nodularity and desmoplasia, grading of anaplasia, measurement of nuclear size, mitotic cell count, quantification of angiogenesis, including vascular surface density (VSD) and microvessel number (NVES), and immunohistochemical scoring of vascular endothelial growth factor (VEGF) expression. Univariate and multivariate analyses for prognostic indicators for survival were performed. Univariate analysis revealed that extensive nodularity was a significant favorable prognostic factor, whereas the presence of anaplasia, increased nuclear size, mitotic rate, VSD, and NVES were significant unfavorable prognostic factors. Using multivariate analysis, increased nuclear size was found to be an independent unfavorable prognostic factor for survival. Neither the presence of desmoplasia nor VEGF expression was significantly related to patient survival. Although care must be taken not to overstate the importance of the results of this single-institution preliminary report, pathologic grading of medulloblastomas with respect to grading of anaplasia and quantification of nodularity, nuclear size, and microvessel profiles may be clinically useful for the treatment of medulloblastomas. Further validation of the independent prognostic significance of nuclear size in stratifying patients is required.

  2. Cancer pain management by radiotherapists: a survey of radiation therapy oncology group physicians

    International Nuclear Information System (INIS)

    Cleeland, Charles S.; Janjan, Nora A.; Scott, Charles B.; Seiferheld, Wendy F.; Curran, Walter J.

    2000-01-01

    Purpose: Radiation Therapy Oncology Group (RTOG) physicians were surveyed to determine their approach to and attitudes toward cancer pain management. Methods and Materials: Physicians completed a questionnaire assessing their estimates of the magnitude of pain as a specific problem for cancer patients, their perceptions of the adequacy of pain management, and their report of how they manage pain in their own practice setting. Results: Eighty-three percent believed the majority of cancer patients with pain were undermedicated. Forty percent reported that pain relief in their own practice setting was poor or fair. Assessing a case scenario, 23% would wait until the patient's prognosis was 6 months or less before starting maximal analgesia. Adjuvants and prophylactic side effect management were underutilized in the treatment plan. Barriers to pain management included poor pain assessment (77%), patient reluctance to report pain (60%), patient reluctance to take analgesics (72%), and staff reluctance to prescribe opioids (41%). Conclusions: Physicians' perceptions of barriers to cancer pain management remain quite stable over time, and physicians continue to report inadequate pain treatment education. Future educational efforts should target radiation oncologists as an important resource for the treatment of cancer pain

  3. Pelvic Normal Tissue Contouring Guidelines for Radiation Therapy: A Radiation Therapy Oncology Group Consensus Panel Atlas

    Energy Technology Data Exchange (ETDEWEB)

    Gay, Hiram A., E-mail: hgay@radonc.wustl.edu [Washington University School of Medicine, St Louis, MO (United States); Barthold, H. Joseph [Commonwealth Hematology and Oncology, Weymouth, MA (United States); Beth Israel Deaconess Medical Center, Boston, MA (Israel); O' Meara, Elizabeth [Radiation Therapy Oncology Group, Philadelphia, PA (United States); Bosch, Walter R. [Washington University School of Medicine, St Louis, MO (United States); El Naqa, Issam [Department of Radiation Oncology, McGill University Health Center, Montreal, Quebec (Canada); Al-Lozi, Rawan [Washington University School of Medicine, St Louis, MO (United States); Rosenthal, Seth A. [Radiation Oncology Centers, Radiological Associates of Sacramento, Sacramento, CA (United States); Lawton, Colleen [Department of Radiation Oncology, Medical College of Wisconsin, Milwaukee, WI (United States); Lee, W. Robert [Department of Radiation Oncology, Duke University Medical Center, Durham, NC (United States); Sandler, Howard [Cedars-Sinai Medical Center, Los Angeles, CA (United States); Zietman, Anthony [Department of Radiation Oncology, Massachusetts General Hospital and Harvard Medical School, Boston, MA (United States); Myerson, Robert [Washington University School of Medicine, St Louis, MO (United States); Dawson, Laura A. [Department of Radiation Oncology, Princess Margaret Hospital, University of Toronto, Toronto, Ontario (Canada); Willett, Christopher [Department of Radiation Oncology, Duke University Medical Center, Durham, NC (United States); Kachnic, Lisa A. [Department of Radiation Oncology, Boston Medical Center, Boston University School of Medicine, Boston, MA (United States); Jhingran, Anuja [Department of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, TX (United States); Portelance, Lorraine [University of Miami, Miami, FL (United States); Ryu, Janice [Radiation Oncology Centers, Radiological Associates of Sacramento, Sacramento, CA (United States); and others

    2012-07-01

    Purpose: To define a male and female pelvic normal tissue contouring atlas for Radiation Therapy Oncology Group (RTOG) trials. Methods and Materials: One male pelvis computed tomography (CT) data set and one female pelvis CT data set were shared via the Image-Guided Therapy QA Center. A total of 16 radiation oncologists participated. The following organs at risk were contoured in both CT sets: anus, anorectum, rectum (gastrointestinal and genitourinary definitions), bowel NOS (not otherwise specified), small bowel, large bowel, and proximal femurs. The following were contoured in the male set only: bladder, prostate, seminal vesicles, and penile bulb. The following were contoured in the female set only: uterus, cervix, and ovaries. A computer program used the binomial distribution to generate 95% group consensus contours. These contours and definitions were then reviewed by the group and modified. Results: The panel achieved consensus definitions for pelvic normal tissue contouring in RTOG trials with these standardized names: Rectum, AnoRectum, SmallBowel, Colon, BowelBag, Bladder, UteroCervix, Adnexa{sub R}, Adnexa{sub L}, Prostate, SeminalVesc, PenileBulb, Femur{sub R}, and Femur{sub L}. Two additional normal structures whose purpose is to serve as targets in anal and rectal cancer were defined: AnoRectumSig and Mesorectum. Detailed target volume contouring guidelines and images are discussed. Conclusions: Consensus guidelines for pelvic normal tissue contouring were reached and are available as a CT image atlas on the RTOG Web site. This will allow uniformity in defining normal tissues for clinical trials delivering pelvic radiation and will facilitate future normal tissue complication research.

  4. Phase III Randomized Study of 4 Weeks of High-Dose Interferon-α-2b in Stage T2bNO, T3a-bNO, T4a-bNO, and T1-4N1a-2a (microscopic) Melanoma: A Trial of the Eastern Cooperative Oncology Group-American College of Radiology Imaging Network Cancer Research Group (E1697).

    Science.gov (United States)

    Agarwala, Sanjiv S; Lee, Sandra J; Yip, Waiki; Rao, Uma N; Tarhini, Ahmad A; Cohen, Gary I; Reintgen, Douglas S; Evans, Terry L; Brell, Joanna M; Albertini, Mark R; Atkins, Michael B; Dakhil, Shaker R; Conry, Robert M; Sosman, Jeffrey A; Flaherty, Lawrence E; Sondak, Vernon K; Carson, William E; Smylie, Michael G; Pappo, Alberto S; Kefford, Richard F; Kirkwood, John M

    2017-03-10

    Purpose To test the efficacy of 4 weeks of intravenous (IV) induction with high-dose interferon (IFN) as part of the Eastern Cooperative Oncology Group regimen compared with observation (OBS) in patients with surgically resected intermediate-risk melanoma. Patients and Methods In this intergroup international trial, eligible patients had surgically resected cutaneous melanoma in the following categories: (1) T2bN0, (2) T3a-bN0, (3) T4a-bN0, and (4) T1-4N1a-2a (microscopic). Patients were randomly assigned to receive IFN α-2b at 20 MU/m 2 /d IV for 5 days (Monday to Friday) every week for 4 weeks (IFN) or OBS. Stratification factors were pathologic lymph node status, lymph node staging procedure, Breslow depth, ulceration of the primary lesion, and disease stage. The primary end point was relapse-free survival. Secondary end points included overall survival, toxicity, and quality of life. Results A total of 1,150 patients were randomly assigned. At a median follow-up of 7 years, the 5-year relapse-free survival rate was 0.70 (95% CI, 0.66 to 0.74) for OBS and 0.70, (95% CI, 0.66 to 0.74) for IFN ( P = .964). The 5-year overall survival rate was 0.83 (95% CI, 0.79 to 0.86) for OBS and 0.83 (95% CI, 0.80 to 0.86) for IFN ( P = .558). Treatment-related grade 3 and higher toxicity was 4.6% versus 57.9% for OBS and IFN, respectively ( P weeks of IV induction as part of the Eastern Cooperative Oncology Group high-dose IFN regimen is not better than OBS alone for patients with intermediate-risk melanoma as defined in this trial.

  5. Sociodemographic analysis of patients in radiation therapy oncology group clinical trials

    International Nuclear Information System (INIS)

    Chamberlain, Robert M.; Winter, Kathryn A.; Vijayakumar, Srinivasan; Porter, Arthur T.; Roach, M.; Streeter, Oscar; Cox, James D.; Bondy, Melissa L.

    1998-01-01

    Purpose: To assess the degree to which the sociodemographic characteristics of patients enrolled in Radiation Therapy Oncology Group (RTOG) clinical trails are representative of the general population. Methods and Materials: Sociodemographic data were collected on 4016 patients entered in 33 open RTOG studies between July 1991 and June 1994. The data analyzed included educational attainment, age, gender, and race. For comparison, we obtained similar data from the U.S. Department of Census. We also compared our RTOG data with Surveillance Epidemiology and End Results (SEER) data for patients who received radiation therapy, to determine how RTOG patients compared with cancer patients in general, and with patients with cancers at sites typically treated with radiotherapy. Results: Overall, the sociodemographic characteristics of patients entered in RTOG trials were similar to those of the Census data. We found that, in every age group of African-American men and at nearly every level of educational attainment, the proportion of RTOG trial participants mirrored the proportion in the census data. Significant differences were noted only in the youngest category of African-American men, where the RTOG accrues more in the lower educational categories and fewer with college experience. For African-American women, we found a similar pattern in every age group and at each level of educational attainment. As with men, RTOG trials accrued a considerably larger proportion of younger, less educated African-American women than the census reported. Using SEER for comparison, the RTOG enrolled proportionately more African-American men to trials all cancer sites combined, and for prostate and head and neck cancer. In head and neck trials, the RTOG enrolled nearly twice as many African-American men than would be predicted by SEER data. In lung cancer trials, RTOG underrepresented African-American men significantly; however, there was no difference for brain cancer trials. There were

  6. [Diagnosis-related groups as an instrument to develop suitable case-based lump sums in hematology and oncology].

    Science.gov (United States)

    Thalheimer, Markus

    2011-01-01

    In 2003 a new reimbursement system was established for German hospitals. The approximately 17 million inpatient cases per year are now reimbursed based on a per-case payment regarding diagnoses and procedures, which was developed from an internationally approved system. The aim was a better conformity of costs and efforts in in-patient cases. In the first 2 years after implementation, the German diagnosis-related group (DRG) system was not able to adequately represent the complex structures of treatment in hematological and oncological in-patients. By creating new diagnoses and procedures (International Classification of Diseases 10 (ICD-10) and Surgical Operations and Procedures Classification System (OPS) catalogues), generating new DRGs and better splitting of existing ones, the hematology and oncology field could be much better described in the following years. The implementation of about 70 'co-payment structures' for new and expensive drugs and procedures in oncology was also crucial. To reimburse innovations, an additional system of co-payments for innovations was established to bridge the time until innovations are represented within the DRG system itself. In summary, hematological and oncological in-patients, including cases with extraordinary costs, are meanwhile well mapped in the German reimbursement system. Any tendencies to rationing could thereby be avoided, as most of the established procedures and costly drugs are adequately represented in the DRG system. Copyright © 2011 S. Karger AG, Basel.

  7. Response evaluation criteria for solid tumours in dogs (v1.0): a Veterinary Cooperative Oncology Group (VCOG) consensus document.

    Science.gov (United States)

    Nguyen, S M; Thamm, D H; Vail, D M; London, C A

    2015-09-01

    In veterinary medical oncology, there is currently no standardized protocol for assessing response to therapy in solid tumours. The lack of such a formalized guideline makes it challenging to critically compare outcome measures across various treatment protocols. The Veterinary Cooperative Oncology Group (VCOG) membership consensus document presented here is based on the recommendations of a subcommittee of American College of Veterinary Internal Medicine (ACVIM) board-certified veterinary oncologists. This consensus paper has used the human response evaluation criteria in solid tumours (RECIST v1.1) as a framework to establish standard procedures for response assessment in canine solid tumours that is meant to be easy to use, repeatable and applicable across a variety of clinical trial structures in veterinary oncology. It is hoped that this new canine RECIST (cRECIST v1.0) will be adopted within the veterinary oncology community and thereby facilitate the comparison of current and future treatment protocols used for companion animals with cancer. © 2013 Blackwell Publishing Ltd.

  8. Reliability and accuracy assessment of radiation therapy oncology group-endorsed guidelines for brachial plexus contouring

    Energy Technology Data Exchange (ETDEWEB)

    Velde, Joris van de [Ghent University, Department of Anatomy, Ghent (Belgium); Ghent University, Department of Radiotherapy, Ghent (Belgium); Vercauteren, Tom; Gersem, Werner de; Vandecasteele, Katrien; Vuye, Philippe; Vanpachtenbeke, Frank; Neve, Wilfried de [Ghent University, Department of Radiotherapy, Ghent (Belgium); Wouters, Johan; Herde, Katharina d' ; Kerckaert, Ingrid; Hoof, Tom van [Ghent University, Department of Anatomy, Ghent (Belgium)

    2014-07-15

    The goal of this work was to validate the Radiation Therapy Oncology Group (RTOG)-endorsed guidelines for brachial plexus (BP) contouring by determining the intra- and interobserver agreement. Accuracy of the delineation process was determined using anatomically validated imaging datasets as a gold standard. Five observers delineated the right BP on three cadaver computed tomography (CT) datasets. To assess intraobserver variation, every observer repeated each delineation three times with a time interval of 2 weeks. The BP contours were divided into four regions for detailed analysis. Inter- and intraobserver variation was verified using the Computerized Environment for Radiation Research (CERR) software. Accuracy was measured using anatomically validated fused CT-magnetic resonance imaging (MRI) datasets by measuring the BP inclusion of the delineations. The overall kappa (κ) values were rather low (mean interobserver overall κ: 0.29, mean intraobserver overall κ: 0.45), indicating poor inter- and intraobserver reliability. In general, the κ coefficient decreased gradually from the medial to lateral BP regions. The total agreement volume (TAV) was much smaller than the union volume (UV) for all delineations, resulting in a low Jaccard index (JI; interobserver agreement 0-0.124; intraobserver agreement 0.004-0.636). The overall accuracy was poor, with an average total BP inclusion of 38 %. Inclusions were insufficient for the most lateral regions (region 3: 21.5 %; region 4: 12.6 %). The inter- and intraobserver reliability of the RTOG-endorsed BP contouring guidelines was poor. BP inclusion worsened from the medial to lateral regions. Accuracy assessment of the contours showed an average BP inclusion of 38 %. For the first time, this was assessed using the original anatomically validated BP volume. The RTOG-endorsed BP guidelines have insufficient accuracy and reliability, especially for the lateral head-and-neck regions. (orig.) [German] Ziel der Studie war

  9. The use, publication and future directions of immunocytochemistry in veterinary medicine: a consensus of the Oncology-Pathology Working Group.

    Science.gov (United States)

    Priest, H L; Hume, K R; Killick, D; Kozicki, A; Rizzo, V L; Seelig, D; Snyder, L A; Springer, N L; Wright, Z M; Robat, C

    2017-09-01

    One of the primary objectives of the Oncology Pathology Working Group (OPWG), a joint initiative of the Veterinary Cancer Society and the American College of Veterinary Pathologists, is for oncologists and pathologists to collaboratively generate consensus documents to standardize aspects of and provide guidelines for oncologic pathology. Consensus is established through review of relevant peer-reviewed literature relative to a subgroup's particular focus. In this document, the authors provide descriptions of the literature reviewed, the review process, and a summary of the information gathered on immunocytochemistry. The intent of this publication is to help educate practitioners and pathologists on the process of immunocytochemistry and to provide a guide for the use of this technique in veterinary medicine. This document represents the opinions of the working group and the authors and does not constitute a formal endorsement by the American College of Veterinary Pathologists or the Veterinary Cancer Society. © 2016 John Wiley & Sons Ltd.

  10. A decade in banking Ewing sarcoma: a report from the children’s oncology group

    Directory of Open Access Journals (Sweden)

    Scott C. Borinstein

    2013-03-01

    Full Text Available Outcomes for patients with metastatic and recurrent Ewing sarcoma remain poor and a better understanding of the biology of this malignancy is critical to the development of prognostic biomarkers and novel therapies. Therefore, the Children’s Oncology Group (COG has created tissue banking protocols designed to collect high quality clinically annotated tumor specimens that can be distributed to researchers to perform basic science and correlative investigation. Data from the COG Ewing sarcoma tissue banking protocols AEWS02B1 and its successor study AEWS07B1 were reviewed in this study. 635 patients were enrolled on AEWS02B1 and 396 patients have had tissue submitted to AEWS07B1. The average age of participation was 13.2 years. 86% were less than 19 years old and only 6% were greater than 21 years of age at diagnosis. When compared to SEER data, approximately 18% of all cases and only 8% of all patients >20 years old diagnosed with Ewing sarcoma annually in the United States have had tumor banked. The majority of participants submitted formalin fixed paraffin embedded primary tumor and blood samples. In total, fresh frozen tissue was submitted for only 29% of cases. Only 7 metastatic tumor samples have been collected. Although the COG has been successful in collecting tumor samples from patients newly diagnosed with Ewing sarcoma, fresh frozen tumor specimens from primary and metastatic disease are critically needed, especially from young adult patients, in order to conduct high quality basic science and translational research investigation with a goal of developing better treatments.

  11. Current calibration, treatment, and treatment planning techniques among institutions participating in the Children's Oncology Group

    International Nuclear Information System (INIS)

    Urie, Marcia; FitzGerald, T.J.; Followill, David; Laurie, Fran; Marcus, Robert; Michalski, Jeff

    2003-01-01

    Purpose: To report current technology implementation, radiation therapy physics and treatment planning practices, and results of treatment planning exercises among 261 institutions belonging to the Children's Oncology Group (COG). Methods and Materials: The Radiation Therapy Committee of the newly formed COG mandated that each institution demonstrate basic physics and treatment planning abilities by satisfactorily completing a questionnaire and four treatment planning exercises designed by the Quality Assurance Review Center. The planning cases are (1) a maxillary sinus target volume (for two-dimensional planning), (2) a Hodgkin's disease mantle field (for irregular-field and off-axis dose calculations), (3) a central axis blocked case, and (4) a craniospinal irradiation case. The questionnaire and treatment plans were submitted (as of 1/30/02) by 243 institutions and completed satisfactorily by 233. Data from this questionnaire and analyses of the treatment plans with monitor unit calculations are presented. Results: Of the 243 clinics responding, 54% use multileaf collimators routinely, 94% use asymmetric jaws routinely, and 13% use dynamic wedges. Nearly all institutions calibrate their linear accelerators following American Association of Physicists in Medicine protocols, currently 16% with TG-51 and 81% with TG-21 protocol. Treatment planning systems are relied on very heavily for all calculations, including monitor units. Techniques and results of each of the treatment planning exercises are presented. Conclusions: Together, these data provide a unique compilation of current (2001) radiation therapy practices in institutions treating pediatric patients. Overall, the COG facilities have the equipment and the personnel to perform high-quality radiation therapy. With ongoing quality assurance review, radiation therapy compliance with COG protocols should be high

  12. External evaluation of the Radiation Therapy Oncology Group brachial plexus contouring protocol: several issues identified

    International Nuclear Information System (INIS)

    Min, Myo; Carruthers, Scott; Zanchetta, Lydia; Roos, Daniel; Keating, Elly; Shakeshaft, John; Baxi, Siddhartha; Penniment, Michael; Wong, Karen

    2014-01-01

    The aims of the study were to evaluate interobserver variability in contouring the brachial plexus (BP) using the Radiation Therapy Oncology Group (RTOG)-approved protocol and to analyse BP dosimetries. Seven outliners independently contoured the BPs of 15 consecutive patients. Interobserver variability was reviewed qualitatively (visually by using planning axial computed-tomography images and anteroposterior digitally reconstructed radiographs) and quantitatively (by volumetric and statistical analyses). Dose–volume histograms of BPs were calculated and compared. We found significant interobserver variability among outliners in both qualitative and quantitative analyses. These were most pronounced for the T1 nerve roots on visual inspection and for the BP volume on statistical analysis. The BP volumes were smaller than those described in the RTOG atlas paper, with a mean volume of 20.8cc (range 11–40.7 cc) compared with 33±4cc (25.1–39.4cc). The average values of mean dose, maximum dose, V60Gy, V66Gy and V70Gy for patients treated with conventional radiotherapy and IMRT were 42.2Gy versus 44.8Gy, 64.5Gy versus 68.5Gy, 6.1% versus 7.6%, 2.9% versus 2.4% and 0.6% versus 0.3%, respectively. This is the first independent external evaluation of the published protocol. We have identified several issues, including significant interobserver variation. Although radiation oncologists should contour BPs to avoid dose dumping, especially when using IMRT, the RTOG atlas should be used with caution. Because BPs are largely radiologically occult on CT, we propose the term brachial-plexus regions (BPRs) to represent regions where BPs are likely to be present. Consequently, BPRs should in principle be contoured generously.

  13. A Decade in Banking Ewing Sarcoma: A Report from the Children’s Oncology Group

    Science.gov (United States)

    Borinstein, Scott C.; Beeler, Natalie; Block, John J.; Gorlick, Richard; Grohar, Patrick; Jedlicka, Paul; Krailo, Mark; Morris, Carol; Phillips, Sharon; Siegal, Gene P.; Lawlor, Elizabeth R.; Lessnick, Stephen L.

    2013-01-01

    Outcomes for patients with metastatic and recurrent Ewing sarcoma remain poor and a better understanding of the biology of this malignancy is critical to the development of prognostic biomarkers and novel therapies. Therefore, the Children’s Oncology Group (COG) has created tissue banking protocols designed to collect high quality, clinically annotated, tumor specimens that can be distributed to researchers to perform basic science and correlative investigation. Data from the COG Ewing sarcoma tissue banking protocols AEWS02B1 and its successor study AEWS07B1 were reviewed in this study. Six-hundred and thirty five patients were enrolled on AEWS02B1 and 396 patients have had tissue submitted to AEWS07B1. The average age of participation was 13.2 years. About 86% were less than 19 years old and only 6% were greater than 21 years of age at diagnosis. When compared to SEER data, approximately 18% of all cases and only 8% of all patients >20 years old diagnosed with Ewing sarcoma annually in the United States have had tumor banked. The majority of participants submitted formalin fixed, paraffin embedded, primary tumor and blood samples. In total, fresh frozen tissue was submitted for only 29% of cases. Only seven metastatic tumor samples have been collected. Although the COG has been successful in collecting tumor samples from patients newly diagnosed with Ewing sarcoma, fresh frozen tumor specimens from primary and metastatic disease are critically needed, especially from young adult patients, in order to conduct high quality basic science and translational research investigation with a goal of developing better treatments. PMID:23519678

  14. Young patients', parents', and survivors' communication preferences in paediatric oncology: using online focus groups.

    NARCIS (Netherlands)

    Zwaanswijk, M.; Tates, K.; Dulmen, S. van; Hoogerbrugge, M.; Kamps, W.A.; Bensing, J.M.

    2007-01-01

    BACKGROUND: Guidelines in paediatric oncology encourage health care providers to share relevant information with young patients and parents to enable their active participation in decision making. It is not clear to what extent this mirrors patients' and parents' preferences. This study investigated

  15. Pretreatment Quality of Life Predicts for Locoregional Control in Head and Neck Cancer Patients: A Radiation Therapy Oncology Group Analysis

    International Nuclear Information System (INIS)

    Siddiqui, Farzan; Pajak, Thomas F.; Watkins-Bruner, Deborah; Konski, Andre A.; Coyne, James C.; Gwede, Clement K.; Garden, Adam S.; Spencer, Sharon A.; Jones, Christopher; Movsas, Benjamin

    2008-01-01

    Purpose: To analyze the prospectively collected health-related quality-of-life (HRQOL) data from patients enrolled in two Radiation Therapy Oncology Group randomized Phase III head and neck cancer trials (90-03 and 91-11) to assess their value as an independent prognostic factor for locoregional control (LRC) and/or overall survival (OS). Methods and Materials: HRQOL questionnaires, using a validated instrument, the Functional Assessment of Cancer Therapy-Head and Neck (FACT-H and N), version 2, were completed by patients before the start of treatment. OS and LRC were the outcome measures analyzed using a multivariate Cox proportional hazard model. Results: Baseline FACT-H and N data were available for 1,093 patients and missing for 417 patients. No significant difference in outcome was found between the patients with and without baseline FACT-H and N data (p = 0.58). The median follow-up time was 27.2 months for all patients and 49 months for surviving patients. Multivariate analyses were performed for both OS and LRC. Beyond tumor and nodal stage, Karnofsky performance status, primary site, cigarette use, use of concurrent chemotherapy, and altered fractionation schedules, the FACT-H and N score was independently predictive of LRC (but not OS), with p = 0.0038. The functional well-being component of the FACT-H and N predicted most significantly for LRC (p = 0.0004). Conclusions: This study represents, to our knowledge, the largest analysis of HRQOL as a prognostic factor in locally advanced head and neck cancer patients. The results of this study have demonstrated the importance of baseline HRQOL as a significant and independent predictor of LRC in patients with locally advanced head and neck cancer

  16. Long-term oncological outcomes of a phase II trial of neoadjuvant chemohormonal therapy followed by radical prostatectomy for patients with clinically localised, high-risk prostate cancer.

    Science.gov (United States)

    Silberstein, Jonathan L; Poon, Stephen A; Sjoberg, Daniel D; Maschino, Alexandra C; Vickers, Andrew J; Bernie, Aaron; Konety, Badrinath R; Kelly, W Kevin; Eastham, James A

    2015-07-01

    To determine long-term oncological outcomes of radical prostatectomy (RP) after neoadjuvant chemohormonal therapy (CHT) for clinically localised, high-risk prostate cancer. In this phase II multicentre trial of patients with high-risk prostate cancer (PSA level >20 ng/mL, Gleason ≥8, or clinical stage ≥T3), androgen-deprivation therapy (goserelin acetate depot) and paclitaxel, carboplatin and estramustine were administered before RP. We report the long-term oncological outcomes of these patients and compared them to a contemporary cohort who met oncological inclusion criteria but received RP only. In all, 34 patients were enrolled and followed for a median of 13.1 years. Within 10 years most patients had biochemical recurrence (BCR-free probability 22%; 95% confidence interval [CI] 10-37%). However, the probability of disease-specific survival at 10 years was 84% (95% CI 66-93%) and overall survival was 78% (95% CI 60-89%). The CHT group had higher-risk features than the comparison group (123 patients), with an almost doubled risk of calculated preoperative 5-year BCR (69% vs 36%, P < 0.01). After adjusting for these imbalances the CHT group had trends toward improvement in BCR (hazard ratio [HR] 0.76, 95% CI 0.43-1.34; P = 0.3) and metastasis-free survival (HR 0.55, 95% CI 0.24-1.29; P = 0.2) although these were not statistically significant. Neoadjuvant CHT followed by RP was associated with lower rates of BCR and metastasis compared with the RP-only group; however, these results were not statistically significant. Because this treatment strategy has known harms and unproven benefit, this strategy should only be instituted in the setting of a clinical trial. © 2014 The Authors BJU International © 2014 BJU International Published by John Wiley & Sons Ltd.

  17. Preliminary evaluation of factors associated with premature trial closure and feasibility of accrual benchmarks in phase III oncology trials.

    Science.gov (United States)

    Schroen, Anneke T; Petroni, Gina R; Wang, Hongkun; Gray, Robert; Wang, Xiaofei F; Cronin, Walter; Sargent, Daniel J; Benedetti, Jacqueline; Wickerham, Donald L; Djulbegovic, Benjamin; Slingluff, Craig L

    2010-08-01

    A major challenge for randomized phase III oncology trials is the frequent low rates of patient enrollment, resulting in high rates of premature closure due to insufficient accrual. We conducted a pilot study to determine the extent of trial closure due to poor accrual, feasibility of identifying trial factors associated with sufficient accrual, impact of redesign strategies on trial accrual, and accrual benchmarks designating high failure risk in the clinical trials cooperative group (CTCG) setting. A subset of phase III trials opened by five CTCGs between August 1991 and March 2004 was evaluated. Design elements, experimental agents, redesign strategies, and pretrial accrual assessment supporting accrual predictions were abstracted from CTCG documents. Percent actual/predicted accrual rate averaged per month was calculated. Trials were categorized as having sufficient or insufficient accrual based on reason for trial termination. Analyses included univariate and bivariate summaries to identify potential trial factors associated with accrual sufficiency. Among 40 trials from one CTCG, 21 (52.5%) trials closed due to insufficient accrual. In 82 trials from five CTCGs, therapeutic trials accrued sufficiently more often than nontherapeutic trials (59% vs 27%, p = 0.05). Trials including pretrial accrual assessment more often achieved sufficient accrual than those without (67% vs 47%, p = 0.08). Fewer exclusion criteria, shorter consent forms, other CTCG participation, and trial design simplicity were not associated with achieving sufficient accrual. Trials accruing at a rate much lower than predicted (accrual rate) were consistently closed due to insufficient accrual. This trial subset under-represents certain experimental modalities. Data sources do not allow accounting for all factors potentially related to accrual success. Trial closure due to insufficient accrual is common. Certain trial design factors appear associated with attaining sufficient accrual. Defining

  18. Dose Specification and Quality Assurance of Radiation Therapy Oncology Group Protocol 95-17; a Cooperative Group Study of Iridium-192 Breast Implants as Sole Therapy

    International Nuclear Information System (INIS)

    Ibbott, Geoffrey S.; Hanson, W.F.; O'Meara, Elizabeth; Kuske, Robert R.; Arthur, Douglas; Rabinovitch, Rachel; White, Julia; Wilenzick, Raymond M.; Harris, Irene; Tailor, Ramesh C.

    2007-01-01

    Purpose: The Radiation Therapy Oncology Group (RTOG) protocol 95-17 was a Phase I/II trial to evaluate multicatheter brachytherapy as the sole method of adjuvant breast radiotherapy for Stage I/II breast carcinoma after breast-conserving surgery. Low- or high-dose-rate sources were allowed. Dose prescription and treatment evaluation were based on recommendations in the International Commission on Radiation Units and Measurements (ICRU), Report 58 and included the parameters mean central dose (MCD), average peripheral dose, dose homogeneity index (DHI), and the dimensions of the low- and high-dose regions. Methods and Materials: Three levels of quality assurance were implemented: (1) credentialing of institutions was required before entering patients into the study; (2) rapid review of each treatment plan was conducted before treatment; and (3) retrospective review was performed by the Radiological Physics Center in conjunction with the study chairman and RTOG dosimetry staff. Results: Credentialing focused on the accuracy of dose calculation algorithm and compliance with protocol guidelines. Rapid review was designed to identify and correct deviations from the protocol before treatment. The retrospective review involved recalculation of dosimetry parameters and review of dose distributions to evaluate the treatment. Specifying both central and peripheral doses resulted in uniform dose distributions, with a mean dose homogeneity index of 0.83 ± 0.06. Conclusions: Vigorous quality assurance resulted in a high-quality study with few deviations; only 4 of 100 patients were judged as representing minor variations from protocol, and no patient was judged as representing major deviation. This study should be considered a model for quality assurance of future trials

  19. Examestane in advanced or recurrent endometrial carcinoma: a prospective phase II study by the Nordic Society of Gynecologic Oncology (NSGO)

    International Nuclear Information System (INIS)

    Lindemann, Kristina; Nordstrøm, Britta; Malander, Susanne; Christensen, Rene D; Mirza, Mansoor R; Kristensen, Gunnar B; Aavall-Lundqvist, Elisabeth; Vergote, Ignace; Rosenberg, Per; Boman, Karin

    2014-01-01

    We evaluated the efficacy and safety of the aromatase inhibitor exemestane in patients with advanced, persistent or recurrent endometrial carcinoma. We performed an open-label one-arm, two-stage, phase II study of 25 mg of oral exemestane in 51 patients with advanced (FIGO stage III-IV) or relapsed endometrioid endometrial cancer. Patients were stratified into subsets of estrogen receptor (ER) positive and ER negative patients. Recruitment to the ER negative group was stopped prematurely after 12 patients due to slow accrual. In the ER positive patients, we observed an overall response rate of 10%, and a lack of progression after 6 months in 35% of the patients. No responses were registered in the ER negative patients, and all had progressive disease within 6 months. For the total group of patients, the median progression free survival (PFS) was 3.1 months (95% CI: 2.0-4.1). In the ER positive patients the median PFS was 3.8 months (95% CI: 0.7-6.9) and in the ER negative patients it was 2.6 months (95% CI: 2.1-3-1). In the ER positive patients the median overall survival (OS) time was 13.3 months (95% CI: 7.7-18.9), in the ER negative patients the corresponding numbers were 6.1 months (95% CI: 4.1-8.2). Treatment with exemestane was well tolerated. Treatment of estrogen positive advanced or recurrent endometrial cancer with exemestane, an aromatase inhibitor, resulted in a response rate of 10% and lack of progression after 6 months in 35% of the patients. Trial identification number (Clinical Trials.gov): http://www.clinicaltrials.gov/NCT01965080. Nordic Society of Gynecological Oncology: NSGO–EC–0302. EudraCT number: 2004-001103-35

  20. Oral and dental late effects in survivors of childhood cancer: a Children’s Oncology Group report

    Science.gov (United States)

    Migliorati, Cesar A.; Hudson, Melissa M.; McMullen, Kevin P.; Kaste, Sue C.; Ruble, Kathy; Guilcher, Gregory M. T.; Shah, Ami J.; Castellino, Sharon M.

    2014-01-01

    Purpose Multi-modality therapy has resulted in improved survival for childhood malignancies. The Children’s Oncology Group Long-Term Follow-Up Guidelines for Survivors of Childhood, Adolescent, and Young Adult Cancers provide practitioners with exposure- and risk-based recommendations for the surveillance and management of asymptomatic survivors who are at least 2 years from completion of therapy. This review outlines the pathophysiology and risks for oral and dental late effects in pediatric cancer survivors and the rationale for oral and dental screening recommended by the Children’s Oncology Group. Methods An English literature search for oral and dental complications of childhood cancer treatment was undertaken via MEDLINE and encompassed January 1975 to January 2013. Proposed guideline content based on the literature review was approved by a multi-disciplinary panel of survivorship experts and scored according to a modified version of the National Comprehensive Cancer Network “Categories of Consensus” system. Results The Children’s Oncology Group oral-dental pan el selected 85 relevant citations. Childhood cancer therapy may impact tooth development, salivary function, craniofacial development, and temporomandibular joint function placing some childhood cancer survivors at an increased risk for poor oral and dental health. Addition ally, head and neck radiation and hematopoietic stem cell transplantation increase the risk of subsequent ma lignant neoplasms in the oral cavity. Survivors require routine dental care to evaluate for potential side effects and initiate early treatment. Conclusions Certain childhood cancer survivors are at an increased risk for poor oral and dental health. Early identification of oral and dental morbidity and early interventions can optimize health and quality of life. PMID:24781353

  1. Evaluation of the quality of the reporting of phase II clinical trials in oncology: A systematic review.

    Science.gov (United States)

    Rivoirard, Romain; Langrand-Escure, Julien; Oriol, Mathieu; Tinquaut, Fabien; Chauvin, Franck; Rancoule, Chloé; Magné, Nicolas; Bourmaud, Aurélie

    2018-05-01

    To describe the current state of knowledge concerning the quality of reporting in phase II clinical trials in oncology and to describe the various methods published allowing this quality evaluation. databases including MEDLINE and COCHRANE were searched. Reviews and meta-analyses analyzing the quality of the reporting of phase II trials in oncology were included. Descriptive analysis of the results was performed. Thirteen publications were retained. Only 2 publications adopted a systematic approach of evaluation of the quality of reporting by overall scores. The Key Methodological Score (KMS), proposed by Grellety et al., gathering 3 items, seemed adapted for such an evaluation. A score of 3/3 was found in 16.1% of the 156 phase II trials analysed by this score. The other reviews used a qualitative analysis to evaluate the reporting, via an analysis of a single criterion, generally the statistical plan of the study. This item was considered as having been correctly reported in less than 50% of the analysed articles. The quality of reporting in phase II trials in oncology is a field that has been investigated very little (13 publications). When it is studied, the estimated level of quality is not satisfactory, whatever the method employed. The use of an overall score of evaluation is a path which should be pursued, in order to get reliable results. It also seems necessary to propose strong recommendations, which would create a consensus for the methodology and the reporting of these studies. Copyright © 2018 Elsevier B.V. All rights reserved.

  2. Coping style and performance status in a group of oncological inpatients

    Directory of Open Access Journals (Sweden)

    Cecilia Chau Pérez-Aranibar

    2002-06-01

    Full Text Available The associations between coping styles, measured by COPE Test, dispositional version (Carver,Scheier and Weintraub, 1989, and Health Status inferred through a performance status, measured by Karnofsky's Index of Behavioral Performance are examined. The study focuses upon 28 oncological in patients. Positive moderate Pearson's correlations were found between these two variables in this correlational-descriptive study. These were interpreted in the following sense: the larger use of the style, the less health status among the scales suppression of competent activities, procrastination of coping, instrumental social support, focusing and releasing of emotions and behavioral disengagement. The active coping scale presented a negative correlationwith regard to Performance Status as a health measure.

  3. Renormalization group approach to QCD phase transitions

    International Nuclear Information System (INIS)

    Midorikawa, S.; Yoshimoto, S.; So, H.

    1987-01-01

    Effective scalar theories for QCD are proposed to investigate the deconfining and chiral phase transitions. The orders of the phase transitions are determined by infrared stabilities of the fixed points. It is found that the transitions in SU(3) gauge theories are of 1st order for any number of massless flavors. The cases of SU(2) and SU(4) gauge theories are also discussed. (orig.)

  4. Modern Radiation Therapy for Extranodal Lymphomas: Field and Dose Guidelines From the International Lymphoma Radiation Oncology Group

    Energy Technology Data Exchange (ETDEWEB)

    Yahalom, Joachim, E-mail: yahalomj@mskcc.org [Department of Radiation Oncology, Memorial Sloan-Kettering Cancer Center, New York, New York (United States); Illidge, Tim [Institute of Cancer Sciences, University of Manchester, Manchester Academic Health Sciences Centre, The Christie National Health Service Foundation Trust, Manchester (United Kingdom); Specht, Lena [Department of Oncology and Hematology, Rigshospitalet, University of Copenhagen, Copenhagen (Denmark); Hoppe, Richard T. [Department of Radiation Oncology, Stanford University, Palo Alto, California (United States); Li, Ye-Xiong [Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (China); Tsang, Richard [Department of Radiation Oncology, Princess Margaret Hospital, University of Toronto, Toronto, Ontario (Canada); Wirth, Andrew [Division of Radiation Oncology, Peter MacCallum Cancer Institute, St. Andrews Place, East Melbourne (Australia)

    2015-05-01

    Extranodal lymphomas (ENLs) comprise about a third of all non-Hodgkin lymphomas (NHL). Radiation therapy (RT) is frequently used as either primary therapy (particularly for indolent ENL), consolidation after systemic therapy, salvage treatment, or palliation. The wide range of presentations of ENL, involving any organ in the body and the spectrum of histological sub-types, poses a challenge both for routine clinical care and for the conduct of prospective and retrospective studies. This has led to uncertainty and lack of consistency in RT approaches between centers and clinicians. Thus far there is a lack of guidelines for the use of RT in the management of ENL. This report presents an effort by the International Lymphoma Radiation Oncology Group (ILROG) to harmonize and standardize the principles of treatment of ENL, and to address the technical challenges of simulation, volume definition and treatment planning for the most frequently involved organs. Specifically, detailed recommendations for RT volumes are provided. We have applied the same modern principles of involved site radiation therapy as previously developed and published as guidelines for Hodgkin lymphoma and nodal NHL. We have adopted RT volume definitions based on the International Commission on Radiation Units and Measurements (ICRU), as has been widely adopted by the field of radiation oncology for solid tumors. Organ-specific recommendations take into account histological subtype, anatomy, the treatment intent, and other treatment modalities that may be have been used before RT.

  5. Modern Radiation Therapy for Extranodal Lymphomas: Field and Dose Guidelines From the International Lymphoma Radiation Oncology Group

    International Nuclear Information System (INIS)

    Yahalom, Joachim; Illidge, Tim; Specht, Lena; Hoppe, Richard T.; Li, Ye-Xiong; Tsang, Richard; Wirth, Andrew

    2015-01-01

    Extranodal lymphomas (ENLs) comprise about a third of all non-Hodgkin lymphomas (NHL). Radiation therapy (RT) is frequently used as either primary therapy (particularly for indolent ENL), consolidation after systemic therapy, salvage treatment, or palliation. The wide range of presentations of ENL, involving any organ in the body and the spectrum of histological sub-types, poses a challenge both for routine clinical care and for the conduct of prospective and retrospective studies. This has led to uncertainty and lack of consistency in RT approaches between centers and clinicians. Thus far there is a lack of guidelines for the use of RT in the management of ENL. This report presents an effort by the International Lymphoma Radiation Oncology Group (ILROG) to harmonize and standardize the principles of treatment of ENL, and to address the technical challenges of simulation, volume definition and treatment planning for the most frequently involved organs. Specifically, detailed recommendations for RT volumes are provided. We have applied the same modern principles of involved site radiation therapy as previously developed and published as guidelines for Hodgkin lymphoma and nodal NHL. We have adopted RT volume definitions based on the International Commission on Radiation Units and Measurements (ICRU), as has been widely adopted by the field of radiation oncology for solid tumors. Organ-specific recommendations take into account histological subtype, anatomy, the treatment intent, and other treatment modalities that may be have been used before RT

  6. Building a National Framework for Adolescent and Young Adult Hematology and Oncology and Transition from Pediatric to Adult Care: Report of the Inaugural Meeting of the "AjET" Working Group of the German Society for Pediatric Oncology and Hematology.

    Science.gov (United States)

    Escherich, Gabriele; Bielack, Stefan; Maier, Stephan; Braungart, Ralf; Brümmendorf, Tim H; Freund, Mathias; Grosse, Regine; Hoferer, Anette; Kampschulte, Rebecca; Koch, Barbara; Lauten, Melchior; Milani, Valeria; Ross, Henning; Schilling, Freimut; Wöhrle, Dieter; Cario, Holger; Dirksen, Uta

    2017-06-01

    Adolescents and young adults (AYAs) with hemato-oncological problems constitute a heterogenous group with characteristic particularities, specific needs, and age-related clinical and unique psychosocial features. Strong collaboration between pediatric and adult hemato-oncology settings is essential to address their needs appropriately. This is not only true for patients who first become ill during adolescence or young adulthood, but equally so for people who contract hemato-oncological diseases congenitally or as younger children and who are now becoming old enough to leave the pediatric setting and have to transit into "adult" medical care. Efforts to create environments that meet the specific needs of the AYA population affected by hemato-oncological diseases have been initiated in many countries. Due to international variations between societies in general and healthcare infrastructures in particular, the challenges posed to creating such environments vary considerably from country to country. Aiming at addressing these on a national basis for Germany, a dedicated Working Group on Adolescents, Young Adults, and Transition (Arbeitsgemeinschaft Adoleszenten, junge Erwachsene, Transition, AjET) was established. This meeting report depicts the content and discussions of the first interdisciplinary conference on treatment, transition, and long-term follow-up in AYAs with cancer or chronic/inborn hematological diseases. The AjET group of the German Society for Pediatric Oncology and Hematology (GPOH) intends to increase the national awareness for AYAs; strengthen the collaboration of pediatric and adult care givers; and initiate, promote, and coordinate collaborative activities in the fields of basic and translational research, clinical care, and long-term follow-up aimed at improving the current situation.

  7. Exercise and Fatigue in Adolescent and Young Adult Survivors of Hodgkin Lymphoma: A Report from the Children's Oncology Group

    Science.gov (United States)

    Hooke, Mary C.; Friedman, Debra L.; Campbell, Kristin; Withycombe, Janice; Schwartz, Cindy L.; Kelly, Kara; Meza, Jane

    2015-01-01

    Fatigue is a significant problem for adolescent and young adult (AYA) Hodgkin lymphoma (HL) survivors. The relationship between exercise and fatigue is complex. This study explored the trajectory of and the relationship between exercise and fatigue over 36 months post-therapy in a cohort of 103 AYA-aged HL survivors treated on Children's Oncology Group (COG) study AHOD0031. Descriptive statistics and generalized estimating equations were used in this secondary data analysis. Exercise and fatigue improved over time but were unrelated; amount of exercise at end of therapy predicted amount of exercise at 12 (p = 0.02) and 36 (p = 0.0008) months post-therapy. PMID:26421221

  8. Developing a decision-making model based on an interdisciplinary oncological care group for the management of colorectal cancer.

    Science.gov (United States)

    Genovesi, Domenico; Mazzilli, Lorenzo; Trignani, Marianna; DI Tommaso, Monica; Nuzzo, Antonio; Biondi, Edoardo; Tinari, Nicola; Martino, Maria Teresa; Innocenti, Paolo; DI Sebastiano, Pierluigi; Mazzola, Lorenzo; Lanci, Carmine; Neri, Matteo; Laterza, Francesco; Marino, Maria; Ferrini, Giovanni; Spadaccini, Antonio; Filippone, Antonella; DI Giandomenico, Enzo; Marulli, Antonio; Palombo, Giuseppe; Sparvieri, Antonio; Marchetti, Antonio; Pizzicannella, Giuseppe; Petrini, Flavia; DI Felice, Maria; Ottaviani, Floriana; Monteodorisio, Antonio; DI Nicola, Marta; Cefaro, Giampiero Ausili

    2014-05-01

    To report our experience on implementation and preliminary results of a decision-making model based on the recommendations of an Interdisciplinary Oncological Care Group developed for the management of colorectal cancer. The multidisciplinary team identified a reference guideline using appraisal of guidelines for research and evaluation (AGREE) tool based on a sequential assessment of the guideline quality. Thereafter, internal guidelines with diagnostic and therapeutic management for early, locally advanced and metastatic colonic and rectal cancer were drafted; organizational aspects, responsibility matrices, protocol actions for each area of specialty involved and indicators for performing audits were also defined. The National Institute for Health and Care Excellence (NICE) UK guideline was the reference for drafting the internal guideline document; from February to November 2013, 125 patients with colorectal cancer were discussed by and taken under the care of the Interdisciplinary Oncological Care Group. The first audit performed in December 2013 revealed optimal adherence to the internal guideline, mainly in terms of uniformity and accuracy of perioperative staging, coordination and timing of multi-modal therapies. To date, all patients under observation are within the diagnostic and therapeutic course, no patient came out from the multidisciplinary "path" and only in 14% of cases have the first recommendations proposed been changed. The selected indicators appear effective and reliable, while at the moment, it is not yet possible to assess the impact of the multidisciplinary team on clinical outcome. Although having a short observation period, our model seems capable of determining optimal uniformity of diagnostic and therapeutic management, to a high degree of patient satisfaction. A longer observation period is necessary in order to confirm these observations and for assessing the impact on clinical outcome.

  9. Impact of cancer support groups on childhood cancer treatment and abandonment in a private pediatric oncology centre

    Directory of Open Access Journals (Sweden)

    Arathi Srinivasan

    2015-01-01

    Full Text Available Aims: To analyze the impact of two cancer support groups in the treatment and abandonment of childhood cancer. Materials and Methods: This is a retrospective review of children with cancer funded and non-funded who were treated at Kanchi Kamakoti CHILDS Trust Hospital from 2010 to 2013. A total of 100 patients were funded, 57 by Ray of Light Foundation and 43 by Pediatric Lymphoma Project and 70 non-funded. Results: The total current survival of 80%, including those who have completed treatment and those currently undergoing treatment, is comparable in both the groups. Abandonment of treatment after initiating therapy was not seen in the financially supported group whereas abandonment of treatment after initiation was seen in one child in the non-funded group. Conclusions: Besides intensive treatment with good supportive care, financial support also has an important impact on compliance and abandonment in all socioeconomic strata of society. Financial support from private cancer support groups also has its impact beyond the patient and family, in reducing the burden on government institutions by non-governmental funding in private sector. Improvement in the delivery of pediatric oncology care in developing countries could be done by financial support from the private sector.

  10. A SAS-based solution to evaluate study design efficiency of phase I pediatric oncology trials via discrete event simulation.

    Science.gov (United States)

    Barrett, Jeffrey S; Jayaraman, Bhuvana; Patel, Dimple; Skolnik, Jeffrey M

    2008-06-01

    Previous exploration of oncology study design efficiency has focused on Markov processes alone (probability-based events) without consideration for time dependencies. Barriers to study completion include time delays associated with patient accrual, inevaluability (IE), time to dose limiting toxicities (DLT) and administrative and review time. Discrete event simulation (DES) can incorporate probability-based assignment of DLT and IE frequency, correlated with cohort in the case of DLT, with time-based events defined by stochastic relationships. A SAS-based solution to examine study efficiency metrics and evaluate design modifications that would improve study efficiency is presented. Virtual patients are simulated with attributes defined from prior distributions of relevant patient characteristics. Study population datasets are read into SAS macros which select patients and enroll them into a study based on the specific design criteria if the study is open to enrollment. Waiting times, arrival times and time to study events are also sampled from prior distributions; post-processing of study simulations is provided within the decision macros and compared across designs in a separate post-processing algorithm. This solution is examined via comparison of the standard 3+3 decision rule relative to the "rolling 6" design, a newly proposed enrollment strategy for the phase I pediatric oncology setting.

  11. Elective Clinical Target Volumes for Conformal Therapy in Anorectal Cancer: A Radiation Therapy Oncology Group Consensus Panel Contouring Atlas

    International Nuclear Information System (INIS)

    Myerson, Robert J.; Garofalo, Michael C.; El Naqa, Issam; Abrams, Ross A.; Apte, Aditya; Bosch, Walter R.; Das, Prajnan; Gunderson, Leonard L.; Hong, Theodore S.; Kim, J.J. John; Willett, Christopher G.; Kachnic, Lisa A.

    2009-01-01

    Purpose: To develop a Radiation Therapy Oncology Group (RTOG) atlas of the elective clinical target volume (CTV) definitions to be used for planning pelvic intensity-modulated radiotherapy (IMRT) for anal and rectal cancers. Methods and Materials: The Gastrointestinal Committee of the RTOG established a task group (the nine physician co-authors) to develop this atlas. They responded to a questionnaire concerning three elective CTVs (CTVA: internal iliac, presacral, and perirectal nodal regions for both anal and rectal case planning; CTVB: external iliac nodal region for anal case planning and for selected rectal cases; CTVC: inguinal nodal region for anal case planning and for select rectal cases), and to outline these areas on individual computed tomographic images. The imaging files were shared via the Advanced Technology Consortium. A program developed by one of the co-authors (I.E.N.) used binomial maximum-likelihood estimates to generate a 95% group consensus contour. The computer-estimated consensus contours were then reviewed by the group and modified to provide a final contouring consensus atlas. Results: The panel achieved consensus CTV definitions to be used as guidelines for the adjuvant therapy of rectal cancer and definitive therapy for anal cancer. The most important difference from similar atlases for gynecologic or genitourinary cancer is mesorectal coverage. Detailed target volume contouring guidelines and images are discussed. Conclusion: This report serves as a template for the definition of the elective CTVs to be used in IMRT planning for anal and rectal cancers, as part of prospective RTOG trials.

  12. Patterns of Radiotherapy Practice for Pancreatic Cancer in Japan: Results of the Japanese Radiation Oncology Study Group (JROSG) Survey

    International Nuclear Information System (INIS)

    Ogawa, Kazuhiko; Ito, Yoshinori; Karasawa, Katsuyuki; Ogawa, Yoshihiro; Onishi, Hiroshi; Kazumoto, Tomoko; Shibuya, Keiko; Shibuya, Hitoshi; Okuno, Yoshishige; Nishino, Shigeo; Ogo, Etsuyo; Uchida, Nobue; Karasawa, Kumiko; Nemoto, Kenji; Nishimura, Yasumasa

    2010-01-01

    Purpose: To determine the patterns of radiotherapy practice for pancreatic cancer in Japan. Methods and Materials: A questionnaire-based national survey of radiotherapy for pancreatic cancer treated between 2000 and 2006 was conducted by the Japanese Radiation Oncology Study Group (JROSG). Detailed information on 870 patients from 34 radiation oncology institutions was accumulated. Results: The median age of all patients was 64 years (range, 36-88), and 80.2% of the patients had good performance status. More than 85% of patients had clinical Stage T3-T4 disease, and 68.9% of patients had unresectable disease at diagnosis. Concerning radiotherapy (RT), 49.8% of patients were treated with radical external beam RT (EBRT) (median dose, 50.4 Gy), 44.4% of patients were treated with intraoperative RT (median dose, 25 Gy) with or without EBRT (median dose, 45 Gy), and 5.9% of patients were treated with postoperative radiotherapy (median dose, 50 Gy). The treatment field consisted of the primary tumor (bed) only in 55.6% of the patients. Computed tomography-based treatment planning and conformal RT was used in 93.1% and 83.1% of the patients treated with EBRT, respectively. Chemotherapy was used for 691 patients (79.4%; before RT for 66 patients; during RT for 531; and after RT for 364). Gemcitabine was the most frequently used drug, followed by 5-fluorouracil. Conclusion: This study describes the general patterns of RT practice for pancreatic cancer in Japan. Most patients had advanced unresectable disease, and radical EBRT, as well as intraoperative RT with or without EBRT, was frequently used. Chemotherapy with gemcitabine was commonly used in conjunction with RT during the survey period.

  13. Evaluation of the prognostic role of centromere 17 gain and HER2/topoisomerase II alpha gene status and protein expression in patients with breast cancer treated with anthracycline-containing adjuvant chemotherapy: pooled analysis of two Hellenic Cooperative Oncology Group (HeCOG) phase III trials

    International Nuclear Information System (INIS)

    Fountzilas, George; Tsolaki, Eleftheria; Televantou, Despina; Timotheadou, Eleni; Koutras, Angelos; Klouvas, George; Samantas, Epaminontas; Pisanidis, Nikolaos; Karanikiotis, Charisios; Sfakianaki, Ioanna; Pavlidis, Nicholas; Dafni, Urania; Gogas, Helen; Linardou, Helena; Kalogeras, Konstantine T; Pectasides, Dimitrios; Dimopoulos, Meletios A; Bobos, Mattheos; Kotoula, Vassiliki; Batistatou, Anna; Xanthakis, Ioannis; Papadimitriou, Christos; Kostopoulos, Ioannis; Koletsa, Triantafillia

    2013-01-01

    The HER2 gene has been established as a valid biological marker for the treatment of breast cancer patients with trastuzumab and probably other agents, such as paclitaxel and anthracyclines. The TOP2A gene has been associated with response to anthracyclines. Limited information exists on the relationship of HER2/TOP2A gene status in the presence of centromere 17 (CEP17) gain with outcome of patients treated with anthracycline-containing adjuvant chemotherapy. Formalin-fixed paraffin-embedded tumor tissue samples from 1031 patients with high-risk operable breast cancer, enrolled in two consecutive phase III trials, were assessed in a central laboratory by fluorescence in situ hybridization for HER2/TOP2A gene amplification and CEP17 gain (CEP17 probe). Amplification of HER2 and TOP2A were defined as a gene/CEP17 ratio of >2.2 and ≥2.0, respectively, or gene copy number higher than 6. Additionally, HER2, TopoIIa, ER/PgR and Ki67 protein expression was assessed by immunohistochemistry (IHC) and patients were classified according to their IHC phenotype. Treatment consisted of epirubicin-based adjuvant chemotherapy followed by hormonal therapy and radiation, as indicated. HER2 amplification was found in 23.7% of the patients and TOP2A amplification in 10.1%. In total, 41.8% of HER2-amplified tumors demonstrated TOP2A co-amplification. The median (range) of HER2, TOP2A and CEP17 gain was 2.55 (0.70-45.15), 2.20 (0.70-26.15) and 2.00 (0.70-26.55), respectively. Forty percent of the tumors had CEP17 gain (51% of those with HER2 amplification). Adjusting for treatment groups in the Cox model, HER2 amplification, TOP2A amplification, CEP17 gain and HER2/TOP2A co-amplification were not associated with time to relapse or time to death. HER2 amplification, TOP2A amplification, CEP17 gain and HER2/TOP2A co-amplification were not associated with outcome in high-risk breast cancer patients treated with anthracycline-based adjuvant chemotherapy. Australian New Zealand Clinical

  14. Recommendations for the Return of Research Results to Study Participants and Guardians: A Report From the Children's Oncology Group

    Science.gov (United States)

    Fernandez, Conrad V.; Ruccione, Kathleen; Wells, Robert J.; Long, Jay B.; Pelletier, Wendy; Hooke, Mary C.; Pentz, Rebecca D.; Noll, Robert B.; Baker, Justin N.; O'Leary, Maura; Reaman, Gregory; Adamson, Peter C.; Joffe, Steven

    2012-01-01

    Purpose The Children's Oncology Group (COG) strongly supports the widely recognized principle that research participants should be offered a summary of study results. The mechanism by which to do so in a cooperative research group setting has not been previously described. Methods On the basis of a review of the available empirical and theoretic literature and on iterative, multidisciplinary discussion, a COG Return of Results Task Force (RRTF) offered detailed recommendations for the return of results to research study participants. Results The RRTF established guidelines for the notification of research participants and/or their parents/guardians about the availability of research results, a mechanism for and timing of sharing results via registration on the COG public Web site, the scope of the research to be shared, the target audience, and a process for creating and vetting lay summaries of study results. The RRTF recognized the challenges in adequately conveying complex scientific results to audiences with varying levels of health literacy and recommended that particularly sensitive or complex results be returned using direct personal contact. The RRTF also recommended evaluation of the cost, effectiveness, and impact of sharing results. Conclusion These recommendations provide a framework for the offering and returning of results to participants. They can be used by individual investigators, multi-investigator research collaboratives, and large cooperative groups. PMID:23109703

  15. Guidelines on oncologic imaging

    International Nuclear Information System (INIS)

    1989-01-01

    The present issue of European Journal of Radiology is devoted to guidelines on oncologic imaging. 9 experts on imaging in suspected or evident oncologic disease have compiled a broad survey on strategies as well as techniques on oncologic imaging. The group gives advice for detecting tumours at specific tumour sites and use modern literature to emphasize their recommendations. All recommendations are short, comprehensive and authoritative. (orig./MG)

  16. Comparison of the ‘ESPEN guidelines on nutrition in cancer patients 2016’ with the recommendations of the Dutch Dietitians in Oncology Group

    NARCIS (Netherlands)

    Kok, Annemieke; Doornink, Niki; Ariens, Marleen; Beijer, Sandra; van den Berg, Manon; Jager-Wittenaar, Harriët; van Lieshout, Rianne; Sijtema, Bea; van Veen, Merel; Breedveld-Peters, Jose

    Rationale: In 2016, a completely revised second version of the ‘Handbook Nutrition in Cancer’ (HNC, in Dutch) by the Dutch Dietitians Oncology Group (DDOG) was published. In this project, the DDOG evaluated similarities and potential discrepancies between DDOG recommendations and the ESPEN

  17. Decree 302/013. It amend Art. 5 of Decree 202/005 on the integration of the National Oncology Committee and it create a Standing Advisory Group

    International Nuclear Information System (INIS)

    2013-01-01

    The decree is about an adaptation of the integration of the national committee on oncologic o including representatives of the Faculty of Medicine of the University of the Republic and representatives of the National Board of Health and Honorary Commission to Fight Cancer that is proposed.Creating a Standing Advisory Group is also suggested

  18. Differences in Funding Sources of Phase III Oncology Clinical Trials by Treatment Modality and Cancer Type.

    Science.gov (United States)

    Jairam, Vikram; Yu, James B; Aneja, Sanjay; Wilson, Lynn D; Lloyd, Shane

    2017-06-01

    Given the limited resources available to conduct clinical trials, it is important to understand how trial sponsorship differs among different therapeutic modalities and cancer types and to consider the ramifications of these differences. We searched clinicaltrials.gov for a cross-sectional register of active, phase III, randomized controlled trials (RCTs) studying treatment-related endpoints such as survival and recurrence for the 24 most prevalent malignancies. We classified the RCTs into 7 categories of therapeutic modality: (1) chemotherapy/other cancer-directed drugs, (2) targeted therapy, (3) surgery, (4) radiation therapy (RT), (5) RT with other modalities, (6) multimodality therapy without RT, and (7) other. RCTs were categorized as being funded by one or more of the following groups: (1) government, (2) hospital/university, (3) industry, and (4) other. χ analysis was performed to detect differences in funding source distribution between modalities and cancer types. The percentage of multimodality trials (5%) and radiation RCTs (4%) funded by industry was less than that for chemotherapy (32%, Pfunding than any of the other modalities (Pfunded by industry if they also studied targeted therapy (Pfunded by industry than trials studying multimodality therapy or radiation. The impact of industry funding versus institutional or governmental sources of funding for cancer research is unclear and requires further study.

  19. Pretreatment factors significantly influence quality of life in cancer patients: A Radiation Therapy Oncology Group (RTOG) analysis

    International Nuclear Information System (INIS)

    Movsas, Benjamin; Scott, Charles; Watkins-Bruner, Deborah

    2006-01-01

    Purpose The purpose of this analysis was to assess the impact of pretreatment factors on quality of life (QOL) in cancer patients. Methods and Materials Pretreatment QOL (via Functional Assessment of Cancer Therapy [FACT], version 2) was obtained in 1,428 patients in several prospective Radiation Therapy Oncology Group (RTOG) trials including nonmetastatic head-and-neck (n = 1139), esophageal (n = 174), lung (n = 51), rectal (n = 47), and prostate (n = 17) cancer patients. Clinically meaningful differences between groups were defined as a difference of 1 standard error of measurement (SEM). Results The mean FACT score for all patients was 86 (20.7-112) with SEM of 5.3. Statistically significant differences in QOL were observed based on age, race, Karnofsky Performance Status, marital status, education level, income level, and employment status, but not by gender or primary site. Using the SEM, there were clinically meaningful differences between patients ≤50 years vs. ≥65 years. Hispanics had worse QOL than whites. FACT increased linearly with higher Karnofsky Performance Status and income levels. Married patients (or live-in relationships) had a better QOL than single, divorced, or widowed patients. College graduates had better QOL than those with less education. Conclusion Most pretreatment factors meaningfully influenced baseline QOL. The potentially devastating impact of a cancer diagnosis, particularly in young and minority patients, must be addressed

  20. [Role of multicenter study groups for clinical research in hematology and oncology].

    Science.gov (United States)

    Gökbuget, N; Hoelzer, D

    2009-04-01

    During the past 25 years a highly effective infrastructure for clinical trials was developed in hematology. Following initial funding by the BMFT (Ministry for Research and Technology) a number of large multicenter study groups for leukemia and lymphoma were developed. Treatment results from these studies often represent the"gold standard". However, since no standard therapy is defined for these diseases, the study groups aim to treat all patients within treatment optimization trials (TOT) to combine research and care. They contribute considerably to quality control in therapy and diagnostics, e.g., by establishing central reference laboratories. The regulatory requirements for clinical trials were extended considerably after the activation of the 12th drug law and TOTs now have to fulfill requirements similar to registration trials in the pharmaceutical industry. Due to the considerable bureaucratic effort and increased costs, only few large multicenter trials could thereafter be initiated and a substantial disadvantage for independent academic research becomes clearly evident.

  1. EORTC Radiation Oncology Group quality assurance platform: Establishment of a digital central review facility

    International Nuclear Information System (INIS)

    Fairchild, Alysa; Aird, Edwin; Fenton, Paul A.; Gregoire, Vincent; Gulyban, Akos; Lacombe, Denis; Matzinger, Oscar; Poortmans, Philip; Ruyskart, Pascal; Weber, Damien C.; Hurkmans, Coen W.

    2012-01-01

    Objective: Quality assurance (QA) in clinical trials is essential to ensure treatment is safely and effectively delivered. As QA requirements have increased in complexity in parallel with evolution of radiation therapy (RT) delivery, a need to facilitate digital data exchange emerged. Our objective is to present the platform developed for the integration and standardization of QART activities across all EORTC trials involving RT. Methods: The following essential requirements were identified: secure and easy access without on-site software installation; integration within the existing EORTC clinical remote data capture system; and the ability to both customize the platform to specific studies and adapt to future needs. After retrospective testing within several clinical trials, the platform was introduced in phases to participating sites and QART study reviewers. Results: The resulting QA platform, integrating RT analysis software installed at EORTC Headquarters, permits timely, secure, and fully digital central DICOM-RT based data review. Participating sites submit data through a standard secure upload webpage. Supplemental information is submitted in parallel through web-based forms. An internal quality check by the QART office verifies data consistency, formatting, and anonymization. QART reviewers have remote access through a terminal server. Reviewers evaluate submissions for protocol compliance through an online evaluation matrix. Comments are collected by the coordinating centre and institutions are informed of the results. Conclusions: This web-based central review platform facilitates rapid, extensive, and prospective QART review. This reduces the risk that trial outcomes are compromised through inadequate radiotherapy and facilitates correlation of results with clinical outcomes.

  2. Radiotherapy in cooperative clinical trials: Northern California Oncology Group (NCOG) method

    International Nuclear Information System (INIS)

    MacDonald, E.A.; Meurk, M.L.; Ray, G.; Phillips, T.L.; Carter, S.K.

    1980-01-01

    The inclusion of radiation therapy in multimodality clinical research has demonstrated the need for consultion and standardization of terminology and practice between participating centers. A set of guidelines has been developed to ensure that the radiotherapy section of a cooperative study is comprehensive and unambiguous, and that the techniques, fractionation and dosage used are sufficiently uniform to provide a homogeneous group of patients for comparative purposes. An outline is given for the preparation of radiotherapy protocols including the necessary details of physical factors, localization and simulation, portal and treatment volume definition, dosimetry requirements, specification of dose, and treatment documentation

  3. Ultra-rapid high dose irradiation schedules for the palliation of brain metastases: final results of the first two studies by the radiation therapy oncology group

    International Nuclear Information System (INIS)

    Borgelt, B.; Gelber, R.; Larson, M.; Hendrickson, F.; Griffin, T.; Rother, R.

    1981-01-01

    Between January, 1971, and February, 1976, the Radiation Therapy Oncology Group entered 1902 evaluable patients into two sequential Phase III national cooperative trials to study the effectiveness of different time dose radiotherapy schemes on the palliation of patients with brain metastases. Each trial included an optional arm into which patients were randomized to receive 1000 rad/1 fraction (26 patients, First study) or 1200 rad/2 fractions (33 patients, Second study). Comparisons were made with 143 control patients randomized by the same participating institutions to receive a more protracted course of irradiation (2000, 3000 or 4000 rad/1-4wks). Response of patients receiving ultra-rapid treatment, as assessed by the percent who had improvement in neurologic function, was comparable to that of patients receiving the more protracted schedules. Promptness of neurologic function improvement, treatment morbidity and median survival were also comparable to those of patients receiving 2000 to 4000 rad. However, the duration of improvement, time to progression of neurologic status and rate of complete disappearance of neurologic symptoms were generally less for those patients who received 1000 or 1200 rad. These results suggest that ultra-rapid, high dose irradiation schedules may not be so effective as higher dose schedules in the palliation of patients with brain metastases

  4. Outcome of pediatric patients with acute lymphoblastic leukemia/lymphoblastic lymphoma with hypersensitivity to pegaspargase treated with PEGylated Erwinia asparaginase, pegcrisantaspase: A report from the Children's Oncology Group

    Science.gov (United States)

    Rau, Rachel E.; Dreyer, ZoAnn; Choi, Mi Rim; Liang, Wei; Skowronski, Roman; Allamneni, Krishna P.; Devidas, Meenakshi; Raetz, Elizabeth A.; Adamson, Peter C.; Blaney, Susan M.; Loh, Mignon L; Hunger, Stephen P.

    2018-01-01

    Background Erwinia asparaginase is a Food and Drug Administration approved agent for the treatment of acute lymphoblastic leukemia (ALL) for patients who develop hypersensitivity to Escherichia coli derived asparaginases. Erwinia asparaginase is efficacious, but has a short half-life, requiring six doses to replace one dose of the most commonly used first-line asparaginase, pegaspargase, a polyethylene glycol (PEG) conjugated E. coli asparaginase. Pegcristantaspase, a recombinant PEGylated Erwinia asparaginase with improved pharmacokinetics, was developed for patients with hypersensitivity to pegaspargase. Here, we report a series of patients treated on a pediatric phase 2 trial of pegcrisantaspase. Procedure Pediatric patients with ALL or lymphoblastic lymphoma and hypersensitivity to pegaspargase enrolled on Children's Oncology Group trial AALL1421 (Jazz 13-011) and received intravenous pegcrisantaspase. Serum asparaginase activity (SAA) was monitored before and after dosing; immunogenicity assays were performed for antiasparaginase and anti-PEG antibodies and complement activation was evaluated. Results Three of the four treated patients experienced hypersensitivity to pegcrisantaspase manifested as clinical hypersensitivity reactions or rapid clearance of SAA. Immunogenicity assays demonstrated the presence of anti-PEG immunoglobulin G antibodies in all three hypersensitive patients, indicating a PEG-mediated immune response. Conclusions This small series of patients, nonetheless, provides data, suggesting preexisting immunogenicity against the PEG moiety of pegaspargase and poses the question as to whether PEGylation may be an effective strategy to optimize Erwinia asparaginase administration. Further study of larger cohorts is needed to determine the incidence of preexisting antibodies against PEG-mediated hypersensitivity to pegaspargase. PMID:29090524

  5. Radiotherapy Quality Assurance Report From Children's Oncology Group AHOD0031

    International Nuclear Information System (INIS)

    Dharmarajan, Kavita V.; Friedman, Debra L.; FitzGerald, T.J.; McCarten, Kathleen M.; Constine, Louis S.; Chen, Lu; Kessel, Sandy K.; Iandoli, Matt; Laurie, Fran; Schwartz, Cindy L.; Wolden, Suzanne L.

    2015-01-01

    Purpose: A phase 3 trial assessing response-based therapy in intermediate-risk Hodgkin lymphoma mandated real-time central review of involved field radiation therapy (IFRT) and imaging records by a centralized review center to maximize protocol compliance. We report the impact of centralized radiation therapy review on protocol compliance. Methods and Materials: Review of simulation films, port films, and dosimetry records was required before and after treatment. Records were reviewed by study-affiliated or review center–affiliated radiation oncologists. A deviation of 6% to 10% from protocol-specified dose was scored as “minor”; a deviation of >10% was “major.” A volume deviation was scored as “minor” if margins were less than specified or “major” if fields transected disease-bearing areas. Interventional review and final compliance review scores were assigned to each radiation therapy case and compared. Results: Of 1712 patients enrolled, 1173 underwent IFRT at 256 institutions in 7 countries. An interventional review was performed in 88% of patients and a final review in 98%. Overall, minor and major deviations were found in 12% and 6% of patients, respectively. Among the cases for which ≥1 pre-IFRT modification was requested by the Quality Assurance Review Center and subsequently made by the treating institution, 100% were made compliant on final review. By contrast, among the cases for which ≥1 modification was requested but not made by the treating institution, 10% were deemed compliant on final review. Conclusions: In a large trial with complex treatment pathways and heterogeneous radiation therapy fields, central review was performed in a large percentage of cases before IFRT and identified frequent potential deviations in a timely manner. When suggested modifications were performed by the institutions, deviations were almost eliminated

  6. Radiotherapy Quality Assurance Report From Children's Oncology Group AHOD0031

    Energy Technology Data Exchange (ETDEWEB)

    Dharmarajan, Kavita V. [Mount Sinai Medical Center, New York, New York (United States); Friedman, Debra L. [Vanderbilt University, Nashville, Tennessee (United States); FitzGerald, T.J. [Quality Assurance Review Center, Lincoln, Rhode Island (United States); McCarten, Kathleen M. [Rhode Island Hospital/Warren Alpert Medical School of Brown University, Providence, Rhode Island (United States); Constine, Louis S. [University of Rochester Medical Center, Rochester, New York (United States); Chen, Lu [Children' s Oncology Group, Arcadia, California (United States); Kessel, Sandy K.; Iandoli, Matt; Laurie, Fran [Quality Assurance Review Center, Lincoln, Rhode Island (United States); Schwartz, Cindy L. [MD Anderson Cancer Center, Houston, Texas (United States); Wolden, Suzanne L., E-mail: woldens@mskcc.org [Memorial Sloan-Kettering Cancer Center, New York, New York (United States)

    2015-04-01

    Purpose: A phase 3 trial assessing response-based therapy in intermediate-risk Hodgkin lymphoma mandated real-time central review of involved field radiation therapy (IFRT) and imaging records by a centralized review center to maximize protocol compliance. We report the impact of centralized radiation therapy review on protocol compliance. Methods and Materials: Review of simulation films, port films, and dosimetry records was required before and after treatment. Records were reviewed by study-affiliated or review center–affiliated radiation oncologists. A deviation of 6% to 10% from protocol-specified dose was scored as “minor”; a deviation of >10% was “major.” A volume deviation was scored as “minor” if margins were less than specified or “major” if fields transected disease-bearing areas. Interventional review and final compliance review scores were assigned to each radiation therapy case and compared. Results: Of 1712 patients enrolled, 1173 underwent IFRT at 256 institutions in 7 countries. An interventional review was performed in 88% of patients and a final review in 98%. Overall, minor and major deviations were found in 12% and 6% of patients, respectively. Among the cases for which ≥1 pre-IFRT modification was requested by the Quality Assurance Review Center and subsequently made by the treating institution, 100% were made compliant on final review. By contrast, among the cases for which ≥1 modification was requested but not made by the treating institution, 10% were deemed compliant on final review. Conclusions: In a large trial with complex treatment pathways and heterogeneous radiation therapy fields, central review was performed in a large percentage of cases before IFRT and identified frequent potential deviations in a timely manner. When suggested modifications were performed by the institutions, deviations were almost eliminated.

  7. Doxorubicin and ifosfamide combination chemotherapy in previously treated acute leukemia in adults: a Southwest Oncology Group pilot study.

    Science.gov (United States)

    Ryan, D H; Bickers, J N; Vial, R H; Hussein, K; Bottomley, R; Hewlett, J S; Wilson, H E; Stuckey, W J

    1980-01-01

    The Southwest Oncology Group did a limited institutional pilot study of the combination of doxorubicin and ifosfamide in the treatment of previously treated adult patients with acute leukemia. Thirty-four patients received one or two courses of the combination. All patients had received prior chemotherapy and 32 had received prior anthracycline chemotherapy. Three patients died before their responses could be fully evaluated. Fourteen patients achieved complete remission (41%) and one patient achieved partial remission. The complete remission rate was 27% for patients with acute myeloblastic leukemia (myelomonoblastic leukemia, monoblastic leukemia, and erythroleukemia) and 89% for patients with acute lymphocytic and undifferentiated leukemia (ALL). Toxic effects included severe hematologic reactions in 33 of 34 patients, hematuria in six patients, altered sensorium in one patient, and congestive heart failure in one patient. The safety of the combination was established and toxic side effects of this therapy were tolerable. The 89% complete remission rate for previously treated patients with ALL suggests that the combination of doxorubicin and ifosfamide may be particularly effective in ALL.

  8. Sporadic Retinoblastoma and Parental Smoking and Alcohol Consumption before and after Conception: A Report from the Children's Oncology Group.

    Directory of Open Access Journals (Sweden)

    Saeedeh Azary

    Full Text Available Retinoblastoma is the most frequent tumor of the eye in children and very little is known about the etiology of non-familial (sporadic retinoblastoma. In this study we examined whether parental tobacco smoking or alcohol consumption (pre- or post-conception contribute to the two phenotypes (bilateral or unilateral of sporadic retinoblastoma.Two large multicenter case-control studies identified 488 cases through eye referral centers in the United States and Canada or through the Children's Oncology Group. Controls (n = 424 were selected from among friends and relatives of cases and matched by age. Risk factor information was obtained via telephone interview. We employed multivariable logistic regression to estimate the effects of parental tobacco smoking and alcohol consumption on retinoblastoma.Maternal smoking before and during pregnancy contributed to unilateral retinoblastoma risk in the child: year before pregnancy conditional Odds Ratio (OR, 8.9; 95% confidence interval (CI 1.5-51, and unconditional OR, 2.4; 95% CI, 1.3-4.7; month before or during pregnancy, conditional OR, 3.3; 95% CI, 0.5-20.8, and unconditional OR, 2.8; 95% CI, 1.1-7.0. No association was found for maternal or paternal alcohol consumption.The results of this study indicate that maternal active smoking during pregnancy may be a risk factor for sporadic retinoblastoma. Our study supports a role for tobacco exposures in embryonal tumors.

  9. Post-prostatectomy radiation therapy: Consensus guidelines of the Australian and New Zealand Radiation Oncology Genito-Urinary Group

    International Nuclear Information System (INIS)

    Sidhom, Mark A.; Kneebone, Andrew B.; Lehman, Margot; Wiltshire, Kirsty L.; Millar, Jeremy L.; Mukherjee, Rahul K.; Shakespeare, Thomas P.; Tai, Keen-Hun

    2008-01-01

    Background and purpose: Three randomised trials have demonstrated the benefit of adjuvant post-prostatectomy radiotherapy (PPRT) for high risk patients. Data also documents the effectiveness of salvage radiotherapy following a biochemical relapse post-prostatectomy. The Radiation Oncology Genito-Urinary Group recognised the need to develop consensus guidelines on to whom, when and how to deliver PPRT. Materials and methods: Draft guidelines were developed and refined at a consensus conference in June 2006 attended by 63 delegates where urological, radiotherapy and diagnostic imaging experts spoke on aspects of PPRT. Unresolved issues were further developed by working parties and redistributed until consensus was reached. Results: Central to the recommendations is that patients with positive surgical margins, seminal vesicle invasion and/or extracapsular extension have a high risk of residual local disease and should be informed of the options of either immediate adjuvant radiotherapy or active surveillance with early salvage in the event of biochemical recurrence. Salvage radiotherapy should be instituted at the earliest confirmation of biochemical recurrence. Detailed contouring guidelines have been developed, defining the regions at risk of residual microscopic disease which should be included in the clinical target volume. The recommended doses are 60-64 Gy for adjuvant, and 60-66 Gy for salvage radiotherapy. The role of hormone therapy in conjunction with PPRT is yet to be defined. Conclusions: These consensus guidelines have been developed to give clinical and technical guidance to radiation oncologists and urologists in the management of high risk post-prostatectomy patients

  10. MIBG avidity correlates with clinical features, tumor biology, and outcomes in neuroblastoma: A report from the Children's Oncology Group.

    Science.gov (United States)

    DuBois, Steven G; Mody, Rajen; Naranjo, Arlene; Van Ryn, Collin; Russ, Douglas; Oldridge, Derek; Kreissman, Susan; Baker, David L; Parisi, Marguerite; Shulkin, Barry L; Bai, Harrison; Diskin, Sharon J; Batra, Vandana; Maris, John M; Park, Julie R; Matthay, Katherine K; Yanik, Gregory

    2017-11-01

    Prior studies suggest that neuroblastomas that do not accumulate metaiodobenzylguanidine (MIBG) on diagnostic imaging (MIBG non-avid) may have more favorable features compared with MIBG avid tumors. We compared clinical features, biologic features, and clinical outcomes between patients with MIBG nonavid and MIBG avid neuroblastoma. Patients had metastatic high- or intermediate-risk neuroblastoma and were treated on Children's Oncology Group protocols A3973 or A3961. Comparisons of clinical and biologic features according to MIBG avidity were made with chi-squared or Fisher exact tests. Event-free (EFS) and overall (OS) survival compared using log-rank tests and modeled using Cox models. Thirty of 343 patients (8.7%) had MIBG nonavid disease. Patients with nonavid tumors were less likely to have adrenal primary tumors (34.5 vs. 57.2%; P = 0.019), bone metastases (36.7 vs. 61.7%; P = 0.008), or positive urine catecholamines (66.7 vs. 91.0%; P neuroblastoma have lower rates of adrenal primary tumors, bone metastasis, and catecholamine secretion. Despite being more likely to have MYCN-amplified tumors, these patients have superior outcomes compared with patients with MIBG avid disease. © 2017 Wiley Periodicals, Inc.

  11. Geriatric assessment in daily oncology practice for nurses and allied health care professionals: Opinion paper of the Nursing and Allied Health Interest Group of the International Society of Geriatric Oncology (SIOG).

    Science.gov (United States)

    Burhenn, Peggy S; McCarthy, Alexandra L; Begue, Aaron; Nightingale, Ginah; Cheng, Karis; Kenis, Cindy

    2016-09-01

    The management of older persons with cancer has become a major public health concern in developed countries because of the aging of the population and the steady increase in cancer incidence with advancing age. Nurses and allied health care professionals are challenged to address the needs of this growing population. The International Society of Geriatric Oncology (SIOG) Nursing and Allied Health (NAH) Interest Group described key issues that nurses and allied health care professionals face when caring for older persons with cancer. The domains of the Geriatric Assessment (GA) are used as a guiding framework. The following geriatric domains are described: demographic data and social support, functional status, cognition, mental health, nutritional status, fatigue, comorbidities, polypharmacy, and other geriatric syndromes (e.g. falls, delirium). In addition to these geriatric domains, quality of life (QoL) is described based on the overall importance in this particular population. Advice for integration of assessment of these geriatric domains into daily oncology practice is made. Research has mainly focused on the role of treating physicians but the involvement of nurses and allied health care professionals is crucial in the care of older persons with cancer through the GA process. The ability of nurses and allied health care professionals to perform this assessment requires specialized training and education beyond standard oncology knowledge. Copyright © 2016 Elsevier Inc. All rights reserved.

  12. A phase III trial of docetaxel/carboplatin versus mitomycin C/ifosfamide/cisplatin (MIC) or mitomycin C/vinblastine/cisplatin (MVP) in patients with advanced non-small-cell lung cancer: a randomised multicentre trial of the British Thoracic Oncology Group (BTOG1).

    Science.gov (United States)

    Booton, R; Lorigan, P; Anderson, H; Baka, S; Ashcroft, L; Nicolson, M; O'Brien, M; Dunlop, D; O'Byrne, K; Laurence, V; Snee, M; Dark, G; Thatcher, N

    2006-07-01

    Phase III studies suggest that non-small-cell lung cancer (NSCLC) patients treated with cisplatin-docetaxel may have higher response rates and better survival compared with other platinum-based regimens. We report the final results of a randomised phase III study of docetaxel and carboplatin versus MIC or MVP in patients with advanced NSCLC. Patients with biopsy proven stage III-IV NSCLC not suitable for curative surgery or radiotherapy were randomised to receive four cycles of either DCb (docetaxel 75 mg/m(2), carboplatin AUC 6), or MIC/MVP (mitomycin 6 mg/m(2), ifosfamide 3 g/m(2) and cisplatin 50 mg/m(2) or mitomycin 6 mg/m(2), vinblastine 6 mg/m(2) and cisplatin 50 mg/m(2), respectively), 3 weekly. The primary end point was survival, secondary end points included response rates, toxicity and quality of life. The median follow-up was 17.4 months. Overall response rate was 32% for both arms (partial response = 31%, complete response = 1%); 32% of MIC/MVP and 26% of DCb patients had stable disease. One-year survival was 39% and 35% for DCb and MIC/MVP, respectively. Two-year survival was 13% with both arms. Grade 3/4 neutropenia (74% versus 43%, P MVP. The MIC/MVP arm had significant worsening in overall EORTC score and global health status whereas the DCb arm showed no significant change. The combination of DCb had similar efficacy to MIC/MVP but quality of life was better maintained.

  13. Testing different brain metastasis grading systems in stereotactic radiosurgery: Radiation Therapy Oncology Group's RPA, SIR, BSBM, GPA, and modified RPA.

    Science.gov (United States)

    Serizawa, Toru; Higuchi, Yoshinori; Nagano, Osamu; Hirai, Tatsuo; Ono, Junichi; Saeki, Naokatsu; Miyakawa, Akifumi

    2012-12-01

    The authors conducted validity testing of the 5 major reported indices for radiosurgically treated brain metastases- the original Radiation Therapy Oncology Group's Recursive Partitioning Analysis (RPA), the Score Index for Radiosurgery in Brain Metastases (SIR), the Basic Score for Brain Metastases (BSBM), the Graded Prognostic Assessment (GPA), and the subclassification of RPA Class II proposed by Yamamoto-in nearly 2500 cases treated with Gamma Knife surgery (GKS), focusing on the preservation of neurological function as well as the traditional endpoint of overall survival. The authors analyzed data from 2445 cases treated with GKS by the first author (T.S.), the primary surgeon. The patient group consisted of 1716 patients treated between January 1998 and March 2008 (the Chiba series) and 729 patients treated between April 2008 and December 2011 (the Tokyo series). The interval from the date of GKS until the date of the patient's death (overall survival) and impaired activities of daily living (qualitative survival) were calculated using the Kaplan-Meier method, while the absolute risk for two adjacent classes of each grading system and both hazard ratios and 95% confidence intervals were estimated using the Cox proportional hazards model. For overall survival, there were highly statistically significant differences between each two adjacent patient groups characterized by class or score (all p values RPA appeared to be better than the original RPA and GPA. The modified RPA subclassification, proposed by Yamamoto, is well balanced in scoring simplicity with respect to case number distribution and statistical results for overall survival. However, a new or revised grading system is necessary for predicting qualitative survival and for selecting the optimal treatment for patients with brain metastasis treated by GKS.

  14. The management of respiratory motion in radiation oncology report of AAPM Task Group 76

    International Nuclear Information System (INIS)

    Keall, Paul J.; Mageras, Gig S.; Balter, James M.

    2006-01-01

    This document is the report of a task group of the AAPM and has been prepared primarily to advise medical physicists involved in the external-beam radiation therapy of patients with thoracic, abdominal, and pelvic tumors affected by respiratory motion. This report describes the magnitude of respiratory motion, discusses radiotherapy specific problems caused by respiratory motion, explains techniques that explicitly manage respiratory motion during radiotherapy and gives recommendations in the application of these techniques for patient care, including quality assurance (QA) guidelines for these devices and their use with conformal and intensity modulated radiotherapy. The technologies covered by this report are motion-encompassing methods, respiratory gated techniques, breath-hold techniques, forced shallow-breathing methods, and respiration-synchronized techniques. The main outcome of this report is a clinical process guide for managing respiratory motion. Included in this guide is the recommendation that tumor motion should be measured (when possible) for each patient for whom respiratory motion is a concern. If target motion is greater than 5 mm, a method of respiratory motion management is available, and if the patient can tolerate the procedure, respiratory motion management technology is appropriate. Respiratory motion management is also appropriate when the procedure will increase normal tissue sparing. Respiratory motion management involves further resources, education and the development of and adherence to QA procedures

  15. Reinduction therapy for adult acute leukemia with adriamycin, vincristine, and prednisone: a Southwest Oncology Group study.

    Science.gov (United States)

    Elias, L; Shaw, M T; Raab, S O

    1979-08-01

    In an attempt to improve remissions and survivals in previously treated patients with adult acute leukemia, we gave Adriamycin, vincristine, and prednisone for induction therapy, followed by 6-mercaptopurine and methotrexate for maintenance therapy to patients attaining complete remission (CR). The study group consisted of 18 patients with acute myeloblastic leukemia (AML), ten with acute lymphoblastic leukemia, and one with acute undifferentiated leukemia. Only one patient had previously received Adriamycin. Overall, there were ten CRs and two partial remissions. The five CRs and one partial remission in patients with AML occurred among those with one prior induction attempt; none of the eight AML patients with more than one prior induction attempt responded. The actuarial median duration of CR was 15 weeks and was similar for AML and acute lymphoblastic leukemia patients. Responders had a longer median survival (30 weeks) than nonresponders (9 weeks). Thus, although a reasonable number of responses in previously treated patients were obtained with this program, improvements in maintenance therapy are clearly needed.

  16. Allergies, atopy, immune-related factors and childhood rhabdomyosarcoma: a report from the Children's Oncology Group.

    Science.gov (United States)

    Lupo, Philip J; Zhou, Renke; Skapek, Stephen X; Hawkins, Douglas S; Spector, Logan G; Scheurer, Michael E; Fatih Okcu, M; Melin, Beatrice; Papworth, Karin; Erhardt, Erik B; Grufferman, Seymour

    2014-01-15

    Rhabdomyosarcoma (RMS) is a highly malignant tumor of developing muscle that can occur anywhere in the body. Due to its rarity, relatively little is known about the epidemiology of RMS. Atopic disease is hypothesized to be protective against several malignancies; however, to our knowledge, there have been no assessments of atopy and childhood RMS. Therefore, we explored this association in a case-control study of 322 childhood RMS cases and 322 pair-matched controls. Cases were enrolled in a trial run by the Intergroup Rhabdomyosarcoma Study Group. Controls were matched to cases on race, sex and age. The following atopic conditions were assessed: allergies, asthma, eczema and hives; in addition, we examined other immune-related factors: birth order, day-care attendance and breastfeeding. Conditional logistic-regression models were used to calculate an odds ratio (OR) and 95% confidence interval (CI) for each exposure, adjusted for age, race, sex, household income and parental education. As the two most common histologic types of RMS are embryonal (n=215) and alveolar (n=66), we evaluated effect heterogeneity of these exposures. Allergies (OR=0.60, 95% CI: 0.41-0.87), hives (OR = 0.61, 95% CI: 0.38-0.97), day-care attendance (OR=0.48, 95% CI: 0.32-0.71) and breastfeeding for ≥ 12 months (OR=0.36, 95% CI: 0.18-0.70) were inversely associated with childhood RMS. These exposures did not display significant effect heterogeneity between histologic types (p>0.52 for all exposures). This is the first study indicating that atopic exposures may be protective against childhood RMS, suggesting additional studies are needed to evaluate the immune system's role in the development of this tumor. © 2013 UICC.

  17. Group theoretical construction of planar noncommutative phase spaces

    Energy Technology Data Exchange (ETDEWEB)

    Ngendakumana, Ancille, E-mail: nancille@yahoo.fr; Todjihoundé, Leonard, E-mail: leonardt@imsp.uac.org [Institut de Mathématiques et des Sciences Physiques (IMSP), Porto-Novo (Benin); Nzotungicimpaye, Joachim, E-mail: kimpaye@kie.ac.rw [Kigali Institute of Education (KIE), Kigali (Rwanda)

    2014-01-15

    Noncommutative phase spaces are generated and classified in the framework of centrally extended anisotropic planar kinematical Lie groups as well as in the framework of noncentrally abelian extended planar absolute time Lie groups. Through these constructions the coordinates of the phase spaces do not commute due to the presence of naturally introduced fields giving rise to minimal couplings. By symplectic realizations methods, physical interpretations of generators coming from the obtained structures are given.

  18. Group theoretical construction of planar noncommutative phase spaces

    International Nuclear Information System (INIS)

    Ngendakumana, Ancille; Todjihoundé, Leonard; Nzotungicimpaye, Joachim

    2014-01-01

    Noncommutative phase spaces are generated and classified in the framework of centrally extended anisotropic planar kinematical Lie groups as well as in the framework of noncentrally abelian extended planar absolute time Lie groups. Through these constructions the coordinates of the phase spaces do not commute due to the presence of naturally introduced fields giving rise to minimal couplings. By symplectic realizations methods, physical interpretations of generators coming from the obtained structures are given

  19. Validation and predictive power of radiation therapy oncology group (RTOG) recursive partitioning analysis classes for malignant glioma patients: a report using RTOG 90-06

    International Nuclear Information System (INIS)

    Scott, Charles B.; Scarantino, Charles; Urtasun, Raul; Movsas, Benjamin; Jones, Christopher U.; Simpson, Joseph R.; Fischbach, A. Jennifer; Curran, Walter J.

    1996-01-01

    Background/Purpose: The recursive partitioning analysis (RPA) classes for malignant glioma patients were previously established by Curran et al. (JNCI 85:704-10, 1993) using data on over 1500 patients from the Radiation Therapy Oncology Group (RTOG). The current analysis was to validate the RPA classes on a new dataset (RTOG 90-06) and determine the predictive power of the RPA classes. Patients and Methods: There are six RPA classes for malignant glioma patients that comprise distinct groups of patients with significantly different survival outcome. RTOG 90-06 is a randomized phase III study of 712 patients accrued from 1990 to 1994. The minimum potential follow-up is 18 months. The treatment arms were combined for the purpose of this analysis. There were 84, 13, 105, 240, 150, and 23 patients in the six RPA classes from RTOG 90-06. Results: The median survival times (MST) and two-year survivals for the six RPA classes in RTOG 90-06 are compared to those published by Curran et al. (JNCI 1993). The RPA classes appear in descending order in the following table. The MST and 2-year survivals for the RTOG RPA classes were within 95% confidence intervals of the 90-06 estimates for classes I, III, IV, and V. The RPA classes explained 43% of the variation (squared error loss). By comparison, a model containing only histology explains only 13% of the variation. The RPA classes are statistically distinct with all comparisons exceeding 0.0001, except those involving class II. Conclusion: The validity of the model is verified by the reliability of the RPA classes to define distinct groups with respect to survival. Further evidence is given by prediction of MST and 2-year survival for all classes except class II. The RPA classes explained a good portion of the variation in the data. RPA class II did not perform well which may be an artifact of the small sample size or an indication that this class is not distinct. The validation of the RPA classes attests to their usefulness as

  20. Oncologic imaging

    International Nuclear Information System (INIS)

    Bragg, D.G.; Rubin, P.; Youker, J.E.

    1985-01-01

    This book presents papers on nuclear medicine. Topics considered include the classification of cancers, oncologic diagnosis, brain and spinal cord neoplasms, lymph node metastases, the larynx and hypopharynx, thyroid cancer, breast cancer, esophageal cancer, bladder cancer, tumors of the skeletal system, pediatric oncology, computed tomography and radiation therapy treatment planning, and the impact of future technology on oncologic diagnosis

  1. Quality assurance experience with the randomized neuropathic bone pain trial (Trans-Tasman Radiation Oncology Group, 96.05)

    International Nuclear Information System (INIS)

    Roos, Daniel E.; Davis, Sidney R.; Turner, Sandra L.; O'Brien, Peter C.; Spry, Nigel A.; Burmeister, Bryan H.; Hoskin, Peter J.; Ball, David L.

    2003-01-01

    Background and purpose: Trans-Tasman Radiation Oncology Group 96.05 is a prospective randomized controlled trial comparing a single 8 Gy with 20 Gy in five fractions of radiotherapy (RT) for neuropathic pain due to bone metastases. This paper summarizes the quality assurance (QA) activities for the first 234 patients (accrual target 270). Materials and methods: Independent audits to assess compliance with eligibility/exclusion criteria and appropriateness of treatment of the index site were conducted after each cohort of approximately 45 consecutive patients. Reported serious adverse events (SAEs) in the form of cord/cauda equina compression or pathological fracture developing at the index site were investigated and presented in batches to the Independent Data Monitoring Committee. Finally, source data verification of the RT prescription page and treatment records was undertaken for each of the first 234 patients to assess compliance with the protocol. Results: Only one patient was found conclusively not to have genuine neuropathic pain, and there were no detected 'geographical misses' with RT fields. The overall rate of detected infringements for other eligibility criteria over five audits (225 patients) was 8% with a dramatic improvement after the first audit. There has at no stage been a statistically significant difference in SAEs by randomization arm. There was a 22% rate of RT protocol variations involving ten of the 14 contributing centres, although the rate of major dose violations (more than ±10% from protocol dose) was only 6% with no statistically significant difference by randomization arm (P=0.44). Conclusions: QA auditing is an essential but time-consuming component of RT trials, including those assessing palliative endpoints. Our experience confirms that all aspects should commence soon after study activation

  2. Portal imaging practice patterns of children's oncology group institutions: Dosimetric assessment and recommendations for minimizing unnecessary exposure

    International Nuclear Information System (INIS)

    Olch, Arthur J.; Geurts, Mark; Thomadsen, Bruce; Famiglietti, Robin; Chang, Eric L.

    2007-01-01

    Purpose: To determine and analyze the dosimetric consequences of current portal imaging practices for pediatric patients, and make specific recommendations for reducing exposure from portal imaging procedures. Methods and Materials: A survey was sent to approximately 250 Children's Oncology Group (COG) member institutions asking a series of questions about their portal imaging practices. Three case studies are presented with dosimetric analysis to illustrate the magnitude of unintended dose received by nontarget tissues using the most common techniques from the survey. Results: The vast majority of centers use double-exposure portal image techniques with a variety of open field margins. Only 17% of portal images were obtained during treatment, and for other imaging methods, few centers subtract monitor units from the treatment delivery. The number of monitor units used was nearly the same regardless of imager type, including electronic portal imaging devices. Eighty-six percent imaged all fields the first week and 17% imaged all fields every week. An additional 1,112 cm 3 of nontarget tissue received 1 Gy in one of the example cases. Eight new recommendations are made, which will lower nontarget radiation doses with minimal impact on treatment verification accuracy. Conclusion: Based on the survey, changes can be made in portal imaging practices that will lower nontarget doses. It is anticipated that treatment verification accuracy will be minimally affected. Specific recommendations made to decrease the imaging dose and help lower the rate of radiation-induced secondary cancers in children are proposed for inclusion in future COG protocols using radiation therapy

  3. Pathologic Findings at Risk-Reducing Salpingo-Oophorectomy: Primary Results From Gynecologic Oncology Group Trial GOG-0199

    Science.gov (United States)

    Sherman, Mark E.; Piedmonte, Marion; Mai, Phuong L.; Ioffe, Olga B.; Ronnett, Brigitte M.; Van Le, Linda; Ivanov, Iouri; Bell, Maria C.; Blank, Stephanie V.; DiSilvestro, Paul; Hamilton, Chad A.; Tewari, Krishnansu S.; Wakeley, Katie; Kauff, Noah D.; Yamada, S. Diane; Rodriguez, Gustavo; Skates, Steven J.; Alberts, David S.; Walker, Joan L.; Minasian, Lori; Lu, Karen; Greene, Mark H.

    2014-01-01

    Purpose Risk-reducing salpingo-oophorectomy (RRSO) lowers mortality from ovarian/tubal and breast cancers among BRCA1/2 mutation carriers. Uncertainties persist regarding potential benefits of RRSO among high-risk noncarriers, optimal surgical age, and anatomic origin of clinically occult cancers detected at surgery. To address these topics, we analyzed surgical treatment arm results from Gynecologic Oncology Group Protocol-0199 (GOG-0199), the National Ovarian Cancer Prevention and Early Detection Study. Participants and Methods This analysis included asymptomatic high-risk women age ≥ 30 years who elected RRSO at enrollment. Women provided risk factor data and underwent preoperative cancer antigen 125 (CA-125) serum testing and transvaginal ultrasound (TVU). RRSO specimens were processed according to a standardized tissue processing protocol and underwent central pathology panel review. Research-based BRCA1/2 mutation testing was performed when a participant's mutation status was unknown at enrollment. Relationships between participant characteristics and diagnostic findings were assessed using univariable statistics and multivariable logistic regression. Results Invasive or intraepithelial ovarian/tubal/peritoneal neoplasms were detected in 25 (2.6%) of 966 RRSOs (BRCA1 mutation carriers, 4.6%; BRCA2 carriers, 3.5%; and noncarriers, 0.5%; P < .001). In multivariable models, positive BRCA1/2 mutation status (P = .0056), postmenopausal status (P = .0023), and abnormal CA-125 levels and/or TVU examinations (P < .001) were associated with detection of clinically occult neoplasms at RRSO. For 387 women with negative BRCA1/2 mutation testing and normal CA-125 levels, findings at RRSO were benign. Conclusion Clinically occult cancer was detected among 2.6% of high-risk women undergoing RRSO. BRCA1/2 mutation, postmenopausal status, and abnormal preoperative CA-125 and/or TVU were associated with cancer detection at RRSO. These data can inform management decisions

  4. Profile of European radiotherapy departments contributing to the EORTC Radiation Oncology Group (ROG) in the 21st century

    International Nuclear Information System (INIS)

    Budiharto, Tom; Musat, Elena; Poortmans, Philip; Hurkmans, Coen; Monti, Angelo; Bar-Deroma, Raquel; Bernstein, Zvi; Tienhoven, Geertjan van; Collette, Laurence; Duclos, Frederic; Davis, Bernard; Aird, Edwin

    2008-01-01

    Purpose: Since 1982, the Radiation Oncology Group of the EORTC (EORTC ROG) has pursued an extensive Quality Assurance (QA) program involving all centres actively participating in its clinical research. The first step is the evaluation of the structure and of the human, technical and organisational resources of the centres, to assess their ability to comply with the current requirements for high-tech radiotherapy (RT). Materials and methods: A facility questionnaire (FQ) was developed in 1989 and adapted over the years to match the evolution of RT techniques. We report on the contents of the current FQ that was completed online by 98 active EORTC ROG member institutions from 19 countries, between December 2005 and October 2007. Results: Similar to the data collected previously, large variations in equipment, staffing and workload between centres remain. Currently only 15 centres still use a Cobalt unit. All centres perform 3D Conformal RT, 79% of them can perform IMRT and 54% are able to deliver stereotactic RT. An external reference dosimetry audit (ERDA) was performed in 88% of the centres for photons and in 73% for electrons, but it was recent (<2 years) in only 74% and 60%, respectively. Conclusion: The use of the FQ helps maintain the minimum quality requirements within the EORTC ROG network: recommendations are made on the basis of the analysis of its results. The present analysis shows that modern RT techniques are widely implemented in the clinic but also that ERDA should be performed more frequently. Repeated assessment using the FQ is warranted to document the future evolution of the EORTC ROG institutions

  5. Electronic cigarettes: a survey of perceived patient use and attitudes among members of the British thoracic oncology group.

    Science.gov (United States)

    Sherratt, Frances C; Newson, Lisa; Field, John K

    2016-05-17

    Smoking cessation following lung cancer diagnosis has been found to improve several patient outcomes. Electronic cigarette (e-cigarette) use is now prevalent within Great Britain, however, use and practice among patients with lung cancer has not as yet been explored. The current study aims to explore e-cigarette use among patients and examine current practice among clinicians. The results have important implications for future policy and practice. Members of The British Thoracic Oncology Group (BTOG) were contacted via several e-circulations (N = 2,009), requesting them to complete an online survey. Of these, 7.7 % (N = 154) completed the survey, which explored participant demographics and smoking history, perceptions of patient e-cigarette use, practitioner knowledge regarding sources of guidance pertaining to e-cigarettes, and practitioner advice. Practitioners frequently observed e-cigarette use among patients with lung cancer. The majority of practitioners (81.4 %) reported responding to patient queries pertaining to e-cigarettes within the past year; however, far fewer (21.0 %) felt confident providing patients with e-cigarette advice. Practitioner confidence was found to differentiate by gender (p = 0.012) and employment speciality (p = 0.030), with nurses reporting particularly low levels of confidence in advising. The results also demonstrate extensive variability regarding the practitioner advice content. The results demonstrate that patients refer to practitioners as a source of e-cigarette guidance, yet few practitioners feel confident advising. The absence of evidence-based guidance may have contributed towards the exhibited inconsistencies in practitioner advice. The findings highlight that training should be delivered to equip practitioners with the knowledge and confidence to advise patients effectively; this could subsequently improve smoking cessation rates and patient outcomes.

  6. Radiation Therapy for Primary Cutaneous Anaplastic Large Cell Lymphoma: An International Lymphoma Radiation Oncology Group Multi-institutional Experience

    Energy Technology Data Exchange (ETDEWEB)

    Million, Lynn, E-mail: lmillion@stanford.edu [Stanford Cancer Institute, Stanford, California (United States); Yi, Esther J.; Wu, Frank; Von Eyben, Rie [Stanford Cancer Institute, Stanford, California (United States); Campbell, Belinda A. [Department of Radiation Oncology and Cancer Imaging, Peter MacCallum Cancer Centre, East Melbourne (Australia); Dabaja, Bouthaina [The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Tsang, Richard W. [Department of Radiation Oncology, Princess Margaret Cancer Centre, Toronto, Ontario (Canada); Ng, Andrea [Department of Radiation Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts (United States); Wilson, Lynn D. [Department of Therapeutic Radiology/Radiation Oncology, Yale School of Medicine, Yale Cancer Center, New Haven, Connecticut (United States); Ricardi, Umberto [Department of Oncology, University of Turin, Turin (Italy); Kirova, Youlia [Institut Curie, Paris (France); Hoppe, Richard T. [Stanford Cancer Institute, Stanford, California (United States)

    2016-08-01

    Purpose: To collect response rates of primary cutaneous anaplastic large cell lymphoma, a rare cutaneous T-cell lymphoma, to radiation therapy (RT), and to determine potential prognostic factors predictive of outcome. Methods and Materials: The study was a retrospective analysis of patients with primary cutaneous anaplastic large cell lymphoma who received RT as primary therapy or after surgical excision. Data collected include initial stage of disease, RT modality (electron/photon), total dose, fractionation, response to treatment, and local recurrence. Radiation therapy was delivered at 8 participating International Lymphoma Radiation Oncology Group institutions worldwide. Results: Fifty-six patients met the eligibility criteria, and 63 tumors were treated: head and neck (27%), trunk (14%), upper extremities (27%), and lower extremities (32%). Median tumor size was 2.25 cm (range, 0.6-12 cm). T classification included T1, 40 patients (71%); T2, 12 patients (21%); and T3, 4 patients (7%). The median radiation dose was 35 Gy (range, 6-45 Gy). Complete clinical response (CCR) was achieved in 60 of 63 tumors (95%) and partial response in 3 tumors (5%). After CCR, 1 tumor recurred locally (1.7%) after 36 Gy and 7 months after RT. This was the only patient to die of disease. Conclusions: Primary cutaneous anaplastic large cell lymphoma is a rare, indolent cutaneous lymphoma with a low death rate. This analysis, which was restricted to patients selected for treatment with radiation, indicates that achieving CCR was independent of radiation dose. Because there were too few failures (<2%) for statistical analysis on dose response, 30 Gy seems to be adequate for local control, and even lower doses may suffice.

  7. Weight change during childhood acute lymphoblastic leukemia induction therapy predicts obesity: a report from the Children's Oncology Group.

    Science.gov (United States)

    Withycombe, Janice S; Smith, Lynette M; Meza, Jane L; Merkle, Carrie; Faulkner, Melissa Spezia; Ritter, Leslie; Seibel, Nita L; Moore, Ki

    2015-03-01

    Obesity is a well documented problem associated with childhood acute lymphoblastic leukemia (ALL) with increasing body mass index often observed during therapy. This study aims to evaluate if weight gain, early in therapy, is predictive of obesity at the end of treatment. In this secondary analysis, data from 1,017 high-risk ALL patients previously treated on a Children's Oncology Group protocol (CCG study 1961) were reviewed. Logistic regression was used to examine whether change in BMI z-score at Induction or Delayed Intensification (DI) 1 were predictive of obesity at the end of therapy. The BMI z-score at the beginning of Induction and the change in BMI z-score during Induction were both significant predictors of obesity at the end of therapy. The change in BMI z-score during cycle 1 of DI was not found to be associated with obesity. It is well know that obesity at the beginning of therapy is predictive of obesity at the end of ALL therapy. The new, and more important, finding from this study is that even after adjusting for baseline weight, the increase in BMI z-scores during induction was an independent predictor of obesity at the end of therapy. Most researchers agree that prevention is the best form of treatment for obesity as it is difficult to reverse once it is present. This study suggests that monitoring weight trends during Induction may be useful in guiding healthcare practitioners in identifying which patients are at highest risk for obesity development so that early intervention may occur. © 2014 Wiley Periodicals, Inc.

  8. PAX-FOXO1 fusion status drives unfavorable outcome for children with rhabdomyosarcoma: a children's oncology group report.

    Science.gov (United States)

    Skapek, Stephen X; Anderson, James; Barr, Frederic G; Bridge, Julia A; Gastier-Foster, Julie M; Parham, David M; Rudzinski, Erin R; Triche, Timothy; Hawkins, Douglas S

    2013-09-01

    Rhabdomyosarcoma (RMS) is divided into two major histological subtypes: alveolar (ARMS) and embryonal (ERMS), with most ARMS expressing one of two oncogenic genes fusing PAX3 or PAX7 with FOXO1 (P3F and P7F, respectively). The Children's Oncology Group (COG) carried out a multi-institutional clinical trial to evaluate the prognostic value of PAX-FOXO1 fusion status. Study participants were treated on COG protocol D9803 for intermediate risk ARMS or ERMS using multi-agent chemotherapy, radiotherapy, and surgery. Central diagnostic pathology review and molecular testing for fusion genes were carried out on prospectively collected specimens. Event-free (EFS) and overall survival (OS) at 5 years were correlated with histological subtype and PAX-FOXO1 status. Of 616 eligible D9803 enrollees, 434 cases had adequate clinical, molecular, and pathology data for definitive classification as ERMS, ARMS P3F+ or P7F+, or ARMSn (without detectable fusion). EFS was worse for those with ARMS P3F+ (54%) and P7F+ (65%) than those with ERMS (77%; P < 0.001). EFS for ARMSn and ERMS were not statistically different (90% vs. 77%, P = 0.15). ARMS P3F+ had poorer OS (64%) than ARMS P7F+ (87%), ARMSn (89%), and ERMS (82%; P = 0.006). ARMSn has an outcome similar to ERMS and superior EFS compared to ARMS with either P3F or P7F, when given therapy designed for children with intermediate risk RMS. This prospective analysis supports incorporation of PAX-FOXO1 fusion status into risk stratification and treatment allocation. Copyright © 2013 Wiley Periodicals, Inc.

  9. PAX-FOXO1 Fusion Status Drives Unfavorable Outcome for Children With Rhabdomyosarcoma: A Children’s Oncology Group Report

    Science.gov (United States)

    Skapek, Stephen X.; Anderson, James; Barr, Frederic G.; Bridge, Julia A.; Gastier-Foster, Julie M.; Parham, David M.; Rudzinski, Erin R.; Triche, Timothy; Hawkins, Douglas S.

    2015-01-01

    Background Rhabdomyosarcoma (RMS) is divided into two major histological subtypes: alveolar (ARMS) and embryonal (ERMS), with most ARMS expressing one of two oncogenic genes fusing PAX3 or PAX7 with FOXO1 (P3F and P7F, respectively). The Children’s Oncology Group (COG) carried out a multi-institutional clinical trial to evaluate the prognostic value of PAX-FOXO1 fusion status. Methods Study participants were treated on COG protocol D9803 for intermediate risk ARMS or ERMS using multi-agent chemotherapy, radiotherapy, and surgery. Central diagnostic pathology review and molecular testing for fusion genes were carried out on prospectively collected specimens. Event-free (EFS) and overall survival (OS) at 5 years were correlated with histological subtype and PAX-FOXO1 status. Results Of 616 eligible D9803 enrollees, 434 cases had adequate clinical, molecular, and pathology data for definitive classification as ERMS, ARMS P3F+ or P7F+, or ARMSn (without detectable fusion). EFS was worse for those with ARMS P3F+ (54%) and P7F+ (65%) than those with ERMS (77%; P < 0.001). EFS for ARMSn and ERMS were not statistically different (90% vs. 77%, P = 0.15). ARMS P3F+had poorer OS (64%) than ARMS P7F+ (87%), ARMSn (89%), and ERMS (82%; P = 0.006). Conclusions ARMSn has an outcome similar to ERMS and superior EFS compared to ARMS with either P3F or P7F, when given therapy designed for children with intermediate risk RMS. This prospective analysis supports incorporation of PAX-FOXO1 fusion status into risk stratification and treatment allocation. PMID:23526739

  10. Implementation of Remote 3-Dimensional Image Guided Radiation Therapy Quality Assurance for Radiation Therapy Oncology Group Clinical Trials

    Energy Technology Data Exchange (ETDEWEB)

    Cui Yunfeng [Department of Radiation Oncology, Jefferson Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania (United States); Galvin, James M. [Department of Radiation Oncology, Jefferson Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania (United States); Radiation Therapy Oncology Group, American College of Radiology, Philadelphia, Pennsylvania (United States); Parker, William [Department of Medical Physics, McGill University Health Center, Montreal, QC (Canada); Breen, Stephen [Department of Radiation Physics, Princess Margaret Hospital, Toronto, ON (Canada); Yin Fangfang; Cai Jing [Department of Radiation Oncology, Duke University Medical Center, Durham, North Carolina (United States); Papiez, Lech S. [Department of Radiation Oncology, University of Texas Southwestern Medical Center, Dallas, Texas (United States); Li, X. Allen [Department of Radiation Oncology, Medical College of Wisconsin, Milwaukee, Wisconsin (United States); Bednarz, Greg [Department of Radiation Oncology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania (United States); Chen Wenzhou [Department of Radiation Oncology, Jefferson Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania (United States); Xiao Ying, E-mail: ying.xiao@jefferson.edu [Department of Radiation Oncology, Jefferson Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania (United States); Radiation Therapy Oncology Group, American College of Radiology, Philadelphia, Pennsylvania (United States)

    2013-01-01

    Purpose: To report the process and initial experience of remote credentialing of three-dimensional (3D) image guided radiation therapy (IGRT) as part of the quality assurance (QA) of submitted data for Radiation Therapy Oncology Group (RTOG) clinical trials; and to identify major issues resulting from this process and analyze the review results on patient positioning shifts. Methods and Materials: Image guided radiation therapy datasets including in-room positioning CT scans and daily shifts applied were submitted through the Image Guided Therapy QA Center from institutions for the IGRT credentialing process, as required by various RTOG trials. A centralized virtual environment is established at the RTOG Core Laboratory, containing analysis tools and database infrastructure for remote review by the Physics Principal Investigators of each protocol. The appropriateness of IGRT technique and volumetric image registration accuracy were evaluated. Registration accuracy was verified by repeat registration with a third-party registration software system. With the accumulated review results, registration differences between those obtained by the Physics Principal Investigators and from the institutions were analyzed for different imaging sites, shift directions, and imaging modalities. Results: The remote review process was successfully carried out for 87 3D cases (out of 137 total cases, including 2-dimensional and 3D) during 2010. Frequent errors in submitted IGRT data and challenges in the review of image registration for some special cases were identified. Workarounds for these issues were developed. The average differences of registration results between reviewers and institutions ranged between 2 mm and 3 mm. Large discrepancies in the superior-inferior direction were found for megavoltage CT cases, owing to low spatial resolution in this direction for most megavoltage CT cases. Conclusion: This first experience indicated that remote review for 3D IGRT as part of QA

  11. Radiation Therapy Planning for Early-Stage Hodgkin Lymphoma: Experience of the International Lymphoma Radiation Oncology Group

    International Nuclear Information System (INIS)

    Maraldo, Maja V.; Dabaja, Bouthaina S.; Filippi, Andrea R.; Illidge, Tim; Tsang, Richard; Ricardi, Umberto; Petersen, Peter M.; Schut, Deborah A.; Garcia, John; Headley, Jayne; Parent, Amy; Guibord, Benoit; Ragona, Riccardo; Specht, Lena

    2015-01-01

    Purpose: Early-stage Hodgkin lymphoma (HL) is a rare disease, and the location of lymphoma varies considerably between patients. Here, we evaluate the variability of radiation therapy (RT) plans among 5 International Lymphoma Radiation Oncology Group (ILROG) centers with regard to beam arrangements, planning parameters, and estimated doses to the critical organs at risk (OARs). Methods: Ten patients with stage I-II classic HL with masses of different sizes and locations were selected. On the basis of the clinical information, 5 ILROG centers were asked to create RT plans to a prescribed dose of 30.6 Gy. A postchemotherapy computed tomography scan with precontoured clinical target volume (CTV) and OARs was provided for each patient. The treatment technique and planning methods were chosen according to each center's best practice in 2013. Results: Seven patients had mediastinal disease, 2 had axillary disease, and 1 had disease in the neck only. The median age at diagnosis was 34 years (range, 21-74 years), and 5 patients were male. Of the resulting 50 treatment plans, 15 were planned with volumetric modulated arc therapy (1-4 arcs), 16 with intensity modulated RT (3-9 fields), and 19 with 3-dimensional conformal RT (2-4 fields). The variations in CTV-to-planning target volume margins (5-15 mm), maximum tolerated dose (31.4-40 Gy), and plan conformity (conformity index 0-3.6) were significant. However, estimated doses to OARs were comparable between centers for each patient. Conclusions: RT planning for HL is challenging because of the heterogeneity in size and location of disease and, additionally, to the variation in choice of treatment techniques and field arrangements. Adopting ILROG guidelines and implementing universal dose objectives could further standardize treatment techniques and contribute to lowering the dose to the surrounding OARs

  12. Screened selection design for randomised phase II oncology trials: an example in chronic lymphocytic leukaemia.

    Science.gov (United States)

    Yap, Christina; Pettitt, Andrew; Billingham, Lucinda

    2013-07-03

    As there are limited patients for chronic lymphocytic leukaemia trials, it is important that statistical methodologies in Phase II efficiently select regimens for subsequent evaluation in larger-scale Phase III trials. We propose the screened selection design (SSD), which is a practical multi-stage, randomised Phase II design for two experimental arms. Activity is first evaluated by applying Simon's two-stage design (1989) on each arm. If both are active, the play-the-winner selection strategy proposed by Simon, Wittes and Ellenberg (SWE) (1985) is applied to select the superior arm. A variant of the design, Modified SSD, also allows the arm with the higher response rates to be recommended only if its activity rate is greater by a clinically-relevant value. The operating characteristics are explored via a simulation study and compared to a Bayesian Selection approach. Simulations showed that with the proposed SSD, it is possible to retain the sample size as required in SWE and obtain similar probabilities of selecting the correct superior arm of at least 90%; with the additional attractive benefit of reducing the probability of selecting ineffective arms. This approach is comparable to a Bayesian Selection Strategy. The Modified SSD performs substantially better than the other designs in selecting neither arm if the underlying rates for both arms are desirable but equivalent, allowing for other factors to be considered in the decision making process. Though its probability of correctly selecting a superior arm might be reduced, it still performs reasonably well. It also reduces the probability of selecting an inferior arm. SSD provides an easy to implement randomised Phase II design that selects the most promising treatment that has shown sufficient evidence of activity, with available R codes to evaluate its operating characteristics.

  13. Guidelines for target volume definition in post-operative radiotherapy for prostate cancer, on behalf of the EORTC Radiation Oncology Group

    International Nuclear Information System (INIS)

    Poortmans, Philip; Bossi, Alberto; Vandeputte, Katia; Bosset, Mathieu; Miralbell, Raymond; Maingon, Philippe; Boehmer, Dirk; Budiharto, Tom; Symon, Zvi; Bergh, Alfons C.M. van den; Scrase, Christopher; Poppel, Hendrik van; Bolla, Michel

    2007-01-01

    The appropriate application of 3-D conformal radiotherapy, intensity modulated radiotherapy or image guided radiotherapy for patients undergoing post-operative radiotherapy for prostate cancer requires a standardisation of the target volume definition and delineation as well as standardisation of the clinical quality assurance procedures. Recommendations for this are presented on behalf of the European Organisation for Research and Treatment of Cancer (EORTC) Radiation Oncology Group and in addition to the already published guidelines for radiotherapy as the primary treatment

  14. Validation and predictive power of Radiation Therapy Oncology Group (RTOG) recursive partitioning analysis classes for malignant glioma patients: A report using RTOG 90-06

    International Nuclear Information System (INIS)

    Scott, Charles B.; Scarantino, Charles; Urtasun, Raul; Movsas, Benjamin; Jones, Christopher U.; Simpson, Joseph R.; Fischbach, A. Jennifer; Curran, Walter J.

    1998-01-01

    Purpose: The recursive partitioning analysis (RPA) classes for malignant glioma patients were previously established using data on over 1500 patients entered on Radiation Therapy Oncology Group (RTOG) clinical trials. The purpose of the current analysis was to validate the RPA classes with a new dataset (RTOG 90-06), determine the predictive power of the RPA classes, and establish the usefulness of the database norms for the RPA classes. Patients and Methods: There are six RPA classes for malignant glioma patients that comprise distinct groups of patients with significantly different survival outcome. RTOG 90-06 is a randomized Phase III study of 712 patients accrued from 1990 to 1994. The minimum potential follow-up is 18 months. The treatment arms were combined for the purpose of this analysis. There were 84, 13, 105, 240, 150, and 23 patients in the RPA Classes I-VI from RTOG 90-06, respectively. Results: The median survival times (MST) and 2-year survival rates for the six RPA classes in RTOG 90-06 are compared to those previously published. The MST and 2-year survival rates for the RTOG RPA classes were within 95% confidence intervals of the 90-06 estimates for Classes I, III, IV, and V. The RPA classes explained 43% of the variation (squared error loss). By comparison, a Cox model explains 30% of the variation. The RPA classes within RTOG 90-06 are statistically distinct with all comparisons exceeding 0.0001, except those involving Class II. A survival analysis from a prior RTOG study indicated that 72.0 Gy had superior outcome to literature controls; analysis of this data by RPA classes indicates the survival results were not superior to the RTOG database norms. Conclusion: The validity of the model is verified by the reliability of the RPA classes to define distinct groups with respect to survival. Further evidence is given by prediction of MST and 2-year survival for all classes except Class II. The RPA classes explained a good portion of the variation in

  15. Quantum renormalization group approach to geometric phases in spin chains

    International Nuclear Information System (INIS)

    Jafari, R.

    2013-01-01

    A relation between geometric phases and criticality of spin chains are studied using the quantum renormalization-group approach. I have shown how the geometric phase evolve as the size of the system becomes large, i.e., the finite size scaling is obtained. The renormalization scheme demonstrates how the first derivative of the geometric phase with respect to the field strength diverges at the critical point and maximum value of the first derivative, and its position, scales with the exponent of the system size

  16. Phase III clinical evaluation of gadoteridol injection: Experience in pediatric neuro-oncologic MR imaging

    International Nuclear Information System (INIS)

    Debatin, J.F.; Nadel, S.N.; Gray, L.; Trotter, P.; Friedman, H.S.; Hockenberger, B.; Oakes, W.J.

    1992-01-01

    Twenty-two pediatric patients with known CNS neoplasms underwent magnetic resonance (MR) imaging before and after intravenous injection of 0.1 mmol/kg gadoteridol injection as part of a Phase IIIB open label multicenter clinical trial. Intravenous adminstration of this neutral, nonionic contrast agent was found to be safe in children. No clinically relevant changes in vital signs or laboratory values were attributed to the administration of gadoteridol injection. There were no systemic complaints. The imaging characteristics of gadoteridol in pediatric CNS disease appeared similar to those of gadopentetate dimeglumine. The very low toxicity, inherent to this nonionic low osmolal paramagnetic contrast formulation may allow administration of increased doses at increased infusion rates for an increased number of indications with improved sensitivity. (orig.)

  17. Interobserver variability in target volume delineation of hepatocellular carcinoma : An analysis of the working group "Stereotactic Radiotherapy" of the German Society for Radiation Oncology (DEGRO).

    Science.gov (United States)

    Gkika, E; Tanadini-Lang, S; Kirste, S; Holzner, P A; Neeff, H P; Rischke, H C; Reese, T; Lohaus, F; Duma, M N; Dieckmann, K; Semrau, R; Stockinger, M; Imhoff, D; Kremers, N; Häfner, M F; Andratschke, N; Nestle, U; Grosu, A L; Guckenberger, M; Brunner, T B

    2017-10-01

    Definition of gross tumor volume (GTV) in hepatocellular carcinoma (HCC) requires dedicated imaging in multiple contrast medium phases. The aim of this study was to evaluate the interobserver agreement (IOA) in gross tumor delineation of HCC in a multicenter panel. The analysis was performed within the "Stereotactic Radiotherapy" working group of the German Society for Radiation Oncology (DEGRO). The GTVs of three anonymized HCC cases were delineated by 16 physicians from nine centers using multiphasic CT scans. In the first case the tumor was well defined. The second patient had multifocal HCC (one conglomerate and one peripheral tumor) and was previously treated with transarterial chemoembolization (TACE). The peripheral lesion was adjacent to the previous TACE site. The last patient had an extensive HCC with a portal vein thrombosis (PVT) and an inhomogeneous liver parenchyma due to cirrhosis. The IOA was evaluated according to Landis and Koch. The IOA for the first case was excellent (kappa: 0.85); for the second case moderate (kappa: 0.48) for the peripheral tumor and substantial (kappa: 0.73) for the conglomerate. In the case of the peripheral tumor the inconsistency is most likely explained by the necrotic tumor cavity after TACE caudal to the viable tumor. In the last case the IOA was fair, with a kappa of 0.34, with significant heterogeneity concerning the borders of the tumor and the PVT. The IOA was very good among the cases were the tumor was well defined. In complex cases, where the tumor did not show the typical characteristics, or in cases with Lipiodol (Guerbet, Paris, France) deposits, IOA agreement was compromised.

  18. Relativized problems with abelian phase group in topological dynamics.

    Science.gov (United States)

    McMahon, D

    1976-04-01

    Let (X, T) be the equicontinuous minimal transformation group with X = pi(infinity)Z(2), the Cantor group, and S = [unk](infinity)Z(2) endowed with the discrete topology acting on X by right multiplication. For any countable group T we construct a function F:X x S --> T such that if (Y, T) is a minimal transformation group, then (X x Y, S) is a minimal transformation group with the action defined by (x, y)s = [xs, yF(x, s)]. If (W, T) is a minimal transformation group and varphi:(Y, T) --> (W, T) is a homomorphism, then identity x varphi:(X x Y, S) --> (X x W, S) is a homomorphism and has many of the same properties that varphi has. For this reason, one may assume that the phase group is abelian (or S) without loss of generality for many relativized problems in topological dynamics.

  19. Vanadium (4) complexing in phase of adsorbent with benzimidazole groups

    Energy Technology Data Exchange (ETDEWEB)

    Shvoeva, O P; Kuchava, G P; Evtikova, G A; Belyaeva, V K; Myasoedova, G V; Marov, I N [AN SSSR, Moscow (USSR). Inst. Geokhimii i Analiticheskoj Khimii

    1989-04-01

    Equilibrium and kinetic characteristics of V{sup 4+} sorption by POLYORGS XI-H adsorbent with benzimidazole groups (BIm) are investigated. Using ESR method it is stated that (VO{sup 2+}):(BIm)1:2 complex, where VO{sup 2+} is combined with nitrogen atoms of two imidazole groups, is formed in adsorbent phase. The highest distribution factor of 4.7x10{sup 3} is attained at pH6.

  20. Vanadium (4) complexing in phase of adsorbent with benzimidazole groups

    International Nuclear Information System (INIS)

    Shvoeva, O.P.; Kuchava, G.P.; Evtikova, G.A.; Belyaeva, V.K.; Myasoedova, G.V.; Marov, I.N.

    1989-01-01

    Equilibrium and kinetic characteristics of V 4+ sorption by POLYORGS XI-H adsorbent with benzimidazole groups (BIm) are investigated. Using ESR method it is stated that [VO 2+ ]:[BIm]1:2 complex, where VO 2+ is combined with nitrogen atoms of two imidazole groups, is formed in adsorbent phase. The highest distribution factor of 4.7x10 3 is attained at pH6

  1. Imaging of renal medullary carcinoma in children and young adults: a report from the Children's Oncology Group

    Energy Technology Data Exchange (ETDEWEB)

    Sandberg, Jesse K.; Khanna, Geetika [Washington University School of Medicine, Mallinckrodt Institute of Radiology, St. Louis, MO (United States); Mullen, Elizabeth A. [Children' s Hospital Boston/Dana-Farber Cancer Institute, Department of Pediatric Oncology, Boston, MA (United States); Cajaiba, Mariana M.; Perlman, Elizabeth J. [Northwestern University Feinberg School of Medicine, Department of Pathology and Laboratory Medicine, Ann and Robert H. Lurie Children' s Hospital of Chicago, Chicago, IL (United States); Smith, Ethan A. [University of Michigan Health System, Section of Pediatric Radiology, C. S. Mott Children' s Hospital, Department of Radiology, Ann Arbor, MI (United States); Servaes, Sabah [Children' s Hospital of Philadelphia, Department of Radiology, Philadelphia, PA (United States); Geller, James I. [University of Cincinnati, Division of Pediatric Oncology, Cincinnati Children' s Hospital Medical Center, Cincinnati, OH (United States); Ehrlich, Peter F. [University of Michigan Health System, Section of Pediatric Surgery, C. S. Mott Children' s Hospital, Department of Surgery, Ann Arbor, MI (United States); Cost, Nicholas G. [University of Colorado School of Medicine, Division of Urology, Department of Surgery, Aurora, CO (United States); Dome, Jeffrey S. [Children' s National Medical Center, Division of Pediatric Oncology, Washington, DC (United States); Fernandez, Conrad V. [Dalhousie University and IWK Health Centre, Department of Pediatrics, Halifax, NS (Canada)

    2017-11-15

    Renal medullary carcinoma is a rare renal malignancy of childhood. There are no large series describing the imaging appearance of renal medullary carcinoma in children. To characterize the clinical and imaging features of pediatric renal medullary carcinoma at initial presentation. We retrospectively analyzed images of 25 pediatric patients with renal medullary carcinoma enrolled in the Children's Oncology Group renal tumors classification, biology and banking study (AREN03B2) from March 2006 to August 2016. Imaging findings of the primary mass, and patterns of locoregional and distant spread were evaluated in correlation with pathological and surgical findings. Median age at presentation was 13 years (range: 6-21 years), with a male predominance (3.2:1). The overall stage of disease at initial presentation was stage 1 in 1, stage 2 in 2 and stage 4 in 22. Maximum diameter of the primary renal mass ranged from 1.6 to 10.3 cm (mean: 6.6 cm) with a slight right side predilection (1.5:1). Enlarged (>1 cm short axis) retroperitoneal lymph nodes were identified at initial staging in 20/25 (80%) cases, 10 of which were histologically confirmed while the others did not undergo surgical sampling. Enlarged lymph nodes were also identified in the mediastinum (14/25; 56%) and supraclavicular regions (4/25; 16%). Metastatic disease was present in the lungs in 19/25 (76%) and liver in 6/25 (24%). The pattern of lung metastases was pulmonary lymphangitic carcinomatosis: 10 cases (9 bilateral, 1 unilateral), pulmonary nodules with indistinct margins: 6 cases, pulmonary nodules with distinct margins: 2 cases, while 1 case had pulmonary nodules with both indistinct and distinct margins. Pulmonary lymphangitic carcinomatosis was pathologically confirmed in 4/10 cases. All cases with pulmonary lymphangitic carcinomatosis had associated enlarged mediastinal lymph nodes. Renal medullary carcinoma in children and young adults presents at an advanced local and distant stage in the

  2. Modern Radiation Therapy for Hodgkin Lymphoma: Field and Dose Guidelines From the International Lymphoma Radiation Oncology Group (ILROG)

    International Nuclear Information System (INIS)

    Specht, Lena; Yahalom, Joachim; Illidge, Tim; Berthelsen, Anne Kiil; Constine, Louis S.; Eich, Hans Theodor; Girinsky, Theodore; Hoppe, Richard T.; Mauch, Peter; Mikhaeel, N. George; Ng, Andrea

    2014-01-01

    use of ISRT has not yet been validated in a formal study, it is more conservative than INRT, accounting for suboptimal information and appropriately designed for safe local disease control. The goal of modern smaller field radiation therapy is to reduce both treatment volume and treatment dose while maintaining efficacy and minimizing acute and late sequelae. This review is a consensus of the International Lymphoma Radiation Oncology Group (ILROG) Steering Committee regarding the modern approach to RT in the treatment of HL, outlining a new concept of ISRT in which reduced treatment volumes are planned for the effective control of involved sites of HL. Nodal and extranodal non-Hodgkin lymphomas (NHL) are covered separately by ILROG guidelines

  3. Imaging of renal medullary carcinoma in children and young adults: a report from the Children's Oncology Group

    International Nuclear Information System (INIS)

    Sandberg, Jesse K.; Khanna, Geetika; Mullen, Elizabeth A.; Cajaiba, Mariana M.; Perlman, Elizabeth J.; Smith, Ethan A.; Servaes, Sabah; Geller, James I.; Ehrlich, Peter F.; Cost, Nicholas G.; Dome, Jeffrey S.; Fernandez, Conrad V.

    2017-01-01

    Renal medullary carcinoma is a rare renal malignancy of childhood. There are no large series describing the imaging appearance of renal medullary carcinoma in children. To characterize the clinical and imaging features of pediatric renal medullary carcinoma at initial presentation. We retrospectively analyzed images of 25 pediatric patients with renal medullary carcinoma enrolled in the Children's Oncology Group renal tumors classification, biology and banking study (AREN03B2) from March 2006 to August 2016. Imaging findings of the primary mass, and patterns of locoregional and distant spread were evaluated in correlation with pathological and surgical findings. Median age at presentation was 13 years (range: 6-21 years), with a male predominance (3.2:1). The overall stage of disease at initial presentation was stage 1 in 1, stage 2 in 2 and stage 4 in 22. Maximum diameter of the primary renal mass ranged from 1.6 to 10.3 cm (mean: 6.6 cm) with a slight right side predilection (1.5:1). Enlarged (>1 cm short axis) retroperitoneal lymph nodes were identified at initial staging in 20/25 (80%) cases, 10 of which were histologically confirmed while the others did not undergo surgical sampling. Enlarged lymph nodes were also identified in the mediastinum (14/25; 56%) and supraclavicular regions (4/25; 16%). Metastatic disease was present in the lungs in 19/25 (76%) and liver in 6/25 (24%). The pattern of lung metastases was pulmonary lymphangitic carcinomatosis: 10 cases (9 bilateral, 1 unilateral), pulmonary nodules with indistinct margins: 6 cases, pulmonary nodules with distinct margins: 2 cases, while 1 case had pulmonary nodules with both indistinct and distinct margins. Pulmonary lymphangitic carcinomatosis was pathologically confirmed in 4/10 cases. All cases with pulmonary lymphangitic carcinomatosis had associated enlarged mediastinal lymph nodes. Renal medullary carcinoma in children and young adults presents at an advanced local and distant stage in the

  4. Interest groups, the Lesotho Highlands Water Project Phase 1

    African Journals Online (AJOL)

    interest groups can bring about changes in the water policy arena. ... Lesotho Highlands Water Project Phase 1 as a case study. ... attempts to influence public policy and their representation ... ties concern the relations between state actors and non-state ..... 'bears responsibility here [LHWP], since it is the sponsor of.

  5. Surfacing the life phases of a mental health support group.

    Science.gov (United States)

    Mohr, Wanda K

    2004-01-01

    Support groups have increased rapidly in number and become a viable alternative to formal treatment in the United States. However, little is known regarding how mental health advocacy or support groups start and develop, or about challenges that can threaten their survival. In this 2 1/2-year ethnography, the author studied the culture of a developing family support program associated with a system of care. Several phases emerged, reflecting an organizational dynamic. The group dynamics and response to challenges have implications for organizers and parent organizations about the need for technical assistance necessary for survival of the group. Participant observation and immersion in the culture of such groups can provide a deeper understanding of the ideologies and values around which they organize and the kinds of tensions that members can experience during the group's cycle.

  6. Analysis of toxicity of Milkier cell carcinoma of the skin treated with synchronous carboplatin/etoposide and radiation: a Trans-Tasman Radiation Oncology Group study

    International Nuclear Information System (INIS)

    Poulsen, Michael; Rischin, Danny; Walpole, Evan; Harvey, Jennifer; Macintosh, John; Ainslie, Jill; Hamilton, Chris; Keller, Jacqui B.; Tripcony, Lee B.

    2001-01-01

    Purpose: The acute and late toxicities of synchronous carboplatin, etoposide, and radiation therapy were prospectively assessed in a group of patients with high-risk Milkier cell carcinoma of the skin. Patients and Methods: Forty patients from six different centers throughout Australia were entered into a Phase II study under the auspices of the Trans-Tasman Radiation Oncology Group. The trial was activated in 1996 and continues to accrue. Patients are eligible if they have disease localized to the primary site and nodes and are required to have at least one of the following high-risk features: recurrence after initial therapy, involved nodes, primary size greater than 1 cm, gross residual disease after surgery, or occult primary with nodes. Radiation was delivered to the primary site and nodes to a dose of 50 Gy in 25 fractions over 5 weeks, and synchronous carboplatin (area under curve [Auc] 4.5) and etoposide (80 mg/M 2 i.v.) were given on days 1-3 during weeks 1, 4, 7, and 10. The median age of the group was 67 years (43-78). Results: The median duration of follow-up was 22 months (2-45). There were no treatment-related deaths. Grade 3 or 4 skin toxicity occurred in 63% of patients (95% CI 48, 78). The most serious acute effect was on neutrophils with Grade 3 or 4 (neutrophils 9 /L), occurring in 60% (95% CI 45, 75) of cases. Complications from neutropenia (fever and sepsis) occurred in 16 patients (40% of cases). The median time for neutropenic complications was 27 days (9-35), and 10/16 (62%) cases of neutropenic fever occurred after the second cycle of chemotherapy. The probability of Grade 3 or 4 late effects on platelets ( 9 /L) and hemoglobin (<8 g/dl) was 10% (95% CI 1, 20) and 6% (95% CI 2, 15), respectively. Of the 40 patients, 35 were able to complete 4 cycles of chemotherapy. There were no factors predictive for neutropenic toxicity at a p value < 0.05. Conclusions: The protocol has acceptable toxicity, and the treatment has been deliverable in a

  7. Phase 2 of the International Piping Integrity Research Group programme

    International Nuclear Information System (INIS)

    Darlaston, B.J.

    1994-01-01

    The results of phase 1 of the International Piping Integrity Research Group (IPIRG-1) programme have been widely reported. The significance of the results is reviewed briefly, in order to put the phase 2 programme into perspective. The success of phase 1 led the participants to consider further development and validation of pipe and pipe component fracture analysis technology as part of another international group programme (IPIRG-2). The benefits of combined funding and of the technical exchanges and interactions are considered to be of significant advantage and value. The phase 2 programme has been designed with the overall objective of developing and experimentally validating methods of predicting the fracture behaviour of nuclear reactor safety-related piping, to both normal operating and accident loads. The programme will add to the engineering estimation analysis methods that have been developed for straight pipes. The pipe system tests will expand the database to include seismic loadings and flaws in fittings, such as bends, elbows and tees, as well as ''short'' cracks. The results will be used to validate further the analytical methods, expand the capability to make fittings and extend the quasi-static results for the USNRC's new programme on short cracks in piping and piping welds. The IPIRG-2 programme is described to provide a clear understanding of the content, strategy, potential benefits and likely significance of the work. ((orig.))

  8. Extended Group Contribution Model for Polyfunctional Phase Equilibria

    DEFF Research Database (Denmark)

    Abildskov, Jens

    of physical separation processes. In a thermodynamic sense, design requires detailed knowledge of activity coefficients in the phases at equilibrium. The prediction of these quantities from a minimum of experimental data is the broad scope of this thesis. Adequate equations exist for predicting vapor......Material and energy balances and equilibrium data form the basis of most design calculations. While material and energy balances may be stated without much difficulty, the design engineer is left with a choice between a wide variety of models for describing phase equilibria in the design......-liquid equilibria from data on binary mixtures, composed of structurally simple molecules with a single functional group. More complex is the situation with mixtures composed of structurally more complicated molecules or molecules with more than one functional group. The UNIFAC method is extended to handle...

  9. Renormalization group theory of phase transitions in square Ising systems

    International Nuclear Information System (INIS)

    Nienhuis, B.

    1978-01-01

    Some renormalization group calculations are presented on a number of phase transitions in a square Ising model, both second and first order. Of these transitions critical exponents are calculated, the amplitudes of the power law divergences and the locus of the transition. In some cases attention is paid to the thermodynamic functions also far from the critical point. Universality and scaling are discussed and the renormalization group theory is reviewed. It is shown how a renormalization transformation, which relates two similar systems with different macroscopic dimensions, can be constructed, and how some critical properties of the system follow from this transformation. Several numerical and analytical applications are presented. (Auth.)

  10. Control of group velocity by phase-changing collisions

    International Nuclear Information System (INIS)

    Goren, C.; Rosenbluh, M.; Wilson-Gordon, A.D.; Friedmann, H.

    2005-01-01

    We discuss the influence of phase-changing collisions on the group velocities in Doppler-broadened, cycling, degenerate two-level systems where F e =F g +1 and F g >0, interacting with pump and probe lasers, that exhibit electromagnetically induced absorption (EIA). Two model systems are considered: the N system where the pump and probe are polarized perpendicularly, and EIA is due to transfer of coherence (TOC), and the double two-level system (TLS) where both lasers have the same polarization, and EIA is due to transfer of population (TOP). For the case of Doppler-broadened EIA TOC, which occurs at low pump intensity, there is a switch from positive to negative dispersion and group velocity, as the rate of phase-changing collisions is increased. For the case of EIA TOP at low pump intensity, the dispersion and group velocity remain negative even when the collision rate is increased. Pressure-induced narrowing, accompanied by an increase in the magnitude of the negative dispersion and a decrease in the magnitude of the negative group velocity, occurs in both EIA TOC and EIA TOP, at low pump intensity. When the pump intensity is increased, a switch from negative to positive dispersion and group velocity, with increasing collision rate, also occurs in the double TLS system. However, the effect is far smaller than in the case of the N system at low pump intensity

  11. Quantum field theory and phase transitions: universality and renormalization group

    International Nuclear Information System (INIS)

    Zinn-Justin, J.

    2003-08-01

    In the quantum field theory the problem of infinite values has been solved empirically through a method called renormalization, this method is satisfying only in the framework of renormalization group. It is in the domain of statistical physics and continuous phase transitions that these issues are the easiest to discuss. Within the framework of a course in theoretical physics the author introduces the notions of continuous limits and universality in stochastic systems operating with a high number of freedom degrees. It is shown that quasi-Gaussian and mean field approximation are unable to describe phase transitions in a satisfying manner. A new concept is required: it is the notion of renormalization group whose fixed points allow us to understand universality beyond mean field. The renormalization group implies the idea that long distance correlations near the transition temperature might be described by a statistical field theory that is a quantum field in imaginary time. Various forms of renormalization group equations are presented and solved in particular boundary limits, namely for fields with high numbers of components near the dimensions 4 and 2. The particular case of exact renormalization group is also introduced. (A.C.)

  12. Australian and New Zealand Faculty of Radiation Oncology Genito-Urinary Group: 2011 consensus guidelines for curative radiotherapy for urothelial carcinoma of the bladder

    International Nuclear Information System (INIS)

    Hindson, Benjamin R.; Turner, Sandra L.; Millar, Jeremy L.

    2012-01-01

    Curative radiotherapy, with or without concurrent chemotherapy, is recognized as a standard treatment option for muscle-invasive bladder cancer. It is commonly used for two distinct groups of patients: either for those medically unfit for surgery, or as part of a 'bladder preserving' management plan incorporating the possibility of salvage cystectomy. However, in both situations, the approach to radiotherapy varies widely around the world. The Australian and New Zealand Faculty of Radiation Oncology Genito-Urinary Group recognised a need to develop consistent, evidence-based guidelines for patient selection and radiotherapy technique in the delivery of curative radiotherapy. Following a workshop convened in May 2009, a working party collated opinions and conducted a wide literature appraisal linking each recommendation with the best available evidence. This process was subject to ongoing re-presentation to the Faculty of Radiation Oncology Genito-Urinary Group members prior to final endorsement. These Guidelines include patient selection, radiation target delineation, dose and fractionation schedules, normal tissue constraints and investigational techniques. Particular emphasis is given to the rationale for the target volumes described. These Guidelines provide a consensus-based framework for the delivery of curative radiotherapy for muscle-invasive bladder cancer. Widespread input from radiation oncologists treating bladder cancer ensures that these techniques are feasible in practice. We recommend these Guidelines be adopted widely in order to encourage a uniformly high standard of radiotherapy in this setting, and to allow for better comparison of outcomes.

  13. Phase structure of NJL model with weak renormalization group

    Science.gov (United States)

    Aoki, Ken-Ichi; Kumamoto, Shin-Ichiro; Yamada, Masatoshi

    2018-06-01

    We analyze the chiral phase structure of the Nambu-Jona-Lasinio model at finite temperature and density by using the functional renormalization group (FRG). The renormalization group (RG) equation for the fermionic effective potential V (σ ; t) is given as a partial differential equation, where σ : = ψ bar ψ and t is a dimensionless RG scale. When the dynamical chiral symmetry breaking (DχSB) occurs at a certain scale tc, V (σ ; t) has singularities originated from the phase transitions, and then one cannot follow RG flows after tc. In this study, we introduce the weak solution method to the RG equation in order to follow the RG flows after the DχSB and to evaluate the dynamical mass and the chiral condensate in low energy scales. It is shown that the weak solution of the RG equation correctly captures vacuum structures and critical phenomena within the pure fermionic system. We show the chiral phase diagram on temperature, chemical potential and the four-Fermi coupling constant.

  14. Neurocognitive outcome in brain metastases patients treated with accelerated-fractionation vs. accelerated-hyperfractionated radiotherapy: an analysis from Radiation Therapy Oncology Group Study 91-04

    International Nuclear Information System (INIS)

    Regine, W.F.; Scott, C.; Murray, K.; Curran, W.

    2001-01-01

    Purpose: To evaluate neurocognitive outcome as measured by the Mini-Mental Status Examination (MMSE) among patients with unresectable brain metastases randomly assigned to accelerated fractionation (AF) vs. accelerated hyperfractionated (AH) whole-brain radiation therapy (WBRT). Methods and Materials: The Radiation Therapy Oncology Group (RTOG) accrued 445 patients with unresectable brain metastases to a Phase III comparison of AH (1.6 Gy b.i.d. to 54.4 Gy) vs. AF (3 Gy q.d. to 30 Gy). All had a KPS of ≥ 70 and a neurologic function status of 0-2. Three hundred fifty-nine patients had MMSEs performed and were eligible for this analysis. Changes in the MMSE were analyzed according to criteria previously defined in the literature. Results: The median survival was 4.5 months for both arms. The average change in MMSE at 2 and 3 months was a drop of 1.4 and 1.1, respectively, in the AF arm as compared to a drop of 0.7 and 1.3, respectively, in the AH arm (p=NS). Overall, 91 patients at 2 months and 23 patients at 3 months had both follow-up MMSE and computed tomography/magnetic resonance imaging documentation of the status of their brain metastases. When an analysis was performed taking into account control of brain metastases, a significant effect on MMSE was observed with time and associated proportional increase in uncontrolled brain metastases. At 2 months, the average change in MMSE score was a drop of 0.6 for those whose brain metastases were radiologically controlled as compared to a drop of 1.9 for those with uncontrolled brain metastases (p=0.47). At 3 months, the average change in MMSE score was a drop of 0.5 for those whose brain metastases were radiologically controlled as compared to a drop of 6.3 for those with uncontrolled brain metastases (p=0.02). Conclusion: Use of AH as compared to AF-WBRT was not associated with a significant difference in neurocognitive function as measured by MMSE in this patient population with unresectable brain metastases and

  15. Older Age Predicts Decreased Metastasis and Prostate Cancer-Specific Death for Men Treated With Radiation Therapy: Meta-Analysis of Radiation Therapy Oncology Group Trials

    Energy Technology Data Exchange (ETDEWEB)

    Hamstra, Daniel A., E-mail: dhamm@umich.edu [University of Michigan, Ann Arbor, Michigan (United States); Bae, Kyounghwa [Radiation Therapy Oncology Group, Philadelphia, Pennsylvania (United States); Pilepich, Miljenko V. [UCLA Medical Center, Los Angeles, California (United States); Hanks, Gerald E. [Fox Chase Cancer Center, Philadelphia, Pennsylvania (United States); Grignon, David J. [Indiana University-Purdue University Indianapolis, Indiana (United States); McGowan, David G. [Cross Cancer Institute, Edmonton, Alberta (Canada); Roach, Mack [UCSF, San Francisco, California (United States); Lawton, Colleen [Medical College of Wisconsin, Milwaukee, Wisconsin (United States); Lee, R. Jeffrey [Intermountain Medical Center, Salt Lake City, Utah (United States); Sandler, Howard [Cedars-Sinai Medical Center, Los Angeles, California (United States)

    2011-12-01

    Purpose: The impact of age on prostate cancer (PCa) outcome has been controversial; therefore, we analyzed the effect of age on overall survival (OS), distant metastasis, prostate cancer-specific death (PCSD), and nonprostate cancer death (NPCD) on patients with locally advanced PCa. Methods and Materials: Patients who participated in four Radiation Therapy Oncology Group (RTOG) phase III trials, 8531, 8610, 9202, and 9413, were studied. Cox proportional hazards regression was used for OS analysis, and cumulative events analysis with Fine and Gray's regression was used for analyses of metastasis, PCSD, and NPCD. Results: Median follow-up of 4,128 patients with median age of 70 (range, 43-88 years) was 7.3 years. Most patients had high-risk disease: cT3 to cT4 (54%) and Gleason scores (GS) of 7 (45%) and 8 to 10 (27%). Older age ({<=}70 vs. >70 years) predicted for decreased OS (10-year rate, 55% vs. 41%, respectively; p < 0.0001) and increased NPCD (10-year rate, 28% vs. 46%, respectively; p < 0.0001) but decreased metastasis (10-year rate, 27% vs. 20%, respectively; p < 0.0001) and PCSD (10-year rate, 18% vs. 14%, respectively; p < 0.0001). To account for competing risks, outcomes were analyzed in 2-year intervals, and age-dependent differences in metastasis and PCSD persisted, even in the earliest time periods. When adjusted for other covariates, an age of >70 years remained associated with decreased OS (hazard ratio [HR], 1.56 [95% confidence interval [CI], 1.43-1.70] p < 0.0001) but with decreased metastasis (HR, 0.72 [95% CI, 0.63-0.83] p < 0.0001) and PCSD (HR, 0.78 [95% CI, 0.66-0.92] p < 0.0001). Finally, the impact of the duration of androgen deprivation therapy as a function of age was evaluated. Conclusions: These data support less aggressive PCa in older men, independent of other clinical features. While the biological underpinning of this finding remains unknown, stratification by age in future trials appears to be warranted.

  16. Advanced Stage Mucinous Adenocarcinoma of the Ovary is both Rare and Highly Lethal: A Gynecologic Oncology Group Study

    Science.gov (United States)

    Zaino, Richard J.; Brady, Mark F.; Lele, Subodh M.; Michael, Helen; Greer, Benjamin; Bookman, Michael A.

    2010-01-01

    Background Primary mucinous adenocarcinomas of the ovary are uncommon and their biologic behavior uncertain. Retrospective studies suggest that many mucinous carcinomas diagnosed as primary to the ovary were actually metastatic from another site. A prospective randomized trial provided an opportunity to estimate the frequency of mucinous tumors, diagnostic reproducibility, and clinical outcomes. Methods A phase III trial enrolled 4000 women with stage III or IV ovarian carcinoma, treated by surgical staging and debulking, with randomization to one of five chemotherapeutic arms. Slides and pathology reports classified as primary mucinous carcinoma were reviewed independently by three pathologists. Cases were re-classified as primary or metastatic to the ovary according to two methods. Overall survival (OS) of reclassified groups was compared with each other and with that of patients with serous carcinomas. Results Forty-four cases were classified as mucinous adenocarcinoma at review. Using either method, only about one third were interpreted by the three reviewers as primary mucinous carcinomas. Reproducibility of interpretations among the reviewers was high with unanimity of opinion in 30 of the 44 (68%) cases. The median survival (MS) did not differ significantly between the groups interpreted as primary or metastatic, but the OS was significantly less than that for women with serous carcinoma (14 vs 42 months, povary is very rare and is associated with poor OS. Many mucinous adenocarcinomas that are diagnosed as primary ovarian neoplasms appear to be metastatic to the ovary. PMID:20862744

  17. Phase Grouping Line Extraction Algorithm Using Overlapped Partition

    Directory of Open Access Journals (Sweden)

    WANG Jingxue

    2015-07-01

    Full Text Available Aiming at solving the problem of fracture at the discontinuities area and the challenges of line fitting in each partition, an innovative line extraction algorithm is proposed based on phase grouping using overlapped partition. The proposed algorithm adopted dual partition steps, which will generate overlapped eight partitions. Between the two steps, the middle axis in the first step coincides with the border lines in the other step. Firstly, the connected edge points that share the same phase gradients are merged into the line candidates, and fitted into line segments. Then to remedy the break lines at the border areas, the break segments in the second partition steps are refitted. The proposed algorithm is robust and does not need any parameter tuning. Experiments with various datasets have confirmed that the method is not only capable of handling the linear features, but also powerful enough in handling the curve features.

  18. The need for central pathology tumor grading in prostate cancer using radiation therapy oncology group(RTOG)8531

    International Nuclear Information System (INIS)

    Winter, K.; Grignon, D.; Pajak, T.F.; Pilepich, M.; Byhardt, R.; Lawton, C.; Gallagher, M.; Mesic, J.; Roach, M.; Hanks, G.; Coughlin, C.; Porter, A.

    1997-01-01

    Purpose/Objective: Inconsistent reproducibility among pathologists when grading the tumor with the Gleason system is well known. Its impact on results and conclusions of clinical trials will be investigated. Materials and Methods: RTOG 8531 was a Phase III trial that tested the timing of hormones with radiotherapy in patients with prostate cancer. There were 977 patients were entered into RTOG 8531, of which 760 had both an institutional and a centrally reviewed Gleason Score(GS). The centrally reviewed GS were performed by a single pathologist and institutional GS came from over 70 different participating institutions. Results: The concordance rate between the grouping of the two scores was 36% (GS 2-5), 70% (GS 6-7) and 73% (GS 8-10) with the discrepancies occurring in both directions. Using patients from the delayed hormone arm, there was a highly significant survival difference between the centrally reviewed GS groups (p = .0001). When the institutional GS groups were used, there was no significant survival difference (p=.19). Another survival analysis compared the treatment arms for GS 8-10 patients. When the centrally reviewed GS were used, there was a significant difference(p = .02), but when the institutional GS were used there was no significant difference in survival between the treatments (p=.48). Conclusions: The lack of reproducibility of Gleason scores among pathologists can lead to very different results and conclusions from clinical trials depending on whether the centrally reviewed or institutional Gleason scores are used. Whenever results are being reported by Gleason score, it is necessary to also report how many pathologists were involved in the grading. If Gleason scores are going to be used in the analysis of treatment, a central review of the Gleason scores is crucial

  19. Quality Indicators in Radiation Oncology

    Energy Technology Data Exchange (ETDEWEB)

    Albert, Jeffrey M. [Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Das, Prajnan, E-mail: prajdas@mdanderson.org [Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States)

    2013-03-15

    Oncologic specialty societies and multidisciplinary collaborative groups have dedicated considerable effort to developing evidence-based quality indicators (QIs) to facilitate quality improvement, accreditation, benchmarking, reimbursement, maintenance of certification, and regulatory reporting. In particular, the field of radiation oncology has a long history of organized quality assessment efforts and continues to work toward developing consensus quality standards in the face of continually evolving technologies and standards of care. This report provides a comprehensive review of the current state of quality assessment in radiation oncology. Specifically, this report highlights implications of the healthcare quality movement for radiation oncology and reviews existing efforts to define and measure quality in the field, with focus on dimensions of quality specific to radiation oncology within the “big picture” of oncologic quality assessment efforts.

  20. Quality Indicators in Radiation Oncology

    International Nuclear Information System (INIS)

    Albert, Jeffrey M.; Das, Prajnan

    2013-01-01

    Oncologic specialty societies and multidisciplinary collaborative groups have dedicated considerable effort to developing evidence-based quality indicators (QIs) to facilitate quality improvement, accreditation, benchmarking, reimbursement, maintenance of certification, and regulatory reporting. In particular, the field of radiation oncology has a long history of organized quality assessment efforts and continues to work toward developing consensus quality standards in the face of continually evolving technologies and standards of care. This report provides a comprehensive review of the current state of quality assessment in radiation oncology. Specifically, this report highlights implications of the healthcare quality movement for radiation oncology and reviews existing efforts to define and measure quality in the field, with focus on dimensions of quality specific to radiation oncology within the “big picture” of oncologic quality assessment efforts

  1. A TECHNIQUE OF IDENTIFICATION OF THE PHASE-DISPLACEMENT GROUP OF THREE-PHASE TRANSFORMER

    International Nuclear Information System (INIS)

    Aburjania, A.; Begiashvili, V.; Rezan Turan

    2007-01-01

    It is demonstrated that the arbitrary choice of arbitrarily pisitive direction of induced currents and voltages contradicts the energy conservation law and leads to equilibrium equations and standards making no sense from the physical standpoint. Of 12 recognized standard phase-displacement groups of three-phase transformer, only three have real physical bases. The rest are based on a wrong assumption about mutual biasing of primary and secondary currents. They does not rule out the occurrence of emergency situations and, thus, must be eliminated from use. A new method of identification of the phase-displacement of three-phase transformer is proposed. The method is based on well-known physical laws with consideration for the dual character of the inertia of mutual inductance and exhausts for all possible versions of connection of transformer windings. (author)

  2. The role of prophylactic cranial irradiation in regionally advanced non-small cell lung cancer. A Southwest Oncology Group Study

    Energy Technology Data Exchange (ETDEWEB)

    Rusch, V.W.; Griffin, B.R.; Livingston, R.B. (Univ. of Washington, Seattle (USA))

    1989-10-01

    Lung cancer is the most common malignant disease in the United States. Only the few tumors detected very early are curable, but there has been some progress in the management of more advanced non-small cell lung cancer, particularly in regionally inoperable disease. Prevention of central nervous system relapse is an important issue in this group of patients because brain metastases ultimately develop in 20% to 25% of them. Seventy-three patients with regionally advanced non-small cell lung cancer were entered into a Phase II trial of neutron chest radiotherapy sandwiched between four cycles of chemotherapy including cisplatin, vinblastine, and mitomycin C. Prophylactic cranial irradiation was administered concurrently with chest radiotherapy (3000 cGy in 10 fractions in 15 patients; 3600 cGy in 18 fractions in the remaining 50 patients). Patients underwent computed tomographic scan of the brain before treatment and every 3 months after treatment. The initial overall response rate was 79%, but 65 of the 73 patients have subsequently died of recurrent disease. Median follow-up is 9 months for all 73 patients and 26 months for eight long-term survivors. No patient who completed the prophylactic cranial irradiation program had clinical or radiologic brain metastases. Toxic reactions to prophylactic cranial irradiation included reversible alopecia in all patients, progressive dementia in one patient, and possible optic neuritis in one patient. Both of these patients received 300 cGy per fraction of irradiation. The use of prophylactic cranial irradiation has been controversial, but its safety and efficacy in this trial supports its application in a group of patients at high risk for central nervous system relapse. Further evaluation of prophylactic cranial irradiation in clinical trials for regionally advanced non-small cell lung cancer is warranted.

  3. Differences between early and late involvement of palliative home care in oncology care: A focus group study with palliative home care teams.

    Science.gov (United States)

    Dhollander, Naomi; Deliens, Luc; Van Belle, Simon; De Vleminck, Aline; Pardon, Koen

    2018-05-01

    To date, no randomised controlled trials on the integration of specialised palliative home care into oncology care have been identified. Information on whether existing models of integrated care are applicable to the home care system and how working procedures and skills of the palliative care teams might require adaptation is missing. To gain insight into differences between early and late involvement and the effect on existing working procedures and skills as perceived by palliative home care teams. Qualitative study - focus group interviews. Six palliative home care teams in Flanders, Belgium. Participants included physicians, nurses and psychologists. Differences were found concerning (1) reasons for initiation, (2) planning of care process, (3) focus on future goals versus problems, (4) opportunity to provide holistic care, (5) empowerment of patients and (6) empowerment of professional caregivers. A shift from a medical approach to a more holistic approach is the most noticeable. Being involved earlier also results in a more structured follow-up and in empowering the patient to be part of the decision-making process. Early involvement creates the need for transmural collaboration, which leads to the teams taking on more supporting and coordinating tasks. Being involved earlier leads to different tasks and working procedures and to the need for transmural collaboration. Future research might focus on the development of an intervention model for the early integration of palliative home care into oncology care. To develop this model, components of existing models might need to be adapted or extended.

  4. RECQ1 A159C Polymorphism Is Associated With Overall Survival of Patients With Resected Pancreatic Cancer: A Replication Study in NRG Oncology Radiation Therapy Oncology Group 9704

    Energy Technology Data Exchange (ETDEWEB)

    Li, Donghui, E-mail: dli@mdanderson.org [Department of Gastrointestinal Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Moughan, Jennifer [NRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania (United States); Crane, Christopher [Department of Gastrointestinal Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Hoffman, John P. [Department of Surgical Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania (United States); Regine, William F. [Department of Radiation Oncology, University of Maryland, Baltimore, Maryland (United States); Abrams, Ross A. [Rush University Medical Center, Chicago, Illinois (United States); Safran, Howard [Brown University Oncology Group, Providence, Rhode Island (United States); Liu, Chang; Chang, Ping [Department of Gastrointestinal Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Freedman, Gary M. [Department of Radiation Oncology, University of Pennsylvania, Philadelphia, Pennsylvania (United States); Winter, Kathryn A. [NRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania (United States); Guha, Chandan [Department of Radiation Oncology, Montefiore Medical Center, Bronx, New York (United States); Abbruzzese, James L. [Duke University Medical Center, Durham, North Carolina (United States)

    2016-03-01

    Purpose: To confirm whether a previously observed association between RECQ1 A159C variant and clinical outcome of resectable pancreatic cancer patients treated with preoperative chemoradiation is reproducible in another patient population prospectively treated with postoperative chemoradiation. Methods and Materials: Patients were selected, according to tissue availability, from eligible patients with resected pancreatic cancer who were enrolled on the NRG Oncology Radiation Therapy Oncology Group 9704 trial of 5-fluorouacil (5-FU)-based chemoradiation preceded and followed by 5-FU or gemcitabine. Deoxyribonucleic acid was extracted from paraffin-embedded tissue sections, and genotype was determined using the Taqman method. The correlation between genotype and overall survival was analyzed using a Kaplan-Meier plot, log-rank test, and multivariate Cox proportional hazards models. Results: In the 154 of the study's 451 eligible patients with evaluable tissue, genotype distribution followed Hardy-Weinberg equilibrium (ie, 37% had genotype AA, 43% AC, and 20% CC). The RECQ1 variant AC/CC genotype carriers were associated with being node positive compared with the AA carrier (P=.03). The median survival times (95% confidence interval [CI]) for AA, AC, and CC carriers were 20.6 (16.3-26.1), 18.8 (14.2-21.6), and 14.2 (10.3-21.0) months, respectively. On multivariate analysis, patients with the AC/CC genotypes were associated with worse survival than patients with the AA genotype (hazard ratio [HR] 1.54, 95% CI 1.07-2.23, P=.022). This result seemed slightly stronger for patients on the 5-FU arm (n=82) (HR 1.64, 95% CI 0.99-2.70, P=.055) than for patients on the gemcitabine arm (n=72, HR 1.46, 95% CI 0.81-2.63, P=.21). Conclusions: Results of this study suggest that the RECQ1 A159C genotype may be a prognostic or predictive factor for resectable pancreatic cancer patients who are treated with adjuvant 5-FU before and after 5-FU-based chemoradiation. Further study is

  5. Importance of the mini-mental status examination in the treatment of patients with brain metastases: a report from the radiation therapy oncology group protocol 91-04

    International Nuclear Information System (INIS)

    Murray, Kevin J.; Scott, Charles; Zachariah, Babu; Michalski, Jeff M.; Demas, William; Vora, Nayana L.; Whitton, Anthony; Movsas, Benjamin

    2000-01-01

    Purpose: Little information is available on the importance of pretreatment Mini-Mental Status Exam (MMSE) on long-term survival and neurologic function following treatment for unresectable brain metastases. This study examines the importance of the MMSE in predicting outcome in a group of patients treated with an accelerated fractionation regimen of 30 Gy in 10 daily fractions in 2 weeks. Materials and Methods: The Radiation Therapy Oncology Group (RTOG) accrued 445 patients to a Phase III comparison of accelerated hyperfractionated (AH) radiotherapy (1.6 Gy b.i.d.) to a total dose of 54.4 Gy vs. an accelerated fractionation (AF) of 30 Gy in 10 daily fractions from 1991 through 1995. All patients had histologic proof of malignancy at the primary site. Brain metastases were measurable by CT or MRI scan and all patients had a Karnofsky performance score (KPS) of at least 70 and a neurologic function classification of 1 or 2. Two hundred twenty-four patients were entered on the accelerated fractionated arm, and 182 were eligible for analysis (7 patients were judged ineligible, no MMSE information in 29, no survival data in 1, no forms submitted in 1). Results: Average age was 60 years; 58% were male and 25% had a single intracranial lesion on their pretherapy evaluation. KPS was 70 in 32%, 80 in 31%, 90 in 29%, and 100 in 14%. The average MMSE was 26.5, which is the lower quartile for normal in the U.S. population. The range of the MMSE scores was 11-30 with 30 being the maximum. A score of less than 23 indicates possible dementia, which occurred in 16% of the patients prior to treatment. The median time from diagnosis to treatment was 5 days (range, 0-158 days). The median survival was 4.2 months with a 95% confidence interval of 3.7-5.1 months. Thirty-seven percent of the patients were alive at 6 months, and 17% were alive at 1 year. The following variables were examined in a Cox proportional-hazards model to determine their prognostic value for overall survival

  6. Insufficiency Fractures After Pelvic Radiation Therapy for Uterine Cervical Cancer: An Analysis of Subjects in a Prospective Multi-institutional Trial, and Cooperative Study of the Japan Radiation Oncology Group (JAROG) and Japanese Radiation Oncology Study Group (JROSG)

    Energy Technology Data Exchange (ETDEWEB)

    Tokumaru, Sunao, E-mail: tokumaru@cc.saga-u.ac.jp [Department of Heavy Particle Therapy and Radiation Oncology, Saga University, Saga (Japan); Toita, Takafumi [Department of Radiology, Graduate School of Medical Science, University of the Ryukyus, Okinawa (Japan); Oguchi, Masahiko [Radiation Oncology Department, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo (Japan); Ohno, Tatsuya [Gunma University Heavy Ion Medical Center, Maebashi (Japan); Kato, Shingo [Department of Radiation Oncology, Saitama Medical University, International Medical Center, Saitama (Japan); Niibe, Yuzuru [Department of Radiology, School of Medicine, Kitasato University, Sagamihara (Japan); Kazumoto, Tomoko [Department of Radiology, Saitama Cancer Center, Saitama (Japan); Kodaira, Takeshi [Department of Radiation Oncology, Aichi Cancer Center, Nagoya (Japan); Kataoka, Masaaki [Department of Radiology, National Shikoku Cancer Center, Matsuyama (Japan); Shikama, Naoto [Department of Radiation Oncology, Saitama Medical University, International Medical Center, Saitama (Japan); Kenjo, Masahiro [Department of Radiation Oncology, Graduate School of Medical Science, Hiroshima University, Hiroshima (Japan); Yamauchi, Chikako [Department of Radiation Oncology, Shiga Medical Center for Adults, Moriyama (Japan); Suzuki, Osamu [Department of Radiation Oncology, Osaka Medical Center for Cancer, Osaka (Japan); Sakurai, Hideyuki [Proton Medical Research Center and Tsukuba University, Tuskuba (Japan); Teshima, Teruki [Department of Medical Physics and Engineering, Graduate School of Medicine, Osaka University, Suita (Japan); Kagami, Yoshikazu [Department of Radiology, Showa University School of Medicine, Tokyo (Japan); Nakano, Takashi [Department of Radiation Oncology, Gunma University, Graduate School of Medicine, Maebashi (Japan); Hiraoka, Masahiro [Department of Radiation Oncology and Image-applied Therapy, Kyoto University, Graduate School of Medicine, Kyoto (Japan); and others

    2012-10-01

    Purpose: To investigate pelvic insufficiency fractures (IF) after definitive pelvic radiation therapy for early-stage uterine cervical cancer, by analyzing subjects of a prospective, multi-institutional study. Materials and Methods: Between September 2004 and July 2007, 59 eligible patients were analyzed. The median age was 73 years (range, 37-84 years). The International Federation of Gynecologic Oncology and Obstetrics stages were Ib1 in 35, IIa in 12, and IIb in 12 patients. Patients were treated with the constant method, which consisted of whole-pelvic external-beam radiation therapy of 50 Gy/25 fractions and high-dose-rate intracavitary brachytherapy of 24 Gy/4 fractions without chemotherapy. After radiation therapy the patients were evaluated by both pelvic CT and pelvic MRI at 3, 6, 12, 18, and 24 months. Diagnosis of IF was made when the patients had both CT and MRI findings, neither recurrent tumor lesions nor traumatic histories. The CT findings of IF were defined as fracture lines or sclerotic linear changes in the bones, and MRI findings of IF were defined as signal intensity changes in the bones, both on T1- and T2-weighted images. Results: The median follow-up was 24 months. The 2-year pelvic IF cumulative occurrence rate was 36.9% (21 patients). Using Common Terminology Criteria for Adverse Events version 3.0, grade 1, 2, and 3 IF were seen in 12 (21%), 6 (10%), and 3 patients (5%), respectively. Sixteen patients had multiple fractures, so IF were identified at 44 sites. The pelvic IF were frequently seen at the sacroileal joints (32 sites, 72%). Nine patients complained of pain. All patients' pains were palliated by rest or non-narcotic analgesic drugs. Higher age (>70 years) and low body weight (<50 kg) were thought to be risk factors for pelvic IF (P=.007 and P=.013, Cox hazard test). Conclusions: Cervical cancer patients with higher age and low body weight may be at some risk for the development of pelvic IF after pelvic radiation therapy.

  7. Modern Radiation Therapy for Nodal Non-Hodgkin Lymphoma—Target Definition and Dose Guidelines From the International Lymphoma Radiation Oncology Group

    DEFF Research Database (Denmark)

    Illidge, Tim; Specht, Lena; Yahalom, Joachim

    2014-01-01

    Radiation therapy (RT) is the most effective single modality for local control of non-Hodgkin lymphoma (NHL) and is an important component of therapy for many patients. Many of the historic concepts of dose and volume have recently been challenged by the advent of modern imaging and RT planning...... tools. The International Lymphoma Radiation Oncology Group (ILROG) has developed these guidelines after multinational meetings and analysis of available evidence. The guidelines represent an agreed consensus view of the ILROG steering committee on the use of RT in NHL in the modern era. The roles...... of reduced volume and reduced doses are addressed, integrating modern imaging with 3-dimensional planning and advanced techniques of RT delivery. In the modern era, in which combined-modality treatment with systemic therapy is appropriate, the previously applied extended-field and involved-field RT...

  8. Interobserver Variability in Target Definition for Hepatocellular Carcinoma With and Without Portal Vein Thrombus: Radiation Therapy Oncology Group Consensus Guidelines

    Energy Technology Data Exchange (ETDEWEB)

    Hong, Theodore S., E-mail: tshong1@mgh.harvard.edu [Department of Radiation Oncology, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts (United States); Bosch, Walter R. [Department of Radiation Oncology, Washington University in St. Louis School of Medicine, St. Louis, Missouri (United States); Krishnan, Sunil [Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Kim, Tae K. [Department of Medical Imaging, University Health Network, Mount Sinai Hospital and Women' s College Hospital, University of Toronto, Toronto, Ontario (Canada); Mamon, Harvey J. [Department of Radiation Oncology, Dana-Farber Cancer Institute/Brigham and Women' s Hospital and Harvard Medical School, Boston, Massachusetts (United States); Shyn, Paul [Department of Radiology, Brigham and Women' s Hospital and Harvard Medical School, Boston, Massachusetts (United States); Ben-Josef, Edgar [Department of Radiation Oncology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania (United States); Seong, Jinsil [Department of Radiation Oncology, Yonsei University Medical College, Seoul (Korea, Republic of); Haddock, Michael G. [Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota (United States); Cheng, Jason C. [Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan (China); Feng, Mary U. [Department of Radiation Oncology, University of Michigan Health System, Ann Arbor, Michigan (United States); Stephans, Kevin L. [Department of Radiation Oncology, Cleveland Clinic, Cleveland, Ohio (United States); Roberge, David [Department of Radiation Oncology, Montreal General Hospital/McGill University Health Centre, Montreal, Quebec (Canada); Crane, Christopher [Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); and others

    2014-07-15

    Purpose: Defining hepatocellular carcinoma (HCC) gross tumor volume (GTV) requires multimodal imaging, acquired in different perfusion phases. The purposes of this study were to evaluate the variability in contouring and to establish guidelines and educational recommendations for reproducible HCC contouring for treatment planning. Methods and Materials: Anonymous, multiphasic planning computed tomography scans obtained from 3 patients with HCC were identified and distributed to a panel of 11 gastrointestinal radiation oncologists. Panelists were asked the number of HCC cases they treated in the past year. Case 1 had no vascular involvement, case 2 had extensive portal vein involvement, and case 3 had minor branched portal vein involvement. The agreement between the contoured total GTVs (primary + vascular GTV) was assessed using the generalized kappa statistic. Agreement interpretation was evaluated using Landis and Koch's interpretation of strength of agreement. The S95 contour, defined using the simultaneous truth and performance level estimation (STAPLE) algorithm consensus at the 95% confidence level, was created for each case. Results: Of the 11 panelists, 3 had treated >25 cases in the past year, 2 had treated 10 to 25 cases, 2 had treated 5 to 10 cases, 2 had treated 1 to 5 cases, 1 had treated 0 cases, and 1 did not respond. Near perfect agreement was seen for case 1, and substantial agreement was seen for cases 2 and 3. For case 2, there was significant heterogeneity in the volume identified as tumor thrombus (range 0.58-40.45 cc). For case 3, 2 panelists did not include the branched portal vein thrombus, and 7 panelists contoured thrombus separately from the primary tumor, also showing significant heterogeneity in volume of tumor thrombus (range 4.52-34.27 cc). Conclusions: In a group of experts, excellent agreement was seen in contouring total GTV. Heterogeneity exists in the definition of portal vein thrombus that may impact treatment

  9. Factors which influence quality of life in patients with non-small cell lung cancer (NSCLC): A radiation therapy oncology group study (RTOG 89-01)

    International Nuclear Information System (INIS)

    Scott, C.B.; Sause, W.T.; Johnson, D.; Dar, A.R.; Wasserman, T.H.; Rubin, P.; Khandekar, J.; Byhardt, R.B.; Taylor, S.; McDonald, A.

    1997-01-01

    Purpose: Prospectively evaluate the quality of life (QOL) of patients with NSCLC participating in a randomized phase III study conducted by the RTOG and Eastern Cooperative Oncology Group. Determine the factors which influence QOL during and post therapy. Materials and Methods: From (4(90)) to (4(94)) to 75 patients (pts) were randomized on RTOG 89-01 between a regimen containing radiation therapy (RT) versus a regimen containing surgery (S). All pts received induction vinblastine and cisplatin, followed by either S or RT and consolidation chemotherapy (CT). Pts were given the self-assessment QOL forms prior to the start of therapy, post induction CT, post RT or S, and periodically during follow-up. Two questionnaires were used: Functional Assessment of Cancer Therapy for lung cancer patients (FACT-L) and Functional Living Index-Cancer (FLIC). The FACT-L consists of 44 questions covering 6 domains (physical, social, and emotional well-being, relationship with physician, fulfilment, and lung cancer specific concerns), FLIC contains 22 questions summing to one total score. Results: 51 pts participated in the QOL endpoint, 24 were excluded: 3 pts refused, institution did not administer QOL questionnaires in 9 pts, 3 completed QOL after start of therapy, 1 institution refused to participate, 5 questionnaires were incomplete/unusable, 1 pt could not read English, and 2 were ineligible for treatment. Participation in QOL was not predicted by any pretreatment characteristic. Women had worse pretreatment QOL (p<0.005, by FLIC) and more problems with disease-related symptoms (p<0.005, by FACT) than men. Pts with KPS 90-100 had better pretreatment QOL than pts with KPS 60-80 (p<0.025, FLIC). Neither race, marital status, education level, age, prior weight loss, nor disease symptoms statistically significantly influenced pretreatment QOL. Initial QOL did not predict overall survival. FACT-L was reported on 25 pts post induction CT. Follow-up FACT-L was available on 12 pts

  10. Radiation oncology

    International Nuclear Information System (INIS)

    Anon.

    1977-01-01

    The Radiation Oncology Division has had as its main objectives both to operate an academic training program and to carry out research on radiation therapy of cancer. Since fiscal year 1975, following a directive from ERDA, increased effort has been given to research. The research activities have been complemented by the training program, which has been oriented toward producing radiation oncologists, giving physicians short-term experience in radiation oncology, and teaching medical students about clinical cancer and its radiation therapy. The purpose of the research effort is to improve present modalities of radiation therapy of cancer. As in previous years, the Division has operated as the Radiation Oncology Program of the Department of Radiological Sciences of the University of Puerto Rico School of Medicine. It has provided radiation oncology support to patients at the University Hospital and to academic programs of the University of Puerto Rico Medical Sciences Campus. The patients, in turn, have provided the clinical basis for the educational and research projects of the Division. Funding has been primarily from PRNC (approx. 40%) and from National Cancer Institute grants channeled through the School of Medicine (approx. 60%). Special inter-institutional relationships with the San Juan Veterans Administration Hospital and the Metropolitan Hospital in San Juan have permitted inclusion of patients from these institutions in the Division's research projects. Medical physics and radiotherapy consultations have been provided to the Radiotherapy Department of the VA Hospital

  11. Kohn Anomaly and Phase Stability in Group VB Transition Metals

    Directory of Open Access Journals (Sweden)

    Alexander Landa

    2018-03-01

    Full Text Available In the periodic table, only a few pure metals exhibit lattice or magnetic instabilities associated with Fermi surface nesting, the classical examples being α-U and Cr. Whereas α-U displays a strong Kohn anomaly in the phonon spectrum that ultimately leads to the formation of charge density waves (CDWs, Cr is known for its nesting-induced spin density waves (SDWs. Recently, it has become clear that a pronounced Kohn anomaly and the corresponding softening in the elastic constants is also the key factor that controls structural transformations and mechanical properties in compressed group VB metals—materials with relatively high superconducting critical temperatures. This article reviews the current understanding of the structural and mechanical behavior of these metals under pressure with an introduction to the concept of the Kohn anomaly and how it is related to the important concept of Peierls instability. We review both experimental and theoretical results showing different manifestations of the Kohn anomaly in the transverse acoustic phonon mode TA (ξ00 in V, Nb, and Ta. Specifically, in V the anomaly triggers a structural transition to a rhombohedral phase, whereas in Nb and Ta it leads to an anomalous reduction in yield strength.

  12. Prevalence and clinical impact of anaplasia in childhood rhabdomyosarcoma : a report from the Soft Tissue Sarcoma Committee of the Children's Oncology Group.

    Science.gov (United States)

    Qualman, Stephen; Lynch, James; Bridge, Julia; Parham, David; Teot, Lisa; Meyer, William; Pappo, Alberto

    2008-12-01

    Anapalsia is rare in childhood rhabdomyosarcoma and has not been included in the International Classification of Rhabdomyosarcoma (ICR). A recent review of cases from the Soft Tissue Sarcoma Committee of the Children's Oncology Group (COG) suggests that anaplasia might be more common than previously reported and may impact clinical outcome. The prevalence of anaplasia (focal or diffuse) was prospectively assessed in 546 eligible cases who were registered in an Intergroup Rhabdomyosarcoma Study Group (IRSG) or COG therapeutic trial from 1995 through 1998. The incidence of anaplasia in tumor samples and its impact in predicting clinical outcome was assessed. Overall, 71 (13%) of all samples analyzed had anaplasia. Anaplasia was more common in patients with tumors in favorable sites and was less commonly observed in younger patients and in those with stage II, III, or clinical group III disease. Regardless of its distribution (focal or diffuse), on univariate analysis the presence of anaplasia negatively influenced the failure-free survival rate (63% vs 77% at 5 years) and overall survival (68% vs 82% at 5 years) rates in patients with embryonal rhabdomyosarcoma. This effect was most pronounced in children with intermediate-risk tumors. Anaplasia did not affect outcome in patients with alveolar tumors. The incidence of anaplasia in patients with rhabdomyosarcoma is higher than previously described and may be of prognostic significance in children with intermediate-risk embryonal rhabdomyosarcoma. (c) 2008 American Cancer Society

  13. Conducting Cancer Control and Survivorship Research via Cooperative Groups: A Report from the American Society of Preventive Oncology

    OpenAIRE

    Palesh, Oxana; Demark-Wahnefried, Wendy; Mustian, Karen; Minasian, Lori; Rowland, Julia; Sprod, Lisa; Janelsins, Michelle; Peppone, Luke; Sloan, Jeff; Engquist, Karen Basen; Jones, Lee; Buist, Diana; Paskett, Electra

    2011-01-01

    As the number of cancer survivors expands, the need for cancer control and survivorship research becomes increasingly important. The National Cancer Institute (NCI) Cooperative Groups may offer a viable platform to perform such research. Observational, preventive, and behavioral research can often be performed within the cooperative group setting, especially if resources needed for evaluation are fairly simple, if protocols are easily implemented within the typical clinical setting, and if in...

  14. Conducting cancer control and survivorship research via cooperative groups: a report from the American Society of Preventive Oncology.

    Science.gov (United States)

    Palesh, Oxana; Demark-Wahnefried, Wendy; Mustian, Karen; Minasian, Lori; Rowland, Julia; Sprod, Lisa; Janelsins, Michelle; Peppone, Luke; Sloan, Jeff; Engquist, Karen Basen; Jones, Lee; Buist, Diana; Paskett, Electra D

    2011-05-01

    As the number of cancer survivors expands, the need for cancer control and survivorship research becomes increasingly important. The National Cancer Institute (NCI) Cooperative Groups may offer a viable platform to perform such research. Observational, preventive, and behavioral research can often be performed within the cooperative group setting, especially if resources needed for evaluation are fairly simple, if protocols are easily implemented within the typical clinical setting, and if interventions are well standardized. Some protocols are better suited to cooperative groups than are others, and there are advantages and disadvantages to conducting survivorship research within the cooperative group setting. Behavioral researchers currently involved in cooperative groups, as well as program staff within the NCI, can serve as sources of information for those wishing to pursue symptom management and survivorship studies within the clinical trial setting. The structure of the cooperative groups is currently changing, but going forward, survivorship is bound to be a topic of interest and one that perhaps may be more easily addressed using the proposed more centralized structure. ©2011 AACR.

  15. Strategic Plans to Promote Head and Neck Cancer Translational Research Within the Radiation Therapy Oncology Group: A Report From the Translational Research Program

    International Nuclear Information System (INIS)

    Chung, Christine H.; Wong, Stuart; Ang, K. Kian; Hammond, Elizabeth H.; Dicker, Adam P.; Harari, Paul M.; Le, Quynh-Thu

    2007-01-01

    Head and neck cancer is the fifth most common cancer in the United States, with an overall survival rate of approximately 40-50%. In an effort to improve patient outcomes, research efforts designed to maximize benefit and reduce toxicities of therapy are in progress. Basic research in cancer biology has accelerated this endeavor and provided preclinical data and technology to support clinically relevant advances in early detection, prognostic and predictive biomarkers. Recent completion of the Human Genome Project has promoted the rapid development of novel 'omics' technologies that allow more broad based study from a systems biology perspective. However, clinically relevant application of resultant gene signatures to clinical trials within cooperative groups has advanced slowly. In light of the large numbers of variables intrinsic to biomarker studies, validation of preliminary data for clinical implementation presents a significant challenge and may only be realized with large trials that involve significant patient numbers. The Radiation Therapy Oncology Group (RTOG) Head and Neck Cancer Translational Research Program recognizes this problem and brings together three unique features to facilitate this research: (1) availability of large numbers of clinical specimens from homogeneously treated patients through multi-institutional clinical trials; (2) a team of physicians, scientists, and staff focused on patient-oriented head-and-neck cancer research with the common goal of improving cancer care; and (3) a funding mechanism through the RTOG Seed Grant Program. In this position paper we outline strategic plans to further promote translational research within the framework of the RTOG

  16. Predictors of mother and child DNA yields in buccal cell samples collected in pediatric cancer epidemiologic studies: a report from the Children's Oncology group.

    Science.gov (United States)

    Poynter, Jenny N; Ross, Julie A; Hooten, Anthony J; Langer, Erica; Blommer, Crystal; Spector, Logan G

    2013-08-12

    Collection of high-quality DNA is essential for molecular epidemiology studies. Methods have been evaluated for optimal DNA collection in studies of adults; however, DNA collection in young children poses additional challenges. Here, we have evaluated predictors of DNA quantity in buccal cells collected for population-based studies of infant leukemia (N = 489 mothers and 392 children) and hepatoblastoma (HB; N = 446 mothers and 412 children) conducted through the Children's Oncology Group. DNA samples were collected by mail using mouthwash (for mothers and some children) and buccal brush (for children) collection kits and quantified using quantitative real-time PCR. Multivariable linear regression models were used to identify predictors of DNA yield. Median DNA yield was higher for mothers in both studies compared with their children (14 μg vs. mothers or children in this analysis. The association with seasonality suggests that conditions during transport may influence DNA yield. The low yields observed in most children in these studies highlight the importance of developing alternative methods for DNA collection in younger age groups.

  17. Prognostic factors derived from recursive partition analysis (RPA) of radiation therapy oncology group (RTOG) brain metastases trials applied to surgically resected and irradiated brain metastatic cases

    International Nuclear Information System (INIS)

    Agboola, Olusegun; Benoit, Brien; Cross, Peter; Silva, Vasco da; Esche, Bernd; Lesiuk, Howard; Gonsalves, Carol

    1998-01-01

    Purpose: (a) To identify the prognostic factors that determine survival after surgical resection and irradiation of tumors metastatic to brain. (b) To determine if the prognostic factors used in the recursive partition analysis (RPA) of brain metastases cases from Radiation Therapy Oncology Group (RTOG) studies into three distinct survival classes is applicable to surgically resected and irradiated patients. Method: The medical records of 125 patients who had surgical resection and radiotherapy for brain metastases from 1985 to 1997 were reviewed. The patients' disease and treatment related factors were analyzed to identify factors that independently determine survival after diagnosis of brain metastasis. The patients were also grouped into three classes using the RPA-derived prognostic parameters which are: age, performance status, state of the primary disease, and presence or absence of extracranial metastases. Class 1: patients ≤ 65 years of age, Karnofsky performance status (KPS) of ≥70, with controlled primary disease and no extracranial metastases; Class 3: patients with KPS < 70. Patients who do not qualify for Class 1 or 3 are grouped as Class 2. The survival of these patients was determined from the time of diagnosis of brain metastases to the time of death. Results: The median survival of the entire group was 9.5 months. The three classes of patients as grouped had median survivals of 14.8, 9.9, and 6.0 months respectively (p = 0.0002). Age of < 65 years, KPS of ≥ 70, controlled primary disease, absence of extracranial metastases, complete surgical resection of the brain lesion(s) were found to be independent prognostic factors for survival; the total dose of radiation was not. Conclusion: Based on the results of this study, the patients and disease characteristics have significant impact on the survival of patients with brain metastases treated with a combination of surgical resection and radiotherapy. These parameters could be used in selecting

  18. Primary Renal Sarcomas in the Intergroup Rhabdomyosarcoma Study Group (IRSG) Experience, 1972–2005: A Report from the Children’s Oncology Group

    Science.gov (United States)

    Raney, Beverly; Anderson, James; Arndt, Carola; Crist, Willam; Maurer, Harold; Qualman, Stephen; Wharam, Moody; Meyer, William

    2009-01-01

    Purpose To describe clinical and pathologic characteristics and outcome of patients with renal sarcomas. Patients/Methods The IRSG database includes newly diagnosed patients Anaplasia was present in six (60%) of the tumors. Patients’ ages ranged from 2.6–17.8 years. Tumor diameters ranged from 7–15 cm (median, 12 cm). At diagnosis, seven patients had localized disease: four underwent complete removal of tumor (Group I), two had microscopic residual (Group II), and one had gross residual tumor (Group III). Three patients had distant metastases (Group IV) in lungs and bone. Nine patients received vincristine, actinomycin D and cyclophosphamide (VAC). Two Group I patients received no radiation therapy (XRT); others received XRT to the primary tumor and to some metastatic sites. Nine patients achieved complete disappearance of tumor, six due to the initial operation. Tumors recurred in lung (N=2) or brain (N=1) in Group IV patients; each died within 16 months. The Group III patient died of Aspergillus pneumonia. The six Group I and II patients survive, continuously disease-free, at 2.7 to 17.3 years (median, 4.7 years). Conclusions Patients with renal sarcomas often present with large tumors, many of them containing anaplastic features. Removing all gross disease at diagnosis, if feasible, is a critical component of treatment to curing patients with renal sarcoma. PMID:18523987

  19. Scientific impact of studies published in temporarily available radiation oncology journals: a citation analysis.

    Science.gov (United States)

    Nieder, Carsten; Geinitz, Hans; Andratschke, Nicolaus H; Grosu, Anca L

    2015-01-01

    The purpose of this study was to review all articles published in two temporarily available radiation oncology journals (Radiation Oncology Investigations, Journal of Radiosurgery) in order to evaluate their scientific impact. From several potential measures of impact and relevance of research, we selected article citation rate because landmark or practice-changing research is likely to be cited frequently. The citation database Scopus was used to analyse number of citations. During the time period 1996-1999 the journal Radiation Oncology Investigations published 205 articles, which achieved a median number of 6 citations (range 0-116). However, the most frequently cited article in the first 4 volumes achieved only 23 citations. The Journal of Radiosurgery published only 31 articles, all in the year 1999, which achieved a median number of 1 citation (range 0-11). No prospective randomized studies or phase I-II collaborative group trials were published in these journals. Apparently, the Journal of Radiosurgery acquired relatively few manuscripts that were interesting and important enough to impact clinical practice. Radiation Oncology Investigations' citation pattern was better and closer related to that reported in several previous studies focusing on the field of radiation oncology. The vast majority of articles published in temporarily available radiation oncology journals had limited clinical impact and achieved few citations. Highly influential research was unlikely to be submitted during the initial phase of establishing new radiation oncology journals.

  20. Prognostic implications of c-Ki-ras2 mutations in patients with advanced colorectal cancer treated with 5-fluorouracil and interferon: a study of the eastern cooperative oncology group (EST 2292)

    Science.gov (United States)

    Wadler, S; Bajaj, R; Neuberg, D; Agarwal, V; Haynes, H; Benson, A B

    1997-01-01

    Mutations in c-Ki-ras2 (ras) occur in about 40% of patients with colorectal cancers and occur early in the pathogenesis of this disease. To evaluate the prognostic value of mutations in ras, the Eastern Cooperative Oncology Group (ECOG) conducted a retrospective study (EST 2292) to determine the frequency of mutations in patients with advanced colorectal cancer, and to determine whether ras mutations were associated with altered response to therapy and survival. Patients were enrolled from four studies: P-Z289, an ECOG phase II trial of 5-fluorouracil (5-FU) and interferon (IFN) in patients with advanced colorectal cancer; P-Z991, an ECOG phase I trial of 5-FU and IFN in patients with advanced malignancies; and two trials from the Albert Einstein College of Medicine in patients with advanced colorectal cancer treated with 5-FU and either IFN-alpha or IFN-beta. All patients had advanced colorectal carcinoma and had sufficient histologic material available for analysis for the presence and type of ras, using polymerase chain reaction and dot-blot analysis with sets of probes sufficient to detect all the common mutations of ras at codons 12, 13, and 61. Seventy-two patients were enrolled in this trial. Mutations in ras were detected in 25 (35%), including 17 (23%) in codon 12, four (6%) in codon 13, and four (6%) in codon 61. There was no correlation between the presence of a ras mutation and age, sex, Dukes' stage, histology, or tumor markers. Thirty-one of 72 patients (43%) responded to therapy with 5-FU and IFN, and 10 of 31 responders (32%) and 15 of 41 nonresponders (37%) had mutations in ras. There was no difference in response rates or overall survival between the groups with and without ras mutations. It is unlikely that ras mutations will have significant prognostic value for either response to therapy or survival in patients with colorectal carcinomas treated with 5-FU and IFN.

  1. Confirming the timing of phase-based costing in oncology studies: a case example in advanced melanoma.

    Science.gov (United States)

    Atkins, Michael; Coutinho, Anna D; Nunna, Sasikiran; Gupte-Singh, Komal; Eaddy, Michael

    2018-02-01

    The utilization of healthcare services and costs among patients with cancer is often estimated by the phase of care: initial, interim, or terminal. Although their durations are often set arbitrarily, we sought to establish data-driven phases of care using joinpoint regression in an advanced melanoma population as a case example. A retrospective claims database study was conducted to assess the costs of advanced melanoma from distant metastasis diagnosis to death during January 2010-September 2014. Joinpoint regression analysis was applied to identify the best-fitting points, where statistically significant changes in the trend of average monthly costs occurred. To identify the initial phase, average monthly costs were modeled from metastasis diagnosis to death; and were modeled backward from death to metastasis diagnosis for the terminal phase. Points of monthly cost trend inflection denoted ending and starting points. The months between represented the interim phase. A total of 1,671 patients with advanced melanoma who died met the eligibility criteria. Initial phase was identified as the 5-month period starting with diagnosis of metastasis, after which there was a sharp, significant decline in monthly cost trend (monthly percent change [MPC] = -13.0%; 95% CI = -16.9% to -8.8%). Terminal phase was defined as the 5-month period before death (MPC = -14.0%; 95% CI = -17.6% to -10.2%). The claims-based algorithm may under-estimate patients due to misclassifications, and may over-estimate terminal phase costs because hospital and emergency visits were used as a death proxy. Also, recently approved therapies were not included, which may under-estimate advanced melanoma costs. In this advanced melanoma population, optimal duration of the initial and terminal phases of care was 5 months immediately after diagnosis of metastasis and before death, respectively. Joinpoint regression can be used to provide data-supported phase of cancer care durations, but

  2. Preliminary Toxicity Analysis of 3-Dimensional Conformal Radiation Therapy Versus Intensity Modulated Radiation Therapy on the High-Dose Arm of the Radiation Therapy Oncology Group 0126 Prostate Cancer Trial

    Energy Technology Data Exchange (ETDEWEB)

    Michalski, Jeff M., E-mail: jmichalski@radonc.wustl.edu [Department of Radiation Oncology Washington University Medical Center, St. Louis, Missouri (United States); Yan, Yan [Radiation Therapy Oncology Group Statistical Center, Philadelphia, Pennsylvania (United States); Watkins-Bruner, Deborah [Emory University School of Nursing, Atlanta, Georgia (United States); Bosch, Walter R. [Department of Radiation Oncology Washington University Medical Center, St. Louis, Missouri (United States); Winter, Kathryn [Radiation Therapy Oncology Group Statistical Center, Philadelphia, Pennsylvania (United States); Galvin, James M. [Department of Radiation Oncology Thomas Jefferson University Hospital, Philadelphia, Pennsylvania (United States); Bahary, Jean-Paul [Department of Radiation Oncology Centre Hospitalier de l' Université de Montréal-Notre Dame, Montreal, QC (Canada); Morton, Gerard C. [Department of Radiation Oncology Toronto-Sunnybrook Regional Cancer Centre, Toronto, ON (Canada); Parliament, Matthew B. [Department of Oncology Cross Cancer Institute, Edmonton, AB (Canada); Sandler, Howard M. [Department of Radiation Oncology Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, California (United States)

    2013-12-01

    Purpose: To give a preliminary report of clinical and treatment factors associated with toxicity in men receiving high-dose radiation therapy (RT) on a phase 3 dose-escalation trial. Methods and Materials: The trial was initiated with 3-dimensional conformal RT (3D-CRT) and amended after 1 year to allow intensity modulated RT (IMRT). Patients treated with 3D-CRT received 55.8 Gy to a planning target volume that included the prostate and seminal vesicles, then 23.4 Gy to prostate only. The IMRT patients were treated to the prostate and proximal seminal vesicles to 79.2 Gy. Common Toxicity Criteria, version 2.0, and Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer late morbidity scores were used for acute and late effects. Results: Of 763 patients randomized to the 79.2-Gy arm of Radiation Therapy Oncology Group 0126 protocol, 748 were eligible and evaluable: 491 and 257 were treated with 3D-CRT and IMRT, respectively. For both bladder and rectum, the volumes receiving 65, 70, and 75 Gy were significantly lower with IMRT (all P<.0001). For grade (G) 2+ acute gastrointestinal/genitourinary (GI/GU) toxicity, both univariate and multivariate analyses showed a statistically significant decrease in G2+ acute collective GI/GU toxicity for IMRT. There were no significant differences with 3D-CRT or IMRT for acute or late G2+ or 3+ GU toxicities. Univariate analysis showed a statistically significant decrease in late G2+ GI toxicity for IMRT (P=.039). On multivariate analysis, IMRT showed a 26% reduction in G2+ late GI toxicity (P=.099). Acute G2+ toxicity was associated with late G3+ toxicity (P=.005). With dose–volume histogram data in the multivariate analysis, RT modality was not significant, whereas white race (P=.001) and rectal V70 ≥15% were associated with G2+ rectal toxicity (P=.034). Conclusions: Intensity modulated RT is associated with a significant reduction in acute G2+ GI/GU toxicity. There is a trend for a

  3. A phase II evaluation of ixabepilone in the treatment of recurrent/persistent carcinosarcoma of the uterus, an NRG Oncology/Gynecologic Oncology Group study.

    Science.gov (United States)

    McCourt, Carolyn K; Deng, Wei; Dizon, Don S; Lankes, Heather A; Birrer, Michael J; Lomme, Michele M; Powell, Matthew A; Kendrick, James E; Saltzman, Joel N; Warshal, David; Tenney, Meaghan E; Kushner, David M; Aghajanian, Carol

    2017-01-01

    The primary objectives were to determine the objective response rate (ORR) and safety profile of ixabepilone in women with recurrent or persistent uterine carcinosarcoma (UCS). Secondary objectives included progression-free survival (PFS) and overall survival (OS). Exploratory translational objectives included characterization of class III beta tubulin expression and its association with response, PFS, and OS. Patients had measurable disease; up to two prior chemotherapeutic regimens were allowed, but must have included a taxane. Women received ixabepilone 40mg/m 2 as a 3hour IV infusion on day 1 of a 21daycycle. Treatment was continued until disease progression or unacceptable toxicity occurred. Forty-two women were enrolled, with 34 eligible and evaluable. Median age was 68years. ECOG performance status was 0 in 56% of women, 38% had received radiation, and 15% had received 2 lines of chemotherapy. Overall ORR was 11.8% (4/34, 90% CI 4.2-25.1%); all were partial responses. Stable disease for at least 8weeks was achieved in 8 patients (23.5%). Median PFS and OS were 1.7mo and 7.7mo, respectively, with a median follow-up of 37mo. Six month PFS was 20.6%. Major grade≥3 toxicities were neutropenia (47%), fatigue (15%), dehydration (15%), hypertension (15%), and hyponatremia (15%); grade 2 peripheral neuropathy was reported in 18%. In this small sample size, class III beta tubulin expression in the primary tumor was not associated with the response to ixabepilone, PFS, or OS. In this cohort of women, single agent ixabepilone showed modest but insufficient clinical activity. Copyright © 2016. Published by Elsevier Inc.

  4. Magnetic superspace groups and symmetry constraints in incommensurate magnetic phases

    International Nuclear Information System (INIS)

    Perez-Mato, J M; Aroyo, M I; Ribeiro, J L; Petricek, V

    2012-01-01

    Superspace symmetry has been for many years the standard approach for the analysis of non-magnetic modulated crystals because of its robust and efficient treatment of the structural constraints present in incommensurate phases. For incommensurate magnetic phases, this generalized symmetry formalism can play a similar role. In this context we review from a practical viewpoint the superspace formalism particularized to magnetic incommensurate phases. We analyse in detail the relation between the description using superspace symmetry and the representation method. Important general rules on the symmetry of magnetic incommensurate modulations with a single propagation vector are derived. The power and efficiency of the method is illustrated with various examples, including some multiferroic materials. We show that the concept of superspace symmetry provides a simple, efficient and systematic way to characterize the symmetry and rationalize the structural and physical properties of incommensurate magnetic materials. This is especially relevant when the properties of incommensurate multiferroics are investigated. (topical review)

  5. Comparison of childhood myelodysplastic syndrome, AML FAB M6 or M7, CCG 2891: report from the Children's Oncology Group.

    Science.gov (United States)

    Barnard, Dorothy R; Alonzo, Todd A; Gerbing, Robert B; Lange, Beverly; Woods, William G

    2007-07-01

    Myelodysplastic syndromes (MDS), acute erythroleukemia (FAB M6), and acute megakaryocytic leukemia (FAB M7) have overlapping features. Children without Down syndrome or acute promyelocytic leukemia who were newly diagnosed with primary myelodysplastic syndrome or acute myeloid leukemia (AML) M6 or M7 were compared to children with de novo AML M0-M5. All children were entered on the Children's Cancer Group therapeutic research study CCG 2891. The presentation and outcomes of the 132 children diagnosed with MDS (60 children), AML FAB M6 (19 children), or AML FAB M7 (53 children) were similar. Children with AML FAB M7 were diagnosed at a significantly younger age (P = 0.001). Children with MDS, M6, or M7 had significantly lower white blood cell (WBC) counts (P = 0.001), lower peripheral blast counts (P M6 and AML M7 resemble MDS in presentation, poor induction success rates, and outcomes.

  6. Validation of the 2015 prostate cancer grade groups for predicting long-term oncologic outcomes in a shared equal-access health system.

    Science.gov (United States)

    Schulman, Ariel A; Howard, Lauren E; Tay, Kae Jack; Tsivian, Efrat; Sze, Christina; Amling, Christopher L; Aronson, William J; Cooperberg, Matthew R; Kane, Christopher J; Terris, Martha K; Freedland, Stephen J; Polascik, Thomas J

    2017-11-01

    A 5-tier prognostic grade group (GG) system was enacted to simplify the risk stratification of patients with prostate cancer in which Gleason scores of ≤6, 3 + 4, 4 + 3, 8, and 9 or 10 are considered GG 1 through 5, respectively. The authors investigated the utility of biopsy GG for predicting long-term oncologic outcomes after radical prostatectomy in an equal-access health system. Men who underwent prostatectomy at 1 of 6 Veterans Affairs hospitals in the Shared Equal Access Regional Cancer Hospital database between 2005 and 2015 were reviewed. The prognostic ability of biopsy GG was examined using Cox models. Interactions between GG and race also were tested. In total, 2509 men were identified who had data available on biopsy Gleason scores, covariates, and follow-up. The cohort included men with GG 1 (909 patients; 36.2%), GG 2 (813 patients; 32.4%), GG 3 (398 patients; 15.9%), GG 4 (279 patients; 11.1%), and GG 5 (110 patients; 4.4%) prostate cancer. The cohort included 1002 African American men (41%). The median follow-up was 60 months (interquartile range, 33-90 months). Higher GG was associated with higher clinical stage, older age, more recent surgery, and surgical center (P prostate cancer, metastases, and prostate cancer-specific mortality (all P Cancer 2017;123:4122-4129. © 2017 American Cancer Society. © 2017 American Cancer Society.

  7. Introduction of online adaptive radiotherapy for bladder cancer through a multicentre clinical trial (Trans-Tasman Radiation Oncology Group 10.01): lessons learned

    International Nuclear Information System (INIS)

    Pham, Daniel; Roxby, Paul; Kron, Tomas; Rolfo, Aldo; Foroudi, Farshad

    2013-01-01

    Online adaptive radiotherapy for bladder cancer is a novel radiotherapy technique that was found feasible in a pilot study at a single academic institution. In September 2010 this technique was opened as a multicenter study through the Trans-Tasman Radiation Oncology Group (TROG 10.01 bladder online adaptive radiotherapy treatment). Twelve centers across Australia and New-Zealand registered interest into the trial. A multidisciplinary team of radiation oncologists, radiation therapists and medical physicists represented the trial credentialing and technical support team. To provide timely activation and proper implementation of the adaptive technique the following key areas were addressed at each site: Staff education/training; Practical image guided radiotherapy assessment; provision of help desk and feedback. The trial credentialing process involved face-to-face training and technical problem solving via full day site visits. A dedicated 'help-desk' team was developed to provide support for the clinical trial. 26% of the workload occurred at the credentialing period while the remaining 74% came post-center activation. The workload was made up of the following key areas; protocol clarification (36%), technical problems (46%) while staff training was less than 10%. Clinical trial credentialing is important to minimizing trial deviations. It should not only focus on site activation quality assurance but also provide ongoing education and technical support. (author)

  8. Modern Radiation Therapy for Nodal Non-Hodgkin Lymphoma—Target Definition and Dose Guidelines From the International Lymphoma Radiation Oncology Group

    Energy Technology Data Exchange (ETDEWEB)

    Illidge, Tim, E-mail: Tim.Illidge@ics.manchester.ac.uk [Institute of Cancer Sciences, University of Manchester, Manchester Academic Health Sciences Centre, The Christie National Health Service Foundation Trust, Manchester (United Kingdom); Specht, Lena [Department of Oncology and Hematology, Rigshospitalet, University of Copenhagen, Copenhagen (Denmark); Yahalom, Joachim [Department of Radiation Oncology, Memorial Sloan-Kettering Cancer Center, New York, New York (United States); Aleman, Berthe [Department of Radiotherapy, The Netherlands Cancer Institute, Amsterdam (Netherlands); Berthelsen, Anne Kiil [Department of Radiation Oncology and PET Centre, Rigshospitalet, University of Copenhagen, Copenhagen (Denmark); Constine, Louis [Departments of Radiation Oncology and Pediatrics, James P. Wilmot Cancer Center, University of Rochester Medical Center, Rochester, New York (United States); Dabaja, Bouthaina [Division of Radiation Oncology, Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Dharmarajan, Kavita [Department of Radiation Oncology, Memorial Sloan-Kettering Cancer Center, New York, New York (United States); Ng, Andrea [Department of Radiation Oncology, Brigham and Women' s Hospital and Dana-Farber Cancer Institute, Harvard University, Boston, Massachusetts (United States); Ricardi, Umberto [Radiation Oncology Unit, Department of Oncology, University of Torino, Torino (Italy); Wirth, Andrew [Division of Radiation Oncology, Peter MacCallum Cancer Institute, St. Andrews Place, East Melbourne (Australia)

    2014-05-01

    Radiation therapy (RT) is the most effective single modality for local control of non-Hodgkin lymphoma (NHL) and is an important component of therapy for many patients. Many of the historic concepts of dose and volume have recently been challenged by the advent of modern imaging and RT planning tools. The International Lymphoma Radiation Oncology Group (ILROG) has developed these guidelines after multinational meetings and analysis of available evidence. The guidelines represent an agreed consensus view of the ILROG steering committee on the use of RT in NHL in the modern era. The roles of reduced volume and reduced doses are addressed, integrating modern imaging with 3-dimensional planning and advanced techniques of RT delivery. In the modern era, in which combined-modality treatment with systemic therapy is appropriate, the previously applied extended-field and involved-field RT techniques that targeted nodal regions have now been replaced by limiting the RT to smaller volumes based solely on detectable nodal involvement at presentation. A new concept, involved-site RT, defines the clinical target volume. For indolent NHL, often treated with RT alone, larger fields should be considered. Newer treatment techniques, including intensity modulated RT, breath holding, image guided RT, and 4-dimensional imaging, should be implemented, and their use is expected to decrease significantly the risk for normal tissue damage while still achieving the primary goal of local tumor control.

  9. Introduction of online adaptive radiotherapy for bladder cancer through a multicentre clinical trial (Trans-Tasman Radiation Oncology Group 10.01: Lessons learned

    Directory of Open Access Journals (Sweden)

    Daniel Pham

    2013-01-01

    Full Text Available Online adaptive radiotherapy for bladder cancer is a novel radiotherapy technique that was found feasible in a pilot study at a single academic institution. In September 2010 this technique was opened as a multicenter study through the Trans-Tasman Radiation Oncology Group (TROG 10.01 bladder online adaptive radiotherapy treatment. Twelve centers across Australia and New-Zealand registered interest into the trial. A multidisciplinary team of radiation oncologists, radiation therapists and medical physicists represented the trial credentialing and technical support team. To provide timely activation and proper implementation of the adaptive technique the following key areas were addressed at each site: Staff education/training; Practical image guided radiotherapy assessment; provision of help desk and feedback. The trial credentialing process involved face-to-face training and technical problem solving via full day site visits. A dedicated "help-desk" team was developed to provide support for the clinical trial. 26% of the workload occurred at the credentialing period while the remaining 74% came post-center activation. The workload was made up of the following key areas; protocol clarification (36%, technical problems (46% while staff training was less than 10%. Clinical trial credentialing is important to minimizing trial deviations. It should not only focus on site activation quality assurance but also provide ongoing education and technical support.

  10. Radiotherapeutic management of non-small cell lung cancer (NSCLC). An overview based on the clinical trials of the radiation therapy oncology group (RTOG)

    International Nuclear Information System (INIS)

    Wilson, J.F.; Byhardt, R.W.

    1995-01-01

    Recent clinical trials clarified the role of radiation therapy (RT) in the treatment of non-small cell lung cancer (NSCLC). The evolution of this research is illustrated by a systemic succession of studies conducted during the last twenty years by the Radiation Therapy Oncology Group (RTOG). This article reviews past and present RTOG research efforts in NSCLC. For unresectable NSCLS, major research themes have included radiation dose intensification using both standard and altered fractionation (hyperfractionation or accelerated fraction RT), treatment intensification using combined modality RT and chemotherapy (CT), as well as noncytotoxic adjuvants to RT. These trials have shown that treatment intensification can yield improved survival with acceptable toxicity. Local control and survival was improved with induction CT followed by standard RT to 60 Gy. Current studies will evaluate the timing and sequencing of CT and RT and the combination of CT with altered fractionation RT. Hypoxic cell sensitizers and nonspecific immune stimulants, two noncytotoxic adjuvants to RT, have shown no survival benefit. Biologic response modifiers, including recombinant interferon-beta, will also be evaluated as adjuvants to standard RT, based on interferon-beta radiosensitization observed in the laboratory and clinical investigations suggesting improved survival. Overall, RTOG studies have demonstrated small, but definite, incremental improvements in treatment outcome in NSCLS and provide a solid foundation on which to develop future investigations. (N.K.) 51 refs

  11. [Remarks on the physician-patient relationship with cancer patients. Prerequisites, function, and goal of so-called Balint groups in an internal-oncological department].

    Science.gov (United States)

    Meerwein, F; Kauf, S; Schneider, G

    1976-01-01

    Drawing on their experience with their own cancer patients and with the Balint Group in the Oncological Department of Zürich's University Hospital, the authors describe the special problems arising in the doctor-patient relationship in this field. They show how the diagnosis of cancer can give rise to a feeling of sudden and complete object loss in the patient, thereby confronting the doctor with his own fear of death. The mobilization of archaic defence mechanisms in both the doctor and the patients can lead to an insoluble double-blind situation unless the doctor is able to give up his defence position and thus make it possible for the patient to give up his own fear of death and to accept the nature of his illness. The authors show how the doctor can break through the isolation of the patient in whose body-ego an archaic bad inner-object has been activated by the cancer, and build up good inner objects for him again. In the last chapter Winnicott's idea the "intermediate area" is shown to shed a new light on the phenomenon of redenial or belief in immortality.

  12. [Strategies for improving care of oncologic patients: SHARE Project results].

    Science.gov (United States)

    Reñones Crego, María de la Concepción; Fernández Pérez, Dolores; Vena Fernández, Carmen; Zamudio Sánchez, Antonio

    2016-01-01

    Cancer treatment is a major burden for the patient and its family that requires an individualized management by healthcare professionals. Nurses are in charge of coordinating care and are the closest healthcare professionals to patient and family; however, in Spain, there are not standard protocols yet for the management of oncology patients. The Spanish Oncology Nursing Society developed between 2012 and 2014 the SHARE project, with the aim of establishing strategies to improve quality of life and nursing care in oncology patients. It was developed in 3 phases. First, a literature search and review was performed to identify nursing strategies, interventions and tools to improve cancer patients' care. At the second stage, these interventions were agreed within a group of oncology nursing experts; and at the third phase, a different group of experts in oncology care categorized the interventions to identify the ones with highest priority and most feasible to be implemented. As a result, 3 strategic actions were identified to improve nursing care during cancer treatment: To provide a named nurse to carry out the follow up process by attending to the clinic or telephonic consultation, develop therapeutic education with adapted protocols for each tumor type and treatment and ensure specific training for nurses on the management of the cancer patients. Strategic actions proposed in this paper aim to improve cancer patients' healthcare and quality of life through the development of advanced nursing roles based on a higher level of autonomy, situating nurses as care coordinators to assure an holistic care in oncology patients. Copyright © 2016 Elsevier España, S.L.U. All rights reserved.

  13. Standardized evaluation of tumor-infiltrating lymphocytes in breast cancer: results of the ring studies of the international immuno-oncology biomarker working group.

    Science.gov (United States)

    Denkert, Carsten; Wienert, Stephan; Poterie, Audrey; Loibl, Sibylle; Budczies, Jan; Badve, Sunil; Bago-Horvath, Zsuzsanna; Bane, Anita; Bedri, Shahinaz; Brock, Jane; Chmielik, Ewa; Christgen, Matthias; Colpaert, Cecile; Demaria, Sandra; Van den Eynden, Gert; Floris, Giuseppe; Fox, Stephen B; Gao, Dongxia; Ingold Heppner, Barbara; Kim, S Rim; Kos, Zuzana; Kreipe, Hans H; Lakhani, Sunil R; Penault-Llorca, Frederique; Pruneri, Giancarlo; Radosevic-Robin, Nina; Rimm, David L; Schnitt, Stuart J; Sinn, Bruno V; Sinn, Peter; Sirtaine, Nicolas; O'Toole, Sandra A; Viale, Giuseppe; Van de Vijver, Koen; de Wind, Roland; von Minckwitz, Gunter; Klauschen, Frederick; Untch, Michael; Fasching, Peter A; Reimer, Toralf; Willard-Gallo, Karen; Michiels, Stefan; Loi, Sherene; Salgado, Roberto

    2016-10-01

    Multiple independent studies have shown that tumor-infiltrating lymphocytes (TIL) are prognostic in breast cancer with potential relevance for response to immune-checkpoint inhibitor therapy. Although many groups are currently evaluating TIL, there is no standardized system for diagnostic applications. This study reports the results of two ring studies investigating TIL conducted by the International Working Group on Immuno-oncology Biomarkers. The study aim was to determine the intraclass correlation coefficient (ICC) for evaluation of TIL by different pathologists. A total of 120 slides were evaluated by a large group of pathologists with a web-based system in ring study 1 and a more advanced software-system in ring study 2 that included an integrated feedback with standardized reference images. The predefined aim for successful ring studies 1 and 2 was an ICC above 0.7 (lower limit of 95% confidence interval (CI)). In ring study 1 the prespecified endpoint was not reached (ICC: 0.70; 95% CI: 0.62-0.78). On the basis of an analysis of sources of variation, we developed a more advanced digital image evaluation system for ring study 2, which improved the ICC to 0.89 (95% CI: 0.85-0.92). The Fleiss' kappa value for international standardization project shows that reproducible evaluation of TIL is feasible in breast cancer. This opens the way for standardized reporting of tumor immunological parameters in clinical studies and diagnostic practice. The software-guided image evaluation approach used in ring study 2 may be of value as a tool for evaluation of TIL in clinical trials and diagnostic practice. The experience gained from this approach might be applicable to the standardization of other diagnostic parameters in histopathology.

  14. Prevalence and Clinical Impact of Anaplasia in Childhood Rhabdomyosarcoma: A Report from the Soft Tissue Sarcoma Committee for the Children’s Oncology Group

    Science.gov (United States)

    Qualman, Stephen; Lynch, James; Bridge, Julia; Parham, David; Teot, Lisa; Meyer, William; Pappo, Alberto

    2009-01-01

    Background Anapalsia is rare in childhood rhabdomyosarcoma and has not been included in the International Classification of Rhabdomyosarcoma (ICR). A recent review of cases from the Soft Tissue Sarcoma Committee of the Children’s Oncology Group (COG) suggests that anaplasia might be more common than previously reported and may impact clinical outcome. Materials and Methods The prevalence of anaplasia (focal or diffuse) was prospectively assessed in 546 eligible cases who were registered in an Intergroup Rhabdomyosarcoma Study Group (IRSG) or COG therapeutic trial from 1995–1998. The incidence of anaplasia in tumor samples and its impact in predicting clinical outcome was assessed. Results Overall 71 (13%) of all samples analyzed had anaplasia. Anaplasia was more common in patients with tumors in favorable sites and was less commonly seen in younger patients and in those with stage 2, 3 or clinical Group III disease. Regardless of its distribution (focal or diffuse), on univariate analysis the presence of anaplasia had a significant negative impact for both failure-free survival (FFS: 63% vs 77% at 5 years) and survival (S: 68% vs 82% at 5 years) in patients with embryonal rhabdomyosarcoma. This effect was most pronounced in children with intermediate risk disease. Using multivariate analysis, the hazard ratio was 1.6 for FFS (p=0.085) and 1.7 for overall survival (p=0.081). Anaplasia did not affect outcome in patients with alveolar tumors. Conclusion The incidence of anaplasia in rhabdomyosarcoma is higher than previously described and may be of prognostic significance in children with intermediate risk embryonal rhabdomyosarcoma. PMID:18985676

  15. Characteristics of phase-averaged equations for modulated wave groups

    NARCIS (Netherlands)

    Klopman, G.; Petit, H.A.H.; Battjes, J.A.

    2000-01-01

    The project concerns the influence of long waves on coastal morphology. The modelling of the combined motion of the long waves and short waves in the horizontal plane is done by phase-averaging over the short wave motion and using intra-wave modelling for the long waves, see e.g. Roelvink (1993).

  16. Effect of surgical staging on 539 patients with borderline ovarian tumors: a Turkish Gynecologic Oncology Group study.

    Science.gov (United States)

    Guvenal, Tevfik; Dursun, Polat; Hasdemir, Pinar S; Hanhan, Merih; Guven, Suleyman; Yetimalar, Hakan; Goksedef, Behice P; Sakarya, Derya K; Doruk, Arzu; Terek, Mustafa C; Saatli, Bahadir; Guzin, Kadir; Corakci, Aydin; Deger, Emek; Celik, Husnu; Cetin, Ahmet; Ozsaran, Aydin; Ozbakkaloglu, Ayşe; Kolusari, Ali; Celik, Cetin; Keles, Refik; Sagir, Fulya G; Dilek, Saffet; Uslu, Turhan; Dikmen, Yilmaz; Altundag, Ozden; Ayhan, Ali

    2013-12-01

    The objectives of this study were to examine demographic and clinicopathologic characteristics and to determine the effects of primary surgery, surgical staging and the extensiveness of staging. In a retrospective Turkish multicenter study, 539 patients, from 14 institutions, with borderline ovarian tumors were investigated. Some of the demographic, clinical and surgical characteristics of the cases were evaluated. The effects of type of surgery, surgical staging; complete or incomplete staging on survival rates were calculated by using Kaplan-Meier method. The median age at diagnosis was 40 years (range 15-84) and 71.1% of patients were premenopausal. The most common histologic types were serous and mucinous. Majority of the staged cases were in Stage IA (73.5%). 242 patients underwent conservative surgery. Recurrence rates were significantly higher in conservative surgery group (8.3% vs. 3%). Of all patients in this study, 294 (54.5%) have undergone surgical staging procedures. Of the patients who underwent surgical staging, 228 (77.6%) had comprehensive staging including lymphadenectomy. Appendectomy was performed on 204 (37.8%) of the patients. The median follow-up time was 36 months (range 1-120 months). Five-year survival rate was 100% and median survival time was 120 months. Surgical staging, lymph node sampling or dissection and appendectomy didn't cause any difference on survival. Comprehensive surgical staging, lymph node sampling or dissection and appendectomy are not beneficial in borderline ovarian tumors surgical management. © 2013.

  17. A CASE-CONTROL STUDY OF CHILDHOOD BRAIN TUMORS AND FATHERS’ HOBBIES — A CHILDREN’S ONCOLOGY GROUP STUDY

    Science.gov (United States)

    Rosso, Andrea L.; Hovinga, Mary E.; Rorke-Adams, Lucy B.; Spector, Logan G.; Bunin, Greta R.

    2009-01-01

    Objective A comprehensive case-control study was conducted to evaluate parental risk factors for medulloblastoma (MB) and primitive neuroectodermal tumor (PNET). This analysis was conducted to evaluate associations between fathers’ hobbies and risk of their children developing MB/PNET. The hobbies chosen for study were those with similar exposures as occupations associated with childhood cancers. Methods Cases were 318 subjects under 6 years of age at diagnosis between 1991-1997 and registered with the Children’s Cancer Group. An equal number of controls were selected through random digit dialing and individually matched to cases. Results In multivariate analyses, a significant association was seen for lawn care with pesticides [during pregnancy: odds ratio (OR) = 1.6, 95% confidence interval (CI): 1.0, 2.5; after birth: OR = 1.8, 95% CI: 1.2, 2.8] and a weak association was seen for stripping paint [during pregnancy: OR = 1.4, 95% CI: 0.8, 2.6; after birth: OR = 1.4, 95% CI: 0.7, 2.6]. Conclusions This study suggests that household exposures from hobbies, particularly pesticides, may increase risk of MB/PNET in children; previous research has been mostly limited to occupational exposures. PMID:18560982

  18. A case-control study of childhood brain tumors and fathers' hobbies: a Children's Oncology Group study.

    Science.gov (United States)

    Rosso, Andrea L; Hovinga, Mary E; Rorke-Adams, Lucy B; Spector, Logan G; Bunin, Greta R

    2008-12-01

    A comprehensive case-control study was conducted to evaluate parental risk factors for medulloblastoma (MB) and primitive neuroectodermal tumor (PNET). This analysis was conducted to evaluate associations between fathers' hobbies and risk of their children developing MB/PNET. The hobbies chosen for study were those with similar exposures as occupations associated with childhood cancers. Cases were 318 subjects under six years of age at diagnosis between 1991 and 1997 and registered with the Children's Cancer Group. An equal number of controls were selected through random digit dialing and individually matched to cases. In multivariate analyses, a significant association was seen for lawn care with pesticides [during pregnancy: odds ratio (OR) = 1.6, 95% confidence interval (CI): 1.0, 2.5; after birth: OR = 1.8, 95% CI: 1.2, 2.8] and a weak association was seen for stripping paint [during pregnancy: OR = 1.4, 95% CI: 0.8, 2.6; after birth: OR = 1.4, 95% CI: 0.7, 2.6]. This study suggests that household exposures from hobbies, particularly pesticides, may increase risk of MB/PNET in children; previous research has been mostly limited to occupational exposures.

  19. Phase transition over gauge group center and quark confinement in QCD

    International Nuclear Information System (INIS)

    Khokhlachev, S.B.; Makeenko, Yu.N.

    1979-01-01

    A lattice gauge model with the phase transition corresponding to spontaneous breakdown of the group center symmetry is considered. It is shown that the phase diagram, obtained in multicolor case, separates the high and low-temperature phases with confined and nonconfined quarks. The possibility of the Lorentz-invariant continuum limit in the phase with permanently confined quarks is confirmed

  20. Impact of treatment in long-term survival patients with follicular lymphoma: A Spanish Lymphoma Oncology Group registry

    Science.gov (United States)

    Provencio, Mariano; Sabín, Pilar; Gomez-Codina, Jose; Calvo, Virginia; Llanos, Marta; Gumá, Josep; Quero, Cristina; Blasco, Ana; Cruz, Miguel Angel; Aguiar, David; García-Arroyo, Francisco; Lavernia, Javier; Martinez, Natividad; Morales, Manuel; Saez-Cusi, Alvaro; Rodriguez, Delvys; de la Cruz, Luis; Sanchez, Jose Javier; Rueda, Antonio

    2017-01-01

    Background Follicular lymphoma is the second most common non-Hodgkin lymphoma in the United States and Europe. However, most of the prospective randomized studies have very little follow-up compared to the long natural history of the disease. The primary aim of this study was to investigate the long-term survival of our series of patients with follicular lymphoma. Patients and methods A total of 1074 patients with newly diagnosed FL were enrolled. Patients diagnosed were prospectively enrolled from 1980 to 2013. Results Median follow-up was 54.9 months and median overall survival is over 20 years in our series. We analyzed the patients who are still alive beyond 10 years from diagnosis in order to fully assess the prognostic factors that condition this group. Out of 166 patients who are still alive after more than 10 years of follow-up, 118 of them (73%) are free of evident clinical disease. Variables significantly associated with survival at 10 years were stage < II (p <0.03), age < 60 years (p <0.0001), low FLIPI (p <0.002), normal β2 microglobulin (p <0.005), no B symptoms upon diagnosis (p <0.02), Performance Status 0–1 (p <0.03) and treatment with anthracyclines and rituximab (p <0.001), or rituximab (p <0.0001). Conclusions A longer follow-up and a large series demonstrated a substantial population of patients with follicular lymphoma free of disease for more than 10 years. PMID:28493986

  1. Weight patterns in children with higher risk ALL: A report from the Children's Oncology Group (COG) for CCG 1961.

    Science.gov (United States)

    Withycombe, Janice S; Post-White, Janice E; Meza, Jane L; Hawks, Ria G; Smith, Lynette M; Sacks, Nancy; Seibel, Nita L

    2009-12-15

    This retrospective analysis defined and described patterns and predictors of weight change during treatment in children with acute lymphocytic leukemia (ALL) with high-risk features who received treatment on Children's Cancer Group protocol CCG 1961. Patients (1,638) were enrolled in CCG 1961 from November 1996 to May 2002. Weight was measured as BMI percent (%), specific for age and gender, and defined as 100 x ln(BMI/median BMI). By the end of treatment, 23% of children were obese (BMI >or=95%), compared with 14% at diagnosis. Children who received post-induction intensified therapy (arms C, D, SER with Doxorubicin or Idarubicin) had higher gastrointestinal toxicities and lower BMI% from consolidation through interim maintenance 1. BMI% then increased for all arms between delayed intensification and maintenance 1 or 2. Children who were of Black or Hispanic race, obese at diagnosis, or who had grade 3 or 4 pancreatitis/glucose toxicities during induction had higher BMI% throughout treatment. Children were more likely to be obese at the end of the study if they were aged 5-9 years at diagnosis or female gender. Cranial radiation was not a predictor of obesity. Successful treatment of higher risk childhood ALL was associated with obesity, independent of cranial irradiation. The beginning of maintenance therapy may be the best time to intervene with nutritional and behavioral interventions, particularly for children who are obese or aged 5-9 years at diagnosis, female, Black or Hispanic, or those with metabolic toxicities during induction. (c) 2009 Wiley-Liss, Inc.

  2. Clinical Practice Patterns of Radiotherapy in Patients with Hepatocellular Carcinoma: A Korean Radiation Oncology Group Study (KROG 14-07)

    Science.gov (United States)

    Cha, Hyejung; Park, Hee Chul; Yu, Jeong Il; Kim, Tae Hyun; Nam, Taek-Keun; Yoon, Sang Min; Yoon, Won Sup; Kim, Jun Won; Kim, Mi Sook; Jang, Hong Seok; Choi, Youngmin; Kim, Jin Hee; Kay, Chul Seung; Jung, Inkyung; Seong, Jinsil

    2017-01-01

    Purpose The aim of this study was to examine patterns of radiotherapy (RT) in Korean patients with hepatocellular carcinoma (HCC) according to the evolving guideline for HCC established by the Korean Liver Cancer Study Group-National Cancer Center (KLCSG-NCC). Materials and Methods We reviewed 765 patients with HCC who were treated with RT between January 2011 and December 2012 in 12 institutions. Results The median follow-up period was 13.3 months (range, 0.2 to 51.7 months). Compared with previous data between 2004 and 2005, the use of RT as a first treatment has increased (9.0% vs. 40.8%). Increased application of intensity-modulated RT resulted in an increase in radiation dose (fractional dose, 1.8 Gy vs. 2.5 Gy; biologically effective dose, 53.1 Gy10 vs. 56.3 Gy10). Median overall survival was 16.2 months, which is longer than that reported in previous data (12 months). In subgroup analysis, treatments were significantly different according to stage (p < 0.001). Stereotactic body RT was used in patients with early HCC, and most patients with advanced stage were treated with three-dimensional conformal RT. Conclusion Based on the evolving KLCSG-NCC practice guideline for HCC, clinical practice patterns of RT have changed. Although RT is still used mainly in advanced HCC, the number of patients with good performance status who were treated with RT as a first treatment has increased. This change in practice patterns could result in improvement in overall survival. PMID:27338036

  3. What, why, and when we image: considerations for diagnostic imaging and clinical research in the Children's Oncology Group

    International Nuclear Information System (INIS)

    Reaman, Gregory H.

    2009-01-01

    Success in improving treatment outcomes in childhood cancer has been achieved almost exclusively through multicenter and multidisciplinary clinical and applied research over several decades. While biologically rational as well as empirical approaches have led to combination chemotherapy and multimodality approaches to therapy, which have given rise to evidence-based practice standards, similar scientific rigor has not always been as evidently applied to modalities utilized to assess initial disease burden and, more important, response to investigational approaches to therapy. As the empirical approach to therapeutic advances has likely maximized its benefit, future progress will require translation of biologic discovery most notably from the areas of genomics and proteomics. Hence, attempts to improve efficacy of therapy will require a parallel effort to minimize collateral damage of future therapeutic approaches, and such a parallel approach will mandate the continued dependence on advances in diagnostic imaging for improvements in staging methodologies to best define risk groups for risk-adjusted therapy. In addition, anatomic and functional assessment of response and surveillance for disease recurrence will require improved understanding of the biology as well as natural history of individual diseases, which one hopes will better inform investigators in designing trials. Clinical and research expertise is urgently needed in the selection of specific imaging studies and frequencies that best assess a response as well as to define disease-free intervals. Despite limited resources to develop sufficient infrastructure, emphasis on enabling early assessment of new technology to minimize risks associated with treatment advances and with those critical diagnostic and staging procedures must continue to be a focus of pediatric cancer clinical research. (orig.)

  4. The Role of Childhood Infections and Immunizations on Childhood Rhabdomyosarcoma: A Report From the Children's Oncology Group.

    Science.gov (United States)

    Sankaran, Hari; Danysh, Heather E; Scheurer, Michael E; Okcu, M Fatih; Skapek, Stephen X; Hawkins, Douglas S; Spector, Logan G; Erhardt, Erik B; Grufferman, Seymour; Lupo, Philip J

    2016-09-01

    Rhabdomyosarcoma (RMS) is a rare, highly malignant tumor arising from primitive mesenchymal cells that differentiate into skeletal muscle. Relatively little is known about RMS susceptibility. Based on growing evidence regarding the role of early immunologic challenges on RMS development, we evaluated the role of infections and immunizations on this clinically significant pediatric malignancy. RMS cases (n = 322) were enrolled from the third trial coordinated by the Intergroup Rhabdomyosarcoma Study Group. Population-based controls (n = 322) were pair matched to cases on race, sex, and age. The following immunizations were assessed: diphtheria, pertussis, and tetanus (DPT); measles, mumps, and rubella; and oral polio vaccine. We also evaluated if immunizations were complete versus incomplete. We examined selected infections including chickenpox, mumps, pneumonia, scarlet fever, rubella, rubeola, pertussis, mononucleosis, and lung infections. Conditional logistic regression models were used to calculate an odds ratio (OR) and 95% confidence interval (CI) for each exposure, adjusted for maternal education and total annual income. Incomplete immunization schedules (OR = 5.30, 95% CI: 2.47-11.33) and incomplete DPT immunization (OR = 1.56, 95% CI: 1.06-2.29) were positively associated with childhood RMS. However, infections did not appear to be associated with childhood RMS. This is the largest study of RMS to date demonstrating a possible protective effect of immunizations against the development of childhood RMS. Further studies are needed to validate our findings. Our findings add to the growing body of literature, suggesting a protective role of routine vaccinations in childhood cancer and specifically in childhood RMS. © 2016 Wiley Periodicals, Inc.

  5. Are Radiation Therapy Oncology Group Para-aortic Contouring Guidelines for Pancreatic Neoplasm Applicable to Other Malignancies—Assessment of Nodal Distribution in Gynecological Malignancies

    Energy Technology Data Exchange (ETDEWEB)

    Kabolizadeh, Peyman; Fulay, Suyash; Beriwal, Sushil, E-mail: beriwals@upmc.edu

    2013-09-01

    Purpose: Intensity modulated radiation therapy is used to reduce dose to adjacent critical structures while maintaining adequate target coverage, but it requires precise target localization. We report the 3-dimensional distribution of para-aortic (PA) lymph nodes (LN) in pelvic malignancies. We propose a guideline to accurately define the PA LN by anatomic landmarks and compare our data with published guidelines for pancreatic cancer. Methods and Materials: A retrospective analysis was performed on 46 patients with pelvic malignancies and positive PA LNs. Positive LNs were defined based on size and morphology or fluorodeoxyglucose avidity. All PA LNs were characterized into 3 groups based on location: left PA (between aorta and left psoas muscle), aortocaval (between aorta and inferior vena cava), and right paracaval (between inferior vena cava and right psoas muscle). Patients with retrocrural LNs were also analyzed. Results: One hundred thirty-three positive PA LNs were evaluated. The majority of the PA LNs were in the left PA (59%) and aortocaval (35) regions, and only 8% were in the right paracaval region. All patients with positive right paracaval LNs also had involved left PA LNs, with only 1 exception. The highest PA LN involvement was at the level of the renal vessels and was seen in 28% of patients. Of these patients with disease extending to renal vessels, 38% had retrocrural LN involvement. Conclusions: The nodal contouring for the PA region should not be defined by a fixed circumferential margin around the vessels. The left PA and aortocaval spaces should be covered adequately because these are common locations of PA LNs. For microscopic disease superiorly, contouring should extend up to renal vessels rather than a fixed bony landmark. For patients who have nodal involvement at renal vessels, one can consider including retrocrural LNs. Radiation Therapy Oncology Group Para-aortic Contouring Guidelines for Pancreatic Neoplasm are not applicable to

  6. Are Radiation Therapy Oncology Group Para-aortic Contouring Guidelines for Pancreatic Neoplasm Applicable to Other Malignancies—Assessment of Nodal Distribution in Gynecological Malignancies

    International Nuclear Information System (INIS)

    Kabolizadeh, Peyman; Fulay, Suyash; Beriwal, Sushil

    2013-01-01

    Purpose: Intensity modulated radiation therapy is used to reduce dose to adjacent critical structures while maintaining adequate target coverage, but it requires precise target localization. We report the 3-dimensional distribution of para-aortic (PA) lymph nodes (LN) in pelvic malignancies. We propose a guideline to accurately define the PA LN by anatomic landmarks and compare our data with published guidelines for pancreatic cancer. Methods and Materials: A retrospective analysis was performed on 46 patients with pelvic malignancies and positive PA LNs. Positive LNs were defined based on size and morphology or fluorodeoxyglucose avidity. All PA LNs were characterized into 3 groups based on location: left PA (between aorta and left psoas muscle), aortocaval (between aorta and inferior vena cava), and right paracaval (between inferior vena cava and right psoas muscle). Patients with retrocrural LNs were also analyzed. Results: One hundred thirty-three positive PA LNs were evaluated. The majority of the PA LNs were in the left PA (59%) and aortocaval (35) regions, and only 8% were in the right paracaval region. All patients with positive right paracaval LNs also had involved left PA LNs, with only 1 exception. The highest PA LN involvement was at the level of the renal vessels and was seen in 28% of patients. Of these patients with disease extending to renal vessels, 38% had retrocrural LN involvement. Conclusions: The nodal contouring for the PA region should not be defined by a fixed circumferential margin around the vessels. The left PA and aortocaval spaces should be covered adequately because these are common locations of PA LNs. For microscopic disease superiorly, contouring should extend up to renal vessels rather than a fixed bony landmark. For patients who have nodal involvement at renal vessels, one can consider including retrocrural LNs. Radiation Therapy Oncology Group Para-aortic Contouring Guidelines for Pancreatic Neoplasm are not applicable to

  7. Equivalence of intrathecal chemotherapy and radiotherapy as central nervous system prophylaxis in children with acute lymphatic leukemia: a pediatric oncology group study

    Energy Technology Data Exchange (ETDEWEB)

    Sullivan, M.P. (M.D. Anderson Hospital and Tumor Inst., Houston, TX); Chen, T.; Dyment, P.G.; Hvizdala, E.; Steuber, C.P.

    1982-10-01

    The efficacy of intrathecal (i.t.) chemoprophylaxis was compared with cranial radiotherapy plus i.t. methotrexate (MTX) in a Southwest Oncology Group (SWOG) study accessing 408 patients from September 10, 1974, to October 29, 1976. Randomization was stratified by prognostic groups (PGs) based on age and white blood cell count at diagnosis. All received induction therapy with vincristine and prednisone (Pred); maintenance therapy consisted of daily 6-mercaptopurine and weekly MTX. Consolidation for arm 1 employed cyclophosphamide and L-asparaginase followed by biwekly 5-day courses of parenteral MTX. The first dose of each course of MTX was given i.t. in triple chemoprophylaxis (MTX, hydrocortisone, and cytosine arabinoside). During maintenance, i.t. chemoprophylaxis was bimonthly and 28-day Pred ''pulses'' were given every 3 mo. Arm 2 i.t. chemoprophylaxis was initiated on achievement of remission, and arm 3 i.t. on treatment day 1; both continued 1 yr. Arm 4 induction included two doses of L-asparaginase. On achievement of remission, CNS prophylaxis (radiotherapy, 2400 rad plus i.t. MTX) was given. For all, therapy was discontinued after 3 yr of continuous complete remission. Survival and the incidence of extramedullary relapse were similar for the treatment employing either i.t. chemoprophylaxis or radiotherapy plus i.t. MTX upon achievement of remission. The study indicates that i.t. chemoprophylaxis may be substituted for cranial radiotherapy when utilizing effective systemic regimens. Additionally, chemoprophylaxis may be reduced from 3 to 1 yr in patients with good prognostic factors. (JMT)

  8. Protein Kinase A RI-α Predicts for Prostate Cancer Outcome: Analysis of Radiation Therapy Oncology Group Trial 86-10

    International Nuclear Information System (INIS)

    Khor, Li-Yan; Bae, Kyounghwa; Al-Saleem, Tahseen; Hammond, Elizabeth H.; Grignon, David J.; Sause, William T.; Pilepich, Miljenko V.; Okunieff, Paul P.; Sandler, Howard M.; Pollack, Alan

    2008-01-01

    Purpose: The RI-α regulatory subunit of protein kinase A type 1 (PKA) is constitutively overexpressed in human cancer cell lines and is associated with active cell growth and neoplastic transformation. This report examined the association between PKA expression and the endpoints of biochemical failure (BF), local failure (LF), distant metastasis (DM), cause-specific mortality (CSM), and overall mortality in men treated with radiotherapy, with or without short-term androgen deprivation in Radiation Therapy Oncology Group trial 86-10. Methods and Materials: Pretreatment archival diagnostic tissue samples from 80 patients were stained for PKA by immunohistochemical methods from a parent cohort of 456 cases. PKA intensity was scored manually and by image analysis. The Cox proportional hazards model for overall mortality and Fine and Gray's regression models for CSM, DM, LF and BF were then applied to determine the relationship of PKA expression to the endpoints. Results: The pretreatment characteristics of the missing and determined PKA groups were not significantly different. On univariate analyses, a high PKA staining intensity was associated with BF (image analysis, continuous variable, p = 0.022), LF (image analysis, dichotomized variable, p = 0.011), CSM (manual analysis, p = 0.037; image analysis, continuous, p = 0.014), and DM (manual analysis, p = 0.029). On multivariate analyses, the relationships to BF (image analysis, continuous, p = 0.03), LF (image analysis, dichotomized, p = 0.002), and DM remained significant (manual analysis, p = 0.018). In terms of CSM, a trend toward an association was seen (manual analysis, p = 0.08; image analysis, continuous, p = 0.09). Conclusion: PKA overexpression was significantly related to patient outcome and is a potentially useful biomarker for identifying high-risk prostate cancer patients who might benefit from a PKA knockdown strategy

  9. Metabolic Tumor Volume as a Prognostic Imaging-Based Biomarker for Head-and-Neck Cancer: Pilot Results From Radiation Therapy Oncology Group Protocol 0522

    Energy Technology Data Exchange (ETDEWEB)

    Schwartz, David L., E-mail: david.schwartz@utsw.edu [Department of Radiation Oncology, University of Texas Southwestern School of Medicine, Dallas, Texas (United States); Harris, Jonathan [Radiation Therapy Oncology Group Statistical Center, Philadelphia, Pennsylvania (United States); Yao, Min [Department of Radiation Oncology, Case Western Reserve University School of Medicine, Cleveland, Ohio (United States); Rosenthal, David I. [Department of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Opanowski, Adam; Levering, Anthony [American College of Radiology Imaging Network, Philadelphia, Pennsylvania (United States); Ang, K. Kian [Department of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Trotti, Andy M. [Department of Radiation Oncology, Moffitt Cancer Center, Tampa, Florida (United States); Garden, Adam S. [Department of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Jones, Christopher U. [Sutter Medical Group, Sacramento, California (United States); Harari, Paul [Department of Human Oncology, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin (United States); Foote, Robert [Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota (United States); Holland, John [Department of Radiation Medicine, Oregon Health & Science University, Portland, Oregon (United States); Zhang, Qiang [Radiation Therapy Oncology Group Statistical Center, Philadelphia, Pennsylvania (United States); Le, Quynh-Thu [Department of Radiation Oncology, Stanford University School of Medicine, Palo Alto, California (United States)

    2015-03-15

    Purpose: To evaluate candidate fluorodeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT) imaging biomarkers for head-and-neck chemoradiotherapy outcomes in the cooperative group trial setting. Methods and Materials: Radiation Therapy Oncology Group (RTOG) protocol 0522 patients consenting to a secondary FDG-PET/CT substudy were serially imaged at baseline and 8 weeks after radiation. Maximum standardized uptake value (SUVmax), SUV peak (mean SUV within a 1-cm sphere centered on SUVmax), and metabolic tumor volume (MTV) using 40% of SUVmax as threshold were obtained from primary tumor and involved nodes. Results: Of 940 patients entered onto RTOG 0522, 74 were analyzable for this substudy. Neither high baseline SUVmax nor SUVpeak from primary or nodal disease were associated with poor treatment outcomes. However, primary tumor MTV above the cohort median was associated with worse local-regional control (hazard ratio 4.01, 95% confidence interval 1.28-12.52, P=.02) and progression-free survival (hazard ratio 2.34, 95% confidence interval 1.02-5.37, P=.05). Although MTV and T stage seemed to correlate (mean MTV 6.4, 13.2, and 26.8 for T2, T3, and T4 tumors, respectively), MTV remained a strong independent prognostic factor for progression-free survival in bivariate analysis that included T stage. Primary MTV remained prognostic in p16-associated oropharyngeal cancer cases, although sample size was limited. Conclusion: High baseline primary tumor MTV was associated with worse treatment outcomes in this limited patient subset of RTOG 0522. Additional confirmatory work will be required to validate primary tumor MTV as a prognostic imaging biomarker for patient stratification in future trials.

  10. Patient Age and Tumor Subtype Predict the Extent of Axillary Surgery Among Breast Cancer Patients Eligible for the American College of Surgeons Oncology Group Trial Z0011.

    Science.gov (United States)

    Ong, Cecilia T; Thomas, Samantha M; Blitzblau, Rachel C; Fayanju, Oluwadamilola M; Park, Tristen S; Plichta, Jennifer K; Rosenberger, Laura H; Hyslop, Terry; Shelley Hwang, E; Greenup, Rachel A

    2017-11-01

    The American College of Surgeons Oncology Group (ACOSOG) Z0011 trial established the safety of omitting axillary lymph node dissection (ALND) for early-stage breast cancer patients with limited nodal disease undergoing lumpectomy. We examined the extent of axillary surgery among women eligible for Z0011 based on patient age and tumor subtype. Patients with cT1-2, cN0 breast cancers and one or two positive nodes diagnosed from 2009 to 2014 and treated with lumpectomy were identified in the National Cancer Data Base. Sentinel lymph node biopsy (SLNB) was defined as the removal of 1-5 nodes and ALND as the removal of 10 nodes or more. Tumor subtype was categorized as luminal, human epidermal growth factor 2-positive (HER2+), or triple-negative. Logistic regression was used to estimate the odds of receiving SLNB alone versus ALND. The inclusion criteria were met by 28,631 patients (21,029 SLNB-alone and 7602 ALND patients). Patients 70 years of age or older were more likely to undergo SLNB alone than ALND (27.0% vs 20.1%; p alone and 89.7% after ALND. In the multivariate analysis, the uptake of Z0011 recommendations increased over time (2014 vs 2009: odds ratio [OR] 13.02; p alone than older patients (age alone than those with luminal subtypes. Among women potentially eligible for ACOSOG Z0011, the use of SLNB alone increased over time in all groups, but the extent of axillary surgery differed by patient age and tumor subtype.

  11. Structural Phase Transition Nomenclature, Report of an IUCr Working Group on Phase Transition Nomenclature

    NARCIS (Netherlands)

    Toleddano, J.C.; Glazer, A.M.; Hahn, Th.; Parthe, E.; Roth, R.S.; Berry, R.S.; Metselaar, R.; Abrahams, S.C.

    1998-01-01

    A compact and intuitive nomenclature is recommended for naming each phase formed by a given material in a sequence of phase transitions as a function of temperature and/or pressure. The most commonly used label for each phase in a sequence, such as [alpha], [beta], ..., I, II, ... etc., is included

  12. Imaging Opportunities in Radiation Oncology

    International Nuclear Information System (INIS)

    Balter, James M.; Haffty, Bruce G.; Dunnick, N. Reed; Siegel, Eliot L.

    2011-01-01

    Interdisciplinary efforts may significantly affect the way that clinical knowledge and scientific research related to imaging impact the field of Radiation Oncology. This report summarizes the findings of an intersociety workshop held in October 2008, with the express purpose of exploring 'Imaging Opportunities in Radiation Oncology.' Participants from the American Society for Radiation Oncology (ASTRO), National Institutes of Health (NIH), Radiological Society of North America (RSNA), American Association of physicists in Medicine (AAPM), American Board of Radiology (ABR), Radiation Therapy Oncology Group (RTOG), European Society for Therapeutic Radiology and Oncology (ESTRO), and Society of Nuclear Medicine (SNM) discussed areas of education, clinical practice, and research that bridge disciplines and potentially would lead to improved clinical practice. Findings from this workshop include recommendations for cross-training opportunities within the allowed structured of Radiology and Radiation Oncology residency programs, expanded representation of ASTRO in imaging related multidisciplinary groups (and reciprocal representation within ASTRO committees), increased attention to imaging validation and credentialing for clinical trials (e.g., through the American College of Radiology Imaging Network (ACRIN)), and building ties through collaborative research as well as smaller joint workshops and symposia.

  13. Prospective Evaluation of Quality of Life and Neurocognitive Effects in Patients With Multiple Brain Metastases Receiving Whole-Brain Radiotherapy With or Without Thalidomide on Radiation Therapy Oncology Group (RTOG) Trial 0118

    International Nuclear Information System (INIS)

    Corn, Benjamin W.; Moughan, Jennifer M.S.; Knisely, Jonathan P.S.; Fox, Sherry W.; Chakravarti, Arnab; Yung, W.K. Alfred; Curran, Walter J.; Robins, H. Ian; Brachman, David G.; Henderson, Randal H.; Mehta, Minesh P.; Movsas, Benjamin

    2008-01-01

    Purpose: Radiation Therapy Oncology Group (RTOG) 0118 randomized patients with multiple brain metastases to whole-brain radiotherapy (WBRT) ± thalidomide. This secondary analysis of 156 patients examined neurocognitive and quality of life (QOL) outcomes. Methods and Materials: Quality of life was determined with the Spitzer Quality of Life Index (SQLI). The Folstein Mini-Mental Status Exam (MMSE) assessed neurocognitive function. SQLI and MMSE were administered at baseline and at 2-month intervals. MMSE was scored with a threshold value associated with neurocognitive functioning (absolute cutoff level of 23) and with the use of corrections for age and educational level. Results: Baseline SQLI predicted survival. Patients with SQLI of 7-10 vs. <7 had median survival time (MST) of 4.8 vs. 3.1 months, p = 0.05. Both arms showed steady neurocognitive declines, but SQLI scores remained stable. Higher levels of neurocognitive decline were observed with age and education-level corrections. Of patients considered baseline age/educational level neurocognitive failures, 32% died of intracranial progression. Conclusions: Quality of life and neuropsychological testing can be prospectively administered on a Phase III cooperative group trial. The MMSE should be evaluated with adjustments for age and educational level. Baseline SQLI is predictive of survival. Despite neurocognitive declines, QOL remained stable during treatment and follow-up. Poor neurocognitive function may predict clinical deterioration. Lack of an untreated control arm makes it difficult to determine the contribution of the respective interventions (i.e., WBRT, thalidomide) to neurocognitive decline. The RTOG has developed a trial to study the role of preventative strategies aimed at forestalling neurocognitive decline in this population

  14. Predictive Factor Analysis of Response-Adapted Radiation Therapy for Chemotherapy-Sensitive Pediatric Hodgkin Lymphoma: Analysis of the Children's Oncology Group AHOD 0031 Trial

    International Nuclear Information System (INIS)

    Charpentier, Anne-Marie; Friedman, Debra L.; Wolden, Suzanne; Schwartz, Cindy; Gill, Bethany; Sykes, Jenna; Albert-Green, Alisha; Kelly, Kara M.; Constine, Louis S.; Hodgson, David C.

    2016-01-01

    Purpose: To evaluate whether clinical risk factors could further distinguish children with intermediate-risk Hodgkin lymphoma (HL) with rapid early and complete anatomic response (RER/CR) who benefit significantly from involved-field RT (IFRT) from those who do not, and thereby aid refinement of treatment selection. Methods and Materials: Children with intermediate-risk HL treated on the Children's Oncology Group AHOD 0031 trial who achieved RER/CR with 4 cycles of chemotherapy, and who were randomized to 21-Gy IFRT or no additional therapy (n=716) were the subject of this study. Recursive partitioning analysis was used to identify factors associated with clinically and statistically significant improvement in event-free survival (EFS) after randomization to IFRT. Bootstrap sampling was used to evaluate the robustness of the findings. Result: Although most RER/CR patients did not benefit significantly from IFRT, those with a combination of anemia and bulky limited-stage disease (n=190) had significantly better 4-year EFS with the addition of IFRT (89.3% vs 77.9% without IFRT; P=.019); this benefit was consistently reproduced in bootstrap analyses and after adjusting for other prognostic factors. Conclusion: Although most patients achieving RER/CR had favorable outcomes with 4 cycles of chemotherapy alone, those children with initial bulky stage I/II disease and anemia had significantly better EFS with the addition of IFRT as part of combined-modality therapy. Further work evaluating the interaction of clinical and biologic factors and imaging response is needed to further optimize and refine treatment selection.

  15. Patient-Reported Outcome Coordinator Did Not Improve Quality of Life Assessment Response Rates: A Report from the Children's Oncology Group.

    Directory of Open Access Journals (Sweden)

    Donna Johnston

    Full Text Available Health related quality of life (HRQL assessments during therapy for pediatric cancer provide valuable information to better understand the patient experience. Our objective was to determine the impact of a patient-reported outcome (PRO coordinator on HRQL questionnaire completion rates during a pediatric acute myeloid leukemia (AML trial.AAML1031 is a multicenter Children's Oncology Group therapeutic trial for de novo AML with a secondary aim to assess HRQL of children and adolescents treated with chemotherapy and hematopoietic stem cell transplantation (HSCT. Parents/guardians are the primary respondents and four questionnaires are administered at eight time points. The questionnaires are the PedsQL 4.0 Generic Core Scales, PedsQL 3.0 Acute Cancer Module, PedsQL Multidimensional Fatigue Scale, and the Pediatric Inventory for Parents. To improve response rates, a central PRO coordinator was instituted and reminded sites about upcoming and delinquent questionnaires. The proportion of HRQL questionnaires completed were compared prior to, and following institution of the PRO coordinator. This analysis evaluated the first five assessment time points.There were231 families who consented to participate in the HRQL aim. Overall response rates for all questionnaires were 73-83%. At time point 1, within 14 days of chemotherapy initiation, post-PRO coordinator completion rates were significantly higher for three of four questionnaires. However, the effect was not sustained and at time point 4, one month following last chemotherapy or HSCT, completion rates were significantly lower post-PRO coordinator for all four questionnaires.Addition of a central PRO coordinator did not result in sustained improvement in HRQL questionnaire completion rates. Efforts to improve response rates must consider other strategies.

  16. Immunohistochemically determined total epidermal growth factor receptor levels not of prognostic value in newly diagnosed glioblastoma multiforme: Report from the Radiation Therapy Oncology Group

    International Nuclear Information System (INIS)

    Chakravarti, Arnab; Seiferheld, Wendy; Tu Xiaoyu; Wang Huijun; Zhang Huazhong; Ang, K. Kian; Hammond, Elizabeth; Curran, Walter; Mehta, Minesh

    2005-01-01

    Purpose: The Radiation Therapy Oncology Group (RTOG) performed an analysis of patterns of immunohistochemically detected total epidermal growth factor receptor (EGFR) protein expression levels and their prognostic significance on archival tissue in newly diagnosed glioblastoma multiforme (GBM) patients from prior prospective RTOG clinical trials. Methods and materials: Patients in this study had been treated on previous RTOG GBM trials (RTOG 7401, 7918, 8302, 8409, 9006, 9305, 9602, and 9806). Tissue microarrays were prepared from 155 patients enrolled in these trials. These specimens were stained using a mouse monoclonal antibody specific for the extracellular binding domain of EGFR to detect total EGFR (including both wild-type phosphorylated and wild-type unphosphorylated isoforms with some cross-reactivity with EGFRvIII). The intensity of total EGFR protein expression was measured by computerized quantitative image analysis using the SAMBA 4000 Cell Image Analysis System. The parameters measured were the mean optical densities over the labeled areas and the staining index, which represents the proportion of stained area relative to the mean stain concentration. Both parameters were correlated with the clinical outcome. Results: No differences in either overall or progression-free survival could be demonstrated by the mean optical density class or mean optical density quartile or the staining index of total EGFR immunostaining among the representative RTOG GBM cases. Conclusion: Total EGFR protein expression levels, as measured immunohistochemically, do not appear to be of prognostic value in newly diagnosed GBM patients. Given the accumulating clinical evidence of the activity of anti-EGFR agents in GBM and the preclinical data suggesting the important role of downstream mediators as effectors of EGFR signaling, the RTOG is conducting additional investigations into the prognostic value of activation patterns of EGFR signaling, both at the level of the receptor

  17. Evaluation of the prevalence of burnout and psychological morbidity among radiation oncologist members of the Kyoto Radiation Oncology Study Group (KROSG)

    International Nuclear Information System (INIS)

    Mampuya, Wambaka Ange; Matsuo, Yukinori; Nakamura, Akira; Hiraoka, Masahiro

    2017-01-01

    This study aimed to evaluate the self-reported prevalence of burnout and psychological morbidity among radiation oncologists members of the Kyoto Radiation Oncology Study Group (KROSG) and to identify factors contributing to burnout. We mailed an anonymous survey to 125 radiation oncologists members of the KROSG. The survey included; the demographic data, the Maslach Burnout Inventory – Human Services Survey (MBI-HSS) and the 12-item General Health Questionnaire (GHQ-12). There were 87 responses out of 125 eligible respondents (69.6% response rate). In terms of burnout, three participants (3.4%) fulfilled the MBI-HSS criteria of having simultaneously high emotional exhaustion (EE), high depersonalization (DP) and low sense of personal accomplishment (PA). Eighteen (20.6%) reported a high score for either EE or DP meeting the alternative criteria for burnout with three of these simultaneously having high EE and high DP. The prevalence of psychological morbidity estimated using GHQ-12 was 32%. A high level of EE and low level of PA significantly correlated with high level of psychological morbidity with P < 0.001 and <0.01 respectively. Having palliative care activities other than radiotherapy and number of patients treated per year were the only factors associated with burnout. This is the first study investigating the prevalence of burnout and psychological morbidity among radiation oncologists in Japan. Compared with other studies involving radiation oncologists, the prevalence of low personal accomplishment was particularly high in the present study. The prevalence of psychological morbidity was almost the double that of the Japanese general population and was significantly associated with low PA and high EE.

  18. Cognition and Quality of Life After Chemotherapy Plus Radiotherapy (RT) vs. RT for Pure and Mixed Anaplastic Oligodendrogliomas: Radiation Therapy Oncology Group Trial 9402

    International Nuclear Information System (INIS)

    Wang Meihua; Cairncross, Gregory; Shaw, Edward

    2010-01-01

    Purpose: Radiation Therapy Oncology Group 9402 compared procarbazine, lomustine, and vincristine (PCV) chemotherapy plus radiation therapy (PCV + RT) vs. RT alone for anaplastic oligodendroglioma. Here we report longitudinal changes in cognition and quality of life, effects of patient factors and treatments on cognition, quality of life and survival, and prognostic implications of cognition and quality of life. Methods and Materials: Cognition was assessed by Mini Mental Status Examination (MMSE) and quality of life by Brain-Quality of Life (B-QOL). Scores were analyzed for survivors and within 5 years of death. Shared parameter models evaluated MMSE/B-QOL with survival. Results: For survivors, MMSE and B-QOL scores were similar longitudinally and between treatments. For those who died, MMSE scores remained stable initially, whereas B-QOL slowly declined; both declined rapidly in the last year of life and similarly between arms. In the aggregate, scores decreased over time (p = 0.0413 for MMSE; p = 0.0016 for B-QOL) and were superior with age <50 years (p < 0.001 for MMSE; p = 0.0554 for B-QOL) and Karnofsky Performance Score (KPS) 80-100 (p < 0.001). Younger age and higher KPS were associated with longer survival. After adjusting for patient factors and drop-out, survival was longer after PCV + RT (HR = 0.66, 95% CI = 0.49-0.9, p = 0.0084; HR = 0.74, 95% CI = 0.54-1.01, p = 0.0592) in models with MMSE and B-QOL. In addition, there were no differences in MMSE and B-QOL scores between arms (p = 0.4752 and p = 0.2767, respectively); higher scores predicted longer survival. Conclusion: MMSE and B-QOL scores held steady in the upper range in both arms for survivors. Younger, fitter patients had better MMSE and B-QOL and longer survival.

  19. Bcl-2 and bax expression and prostate cancer outcome in men treated with radiotherapy in Radiation Therapy Oncology Group protocol 86-10

    International Nuclear Information System (INIS)

    Khor, L.-Y.; De Silvio, Michelle; Li, Rile; McDonnell, Timothy J.; Hammond, M. Elizabeth H.; Sause, William T.; Pilepich, Miljenko V.; Okunieff, Paul; Sandler, Howard M.; Pollack, Alan

    2006-01-01

    Purpose: Bcl-2 and bax are proteins with opposing roles in apoptosis regulation; yet abnormal expression of either has been associated with failure after radiotherapy (RT). In this study we examined bcl-2 and bax expression as predictive markers in men treated with radiotherapy ± androgen deprivation on Radiation Therapy Oncology Group (RTOG) protocol 86-10. Experimental Design: Suitable archival diagnostic tissue was obtained from 119 (26%) patients for bcl-2 analysis and 104 (23%) patients for bax analysis. Cox proportional hazards multivariate analysis was used to determine the relationship of abnormal bcl-2 and bax expression to the end points of local failure, distant metastasis, cause-specific mortality, and overall mortality. Bcl-2 overexpression was classified as any tumor cell cytoplasmic staining and altered bax expression was classified as greater or lesser cytoplasmic staining intensity of tumor cells as compared with adjacent normal prostate epithelium. Results: The study cohort exhibited bcl-2 overexpression in 26% (n = 30) of cases and abnormal bax expression in 47% (n = 49) of cases. A borderline significant relationship was observed between abnormal bax expression and higher Gleason score (p = 0.08). In univariate and multivariate analyses, there was no statistically significant relationship seen between abnormal bcl-2 or bax expression and outcome. Conclusions: Abnormal bcl-2 and bax expression were not related to any of the end points tested. The cohort examined was comprised of patients with locally advanced disease and it is possible that these markers may be of greater value in men with earlier-stage prostate cancer

  20. Gender, Race, and Survival: A Study in Non-Small-Cell Lung Cancer Brain Metastases Patients Utilizing the Radiation Therapy Oncology Group Recursive Partitioning Analysis Classification

    International Nuclear Information System (INIS)

    Videtic, Gregory M.M.; Reddy, Chandana A.; Chao, Samuel T.; Rice, Thomas W.; Adelstein, David J.; Barnett, Gene H.; Mekhail, Tarek M.; Vogelbaum, Michael A.; Suh, John H.

    2009-01-01

    Purpose: To explore whether gender and race influence survival in non-small-cell lung cancer (NSCLC) in patients with brain metastases, using our large single-institution brain tumor database and the Radiation Therapy Oncology Group recursive partitioning analysis (RPA) brain metastases classification. Methods and materials: A retrospective review of a single-institution brain metastasis database for the interval January 1982 to September 2004 yielded 835 NSCLC patients with brain metastases for analysis. Patient subsets based on combinations of gender, race, and RPA class were then analyzed for survival differences. Results: Median follow-up was 5.4 months (range, 0-122.9 months). There were 485 male patients (M) (58.4%) and 346 female patients (F) (41.6%). Of the 828 evaluable patients (99%), 143 (17%) were black/African American (B) and 685 (83%) were white/Caucasian (W). Median survival time (MST) from time of brain metastasis diagnosis for all patients was 5.8 months. Median survival time by gender (F vs. M) and race (W vs. B) was 6.3 months vs. 5.5 months (p = 0.013) and 6.0 months vs. 5.2 months (p = 0.08), respectively. For patients stratified by RPA class, gender, and race, MST significantly favored BFs over BMs in Class II: 11.2 months vs. 4.6 months (p = 0.021). On multivariable analysis, significant variables were gender (p = 0.041, relative risk [RR] 0.83) and RPA class (p < 0.0001, RR 0.28 for I vs. III; p < 0.0001, RR 0.51 for II vs. III) but not race. Conclusions: Gender significantly influences NSCLC brain metastasis survival. Race trended to significance in overall survival but was not significant on multivariable analysis. Multivariable analysis identified gender and RPA classification as significant variables with respect to survival.

  1. A Comparative Evaluation of Normal Tissue Doses for Patients Receiving Radiation Therapy for Hodgkin Lymphoma on the Childhood Cancer Survivor Study and Recent Children's Oncology Group Trials

    International Nuclear Information System (INIS)

    Zhou, Rachel; Ng, Angela; Constine, Louis S.; Stovall, Marilyn; Armstrong, Gregory T.; Neglia, Joseph P.; Friedman, Debra L.; Kelly, Kara; FitzGerald, Thomas J.; Hodgson, David C.

    2016-01-01

    Purpose: Survivors of pediatric Hodgkin lymphoma (HL) are recognized to have an increased risk of delayed adverse health outcomes related to radiation therapy (RT). However, the necessary latency required to observe these late effects means that the estimated risks apply to outdated treatments. We sought to compare the normal tissue dose received by children treated for HL and enrolled in the Childhood Cancer Survivor Study (CCSS) (diagnosed 1970-1986) with that of patients treated in recent Children's Oncology Group (COG) trials (enrolled 2002-2012). Methods and Materials: RT planning data were obtained for 50 HL survivors randomly sampled from the CCSS cohort and applied to computed tomography planning data sets to reconstruct the normal tissue dosimetry. For comparison, the normal tissue dosimetry data were obtained for all 191 patients with full computed tomography–based volumetric RT planning on COG protocols AHOD0031 and AHOD0831. Results: For early-stage patients, the mean female breast dose in the COG patients was on average 83.5% lower than that for CCSS patients, with an absolute reduction of 15.5 Gy. For advanced-stage patients, the mean breast dose was decreased on average by 70% (11.6 Gy average absolute dose reduction). The mean heart dose decreased on average by 22.9 Gy (68.6%) and 17.6 Gy (56.8%) for early- and advanced-stage patients, respectively. All dose comparisons for breast, heart, lung, and thyroid were significantly lower for patients in the COG trials than for the CCSS participants. Reductions in the prescribed dose were a major contributor to these dose reductions. Conclusions: These are the first data quantifying the significant reduction in the normal tissue dose using actual, rather than hypothetical, treatment plans for children with HL. These findings provide useful information when counseling families regarding the risks of contemporary RT.

  2. Predictive Factor Analysis of Response-Adapted Radiation Therapy for Chemotherapy-Sensitive Pediatric Hodgkin Lymphoma: Analysis of the Children's Oncology Group AHOD 0031 Trial.

    Science.gov (United States)

    Charpentier, Anne-Marie; Friedman, Debra L; Wolden, Suzanne; Schwartz, Cindy; Gill, Bethany; Sykes, Jenna; Albert-Green, Alisha; Kelly, Kara M; Constine, Louis S; Hodgson, David C

    2016-12-01

    To evaluate whether clinical risk factors could further distinguish children with intermediate-risk Hodgkin lymphoma (HL) with rapid early and complete anatomic response (RER/CR) who benefit significantly from involved-field RT (IFRT) from those who do not, and thereby aid refinement of treatment selection. Children with intermediate-risk HL treated on the Children's Oncology Group AHOD 0031 trial who achieved RER/CR with 4 cycles of chemotherapy, and who were randomized to 21-Gy IFRT or no additional therapy (n=716) were the subject of this study. Recursive partitioning analysis was used to identify factors associated with clinically and statistically significant improvement in event-free survival (EFS) after randomization to IFRT. Bootstrap sampling was used to evaluate the robustness of the findings. Although most RER/CR patients did not benefit significantly from IFRT, those with a combination of anemia and bulky limited-stage disease (n=190) had significantly better 4-year EFS with the addition of IFRT (89.3% vs 77.9% without IFRT; P=.019); this benefit was consistently reproduced in bootstrap analyses and after adjusting for other prognostic factors. Although most patients achieving RER/CR had favorable outcomes with 4 cycles of chemotherapy alone, those children with initial bulky stage I/II disease and anemia had significantly better EFS with the addition of IFRT as part of combined-modality therapy. Further work evaluating the interaction of clinical and biologic factors and imaging response is needed to further optimize and refine treatment selection. Copyright © 2016. Published by Elsevier Inc.

  3. Predictive Factor Analysis of Response-Adapted Radiation Therapy for Chemotherapy-Sensitive Pediatric Hodgkin Lymphoma: Analysis of the Children's Oncology Group AHOD 0031 Trial

    Energy Technology Data Exchange (ETDEWEB)

    Charpentier, Anne-Marie [Department of Radiation Oncology, Centre hospitalier de l' Université de Montréal, Montreal, Québec (Canada); Friedman, Debra L. [Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, Tennessee (United States); Wolden, Suzanne [Radiation Oncology, Memorial Sloan-Kettering Cancer Center, New York, New York (United States); Schwartz, Cindy [Division of Pediatrics, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Gill, Bethany; Sykes, Jenna; Albert-Green, Alisha [Biostatistics, Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario (Canada); Kelly, Kara M. [Division of Hematology and Oncology, Women & Children' s Hospital of Buffalo, Buffalo, New York (United States); Department of Pediatrics, Roswell Park Cancer Institute, Buffalo, New York (United States); Constine, Louis S. [Radiation Oncology, University of Rochester Medical Center, Rochester, New York (United States); Hodgson, David C., E-mail: David.hodgson@rmp.uhn.on.ca [Radiation Medicine Program, Princess Margaret Cancer Centre, University of Toronto, Toronto, Ontario (Canada)

    2016-12-01

    Purpose: To evaluate whether clinical risk factors could further distinguish children with intermediate-risk Hodgkin lymphoma (HL) with rapid early and complete anatomic response (RER/CR) who benefit significantly from involved-field RT (IFRT) from those who do not, and thereby aid refinement of treatment selection. Methods and Materials: Children with intermediate-risk HL treated on the Children's Oncology Group AHOD 0031 trial who achieved RER/CR with 4 cycles of chemotherapy, and who were randomized to 21-Gy IFRT or no additional therapy (n=716) were the subject of this study. Recursive partitioning analysis was used to identify factors associated with clinically and statistically significant improvement in event-free survival (EFS) after randomization to IFRT. Bootstrap sampling was used to evaluate the robustness of the findings. Result: Although most RER/CR patients did not benefit significantly from IFRT, those with a combination of anemia and bulky limited-stage disease (n=190) had significantly better 4-year EFS with the addition of IFRT (89.3% vs 77.9% without IFRT; P=.019); this benefit was consistently reproduced in bootstrap analyses and after adjusting for other prognostic factors. Conclusion: Although most patients achieving RER/CR had favorable outcomes with 4 cycles of chemotherapy alone, those children with initial bulky stage I/II disease and anemia had significantly better EFS with the addition of IFRT as part of combined-modality therapy. Further work evaluating the interaction of clinical and biologic factors and imaging response is needed to further optimize and refine treatment selection.

  4. Limited Chemotherapy and Shrinking Field Radiotherapy for Osteolymphoma (Primary Bone Lymphoma): Results From the Trans-Tasman Radiation Oncology Group 99.04 and Australasian Leukaemia and Lymphoma Group LY02 Prospective Trial

    International Nuclear Information System (INIS)

    Christie, David; Dear, Keith; Le, Thai; Barton, Michael; Wirth, Andrew; Porter, David; Roos, Daniel; Pratt, Gary

    2011-01-01

    Purpose: To establish benchmark outcomes for combined modality treatment to be used in future prospective studies of osteolymphoma (primary bone lymphoma). Methods and Materials: In 1999, the Trans-Tasman Radiation Oncology Group (TROG) invited the Australasian Leukemia and Lymphoma Group (ALLG) to collaborate on a prospective study of limited chemotherapy and radiotherapy for osteolymphoma. The treatment was designed to maintain efficacy but limit the risk of subsequent pathological fractures. Patient assessment included both functional imaging and isotope bone scanning. Treatment included three cycles of CHOP chemotherapy and radiation to a dose of 45 Gy in 25 fractions using a shrinking field technique. Results: The trial closed because of slow accrual after 33 patients had been entered. Accrual was noted to slow down after Rituximab became readily available in Australia. After a median follow-up of 4.3 years, the five-year overall survival and local control rates are estimated at 90% and 72% respectively. Three patients had fractures at presentation that persisted after treatment, one with recurrent lymphoma. Conclusions: Relatively high rates of survival were achieved but the number of local failures suggests that the dose of radiotherapy should remain higher than it is for other types of lymphoma. Disability after treatment due to pathological fracture was not seen.

  5. Sequential Oral Hydroxyurea and Intravenous Cytosine Arabinoside in Refractory Childhood Acute Leukemia: A Pediatric Oncology Group Phase I Study

    OpenAIRE

    Dubowy, Ronald; Graham, Michael; Hakami, Nasrollah; Kletzel, Morris; Mahoney, Donald; Newman, Edward; Ravindranath, Yaddanapudi; Camitta, Bruce

    2008-01-01

    At concentrations >0.1 mM, Hydroxyurea (HU) enhances the accumulation of cytosine arabinoside (ara-C) in leukemia cells in vitro. This study of children with refractory acute leukemia was designed to take advantage of this biochemical modulation. A fixed dose of HU and an escalating dose of ara-C were used. Oral HU, 1200 mg/m2 was followed 2 hours later by ara-C, 250-3100 mg/m2 intravenously in 15 minutes. The combination was given on days 1,2,3 and 8,9,10. Thirty-three children (26 ALL, 7 AN...

  6. Comparing oncology clinical programs by use of innovative designs and expected net present value optimization: Which adaptive approach leads to the best result?

    Science.gov (United States)

    Parke, Tom; Marchenko, Olga; Anisimov, Vladimir; Ivanova, Anastasia; Jennison, Christopher; Perevozskaya, Inna; Song, Guochen

    2017-01-01

    Designing an oncology clinical program is more challenging than designing a single study. The standard approaches have been proven to be not very successful during the last decade; the failure rate of Phase 2 and Phase 3 trials in oncology remains high. Improving a development strategy by applying innovative statistical methods is one of the major objectives of a drug development process. The oncology sub-team on Adaptive Program under the Drug Information Association Adaptive Design Scientific Working Group (DIA ADSWG) evaluated hypothetical oncology programs with two competing treatments and published the work in the Therapeutic Innovation and Regulatory Science journal in January 2014. Five oncology development programs based on different Phase 2 designs, including adaptive designs and a standard two parallel arm Phase 3 design were simulated and compared in terms of the probability of clinical program success and expected net present value (eNPV). In this article, we consider eight Phase2/Phase3 development programs based on selected combinations of five Phase 2 study designs and three Phase 3 study designs. We again used the probability of program success and eNPV to compare simulated programs. For the development strategies, we considered that the eNPV showed robust improvement for each successive strategy, with the highest being for a three-arm response adaptive randomization design in Phase 2 and a group sequential design with 5 analyses in Phase 3.

  7. Local Control for Intermediate-Risk Rhabdomyosarcoma: Results From D9803 According to Histology, Group, Site, and Size: A Report From the Children's Oncology Group

    Energy Technology Data Exchange (ETDEWEB)

    Wolden, Suzanne L., E-mail: woldens@mskcc.org [Department of Radiation Oncology, Memorial Sloan-Kettering Cancer Center, New York, New York (United States); Lyden, Elizabeth R. [Department of Preventive and Societal Medicine, Nebraska Medical Center, Omaha, Nebraska (United States); Arndt, Carola A. [Department of Pediatric and Adolescent Medicine, Mayo Clinic and Foundation, Rochester, Minnesota (United States); Hawkins, Douglas S. [Division of Hematology/Oncology, Seattle Children' s Hospital, Fred Hutchinson Cancer Research Center, University of Washington, Seattle, Washington (United States); Anderson, James R. [Frontier Science and Technology Research Foundation, Madison, Wisconsin (United States); Rodeberg, David A. [Department of Surgery, East Carolina University, Greenville, North Carolina (United States); Morris, Carol D. [Department of Orthopedic Surgery, Johns Hopkins University School of Medicine, Baltimore, Maryland (United States); Donaldson, Sarah S. [Department of Radiation Oncology, Stanford University School of Medicine, Stanford, California (United States)

    2015-12-01

    Purpose: To determine local control according to clinical variables for patients with intermediate-risk rhabdomyosarcoma (RMS) treated on Children's Oncology Group protocol D9803. Patients and Methods: Of 702 patients enrolled, we analyzed 423 patients with central pathology–confirmed group III embryonal (n=280) or alveolar (group III, n=102; group I-II, n=41) RMS. Median age was 5 years. Patients received 42 weeks of VAC (vincristine, dactinomycin, cyclophosphamide) or VAC alternating with VTC (T = topotecan). Local therapy with 50.4 Gy radiation therapy with or without delayed primary excision began at week 12 for group III patients. Patients with group I/II alveolar RMS received 36-41.4 Gy. Local failure (LF) was defined as local progression as a first event with or without concurrent regional or distant failure. Results: At a median follow-up of 6.6 years, patients with clinical group I/II alveolar RMS had a 5-year event-free survival rate of 69% and LF of 10%. Among patients with group III RMS, 5-year event-free survival and LF rates were 70% and 19%, respectively. Local failure rates did not differ by histology, nodal status, or primary site, though there was a trend for increased LF for retroperitoneal (RP) tumors (P=.12). Tumors ≥5 cm were more likely to fail locally than tumors <5 cm (25% vs 10%, P=.0004). Almost all (98%) RP tumors were ≥5 cm, with no difference in LF by site when the analysis was restricted to tumors ≥5 cm (P=.86). Conclusion: Local control was excellent for clinical group I/II alveolar RMS. Local failure constituted 63% of initial events in clinical group III patients and did not vary by histology or nodal status. The trend for higher LF in RP tumors was related to tumor size. There has been no clear change in local control over RMS studies, including IRS-III and IRS-IV. Novel approaches are warranted for larger tumors (≥5 cm).

  8. Validation of the Spine Oncology Study Group-Outcomes Questionnaire to assess quality of life in patients with metastatic spine disease.

    Science.gov (United States)

    Janssen, Stein J; Teunis, Teun; van Dijk, Eva; Ferrone, Marco L; Shin, John H; Hornicek, Francis; Schwab, Joseph H

    2017-06-01

    General questionnaires are often used to assess quality of life in patients with spine metastases, although a disease-specific survey did not exist until recently. The Spine Oncology Study Group has developed an outcomes questionnaire (SOSG-OQ) to measure quality of life in these patients. However, a scoring system was not developed, and the questionnaire was not validated in a group of patients, nor was it compared with other general quality of life questionnaires such as the EuroQol 5 Dimensions (EQ-5D) questionnaire. Our primary null hypothesis is that there is no association between the SOSG-OQ and EQ-5D. Our secondary null hypothesis is that there is no difference in coverage and internal consistency between the SOSG-OQ and EQ-5D. We also assess coverage, consistency, and validity of the domains within the SOSG-OQ. A survey study from a tertiary care spine referral center was used for this study. The patient sample consisted of 82 patients with spine metastases, myeloma, or lymphoma. The SOSG-OQ (27 questions, 6 domains) score ranges from 0 to 80, with a higher score indicating worse quality of life. The EQ-5D (5 questions, 5 domains) index score ranges from 0 to 1, with a higher score indicating better quality of life. The association between the SOSG-OQ and EQ-5D index score was assessed using the Spearman rank correlation. Instrument coverage and precision were assessed by determining item completion rate, median score with range, and floor and ceiling effect. Internal consistency was assessed using Cronbach alpha. Multitrait analysis and exploratory factor analysis were used to analyze properties of the individual domains in the SOSG-OQ. The Spearman rank correlation between the SOSG-OQ and EQ-5D questionnaire was high (r=-0.83, pquality of life in patients with metastatic spine disease. The SOSG-OQ is superior to the EQ-5D in terms of coverage and internal consistency but consists of more questions. Copyright © 2015 Elsevier Inc. All rights reserved.

  9. The feasibility, perceived satisfaction, and value of using synchronous webinars to educate clinical research professionals on reporting adverse events in clinical trials: a report from the Children's Oncology Group.

    Science.gov (United States)

    Borgerson, Dawn; Dino, Jennifer

    2012-01-01

    Clinical research professionals are faced with decreased funding and increased workloads; innovative methods of professional development programs are necessary to accommodate these factors. This study evaluated the feasibility, perceived satisfaction, and value of using webinars to educate clinical research professionals on reporting adverse events commonly experienced in pediatric oncology clinical trials. The setting incorporated synchronous web-based educational technology. Constructivist learning provides the theoretical framework for this study. Participants evaluated the professional development program at 2 time points: (a) at the conclusion and (b) 4 to 6 weeks afterward, using survey method. Synchronous webinars were both economical and effective in educating clinical research professionals across institutional sites. Participants reported exceptionally high levels of satisfaction with the accessibility, scope, quality, and interactivity of the professional development program. The vast majority of participants reported that the education would assist with reporting adverse events in pediatric oncology clinical trials and this perception persisted into clinical practice. Although the results of this study were intended to guide future educational efforts of the Children's Oncology Group, they may also apply to other cooperative groups.

  10. Long-Term Cancer Outcomes From Study NRG Oncology/RTOG 9517: A Phase 2 Study of Accelerated Partial Breast Irradiation With Multicatheter Brachytherapy After Lumpectomy for Early-Stage Breast Cancer

    International Nuclear Information System (INIS)

    White, Julia; Winter, Kathryn; Kuske, Robert R.; Bolton, John S.; Arthur, Douglas W.; Scroggins, Troy; Rabinovitch, Rachel A.; Kelly, Tracy; Toonkel, Leonard M.; Vicini, Frank A.; McCormick, Beryl

    2016-01-01

    Purpose: To examine 10-year rates of local, regional, and distant recurrences, patterns of recurrence, and survival rates for breast cancer patients enrolled on Study NRG Oncology/Radiation Therapy Oncology Group 9517, a multi-institutional prospective trial that studied one of the earliest methods of accelerated partial breast irradiation (APBI), multicatheter brachytherapy (MCT). Methods and Materials: Eligibility included stage I/II unifocal breast cancer <3 cm in size after lumpectomy with negative surgical margins and 0 to 3 positive axillary nodes without extracapsular extension. The APBI dose delivered was 34 Gy in 10 twice-daily fractions over 5 days for high-dose-rate (HDR); and 45 Gy in 3.5 to 5 days for low-dose-rate (LDR) brachytherapy. The primary endpoint was HDR and LDR MCT reproducibility. This analysis focuses on long-term ipsilateral breast recurrence (IBR), contralateral breast cancer events (CBE), regional recurrence (RR), and distant metastases (DM), disease-free, and overall survival. Results: The median follow-up was 12.1 years. One hundred patients were accrued from 1997 to 2000; 98 were evaluable; 65 underwent HDR and 33 LDR MCT. Median age was 62 years; 88% had T1 tumors; 81% were pN0. Seventy-seven percent were estrogen receptor and/or progesterone receptor positive; 33% received adjuvant chemotherapy and 64% antiendocrine therapy. There have been 4 isolated IBRs and 1 IBR with RR, for 5.2% 10-year IBR without DM. There was 1 isolated RR, 1 with IBR, and 1 with a CBE, for 3.1% 10-year RR without DM. The 10-year CBE rate was 4.2%, with 5 total events. Eleven patients have developed DM, 8 have died of breast cancer, and 22 have died from other causes. The 10-year DFS and OS rates are 69.8% and 78.0%, respectively. Conclusion: This multi-institutional, phase 2 trial studying MCT-APBI continues to report durable in-breast cancer control rates with long-term follow-up.

  11. Long-Term Cancer Outcomes From Study NRG Oncology/RTOG 9517: A Phase 2 Study of Accelerated Partial Breast Irradiation With Multicatheter Brachytherapy After Lumpectomy for Early-Stage Breast Cancer

    Energy Technology Data Exchange (ETDEWEB)

    White, Julia, E-mail: Julia.White@osumc.edu [Department of Radiation Oncology, The James, Ohio State University, Columbus, Ohio (United States); Winter, Kathryn [NRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania (United States); Kuske, Robert R. [Department of Radiation Oncology, Arizona Breast Cancer Specialists, Scottsdale, Arizona (United States); Bolton, John S. [Department of Radiation Oncology, Oschner Clinic, New Orleans, Louisiana (United States); Arthur, Douglas W. [Department of Radiation Oncology, Virginia Commonwealth University, Richmond, Virginia (United States); Scroggins, Troy [Department of Radiation Oncology, Oschner Clinic, New Orleans, Louisiana (United States); Rabinovitch, Rachel A. [Department of Radiation Oncology, University of Colorado Denver, Aurora, Colorado (United States); Kelly, Tracy [Department of Radiation Oncology, Medical College of Wisconsin, Milwaukee, Wisconsin (United States); Toonkel, Leonard M. [Mount Sinai Comprehensive Cancer Center, Miami, Florida (United States); Vicini, Frank A. [Department of Radiation Oncology, Botsford Hospital, Farmington Hills, Michigan (United States); McCormick, Beryl [Department of Radiation Oncology, Memorial Sloan-Kettering Cancer Center, New York, New York (United States)

    2016-08-01

    Purpose: To examine 10-year rates of local, regional, and distant recurrences, patterns of recurrence, and survival rates for breast cancer patients enrolled on Study NRG Oncology/Radiation Therapy Oncology Group 9517, a multi-institutional prospective trial that studied one of the earliest methods of accelerated partial breast irradiation (APBI), multicatheter brachytherapy (MCT). Methods and Materials: Eligibility included stage I/II unifocal breast cancer <3 cm in size after lumpectomy with negative surgical margins and 0 to 3 positive axillary nodes without extracapsular extension. The APBI dose delivered was 34 Gy in 10 twice-daily fractions over 5 days for high-dose-rate (HDR); and 45 Gy in 3.5 to 5 days for low-dose-rate (LDR) brachytherapy. The primary endpoint was HDR and LDR MCT reproducibility. This analysis focuses on long-term ipsilateral breast recurrence (IBR), contralateral breast cancer events (CBE), regional recurrence (RR), and distant metastases (DM), disease-free, and overall survival. Results: The median follow-up was 12.1 years. One hundred patients were accrued from 1997 to 2000; 98 were evaluable; 65 underwent HDR and 33 LDR MCT. Median age was 62 years; 88% had T1 tumors; 81% were pN0. Seventy-seven percent were estrogen receptor and/or progesterone receptor positive; 33% received adjuvant chemotherapy and 64% antiendocrine therapy. There have been 4 isolated IBRs and 1 IBR with RR, for 5.2% 10-year IBR without DM. There was 1 isolated RR, 1 with IBR, and 1 with a CBE, for 3.1% 10-year RR without DM. The 10-year CBE rate was 4.2%, with 5 total events. Eleven patients have developed DM, 8 have died of breast cancer, and 22 have died from other causes. The 10-year DFS and OS rates are 69.8% and 78.0%, respectively. Conclusion: This multi-institutional, phase 2 trial studying MCT-APBI continues to report durable in-breast cancer control rates with long-term follow-up.

  12. A role for radiotherapy in neuropathic bone pain: preliminary response rates from a prospective trial (Trans-Tasman Radiation Oncology Group, TROG 96.05)

    International Nuclear Information System (INIS)

    Roos, Daniel E.; O'Brien, Peter C.; Smith, Jennifer G.; Spry, Nigel A.; Hoskin, Peter J.; Burmeister, Bryan H.; Turner, Sandra L.; Bernshaw, David M.

    2000-01-01

    Purpose: Radiotherapy (RT) has a proven role in palliation of pain from bone metastases with numerous randomized trials obtaining response rates (RRs) of typically 70-80% regardless of the fractionation employed. However RT for neuropathic bone pain (NBP), i.e., pain with a radiating cutaneous component due to compression/irritation of nerves by tumor has not previously been studied, and its role is thus uncertain. Methods and Materials: In February 1996, the Trans-Tasman Radiation Oncology Group (TROG) initiated a multicenter randomized trial comparing a single 8 Gy fraction with 20 Gy in 5 fractions for NBP with an accrual target of 270. Formal interim analyses were planned at 90 and 180 patients. The 90th patient was accrued in June 1998, and data from the first interim analysis with both arms combined form the basis of this report. Results: Forty-four patients were randomized to a single 8 Gy, 46 to 20 Gy in 5 fractions. The commonest primary sites were prostate (34%), lung (28%) and breast (10%). Median age was 68 years (range 37-89). The index site was spine (86%), rib (13%), base of skull (1%). On an intention-to-treat basis, the overall RR was 53/90 = 59% (95% CI = 48-69%), with 27% achieving a complete response and 32% a partial response. The overall RR for eligible patients was 49/81 = 60% (95% CI = 49-71%) with 27% and 33% achieving complete and partial responses respectively. Estimated median time to treatment failure was 3.2 months (95% CI = 2.1-5.1 months), with estimated median survival of 5.1 months (95% CI = 4.2-7.2 months). To date, six spinal cord/cauda equina compressions and four new or progressive pathological fractures have been detected at the index site after randomization, although one cord compression occurred before radiotherapy was planned to commence. In February 1999, the Independent Data Monitoring Committee strongly recommended continuation of the trial. Conclusion: Although these results are preliminary, it seems clear that there

  13. Impact of target volume coverage with Radiation Therapy Oncology Group (RTOG) 98-05 guidelines for transrectal ultrasound guided permanent Iodine-125 prostate implants

    International Nuclear Information System (INIS)

    Horwitz, Eric M.; Mitra, Raj K.; Uzzo, Robert G.; Das, Indra J.; Pinover, Wayne H.; Hanlon, Alexandra L.; McNeeley, Shawn W.; Hanks, Gerald E.

    2003-01-01

    Purpose: Despite the wide use of permanent prostate implants for the treatment of early stage prostate cancer, there is no consensus for optimal pre-implant planning guidelines that results in maximal post-implant target coverage. The purpose of this study was to compare post-implant target volume coverage and dosimetry between patients treated before and after Radiation Therapy Oncology Group (RTOG) 98-05 guidelines were adopted using several dosimetric endpoints. Materials and methods: Ten consecutively treated patients before the adoption of the RTOG 98-05 planning guidelines were compared with ten consecutively treated patients after implementation of the guidelines. Pre-implant planning for patients treated pre-RTOG was based on the clinical target volume (CTV) defined by the pre-implant TRUS definition of the prostate. The CTV was expanded in each dimension according to RTOG 98-05 and defined as the planning target volume. The evaluation target volume was defined as the post-implant computed tomography definition of the prostate based on RTOG 98-05 protocol recommendations. Implant quality indicators included V 100 , V 90 , V 100 , and Coverage Index (CI). Results: The pre-RTOG median V 100 , V 90 , D 90 , and CI values were 82.8, 88.9%, 126.5 Gy, and 17.1, respectively. The median post-RTOG V 100 , V 90 , D 90 , and CI values were 96.0, 97.8%, 169.2 Gy, and 4.0, respectively. These differences were all statistically significant. Conclusions: Implementation of the RTOG 98-05 implant planning guidelines has increased coverage of the prostate by the prescription isodose lines compared with our previous technique, as indicated by post-implant dosimetry indices such as V 100 , V 90 , D 90 . The CI was also improved significantly with the protocol guidelines. Our data confirms the validity of the RTOG 98-05 implant guidelines for pre-implant planning as it relates to enlargement of the CTV to ensure adequate margin between the CTV and the prescription isodose

  14. A phase II trial of a surgical protocol to decrease the incidence of wound complications in obese gynecologic oncology patients.

    Science.gov (United States)

    Novetsky, Akiva P; Zighelboim, Israel; Guntupalli, Saketh R; Ioffe, Yevgeniya J M; Kizer, Nora T; Hagemann, Andrea R; Powell, Matthew A; Thaker, Premal H; Mutch, David G; Massad, L Stewart

    2014-08-01

    Obese women have a high incidence of wound separation after gynecologic surgery. We explored the effect of a prospective care pathway on the incidence of wound complications. Women with a body mass index (BMI) ≥30 kg/m(2) undergoing a gynecologic procedure by a gynecologic oncologist via a vertical abdominal incision were eligible. The surgical protocol required: skin and subcutaneous tissues to be incised using a scalpel or cutting electrocautery, fascial closure using #1 polydioxanone suture, placement of a 7 mm Jackson-Pratt drain below Camper's fascia, closure of Camper's fascia with 3-0 plain catgut suture and skin closure with staples. Wound complication was defined as the presence of either a wound infection or any separation. Demographic and perioperative data were analyzed using contingency tables. Univariable and multivariable regression models were used to identify predictors of wound complications. Patients were compared using a multivariable model to a historical group of obese patients to assess the efficacy of the care pathway. 105 women were enrolled with a median BMI of 38.1. Overall, 39 (37%) had a wound complication. Women with a BMI of 30-39.9 kg/m(2) had a significantly lower risk of wound complication as compared to those with a BMI >40 kg/m(2) (23% vs 59%, pcontrolling for factors associated with wound complications the prospective care pathway was associated with a significantly decreased wound complication rate in women with BMI <40 kg/m(2) (OR 0.40, 95% C.I.: 0.18-0.89). This surgical protocol leads to a decreased rate of wound complications among women with a BMI of 30-39.9 kg/m(2). Copyright © 2014 Elsevier Inc. All rights reserved.

  15. Quality of training in radiation oncology in Germany: where do we stand? : Results from a 2016/2017 survey performed by the working group "young DEGRO" of the German society of radiation oncology (DEGRO).

    Science.gov (United States)

    Dietzel, C T; Jablonska, K; Niyazi, M; Gauer, T; Ebert, N; Ostheimer, C; Krug, D

    2018-04-01

    To evaluate the current situation of young radiation oncologists in Germany with regard to the contents and quality of training and level of knowledge, as well as their working conditions and professional satisfaction. From June 2016 to February 2017, a survey was conducted by the young DEGRO (yDEGRO) using an online platform. The questionnaire consisted of 28 items examining a broad range of aspects influencing residency. There were 96 completed questionnaires RESULTS: 83% of participants stated to be very or mostly pleased with their residency training. Moderate working hours and a good colleagueship contribute to a comfortable working environment. Level of knowledge regarding the most common tumor sites (i.e. palliative indications, lung, head and neck, brain, breast, prostate) was pleasing. Radiochemotherapy embodies a cornerstone in training. Modern techniques such as intensity-modulated radiotherapy (IMRT) and stereotactic procedures are now in widespread use. Education for rare indications and center-based procedures offers room for improvement. Radiation oncology remains an attractive and versatile specialty with favorable working conditions. Continuing surveys in future years will be a valuable measuring tool to set further priorities in order to preserve and improve quality of training.

  16. Neuro-Oncology Branch

    Science.gov (United States)

    ... BTTC are experts in their respective fields. Neuro-Oncology Clinical Fellowship This is a joint program with ... can increase survival rates. Learn more... The Neuro-Oncology Branch welcomes Dr. Mark Gilbert as new Branch ...

  17. Phase diagram of the Hubbard model with arbitrary band filling: renormalization group approach

    International Nuclear Information System (INIS)

    Cannas, Sergio A.; Cordoba Univ. Nacional; Tsallis, Constantino.

    1991-01-01

    The finite temperature phase diagram of the Hubbard model in d = 2 and d = 3 is calculated for arbitrary values of the parameter U/t and chemical potential μ using a quantum real space renormalization group. Evidence for a ferromagnetic phase at low temperatures is presented. (author). 15 refs., 5 figs

  18. United States Air Force Academy Educational Outcomes Assessment Working Group. Phase 2

    National Research Council Canada - National Science Library

    Porter, David

    1997-01-01

    This publication provides an account of educational outcomes assessment activity undertaken by seven assessment teams under the Phase II Charter of the Dean of the Faculty's Educational Outcomes Assessment Working Group...

  19. Group-velocity dispersion effects on quantum noise of a fiber optical soliton in phase space

    International Nuclear Information System (INIS)

    Ju, Heongkyu; Lee, Euncheol

    2010-01-01

    Group-velocity dispersion (GVD) effects on quantum noise of ultrashort pulsed light are theoretically investigated at the soliton energy level, using Gaussian-weighted pseudo-random distribution of phasors in phase space for the modeling of quantum noise properties including phase noise, photon number noise, and quantum noise shape in phase space. We present the effects of GVD that mixes the different spectral components in time, on the self-phase modulation(SPM)-induced quantum noise properties in phase space such as quadrature squeezing, photon-number noise, and tilting/distortion of quantum noise shape in phase space, for the soliton that propagates a distance of the nonlinear length η NL = 1/( γP 0 ) (P 0 is the pulse peak power and γ is the SPM parameter). The propagation dependence of phase space quantum noise properties for an optical soliton is also provided.

  20. Ki67 Proliferation Index as a Tool for Chemotherapy Decisions During and After Neoadjuvant Aromatase Inhibitor Treatment of Breast Cancer: Results From the American College of Surgeons Oncology Group Z1031 Trial (Alliance)

    Science.gov (United States)

    Ellis, Matthew J.; Suman, Vera J.; Hoog, Jeremy; Goncalves, Rodrigo; Sanati, Souzan; Creighton, Chad J.; DeSchryver, Katherine; Crouch, Erika; Brink, Amy; Watson, Mark; Luo, Jingqin; Tao, Yu; Barnes, Michael; Dowsett, Mitchell; Budd, G. Thomas; Winer, Eric; Silverman, Paula; Esserman, Laura; Carey, Lisa; Ma, Cynthia X.; Unzeitig, Gary; Pluard, Timothy; Whitworth, Pat; Babiera, Gildy; Guenther, J. Michael; Dayao, Zoneddy; Ota, David; Leitch, Marilyn; Olson, John A.; Allred, D. Craig; Hunt, Kelly

    2017-01-01

    Purpose To determine the pathologic complete response (pCR) rate in estrogen receptor (ER) –positive primary breast cancer triaged to chemotherapy when the protein encoded by the MKI67 gene (Ki67) level was > 10% after 2 to 4 weeks of neoadjuvant aromatase inhibitor (AI) therapy. A second objective was to examine risk of relapse using the Ki67-based Preoperative Endocrine Prognostic Index (PEPI). Methods The American College of Surgeons Oncology Group (ACOSOG) Z1031A trial enrolled postmenopausal women with stage II or III ER-positive (Allred score, 6 to 8) breast cancer whose treatment was randomly assigned to neoadjuvant AI therapy with anastrozole, exemestane, or letrozole. For the trial ACOSOG Z1031B, the protocol was amended to include a tumor Ki67 determination after 2 to 4 weeks of AI. If the Ki67 was > 10%, patients were switched to neoadjuvant chemotherapy. A pCR rate of > 20% was the predefined efficacy threshold. In patients who completed neoadjuvant AI, stratified Cox modeling was used to assess whether time to recurrence differed by PEPI = 0 score (T1 or T2, N0, Ki67 2) versus PEPI > 0 disease. Results Only two of the 35 patients in ACOSOG Z1031B who were switched to neoadjuvant chemotherapy experienced a pCR (5.7%; 95% CI, 0.7% to 19.1%). After 5.5 years of median follow-up, four (3.7%) of the 109 patients with a PEPI = 0 score relapsed versus 49 (14.4%) of 341 of patients with PEPI > 0 (recurrence hazard ratio [PEPI = 0 v PEPI > 0], 0.27; P = .014; 95% CI, 0.092 to 0.764). Conclusion Chemotherapy efficacy was lower than expected in ER-positive tumors exhibiting AI-resistant proliferation. The optimal therapy for these patients should be further investigated. For patients with PEPI = 0 disease, the relapse risk over 5 years was only 3.6% without chemotherapy, supporting the study of adjuvant endocrine monotherapy in this group. These Ki67 and PEPI triage approaches are being definitively studied in the ALTERNATE trial (Alternate Approaches for

  1. Waste area Grouping 2 Phase I remedial investigation: Sediment and Cesium-137 transport modeling report

    International Nuclear Information System (INIS)

    Clapp, R.B.; Bao, Y.S.; Moore, T.D.; Brenkert, A.L.; Purucker, S.T.; Reece, D.K.; Burgoa, B.B.

    1996-06-01

    This report is one of five reports issued in 1996 that provide follow-up information to the Phase I Remedial Investigation (RI) Report for Waste Area Grouping (WAG) 2 at Oak Ridge National Laboratory (ORNL). The five reports address areas of concern that may present immediate risk to public health at the Clinch River and ecological risk within WAG 2 at ORNL. A sixth report, on groundwater, in the series documenting WAG 2 RI Phase I results were part of project activities conducted in FY 1996. The five reports that complete activities conducted as part of Phase I of the Remedial Investigation (RI) for WAG 2 are as follows: (1) Waste Area Grouping 2, Phase I Task Data Report: Seep Data Assessment, (2) Waste Area Grouping 2, Phase I Task Data Report: Tributaries Data Assessment, (3) Waste Area Grouping 2, Phase I Task Data Report: Ecological Risk Assessment, (4) Waste Area Grouping 2, Phase I Task Data Report: Human Health Risk Assessment, (5) Waste Area Grouping 2, Phase I Task Data Report: Sediment and 137 Cs Transport Modeling In December 1990, the Remedial Investigation Plan for Waste Area Grouping 2 at Oak Ridge National Laboratory was issued (ORNL 1990). The WAG 2 RI Plan was structured with a short-term component to be conducted while upgradient WAGs are investigated and remediated, and a long-term component that will complete the RI process for WAG 2 following remediation of upgradient WAGs. RI activities for the short-term component were initiated with the approval of the Environmental Protection Agency, Region IV (EPA), and the Tennessee Department of Environment and Conservation (TDEC). This report presents the results of an investigation of the risk associated with possible future releases of 137 Cs due to an extreme flood. The results are based on field measurements made during storms and computer model simulations

  2. Late xerostomia after intensity-modulated conformational radiotherapy of upper aero-digestive tract cancers: study 2004-03 by the head and neck oncology and radiotherapy Group (Gortec)

    International Nuclear Information System (INIS)

    Toledano, I.; Lapeyre, M.; Graff, P.; Serre, C.; Bensadoun, R.J.; Bensadoun, R.J.; Ortholan, C.; Calais, G.; Alfonsi, M.; Giraud, P.; Racadot, S.

    2010-01-01

    The authors report a retrospective assessment of late xerostomia according to the RTOG (Radiation Therapy Oncology Group) classification of the European Organization for Research and Treatment of Cancer (EORTC) among patients treated by intensity-modulated conformational radiotherapy (IMRT) and suffering from upper aero-digestive tract carcinomas of different stages. Some of these patients have bee operated, and some have been treated by chemotherapy. It appears that the IMRT results in a reduction of late xerostomia, and even in an absence of salivary toxicity. Short communication

  3. Quantum field theory and phase transitions: universality and renormalization group; Theorie quantique des champs et transitions de phase: universalite et groupe de renormalisation

    Energy Technology Data Exchange (ETDEWEB)

    Zinn-Justin, J

    2003-08-01

    In the quantum field theory the problem of infinite values has been solved empirically through a method called renormalization, this method is satisfying only in the framework of renormalization group. It is in the domain of statistical physics and continuous phase transitions that these issues are the easiest to discuss. Within the framework of a course in theoretical physics the author introduces the notions of continuous limits and universality in stochastic systems operating with a high number of freedom degrees. It is shown that quasi-Gaussian and mean field approximation are unable to describe phase transitions in a satisfying manner. A new concept is required: it is the notion of renormalization group whose fixed points allow us to understand universality beyond mean field. The renormalization group implies the idea that long distance correlations near the transition temperature might be described by a statistical field theory that is a quantum field in imaginary time. Various forms of renormalization group equations are presented and solved in particular boundary limits, namely for fields with high numbers of components near the dimensions 4 and 2. The particular case of exact renormalization group is also introduced. (A.C.)

  4. The Danish Neuro-Oncology Registry

    DEFF Research Database (Denmark)

    Hansen, Steinbjørn

    2016-01-01

    AIM OF DATABASE: The Danish Neuro-Oncology Registry (DNOR) was established by the Danish Neuro-Oncology Group as a national clinical database. It was established for the purpose of supporting research and development in adult patients with primary brain tumors in Denmark. STUDY POPULATION: DNOR has...... advantage of reporting indicators is the related multidisciplinary discussions giving a better understanding of what actually is going on, thereby facilitating the work on adjusting the national guidelines in the Danish Neuro-Oncology Group. CONCLUSION: The establishment of DNOR has optimized the quality...

  5. Competing failure analysis in phased-mission systems with multiple functional dependence groups

    International Nuclear Information System (INIS)

    Wang, Chaonan; Xing, Liudong; Peng, Rui; Pan, Zhusheng

    2017-01-01

    A phased-mission system (PMS) involves multiple, consecutive, non-overlapping phases of operation. The system structure function and component failure behavior in a PMS can change from phase to phase, posing big challenges to the system reliability analysis. Further complicating the problem is the functional dependence (FDEP) behavior where the failure of certain component(s) causes other component(s) to become unusable or inaccessible or isolated. Previous studies have shown that FDEP can cause competitions between failure propagation and failure isolation in the time domain. While such competing failure effects have been well addressed in single-phase systems, only little work has focused on PMSs with a restrictive assumption that a single FDEP group exists in one phase of the mission. Many practical systems (e.g., computer systems and networks), however may involve multiple FDEP groups during the mission. Moreover, different FDEP groups can be dependent due to sharing some common components; they may appear in a single phase or multiple phases. This paper makes new contributions by modeling and analyzing reliability of PMSs subject to multiple FDEP groups through a Markov chain-based methodology. Propagated failures with both global and selective effects are considered. Four case studies are presented to demonstrate application of the proposed method. - Highlights: • Reliability of phased-mission systems subject to competing failure propagation and isolation effects is modeled. • Multiple independent or dependent functional dependence groups are considered. • Propagated failures with global effects and selective effects are studied. • Four case studies demonstrate generality and application of the proposed Markov-based method.

  6. Nanotechnology in Radiation Oncology

    Science.gov (United States)

    Wang, Andrew Z.; Tepper, Joel E.

    2014-01-01

    Nanotechnology, the manipulation of matter on atomic and molecular scales, is a relatively new branch of science. It has already made a significant impact on clinical medicine, especially in oncology. Nanomaterial has several characteristics that are ideal for oncology applications, including preferential accumulation in tumors, low distribution in normal tissues, biodistribution, pharmacokinetics, and clearance, that differ from those of small molecules. Because these properties are also well suited for applications in radiation oncology, nanomaterials have been used in many different areas of radiation oncology for imaging and treatment planning, as well as for radiosensitization to improve the therapeutic ratio. In this article, we review the unique properties of nanomaterials that are favorable for oncology applications and examine the various applications of nanotechnology in radiation oncology. We also discuss the future directions of nanotechnology within the context of radiation oncology. PMID:25113769

  7. The 'Timing of Androgen-Deprivation therapy in incurable prostate cancer' protocol (TOAD)--where are we now? Synopsis of the Victorian Cooperative Oncology Group PR 01-03 and Trans-Tasman Radiation Oncology Group 03.06 clinical trial.

    Science.gov (United States)

    Duchesne, Gillian M; Woo, Henry H

    2014-11-01

    To outline the development of the 'Timing of Androgen Deprivation' (TOAD) protocol, a collaborative randomised clinical trial under the auspices of the Cancer Council Victoria, the Trans-Tasman Radiation Oncology Group, and the Urological Society of Australia and New Zealand (USANZ), which opened to recruitment in 2004. The principal hypothesis for the trial was that the early introduction of androgen-deprivation therapy (ADT; experimental arm) at the time when curative therapies are no longer considered an option, would improve overall survival for these patients, whilst maintaining an acceptable quality of life; compared with waiting for disease progression or the development of symptoms (control arm). An increase in overall survival at 5 years of 10% was judged to be clinically worthwhile. Recruitment was slow, with fewer than half of the protocol requirement of 750 patients eventually accrued, but nonetheless it is considered that the trial will still contribute a major source of evidence in this area. The study closed to follow-up at the end of 2013, with data analysis commencing mid-2014, and with the primary publication anticipated to be submitted by the end of 2014. The question of timing of ADT remains relevant in the current era of newer and more varied treatment methods. Even with the advent of novel chemotherapy and the biological agents that are undergoing investigation for progressively earlier disease stages, the dilemma of when to commence palliative treatment in an asymptomatic patient will remain, unless or until these agents are shown to increase overall survival. The TOAD trial will contribute to answering at least in part, some of these questions. © 2014 The Authors. BJU International © 2014 BJU International.

  8. 40 CFR 76.8 - Early election for Group 1, Phase II boilers.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 16 2010-07-01 2010-07-01 false Early election for Group 1, Phase II boilers. 76.8 Section 76.8 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) ACID RAIN NITROGEN OXIDES EMISSION REDUCTION PROGRAM § 76.8 Early election for Group 1...

  9. Radiation oncology systems integration

    International Nuclear Information System (INIS)

    Ragan, D.P.

    1991-01-01

    ROLE7 is intended as a complementary addition to the HL7 Standard and not as an alternative standard. Attempt should be made to mould data elements which are specific to radiation therapy with existing HL7 elements. This can be accomplished by introducing additional values to some element's table-of-options. Those elements which might be specific to radiation therapy could from new segments to be added to the Ancillary Data Reporting set. In order to accomplish ROLE7, consensus groups need be formed to identify the various functions related to radiation oncology that might motivate information exchange. For each of these functions, the specific data elements and their format must be identified. HL7 is organized with a number of applications which communicate asynchronously. Implementation of ROLE7 would allow uniform access to information across vendors and functions. It would provide improved flexibility in system selection. It would allow a more flexible and affordable upgrade path as systems in radiation oncology improve. (author). 5 refs

  10. Two-group interfacial area concentration correlations of two-phase flows in large diameter pipes

    International Nuclear Information System (INIS)

    Shen, Xiuzhong; Hibiki, Takashi

    2015-01-01

    The reliable empirical correlations and models are one of the important ways to predict the interfacial area concentration (IAC) in two-phase flows. However, up to now, no correlation or model is available for the prediction of the IAC in the two-phase flows in large diameter pipes. This study collected an IAC experimental database of two-phase flows taken under various flow conditions in large diameter pipes and presented a systematic way to predict the IAC for two-phase flows from bubbly, cap-bubbly to churn flow in large diameter pipes by categorizing bubbles into two groups (group-1: spherical and distorted bubble, group-2: cap bubble). Correlations were developed to predict the group-1 void fraction from the void fraction of all bubble. The IAC contribution from group-1 bubbles was modeled by using the dominant parameters of group-1 bubble void fraction and Reynolds number based on the parameter-dependent analysis of Hibiki and Ishii (2001, 2002) using one-dimensional bubble number density and interfacial area transport equations. A new drift velocity correlation for two-phase flow with large cap bubbles in large diameter pipes was derived in this study. By comparing the newly-derived drift velocity correlation with the existing drift velocity correlation of Kataoka and Ishii (1987) for large diameter pipes and using the characteristics of the representative bubbles among the group 2 bubbles, we developed the model of IAC and bubble size for group 2 cap bubbles. The developed models for estimating the IAC are compared with the entire collected database. A reasonable agreement was obtained with average relative errors of ±28.1%, ±54.4% and ±29.6% for group 1, group 2 and all bubbles respectively. (author)

  11. Propagation of the Semidiurnal Internal Tide: Phase Velocity Versus Group Velocity

    Science.gov (United States)

    Zhao, Zhongxiang

    2017-12-01

    The superposition of two waves of slightly different wavelengths has long been used to illustrate the distinction between phase velocity and group velocity. The first-mode M2 and S2 internal tides exemplify such a two-wave model in the natural ocean. The M2 and S2 tidal frequencies are 1.932 and 2 cycles per day, respectively, and their superposition forms a spring-neap cycle in the semidiurnal band. The spring-neap cycle acts like a wave, with its frequency, wave number, and phase being the differences of the M2 and S2 internal tides. The spring-neap cycle and energy of the semidiurnal internal tide propagate at the group velocity. Long-range propagation of M2 and S2 internal tides in the North Pacific is observed by satellite altimetry. Along a 3,400 km beam spanning 24°-54°N, the M2 and S2 travel times are 10.9 and 11.2 days, respectively. For comparison, it takes the spring-neap cycle 21.1 days to travel over this distance. Spatial maps of the M2 phase velocity, the S2 phase velocity, and the group velocity are determined from phase gradients of the corresponding satellite observed internal tide fields. The observed phase and group velocities agree with theoretical values estimated using the World Ocean Atlas 2013 annual-mean ocean stratification.

  12. Parental perspectives on a behavioral health music intervention for adolescent/young adult resilience during cancer treatment: report from the children's oncology group.

    Science.gov (United States)

    Docherty, Sharron L; Robb, Sheri L; Phillips-Salimi, Celeste; Cherven, Brooke; Stegenga, Kristin; Hendricks-Ferguson, Verna; Roll, Lona; Donovan Stickler, Molly; Haase, Joan

    2013-02-01

    This article describes parental perspectives on the helpfulness and meaningfulness of a behavioral health music therapy intervention targeted to adolescents/young adults (AYA) with cancer undergoing stem cell transplantation. We demonstrate how qualitative methods may be used to understand critical aspects of an intervention and mechanisms by which the intervention impacts the target AYA outcomes of resilience and quality of life. A qualitative descriptive design was used to obtain parents' perspectives. A maximum-variation purposive sampling technique was used to sample 16 parents whose AYA had been randomized to the intervention group. A semistructured open-ended interview was conducted between 100 and 160 days after the AYA's transplant. Results were grouped into three categories: (1) helpfulness and meaningfulness of the intervention to AYA adjustment to the transplantation experience; (2) helpfulness and meaningfulness of the intervention for parents; and (3) AYA ability to participate in the intervention during the acute phase of transplant. Parents observed and interacted with their AYA who participated in a targeted behavioral intervention. Thus, parents were able to describe mechanisms through which the intervention was helpful and meaningful for the AYA and indirect personal benefits for themselves. The results suggest the importance of the targeted outcomes identified in the Resilience in Illness Model and mechanisms of action in the Contextual Support Model of Music Therapy, and identify approaches for future study. Copyright © 2013 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

  13. Parental Perspectives on a Behavioral Health Music Intervention for Adolescent/Young Adult Resilience during Cancer Treatment: Report from the Children’s Oncology Group

    Science.gov (United States)

    Docherty, Sharron L.; Robb, Sheri L.; Phillips-Salimi, Celeste; Cherven, Brooke; Stegenga, Kristin; Hendricks-Ferguson, Verna; Roll, Lona; Stickler, Molly Donovan; Haase, Joan

    2012-01-01

    Purpose This paper describes parental perspectives on the helpfulness and meaningfulness of a behavioral health music therapy intervention targeted to adolescents/young adults (AYA) with cancer undergoing stem cell transplantation. We demonstrate how qualitative methods may be used to understand critical aspects of an intervention and mechanisms by which the intervention impacts the target AYA outcomes resilience and quality of life. Methods A qualitative descriptive design was used to obtain parents’ perspectives. Maximum variation purposive sampling was used to sample 16 parents whose AYA had been randomized to the intervention group. A semi-structured, open-ended interview was conducted between 100 and 160 days following their AYA’s transplant. Results Results are grouped into three categories: (1) helpfulness and meaningfulness of the intervention to AYA adjustment to the transplantation experience; (2) helpfulness and meaningfulness of the intervention for parents; and (3) AYA ability to participate in the intervention during acute phase of transplantation. Conclusions Parents observed and interacted with their AYA who participated in a targeted, behavioral intervention. Thus parents were able to describe mechanisms through which the intervention was helpful and meaningful for the AYA and indirect personal benefits for themselves. The results suggest the importance of the targeted outcomes identified in the Resilience in Illness Model and mechanisms of action in the Contextual Support Model of Music Therapy and identifies approaches for future study. PMID:23332481

  14. How to Evaluate Phase Differences between Trial Groups in Ongoing Electrophysiological Signals

    Science.gov (United States)

    VanRullen, Rufin

    2016-01-01

    A growing number of studies endeavor to reveal periodicities in sensory and cognitive functions, by comparing the distribution of ongoing (pre-stimulus) oscillatory phases between two (or more) trial groups reflecting distinct experimental outcomes. A systematic relation between the phase of spontaneous electrophysiological signals, before a stimulus is even presented, and the eventual result of sensory or cognitive processing for that stimulus, would be indicative of an intrinsic periodicity in the underlying neural process. Prior studies of phase-dependent perception have used a variety of analytical methods to measure and evaluate phase differences, and there is currently no established standard practice in this field. The present report intends to remediate this need, by systematically comparing the statistical power of various measures of “phase opposition” between two trial groups, in a number of real and simulated experimental situations. Seven measures were evaluated: one parametric test (circular Watson-Williams test), and three distinct measures of phase opposition (phase bifurcation index, phase opposition sum, and phase opposition product) combined with two procedures for non-parametric statistical testing (permutation, or a combination of z-score and permutation). While these are obviously not the only existing or conceivable measures, they have all been used in recent studies. All tested methods performed adequately on a previously published dataset (Busch et al., 2009). On a variety of artificially constructed datasets, no single measure was found to surpass all others, but instead the suitability of each measure was contingent on several experimental factors: the time, frequency, and depth of oscillatory phase modulation; the absolute and relative amplitudes of post-stimulus event-related potentials for the two trial groups; the absolute and relative trial numbers for the two groups; and the number of permutations used for non-parametric testing

  15. A Phase Transformation with no Change in Space Group Symmetry: Octafluoronaphtalene

    DEFF Research Database (Denmark)

    Pawley, G. S.; Dietrich, O. W.

    1975-01-01

    A solid-state phase transformation in octafluoronaphthalene has been discovered at 266.5K on cooling, and at 15K higher on heating. The symmetry of both phases is found to be the same, namely monoclinic with space group P21/c. The unit cell parameters change by up to 10%, but the integrity...... of a single crystal, which shatters on cooling, is good enough for a single-crystal structure determination. This has been done in both phases to a sufficient accuracy that a mechanism for the transformation can be proposed. Molecules which lie parallel to one another shear to a new parallel position...

  16. Group Lifting Structures For Multirate Filter Banks, II: Linear Phase Filter Banks

    Energy Technology Data Exchange (ETDEWEB)

    Brislawn, Christopher M [Los Alamos National Laboratory

    2008-01-01

    The theory of group lifting structures is applied to linear phase lifting factorizations for the two nontrivial classes of two-channel linear phase perfect reconstruction filter banks, the whole-and half-sample symmetric classes. Group lifting structures defined for the reversible and irreversible classes of whole-and half-sample symmetric filter banks are shown to satisfy the hypotheses of the uniqueness theorem for group lifting structures. It follows that linear phase lifting factorizations of whole-and half-sample symmetric filter banks are therefore independent of the factorization methods used to compute them. These results cover the specification of user-defined whole-sample symmetric filter banks in Part 2 of the ISO JPEG 2000 standard.

  17. The quantum-field renormalization group in the problem of a growing phase boundary

    International Nuclear Information System (INIS)

    Antonov, N.V.; Vasil'ev, A.N.

    1995-01-01

    Within the quantum-field renormalization-group approach we examine the stochastic equation discussed by S.I. Pavlik in describing a randomly growing phase boundary. We show that, in contrast to Pavlik's assertion, the model is not multiplicatively renormalizable and that its consistent renormalization-group analysis requires introducing an infinite number of counterterms and the respective coupling constants (open-quotes chargeclose quotes). An explicit calculation in the one-loop approximation shows that a two-dimensional surface of renormalization-group points exits in the infinite-dimensional charge space. If the surface contains an infrared stability region, the problem allows for scaling with the nonuniversal critical dimensionalities of the height of the phase boundary and time, δ h and δ t , which satisfy the exact relationship 2 δ h = δ t + d, where d is the dimensionality of the phase boundary. 23 refs., 1 tab

  18. Psycho-oncology in Australia: a descriptive review.

    Science.gov (United States)

    Butow, P; Dhillon, H; Shaw, J; Price, M

    2017-01-01

    Australia has a thriving Psycho-Oncology research and clinical community. In this article, the Australian health system in which Psycho-Oncology is embedded is described. Clinical Psycho-Oncology services are outlined, in terms of their composition, processes and reach. The development of the internationally ground-breaking Australian Psychosocial guidelines for the care of adults with cancer is described. Two large Psycho-Oncology organisations which are strongly linked to mainstream Oncology organisations are discussed: the Australian Psycho-Oncology Society (OzPos, a primarily clinician-led and focused organisation) and the Psycho-Oncology Co-operative Research Group (PoCoG, a national cancer clinical trial group). OzPos is a special interest group within the Clinical Oncology Society of Australia, while PoCoG is one of 14 cancer clinical trial groups funded by the national government. It is these strong connections with major multidisciplinary cancer organisations, and a culture of collaboration and co-operation, that have made Psycho-Oncology grow and thrive in Australia. Examples of large collaborative programs of Psycho-Oncology research are provided, as well as the mechanisms used to achieve these outcomes.

  19. Career opportunities in oncology.

    Science.gov (United States)

    Farrow, L

    Oncology nursing offers nurses a wide range of opportunities. Nurses need a wide range of skills in order to care for patients who may have acute oncological illnesses or require palliative care. The nature of the nurse/patient relationship can be intense. Nurses generally find this enhances job satisfaction. The pressures exerted on nurses working in oncology can be immense. Oncology nursing is rewarding but very demanding and therefore the nurse has to be resourceful. Early career planning is advisable to take advantage of the opportunities that are currently available.

  20. Acute oncological emergencies.

    LENUS (Irish Health Repository)

    Gabriel, J

    2012-01-01

    The number of people receiving systemic anti-cancer treatment and presenting at emergency departments with treatment-related problems is rising. Nurses will be the first point of contact for most patients and need to be able to recognise oncological emergencies to initiate urgent assessment of patients and referral to the acute oncology team so that the most appropriate care can be delivered promptly. This article discusses the role of acute oncology services, and provides an overview of the most common acute oncological emergencies.

  1. Consensus statement on definition, diagnosis, and management of high-risk prostate cancer patients on behalf of the Spanish Groups of Uro-Oncology Societies URONCOR, GUO, and SOGUG.

    Science.gov (United States)

    Henríquez, I; Rodríguez-Antolín, A; Cassinello, J; Gonzalez San Segundo, C; Unda, M; Gallardo, E; López-Torrecilla, J; Juarez, A; Arranz, J

    2018-03-01

    Prostate cancer (PCa) is the most prevalent malignancy in men and the second cause of mortality in industrialized countries. Based on Spanish Register of PCa, the incidence of high-risk PCa is 29%, approximately. In spite of the evidence-based beneficial effect of radiotherapy and androgen deprivation therapy in high-risk PCa, these patients (pts) are still a therapeutic challenge for all specialists involved, in part due to the absence of comparative studies to establish which of the present disposable treatments offer better results. Nowadays, high-risk PCa definition is not well consensual through the published oncology guides. Clinical stage, tumour grade, and number of risk factors are relevant to be considered on PCa prognosis. However, these factors are susceptible to change depending on when surgical or radiation therapy is considered to be the treatment of choice. Other factors, such as reference pathologist, different diagnosis biopsy schedules, surgical or radiotherapy techniques, adjuvant treatments, biochemical failures, and follow-up, make it difficult to compare the results between different therapeutic options. This article reviews important issues concerning high-risk PCa. URONCOR, GUO, and SOGUG on behalf of the Spanish Groups of Uro-Oncology Societies have reached a consensus addressing a practical recommendation on definition, diagnosis, and management of high-risk PCa.

  2. Communication competencies of oncology nurses in Malaysia.

    Science.gov (United States)

    Maskor, Nor Aida; Krauss, Steven Eric; Muhamad, Mazanah; Nik Mahmood, Nik Hasnaa

    2013-01-01

    This paper reports on part of a large study to identify competencies of oncology nurses in Malaysia. It focuses on oncology nurses' communications-related competency. As an important cancer care team member, oncology nurses need to communicate effectively with cancer patients. Literature shows that poor communication can make patients feel anxious, uncertain and generally not satisfied with their nurses' care. This paper deliberates on the importance of effective communication by oncology nurses in the context of a public hospital. Four focus group discussions were used in this study with 17 oncology/cancer care nurses from Malaysian public hospitals. The main inclusion criterion was that the nurses had to have undergone a post-basic course in oncology, or have work experience as a cancer care nurse. The findings indicated that nurses do communicate with their patients, patients' families and doctors to provide information about the disease, cancer treatment, disease recurrence and side effects. Nurses should have good communication skills in order to build relationships as well as to provide quality services to their patients. The paper concludes by recommending how oncology nursing competencies can be improved.

  3. The effect of solar and lunar currents on simultaneous phase path, group path and amplitude measurements

    International Nuclear Information System (INIS)

    Baulch, R.N.E.; Butcher, E.C.

    1984-01-01

    The solar and lunar variations in the phase path, group path and amplitude of a fixed frequency transmission were obtained at the September equinox over a slightly oblique path. The phase of the lunar semi-diurnal tide in the phase path and amplitude were similar, the maxima occurring near 0200 lunar time, whereas the group path had a maximum near 0800 lunar time. These results were compared with other results obtained near the same location. The results suggest a complex situation in the E-region, where the height of the lunar current depends on season, and also suggest that the location and distribution of the solar and lunar currents may be different. (author)

  4. 40 CFR 76.7 - Revised NOX emission limitations for Group 1, Phase II boilers.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 16 2010-07-01 2010-07-01 false Revised NOX emission limitations for Group 1, Phase II boilers. 76.7 Section 76.7 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) ACID RAIN NITROGEN OXIDES EMISSION REDUCTION PROGRAM § 76.7 Revised NOX...

  5. Oncologists’ Perspectives on Consolidation Radiation Treatment after Chemotherapy for Lymphomas: A Survey Study by the Lymphoma Working Committee of the Turkish Oncology Group (TOG)

    Science.gov (United States)

    Tanriverdi, Ozgur; Barista, Ibrahim; Paydas, Semra; Nayir, Erdinc; Karakas, Yusuf

    2017-11-26

    In this study, we aimed to determine the perspectives of medical and radiation oncologists regarding consolidation radiotherapy in patients with a complete response after chemotherapy for Hodgkin’s and non-Hodgkin’s lymphomas. The survey was designed to identify demographic and occupational features of medical and radiation oncologists and their views on application of consolidation radiotherapy in their clinical practices, as based on a five-point Likert scale (never, rarely, sometimes, often, and always). The study covered 263, out of 935, physicians working in the oncology field as either medical or radiation oncologists; the rate of return on the invitations to participate was 28%. The majority of the participants were male radiation oncologists, with a duration of between 5 and 10 years of work as a university hospital official, and the mean age was 38 ± 14 (years). Although the most commonly followed international guidelines were NCCN, among the physicians, the majority of the respondents suggested that the guidelines were unclear regarding recommendations for consolidative radiotherapy. The administered dose for consolidative radiotherapy in lymphoma patients was indicated as 40 Gy by 49% of all the physicians and the most common cause of hesitancy concerning consolidative radiation treatment was the risk of secondary malignancies as a long-term adverse effect (54%). In conclusion, we suggest that medical oncologists could be most active in the treatment of lymphoma through a continuous training program about lymphomas and current national guidelines. Creative Commons Attribution License

  6. Initial phase of the development of sunspot groups and their forecast

    International Nuclear Information System (INIS)

    Berlyand, B.O.; Burov, V.A.; Stepanyan, N.N.

    1979-01-01

    Some characteristics of the initial phase of sunspot groups and their forecast have been considered. Experimental data on 340 sunspot groups were obtained in 1967-1969. It was found that oscillations of the magnetic flux in the groups indicate the possibility of the existence of typical periods (2 and 4 days) of the magnetic field development. Most of the groups appears in young plages. The probability of the protons injection from the young groups is very small. The typical time of the development of the proton centre is 10-30 days. The characteristics of the group on the first day of its existence are vaguely connected with the lifetime of the group. On the second and third days the magnetic characteristics (the summary magnetic flux and the number of the unipolar regions) have the highest correlation coefficient (approximately 70%) with the lifetime of the group. The problem of the group lifetime forecast was being solved with the pattern recognition technique. On the base of the second day observation of the existence of the group verification of the received forecast 14% exceeds the verification of the climatological forecast. The forecast of the Zurich class with the same technique is effective beginning with the fifth day of the group existence and the forecast of the flare activity of the group since the day of its appearance. The exceeding of the verification as compared with the climatological forecasts in these problems is 10% and 8% accordingly

  7. Identical phase oscillators with global sinusoidal coupling evolve by Mobius group action.

    Science.gov (United States)

    Marvel, Seth A; Mirollo, Renato E; Strogatz, Steven H

    2009-12-01

    Systems of N identical phase oscillators with global sinusoidal coupling are known to display low-dimensional dynamics. Although this phenomenon was first observed about 20 years ago, its underlying cause has remained a puzzle. Here we expose the structure working behind the scenes of these systems by proving that the governing equations are generated by the action of the Mobius group, a three-parameter subgroup of fractional linear transformations that map the unit disk to itself. When there are no auxiliary state variables, the group action partitions the N-dimensional state space into three-dimensional invariant manifolds (the group orbits). The N-3 constants of motion associated with this foliation are the N-3 functionally independent cross ratios of the oscillator phases. No further reduction is possible, in general; numerical experiments on models of Josephson junction arrays suggest that the invariant manifolds often contain three-dimensional regions of neutrally stable chaos.

  8. Basic radiation oncology

    International Nuclear Information System (INIS)

    Beyzadeoglu, M. M.; Ebruli, C.

    2008-01-01

    Basic Radiation Oncology is an all-in-one book. It is an up-to-date bedside oriented book integrating the radiation physics, radiobiology and clinical radiation oncology. It includes the essentials of all aspects of radiation oncology with more than 300 practical illustrations, black and white and color figures. The layout and presentation is very practical and enriched with many pearl boxes. Key studies particularly randomized ones are also included at the end of each clinical chapter. Basic knowledge of all high-tech radiation teletherapy units such as tomotherapy, cyberknife, and proton therapy are also given. The first 2 sections review concepts that are crucial in radiation physics and radiobiology. The remaining 11 chapters describe treatment regimens for main cancer sites and tumor types. Basic Radiation Oncology will greatly help meeting the needs for a practical and bedside oriented oncology book for residents, fellows, and clinicians of Radiation, Medical and Surgical Oncology as well as medical students, physicians and medical physicists interested in Clinical Oncology. English Edition of the book Temel Radyasyon Onkolojisi is being published by Springer Heidelberg this year with updated 2009 AJCC Staging as Basic Radiation Oncology

  9. Measuring Group Synchrony: A Cluster-Phase Method for Analyzing Multivariate Movement Time-Series

    Directory of Open Access Journals (Sweden)

    Michael eRichardson

    2012-10-01

    Full Text Available A new method for assessing group synchrony is introduced as being potentially useful for objectively determining degree of group cohesiveness or entitativity. The cluster-phase method of Frank and Richardson (2010 was used to analyze movement data from the rocking chair movements of six-member groups who rocked their chairs while seated in a circle facing the center. In some trials group members had no information about others’ movements (their eyes were shut or they had their eyes open and gazed at a marker in the center of the group. As predicted, the group level synchrony measure was able to distinguish between situations where synchrony would have been possible and situations where it would be impossible. Moreover, other aspects of the analysis illustrated how the cluster phase measures can be used to determine the type of patterning of group synchrony, and, when integrated with multi-level modeling, can be used to examine individual-level differences in synchrony and dyadic level synchrony as well.

  10. Digital photography as source documentation of skin toxicity: an analysis from the Trans Tasman Radiation Oncology Group (TROG) 04.01 post-mastectomy radiation skin care trial.

    Science.gov (United States)

    Graham, Peter H; Plant, Natalie A; Graham, Jennifer Louise; Browne, Lois H; Borg, Martin; Capp, Anne; Delaney, Geoff P; Harvey, Jennifer; Kenny, Lizbeth; Francis, Michael; Zissiadis, Yvonne

    2012-08-01

    This study evaluated digital photographs as a method of providing auditable source documentation for radiotherapy-induced skin toxicity and the possibility therefore of centralised, blinded scoring for a multicentre randomised controlled trial. Digital photograph sets from the first five patients from each of 12 participating centres were audited. Minimum camera specifications and photograph requirements were protocol specified. Three readers rated photographs for four key quality items. They also scored skin reactions according to National Cancer Institute Common Terminology Criteria (CTC) v3.0 acute skin score and also for the presence of any moist desquamation. Five hundred fifty-two images were available. Field of view was scored as inadequate in 1-10%, focus inadequate in 0.4-4%, lighting inadequate in 0.2-3% and dividing line marking inadequate for scoring of skin reactions within sectors in 18-23% of photographs by three readers. Reader pairwise inter-observer agreement was 83-88% for CTC acute skin scores, but the kappa value ranged from 0.58 to 0.73. The percentage of image sectors not scored by readers due to difficulty in assessing was 1-10%. Moist desquamation was scored by clinicians in 8 (medial)-13% (lateral) of patients compared with 3-5% and 5-11% by readers. Photo reader inter-observer agreement is only moderate. Photo readers tended to underscore the frequency of moist desquamation, but the trend by sector parallels the clinical scorers. Photographs are useful source documents for auditing and monitoring, but not a replacement for clinical scoring. © 2012 The Authors. Journal of Medical Imaging and Radiation Oncology © 2012 The Royal Australian and New Zealand College of Radiologists.

  11. Cancer Patients and Oncology Nursing: Perspectives of Oncology ...

    African Journals Online (AJOL)

    Background and Aim: Burnout and exhaustion is a frequent problem in oncology nursing. The aim of this study is to evaluate the aspects of oncology nurses about their profession in order to enhance the standards of oncology nursing. Materials and Methods: This survey was conducted with 70 oncology nurses working at ...

  12. Oncology Advanced Practitioners Bring Advanced Community Oncology Care.

    Science.gov (United States)

    Vogel, Wendy H

    2016-01-01

    Oncology care is becoming increasingly complex. The interprofessional team concept of care is necessary to meet projected oncology professional shortages, as well as to provide superior oncology care. The oncology advanced practitioner (AP) is a licensed health care professional who has completed advanced training in nursing or pharmacy or has completed training as a physician assistant. Oncology APs increase practice productivity and efficiency. Proven to be cost effective, APs may perform varied roles in an oncology practice. Integrating an AP into an oncology practice requires forethought given to the type of collaborative model desired, role expectations, scheduling, training, and mentoring.

  13. Interobserver variability in target volume delineation of hepatocellular carcinoma. An analysis of the working group ''Stereotactic Radiotherapy'' of the German Society for Radiation Oncology (DEGRO)

    Energy Technology Data Exchange (ETDEWEB)

    Gkika, E.; Kirste, S. [Medical Center - University of Freiburg, Department of Radiation Oncology, Freiburg im Breisgau (Germany); Tanadini-Lang, S.; Andratschke, N.; Guckenberger, M. [University Hospital Zuerich, Department of Radiation Oncology, Zurich (Switzerland); Holzner, P.A.; Neeff, H.P. [Medical Center - University of Freiburg, Department of Visceral Surgery, Freiburg (Germany); Rischke, H.C. [Medical Center - University of Freiburg, Department of Radiation Oncology, Freiburg im Breisgau (Germany); Medical Center - University of Freiburg, Department of Nuclear Medicine, Freiburg (Germany); Reese, T. [University Hospital Halle-Wittenberg, Department of Radiation Oncology, Halle-Wittenberg (Germany); Lohaus, F. [Technische Universitaet Dresden, Department of Radiation Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Dresden (Germany); German Cancer Research Center (DKFZ), Heidelberg (Germany); Technische Universitaet Dresden, OncoRay - National Center for Radiation Research in Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Dresden (Germany); National Center for Tumor Diseases (NCT), Dresden (Germany); German Cancer Consortium (DKTK), Dresden (Germany); Duma, M.N. [Helmholtz Zentrum Munich, Institute of Innovative Radiotherapy, Department of Radiation Sciences, Munich (Germany); TU Munich, Department of Radiation Oncology, Klinikum Rechts der Isar, Munich (Germany); Dieckmann, K. [Medical University Vienna, Department of Radiation Oncology, General Hospital Vienna, Vienna (Austria); Semrau, R. [University Hospital of Cologne, Department of Radiation Oncology, Cologne (Germany); Stockinger, M. [University Hospital Mainz, Department of Radiation Oncology, Mainz (Germany); Imhoff, D. [University Hospital Frankfurt, Department of Radiation Oncology, Frankfurt (Germany); Saphir Radiosurgery Center, Frankfurt (Germany); Kremers, N. [Medical Center - University of Freiburg, Department of Radiology, Freiburg (Germany); Haefner, M.F. [University Hospital Heidelberg, Department of Radiation Oncology, Heidelberg (Germany); Nestle, U.; Grosu, A.L.; Brunner, T.B. [Medical Center - University of Freiburg, Department of Radiation Oncology, Freiburg im Breisgau (Germany); University of Freiburg, Faculty of Medicine, Freiburg (Germany); German Cancer Consortium (DKTK), Freiburg (Germany); German Cancer Research Center (DKFZ), Heidelberg (Germany)

    2017-10-15

    Definition of gross tumor volume (GTV) in hepatocellular carcinoma (HCC) requires dedicated imaging in multiple contrast medium phases. The aim of this study was to evaluate the interobserver agreement (IOA) in gross tumor delineation of HCC in a multicenter panel. The analysis was performed within the ''Stereotactic Radiotherapy'' working group of the German Society for Radiation Oncology (DEGRO). The GTVs of three anonymized HCC cases were delineated by 16 physicians from nine centers using multiphasic CT scans. In the first case the tumor was well defined. The second patient had multifocal HCC (one conglomerate and one peripheral tumor) and was previously treated with transarterial chemoembolization (TACE). The peripheral lesion was adjacent to the previous TACE site. The last patient had an extensive HCC with a portal vein thrombosis (PVT) and an inhomogeneous liver parenchyma due to cirrhosis. The IOA was evaluated according to Landis and Koch. The IOA for the first case was excellent (kappa: 0.85); for the second case moderate (kappa: 0.48) for the peripheral tumor and substantial (kappa: 0.73) for the conglomerate. In the case of the peripheral tumor the inconsistency is most likely explained by the necrotic tumor cavity after TACE caudal to the viable tumor. In the last case the IOA was fair, with a kappa of 0.34, with significant heterogeneity concerning the borders of the tumor and the PVT. The IOA was very good among the cases were the tumor was well defined. In complex cases, where the tumor did not show the typical characteristics, or in cases with Lipiodol (Guerbet, Paris, France) deposits, IOA agreement was compromised. (orig.) [German] Die Definition des makroskopischen Tumorvolumens (GTV) bei hepatozellulaeren Karzinomen (HCC) erfordert eine dezidierte Bildgebung in mehreren Kontrastmittelphasen. Ziel dieser Studie war es, die Interobservervariabilitaet (IOA) bei der Konturierung von HCC-Laesionen durch ein multizentrisches

  14. On the phase of Chern-Simons theory with complex gauge group

    Energy Technology Data Exchange (ETDEWEB)

    Gibbs, R.; Mokhtari, S. [Dept. of Phys., Louisiana Tech. Univ., Ruston, LA (United States)

    1995-10-07

    We compute the eta function for Chern-Simons quantum field theory with complex gauge group. The calculation is performed using the Schwinger expansion technique. We discuss, in particular, the role of the metric on the field configuration space, and demonstrate that for a certain class of acceptable metrics the one-loop phase contribution to the effective action can be calculated explicitly. The result is found to be proportional to a gauge invariant part of the action. (author)

  15. Line group techniques in description of the structural phase transitions in some superconductors

    Energy Technology Data Exchange (ETDEWEB)

    Meszaros, C.; Bankuti, J. [Roland Eoetvoes Univ., Budapest (Hungary); Balint, A. [Univ. of Agricultural Sciences, Goedoello (Hungary)

    1994-12-31

    The main features of the theory of line groups, and their irreducible representations are briefly discussed, as well as the most important applications of them. A new approach in the general symmetry analysis of the modulated systems is presented. It is shown, that the line group formalism could be a very effective tool in the examination of the structural phase transitions in High Temperature Superconductors. As an example, the material YBa{sub 2}Cu{sub 3}O{sub 7-x} is discussed briefly.

  16. Psychosocial Issues in Pediatric Oncology

    Science.gov (United States)

    Marcus, Joel

    2012-01-01

    Psychosocial oncology, a relatively new discipline, is a multidisciplinary application of the behavioral and social sciences, and pediatric psychosocial oncology is an emerging subspecialty within the domain of psychosocial oncology. This review presents a brief overview of some of the major clinical issues surrounding pediatric psychosocial oncology. PMID:23049457

  17. Metabolic complications in oncology

    International Nuclear Information System (INIS)

    Sycova-Mila, Z.

    2012-01-01

    Currently, a lot of space and time is devoted to the therapy of oncologic diseases itself. To reach the good therapy results, complex care of the oncologic patient is needed. Management of complications linked with the disease itself and management of complications emerged after administration of chemotherapy, radiotherapy or targeted therapy, plays a significant role. In addition to infectious, hematological, neurological, cardiac or other complications, metabolic complications are relatively extensive and serious. One of the most frequent metabolic complications in oncology is tumor lysis syndrome, hyperuricemia, hypercalcaemia and syndrome of inappropriate secretion of antidiuretic hormone. (author)

  18. VII National Congress of Spanish Radiotherapy and Oncology Association, Sevilla 20-22 October 1993 Abstracts

    International Nuclear Information System (INIS)

    1993-01-01

    This special issue of Oncology Journal presents the 142 abstracts of VII National Congress of Spanish Radiotherapy and Oncology Association. The lectures were distributed into 3 groups: a) Radiochemotherapy b) Lymphoma c) Paliative radiotherapy and quality of life

  19. Consciousness viewed in the framework of brain phase space dynamics, criticality, and the Renormalization Group

    International Nuclear Information System (INIS)

    Werner, Gerhard

    2013-01-01

    The topic of this paper will be addressed in three stages: I will first review currently prominent theoretical conceptualizations of the neurobiology of consciousness and, where appropriate, identify ill-advised and flawed notions in theoretical neuroscience that may impede viewing consciousness as a phenomenon in the physics of brain. In this context, I will also introduce relevant facts that tend not to receive adequate attention in much of the current consciousness discourse. Next, I will review the evidence that accrued in the last decade that identifies the resting brain as being in a state of criticality. In the framework of state phase dynamics of statistical physics, this observational evidence also entails that the resting brain is poised at the brink of a second order phase transition. On this basis, I will in the third stage propose applying the framework of the Renormalization Group to viewing consciousness as a phenomenon in statistical physics. In physics, concepts of phase space transitions and the Renormalization Group are powerful tools for interpreting phenomena involving many scales of length and time in complex systems. The significance of these concepts lies in their accounting for the emergence of different levels of new collective behaviors in complex systems, each level with its distinct macroscopic physics, organization, and laws, as a new pattern of reality. In this framework, I propose to view subjectivity as the symbolic description of the physical brain state of consciousness that emerges as one of the levels of phase transitions of the brain-body-environment system, along the trajectory of Renormalization Group Transformations

  20. Phase and group velocities for Lamb waves in DOP-26 iridium alloy sheet

    International Nuclear Information System (INIS)

    Simpson, W.A.; McGuire, D.J.

    1994-07-01

    The relatively coarse grain structure of iridium weldments limits the ultrasonic inspection of these structures to frequencies in the low megahertz range. As the material thickness is nominally 0.635 mm for clad vent set capsules, the low frequencies involved necessarily entail the generation of Lamb waves m the specimen. These waves are, of course, dispersive and detailed knowledge of both the phase and group velocities is required in order to determine accurately the location of flaws detected using Lamb waves. Purpose of this study is to elucidate the behavior of Lamb waves propagating in the capsule alloy and to quantify the velocities so that accurate flaw location is ensured. We describe a numerical technique for computing the phase velocities of Lamb waves (or of any other type of guided wave) and derive the group velocities from this information. A frequency-domain method is described for measuring group velocity when multiple Lamb modes are present and mutually interfering in the time domain, and experimental confirmation of the group velocity is presented for the capsule material

  1. Renormalization group evolution of neutrino parameters in presence of seesaw threshold effects and Majorana phases

    Directory of Open Access Journals (Sweden)

    Shivani Gupta

    2015-04-01

    Full Text Available We examine the renormalization group evolution (RGE for different mixing scenarios in the presence of seesaw threshold effects from high energy scale (GUT to the low electroweak (EW scale in the Standard Model (SM and Minimal Supersymmetric Standard Model (MSSM. We consider four mixing scenarios namely Tri–Bimaximal Mixing, Bimaximal Mixing, Hexagonal Mixing and Golden Ratio Mixing which come from different flavor symmetries at the GUT scale. We find that the Majorana phases play an important role in the RGE running of these mixing patterns along with the seesaw threshold corrections. We present a comparative study of the RGE of all these mixing scenarios both with and without Majorana CP phases when seesaw threshold corrections are taken into consideration. We find that in the absence of these Majorana phases both the RGE running and seesaw effects may lead to θ13<5° at low energies both in the SM and MSSM. However, if the Majorana phases are incorporated into the mixing matrix the running can be enhanced both in the SM and MSSM. Even by incorporating non-zero Majorana CP phases in the SM, we do not get θ13 in its present 3σ range. The current values of the two mass squared differences and mixing angles including θ13 can be produced in the MSSM case with tan⁡β=10 and non-zero Majorana CP phases at low energy. We also calculate the order of effective Majorana mass and Jarlskog Invariant for each scenario under consideration.

  2. Locoregional Recurrence After Sentinel Lymph Node Dissection With or Without Axillary Dissection in Patients With Sentinel Lymph Node Metastases: Long-term Follow-up From the American College of Surgeons Oncology Group (Alliance) ACOSOG Z0011 Randomized Trial.

    Science.gov (United States)

    Giuliano, Armando E; Ballman, Karla; McCall, Linda; Beitsch, Peter; Whitworth, Pat W; Blumencranz, Peter; Leitch, A Marilyn; Saha, Sukamal; Morrow, Monica; Hunt, Kelly K

    2016-09-01

    The early results of the American College of Surgeons Oncology Group (ACOSOG) Z0011 trial demonstrated no difference in locoregional recurrence for patients with positive sentinel lymph nodes (SLNs) randomized either to axillary lymph node dissection (ALND) or sentinel lymph node dissection (SLND) alone. We now report long-term locoregional recurrence results. ACOSOG Z0011 prospectively examined overall survival of patients with SLN metastases undergoing breast-conserving therapy randomized to undergo ALND after SLND or no further axillary specific treatment. Locoregional recurrence was prospectively evaluated and compared between the groups. Four hundred forty-six patients were randomized to SLND alone and 445 to SLND and ALND. Both groups were similar with respect to age, Bloom-Richardson score, Estrogen Receptor status, adjuvant systemic therapy, histology, and tumor size. Patients randomized to ALND had a median of 17 axillary nodes removed compared with a median of only 2 SLNs removed with SLND alone (P alone arm (P = 0.28). Ten-year cumulative locoregional recurrence was 6.2% with ALND and 5.3% with SLND alone (P = 0.36). Despite the potential for residual axillary disease after SLND, SLND without ALND offers excellent regional control for selected patients with early metastatic breast cancer treated with breast-conserving therapy and adjuvant systemic therapy.

  3. High salinity volatile phases in magmatic Ni-Cu-platinum group element deposits

    Science.gov (United States)

    Hanley, J. J.; Mungall, J. E.

    2004-12-01

    The role of "deuteric" fluids (exsolved magmatic volatile phases) in the development of Ni-Cu-PGE (platinum group element) deposits in mafic-ultramafic igneous systems is poorly understood. Although considerable field evidence demonstrates unambiguously that fluids modified most large primary Ni-Cu-PGE concentrations, models which hypothesize that fluids alone were largely responsible for the economic concentration of the base and precious metals are not widely accepted. Determination of the trace element composition of magmatic volatile phases in such ore-forming systems can offer considerable insight into the origin of potentially mineralizing fluids in such igneous environments. Laser ablation ICP-MS microanalysis allows researchers to confirm the original metal budget of magmatic volatile phases and quantify the behavior of trace ore metals in the fluid phase in the absence of well-constrained theoretical or experimental predictions of ore metal solubility. In this study, we present new evidence from major deposits (Sudbury, Ontario, Canada; Stillwater Complex, Montana, U.S.A.) that compositionally distinct magmatic brines and halide melt phases were exsolved from crystallizing residual silicate melt and trapped within high-T fluid conduits now comprised of evolved rock compositions (albite-quartz graphic granite, orthoclase-quartz granophyre). Petrographic evidence demonstrates that brines and halide melts coexisted with immiscible carbonic phases at the time of entrapment (light aliphatic hydrocarbons, CO2). Brine and halide melt inclusions are rich in Na, Fe, Mn, K, Pb, Zn, Ba, Sr, Al and Cl, and homogenize by either halite dissolution at high T ( ˜450-700° C) or by melting of the salt phase (700-800° C). LA-ICPMS analyses of single inclusions demonstrate that high salinity volatile phases contained abundant base metals (Cu, Fe, Sn, Bi) and precious metals (Pt, Pd, Au, Ag) at the time of entrapment. Notably, precious metal concentrations in the inclusions

  4. Quantum phase transition by employing trace distance along with the density matrix renormalization group

    International Nuclear Information System (INIS)

    Luo, Da-Wei; Xu, Jing-Bo

    2015-01-01

    We use an alternative method to investigate the quantum criticality at zero and finite temperature using trace distance along with the density matrix renormalization group. It is shown that the average correlation measured by the trace distance between the system block and environment block in a DMRG sweep is able to detect the critical points of quantum phase transitions at finite temperature. As illustrative examples, we study spin-1 XXZ chains with uniaxial single-ion-type anisotropy and the Heisenberg spin chain with staggered coupling and external magnetic field. It is found that the trace distance shows discontinuity at the critical points of quantum phase transition and can be used as an indicator of QPTs

  5. The Influence of Group Versus Individual Prenatal Care on Phase of Labor at Hospital Admission.

    Science.gov (United States)

    Tilden, Ellen L; Emeis, Cathy L; Caughey, Aaron B; Weinstein, Sarah R; Futernick, Sarah B; Lee, Christopher S

    2016-07-01

    Group prenatal care, an alternate model of prenatal care delivery, has been associated with various improved perinatal outcomes in comparison to standard, individual prenatal care. One important maternity care process measure that has not been explored among women who receive group prenatal care versus standard prenatal care is the phase of labor (latent vs active) at hospital admission. A retrospective case-control study was conducted comparing 150 women who selected group prenatal care with certified nurse-midwives (CNMs) versus 225 women who chose standard prenatal care with CNMs. Analyses performed included descriptive statistics to compare groups and multivariate regression to evaluate the contribution of key covariates potentially influencing outcomes. Propensity scores were calculated and included in regression models. Women within this sample who received group prenatal care were more likely to be in active labor (≥ 4 cm of cervical dilatation) at hospital admission (odds ratio [OR], 1.73; 95% confidence interval [CI], 1.03-2.99; P = .049) and were admitted to the hospital with significantly greater cervical dilatation (mean [standard deviation, SD] 5.7 [2.5] cm vs. 5.1 [2.3] cm, P = .005) compared with women who received standard prenatal care, controlling for potential confounding variables and propensity for group versus individual care selection. Group prenatal care may be an effective and safe intervention for decreasing latent labor hospital admission among low-risk women. Neither group prenatal care nor active labor hospital admission was associated with increased morbidity. © 2016 by the American College of Nurse-Midwives.

  6. Operable Unit 3-13, Group 3, Other Surface Soils (Phase II) Field Sampling Plan

    Energy Technology Data Exchange (ETDEWEB)

    G. L. Schwendiman

    2006-07-27

    This Field Sampling Plan describes the Operable Unit 3-13, Group 3, Other Surface Soils, Phase II remediation field sampling activities to be performed at the Idaho Nuclear Technology and Engineering Center located within the Idaho National Laboratory Site. Sampling activities described in this plan support characterization sampling of new sites, real-time soil spectroscopy during excavation, and confirmation sampling that verifies that the remedial action objectives and remediation goals presented in the Final Record of Decision for Idaho Nuclear Technology and Engineering Center, Operable Unit 3-13 have been met.

  7. Renormalization group improved computation of correlation functions in theories with nontrivial phase diagram

    DEFF Research Database (Denmark)

    Codello, Alessandro; Tonero, Alberto

    2016-01-01

    We present a simple and consistent way to compute correlation functions in interacting theories with nontrivial phase diagram. As an example we show how to consistently compute the four-point function in three dimensional Z2-scalar theories. The idea is to perform the path integral by weighting...... the momentum modes that contribute to it according to their renormalization group (RG) relevance, i.e. we weight each mode according to the value of the running couplings at that scale. In this way, we are able to encode in a loop computation the information regarding the RG trajectory along which we...

  8. Benefit from prolonged dose-intensive chemotherapy for infants with malignant brain tumors is restricted to patients with ependymoma: a report of the Pediatric Oncology Group randomized controlled trial 9233/34.

    Science.gov (United States)

    Strother, Douglas R; Lafay-Cousin, Lucie; Boyett, James M; Burger, Peter; Aronin, Patricia; Constine, Louis; Duffner, Patricia; Kocak, Mehmet; Kun, Larry E; Horowitz, Marc E; Gajjar, Amar

    2014-03-01

    The randomized controlled Pediatric Oncology Group study 9233 tested the hypothesis that dose-intensive (DI) chemotherapy would improve event-free survival (EFS) for children chemotherapy (Regimen A, n = 162) or DI chemotherapy (Regimen B, n = 166). Radiation therapy (RT) was recommended for patients with evidence of disease at completion of chemotherapy or who relapsed within 6 months of chemotherapy completion. Distributions of EFS for Regimens A and B were not significantly different (P = 0.32) with 2- and 10-year rates of 22.8% ± 3.3% and 15.4% ± 3.7%, and 27.1% ± 3.4% and 20.8% ± 3.8%, respectively. Thus, the study hypothesis was rejected. While distributions of EFS and OS were not significantly different between Regimens A and B for patients with medulloblastoma and sPNET, DI chemotherapy resulted in significantly improved EFS distribution (P = .0011) (2-year EFS rates of 42.1% vs. 19.6% with SD chemotherapy), but not OS distribution, for patients with centrally confirmed ependymoma. The degree of surgical resection affected EFS, OS or both for most tumor groups. Approximately 20%, 40% and 20% of patients with medulloblastoma, ependymoma treated with DI chemotherapy, and sPNET, respectively appear to have been cured without RT. Of 11 toxic deaths on study, 10 occurred on the DI chemotherapy arm. Prolonged dose-intensive chemotherapy given to infants with malignant brain tumors resulted in increased EFS only for patients with ependymoma.

  9. Surgical complications associated with sentinel lymph node dissection (SLND) plus axillary lymph node dissection compared with SLND alone in the American College of Surgeons Oncology Group Trial Z0011.

    Science.gov (United States)

    Lucci, Anthony; McCall, Linda Mackie; Beitsch, Peter D; Whitworth, Patrick W; Reintgen, Douglas S; Blumencranz, Peter W; Leitch, A Marilyn; Saha, Sukumal; Hunt, Kelly K; Giuliano, Armando E

    2007-08-20

    The American College of Surgeons Oncology Group trial Z0011 was a prospective, randomized, multicenter trial comparing overall survival between patients with positive sentinel lymph nodes (SLNs) who did and did not undergo axillary lymph node dissection (ALND). The current study compares complications associated with SLN dissection (SLND) plus ALND, versus SLND alone. From May 1999 to December 2004, 891 patients were randomly assigned to SLND + ALND (n = 445) or SLND alone (n = 446). Information on wound infection, axillary seroma, paresthesia, brachial plexus injury (BPI), and lymphedema was available for 821 patients. Adverse surgical effects were reported in 70% (278 of 399) of patients after SLND + ALND and 25% (103 of 411) after SLND alone (P alone group. At 1 year, lymphedema was reported subjectively by 13% (37 of 288) of patients after SLND + ALND and 2% (six of 268) after SLND alone (P alone. Lymphedema was more common after SLND + ALND but was significantly different only by subjective report. The use of SLND alone resulted in fewer complications.

  10. Prognostic index for patients with parotid carcinoma - External validation using the nationwide 1985-1994 Dutch Head and Neck Oncology Cooperative Group database

    NARCIS (Netherlands)

    Vander Poorten, Vincent L. M.; Hart, Augustinus A. M.; van der Laan, Bernardus F. A. M.; Baatenburg de Jong, Robert J.; Manni, Johannes J.; Marres, Henri A. M.; Meeuwis, Cees A.; Lubsen, Herman; Terhaard, Chris H. J.; Balm, Alfonsus J. M.

    2003-01-01

    BACKGROUND. Validation of the prognostic indices for the recurrence-free interval of patients with parotid carcinoma, the development of which was described in a previous report, is needed to be confident of their generalizability and justified prospective use. METHODS. The Dutch Cooperative Group

  11. 76 FR 61713 - Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-10-05

    ...] Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food... of Committee: Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee. General... adult oncology indication, or in late stage development in pediatric patients with cancer. The...

  12. A discrete single server queue with Markovian arrivals and phase type group services

    Directory of Open Access Journals (Sweden)

    Attahiru Sule Alfa

    1995-01-01

    Full Text Available We consider a single-server discrete queueing system in which arrivals occur according to a Markovian arrival process. Service is provided in groups of size no more than M customers. The service times are assumed to follow a discrete phase type distribution, whose representation may depend on the group size. Under a probabilistic service rule, which depends on the number of customers waiting in the queue, this system is studied as a Markov process. This type of queueing system is encountered in the operations of an automatic storage retrieval system. The steady-state probability vector is shown to be of (modified matrix-geometric type. Efficient algorithmic procedures for the computation of the rate matrix, steady-state probability vector, and some important system performance measures are developed. The steady-state waiting time distribution is derived explicitly. Some numerical examples are presented.

  13. A randomized trial of diet and physical activity in women treated for stage II—IV ovarian cancer: Rationale and design of the Lifestyle Intervention for Ovarian Cancer Enhanced Survival (LIVES): An NRG Oncology/Gynecologic Oncology Group (GOG-225) Study☆,☆☆

    Science.gov (United States)

    Thomson, Cynthia A.; Crane, Tracy E.; Miller, Austin; Garcia, David O.; Basen-Engquist, Karen; Alberts, David S.

    2016-01-01

    Ovarian cancer is the most common cause of gynecological cancer death in United States women. Efforts to improve progression free survival (PFS) and quality of life (QoL) after treatment for ovarian cancer are necessary. Observational studies suggest that lifestyle behaviors, including diet and physical activity, are associated with lower mortality in this population. The Lifestyle Intervention for Ovarian Cancer Enhanced Survival (LIVES) NRG 0225 study is a randomized, controlled trial designed to test the hypothesis that a 24 month lifestyle intervention will significantly increase PFS after oncological therapy for stage II-IV ovarian cancer. Women are randomized 1:1 to a high vegetable and fiber, low-fat diet with daily physical activity goals or an attention control group. Secondary outcomes to be evaluated include QoL and gastrointestinal health. Moreover an a priori lifestyle adherence score will be used to evaluate relationships between adoption of the diet and activity goals and PFS. Blood specimens are collected at baseline, 6, 12 and 24 months for analysis of dietary adherence (carotenoids) in addition to mechanistic biomarkers (lipids, insulin, telomere length). Women are enrolled at NRG clinic sites nationally and the telephone based lifestyle intervention is delivered from The University of Arizona call center by trained health coaches. A study specific multi-modal telephone, email, and SMS behavior change software platform is utilized for information delivery, coaching and data capture. When completed, LIVES will be the largest behavior-based lifestyle intervention trial conducted among ovarian cancer survivors. PMID:27394382

  14. Effect of vision angle on the phase transition in flocking behavior of animal groups.

    Science.gov (United States)

    Nguyen, P The; Lee, Sang-Hee; Ngo, V Thanh

    2015-09-01

    The nature of the phase transition in a system of self-propelling particles has been extensively studied during the past few decades. A theoretical model was proposed by [T. Vicsek et al. Phys. Rev. Lett. 75, 1226 (1995)PRLTAO0031-900710.1103/PhysRevLett.75.1226] with a simple rule for updating the direction of motion of each particle. Based on the model of Vicsek et al., in this paper, we consider a group of animals as particles moving freely in a two-dimensional space. Due to the fact that the viewable area of animals depends on the species, we consider the motion of each individual within an angle φ=ϕ/2 (ϕ is called the angle of view) of a circle centered at its position of radius R. We obtained a phase diagram in the space (φ,η_{c}) with η_{c} being the critical noise. We show that the phase transition exists only in the case of a wide view's angle φ≥0.5π. The flocking of animals is a universal behavior of the species of prey but not the one of the predator. Our simulation results are in good agreement with experimental observation [C. Beccoa et al., Physica A 367, 487 (2006)PHYADX0378-437110.1016/j.physa.2005.11.041].

  15. Effect of vision angle on the phase transition in flocking behavior of animal groups

    Science.gov (United States)

    Nguyen, P. The; Lee, Sang-Hee; Ngo, V. Thanh

    2015-09-01

    The nature of the phase transition in a system of self-propelling particles has been extensively studied during the past few decades. A theoretical model was proposed by [T. Vicsek et al. Phys. Rev. Lett. 75, 1226 (1995), 10.1103/PhysRevLett.75.1226] with a simple rule for updating the direction of motion of each particle. Based on the model of Vicsek et al., in this paper, we consider a group of animals as particles moving freely in a two-dimensional space. Due to the fact that the viewable area of animals depends on the species, we consider the motion of each individual within an angle φ =ϕ /2 (ϕ is called the angle of view) of a circle centered at its position of radius R . We obtained a phase diagram in the space (φ ,ηc ) with ηc being the critical noise. We show that the phase transition exists only in the case of a wide view's angle φ ≥0.5 π . The flocking of animals is a universal behavior of the species of prey but not the one of the predator. Our simulation results are in good agreement with experimental observation [C. Beccoa et al., Physica A 367, 487 (2006), 10.1016/j.physa.2005.11.041].

  16. The effect of charged groups on hydrophilic monolithic stationary phases on their chromatographic properties.

    Science.gov (United States)

    Li, Haibin; Liu, Chusheng; Wang, Qiqin; Zhou, Haibo; Jiang, Zhengjin

    2016-10-21

    In order to investigate the effect of charged groups present in hydrophilic monolithic stationary phases on their chromatographic properties, three charged hydrophilic monomers, i.e. N,N-dimethyl-N-acryloyloxyethyl-N-(3-sulfopropyl)ammonium betaine (SPDA), [2-(acryloyloxy)ethyl]trimethylammonium chloride (AETA), and 3-sulfopropyl acrylate potassium salt (SPA) were co-polymerized with the crosslinker N,N'-methylenebisacrylamide (MBA), respectively. The physicochemical properties of the three resulting charged hydrophilic monolithic columns were evaluated using scanning electron microscopy, ζ-potential analysis and micro-HPLC. High column efficiency was obtained on the three monolithic columns at a linear velocity of 1mm/s using thiourea as test compound. Comparative characterization of the three charged HILIC phases was then carried out using a set of model compounds, including nucleobases, nucleosides, benzoic acid derivatives, phenols, β-blockers and small peptides. Depending on the combination of stationary phase/mobile phase/solute, both hydrophilic interaction and other potential secondary interactions, including electrostatic interaction, hydrogen-bonding interaction, molecular shape selectivity, could contribute to the over-all retention of the analytes. Because of the strong electrostatic interaction provided by the quaternary ammonium groups in the poly (AETA-co-MBA) monolith, this cationic HILIC monolith exhibited the strongest retention for benzoic acid derivatives and small peptides with distorted peak shapes and the weakest retention for basic β-blockers. The sulfonyl groups on the poly (SPA-co-MBA) hydrophilic monolith could provide strong electrostatic attraction and hydrogen bonding for positively charged analytes and hydrogen-donor/acceptor containing analytes, respectively. Therefore, basic drugs, nucleobases and nucleotides exhibited the strongest retention on this anionic monolith. Because of the weak but distinct cation exchange properties of

  17. A prospective randomized study of Chop versus Chop plus alpha-2B interferon in patients with intermediate and high grade non-Hodgkin's lymphoma: the International Oncology Study Group NHL1 Study .

    Science.gov (United States)

    Giles, F J; Shan, J; Advani, S H; Akan, H; Aydogdu, I; Aziz, Z; Azim, H A; Bapsy, P P; Buyukkececi, F; Chaimongkol, B; Chen, P M; Cheong, S K; Ferhanoglu, B; Hamza, R; Khalid, H M; Intragumtornchai, T; Kim, S W; Kim, S Y; Koc, H; Kumar, L; Kumar, R; Lei, K I; Lekhakula, A; Muthalib, A; Patel, M; Poovalingam, V P; Prayoonwiwat, W; Rana, F; Reksodiputro, A H; Ruff, P; Sagar, T G; Schwarer, A P; Song, H S; Suh, C W; Suharti, C; Supindiman, I; Tee, G Y; Thamprasit, T; Villalon, A H; Wickham, N R; Wong, J E; Yalcin, A; Jootar, S

    2000-12-01

    The addition of a brief alpha interferon regimen to each CHOP induction cycle, plus one year of alpha interferon thrice weekly maintenance therapy, has no early effect on response rates or survival in patients with Intermediate or High grade cell NHL. The CHOP (Cyclophosphamide, Adriamycin. Vincristine, Prednisone) regimen is the most widely used first-line therapy for patients with Intermediate or High Grade (IG/HG) non-Hodgkin's lymphoma (NHL). Alpha 2b interferon (INF) enhances response rates and improves survival in low-grade NHL. The International Oncology Study Group (IOSG) conducted a prospective randomized study comparing CHOP alone or combined with INF in patients with IG/HG-NHL. The primary study aim was to compare the objective response rates in these patient cohorts. Patients with a confirmed diagnosis of measurable NHL of International Working Formulation (IWF) groups D to H histology were randomized to receive CHOP alone or CHOP with 5Mu INF s.c. for 5 days on days 22 to 26 of each 28 day cycle with INF 5 million units (Mu) given three times per week subcutaneously for 52 weeks in those patients who responded to CHOP plus INF. The overall response rates were equivalent in both groups: CHOP alone (214 patients) 81% (complete 55%, partial 26%); CHOP plus INF (221 patients) 80% (complete 54%, partial 26%). At 36 months, the actuarial survival rate was equivalent in both groups. There is no apparent early advantage in terms of response or survival conferred by adding the study INF regimen to CHOP therapy for patients with IG/HG-NHL.

  18. Innovations in radiation oncology

    International Nuclear Information System (INIS)

    Withers, H.R.

    1988-01-01

    The series 'Medical Radiology - Diagnostic Imaging and Radiation Oncology' is the successor to the well known 'Encyclopedia of Medical Radiology/Handbuch der medizinischen Radiologie'. 'Medical Radiology' brings the state of the art on special topics in a timely fashion. This volume 'Innovation in Radiation Oncology', edited by H.R. Withers and L.J. Peters, presents data on the development of new therapeutic strategies in different oncologic diseases. 57 authors wrote 32 chapters covering a braod range of topics. The contributors have written their chapters with the practicing radiation oncologist in mind. The first chapter sets the stage by reviewing the quality of radiation oncology as it is practiced in the majority of radiation oncology centers in the United States. The second chapter examines how we may better predict the possible causes of failure of conventional radiotherapy in order that the most appropriate of a variety of therapeutic options may eventually be offered to patients on an individual basis. The third chapter discussed how our therapeutic endeavors affect the quality of life, a problem created by our ability to be successful. Following these three introductory chapters there are 29 chapters by highly qualified specialists discussing the newest ideas in subjects of concern to the practicing radiation oncologist. With 111 figs

  19. Randomized study of chemotherapy/radiation therapy combinations for favorable patients with locally advanced inoperable nonsmall cell lung cancer: radiation therapy oncology group (RTOG) 92-04

    International Nuclear Information System (INIS)

    Komaki, Ritsuko; Scott, Charles; Ettinger, David; Lee, Jin S.; Fossella, Frank V.; Curran, Walter; Evans, R.F.; Rubin, Philip; Byhardt, Roger W.

    1997-01-01

    Purpose: The purpose of this study was to compare the severity and distribution of the toxicities associated with the two different combinations of chemotherapy and radiotherapy. Methods and Materials: This prospective randomized trial studied toxicities associated with induction chemotherapy followed by concurrent treatment (Arm 1) vs. immediate concurrent chemotherapy/radiotherapy (CT/RT) (Arm 2). Arm 1 consisted of vinblastine (VB), 5 mg/M 2 IV bolus weekly, weeks 1-5 and cisplatin (DDP), 100 mg/M 2 days 1 and 29, DDP 75 mg/M 2 , days 50, 71, and 92. Daily RT started on day 50; a total dose of 63 Gy was given in 34 fractions in 7 weeks. In Arm 2 RT started day 1; a total dose of 69.6 Gy was given in 58 fractions of 1.2 Gy bid, 5 days per week for 6 weeks with DDP 50 mg/M 2 i.v. days 1 and 8, and oral VP-16 50 mg b.i.d. during the first 10 days of RT. DDP/VP-16 were repeated beginning day 29. Survival was used as the Phase II endpoint. Results: Between July 1992 and February 1994, 168 patients were randomized; 162 evaluable patients had minimum follow-up of 20 months. Eighty patients were registered to Arm 1 and 82 to Arm 2. Pretreatment characteristics were distributed evenly. Arm 1 had significantly more Grade 4 hematologic toxicity (62%) than Arm 2 (33%) (p = 0.021). Acute nonhematologic Grade 3+ toxicity was also greater (p = 0.018) in Arm 2 than Arm 1 due mainly to esophagitis (38 vs. 6%; p < 0.0001). Grade 3+ late esophageal toxicity was 12% on Arm 2 compared to 3% on Arm 1 (p = 0.006). There were no differences between the two arms in compliance with protocol specifications for either RT or CT. At 1 year, 31.7% of patients had in-field progression on Arm 1 compared to 19.8% on Arm 2 (p = 0.042), but overall progression-free survival rates were nearly identical; 50 and 49% for Arms I and II, respectively, at 12 months. One-year and median survivals were 65% and 15.5 months on Arm 1 compared to 58% and 14.4 months on Arm 2. Conclusion: Whereas hematologic

  20. The impact of radiation dose and fractionation on the risk factor of radiation pneumonitis on four radiation therapy oncology group (RTOG) lung cancer trials

    International Nuclear Information System (INIS)

    Roach, Mack; Pajak, Thomas F; Byhardt, Roger; Graham, Mary L; Asbell, Sucha O; Russell, Anthony H; Fu, Karen K; Urtasun, Raul C; Herskovic, Arnold M; Cox, James D

    1997-01-01

    Purpose/Objective: To assess the relationship between total dose of radiation delivered, the fractionation scheme used, age, and Karnofsky Performance Status (KPS) on the risk of moderate to severe (≥ Grade 2) radiation pneumonitis in patients treated with radiotherapy alone for lung cancer on four RTOG Trials. Materials and Methods: Between February of 1984 and April of 1989, 1701 patients with clinically localized (I-IIIb) lung cancer were entered on clinical trials employing radiotherapy alone. Twelve hundred and forty-seven patients were entered on RTOG 8311 or 8407 (phase I/II trials) and 454 patients were entered on RTOG 8321 or 8403 (phase III trials). RTOG 8403 and 8321 patients received once-a-day irradiation to 60 Gy. Patients treated on RTOG 8407 were treated with a concomitant boost technique in a non-randomized fashion to 64.8, 69.6, 74.4 or 79.2 Gy. Patients treated on RTOG 8407 were treated with a concomitant boost technique in a non-randomized fashion to 63 Gy or 70.2 Gy. All patients were assessed for the incidence of Grade 2-5, radiation pneumonitis. One hundred and seven (6%) of patients were either ineligible or canceled (n=60), or were excluded because of incomplete data (n=47). The factors evaluated included total dose of radiation, the fractionation scheme, age and pre-treatment KPS. Patients treated to doses ≥ 72 Gy were considered to have received high doses (72.0 - 81.6 Gy), while the remaining patients treated to doses < 72 Gy (57.6 - 71.9 Gy) were considered to have received standard dose radiation. For the this analysis, information regarding field size and baseline pulmonary function was not available. Results: Age, sex, stage distribution, and the percentage of patients with a KPS ≥90 were similar among the patients treated on these four studies. Patients receiving hyperfractionated radiotherapy to doses ≥ 72 Gy experienced a higher incidence of radiation pneumonitis ≥ Grade 2, than patients treated with standard doses < 72

  1. Outcome of high-risk stage 3 neuroblastoma with myeloablative therapy and 13-cis-retinoic acid: a report from the Children's Oncology Group.

    Science.gov (United States)

    Park, Julie R; Villablanca, Judith G; London, Wendy B; Gerbing, Robert B; Haas-Kogan, Daphne; Adkins, E Stanton; Attiyeh, Edward F; Maris, John M; Seeger, Robert C; Reynolds, C Patrick; Matthay, Katherine K

    2009-01-01

    The components of therapy required for patients with INSS Stage 3 neuroblastoma and high-risk features remain controversial. A retrospective cohort design was used to determine if intensive chemoradiotherapy with purged autologous bone marrow rescue (ABMT) and/or 13-cis-retinoic acid (13-cis-RA) improved outcome for patients with high-risk neuroblastoma that was not metastatic to distant sites. We identified 72 patients with INSS Stage 3 neuroblastoma enrolled between 1991 and 1996 on the Phase 3 CCG-3891 randomized trial. Patients were analyzed on an intent-to-treat basis using a log-rank test. The 5-year event-free survival (EFS) and overall survival (OS) rates for patients with Stage 3 neuroblastoma were 55 +/- 6% and 59 +/- 6%, respectively (n = 72). Patients randomized to ABMT (n = 20) had 5-year EFS of 65 +/- 11% and OS of 65 +/- 11% compared to 41 +/- 11 (P = 0.21) and 46 +/- 11% (P = 0.23) for patients randomized to CC (n = 23), respectively. Patients randomized to 13-cis-RA (n = 23) had 5-year EFS of 70 +/- 10% and OS of 78 +/- 9% compared to 63 +/- 12% (P = 0.67) and 67 +/- 12% (P = 0.55) for those receiving no further therapy (n = 16), respectively. Patients randomized to both ABMT and 13-cis-RA (n = 6) had a 5-year EFS of 80 +/- 11% and OS of 100%. Patients with high-risk Stage 3 neuroblastoma have an overall poor prognosis despite aggressive chemoradiotherapy. Further studies are warranted to determine if myeloablative consolidation followed by 13-cis-RA maintenance therapy statistically significantly improves outcome.

  2. Outcome of High-Risk Stage 3 Neuroblastoma with Myeloablative Therapy and 13-cis-Retinoic Acid: A Report from the Children’s Oncology Group

    Science.gov (United States)

    Park, Julie R.; Villablanca, Judith G.; London, Wendy B.; Gerbing, Robert B.; Haas-Kogan, Daphne; Stanton Adkins, E.; Attiyeh, Edward F.; Maris, John M.; Seeger, Robert C.; Patrick Reynolds, C.; Matthay, Katherine K.

    2009-01-01

    Background The components of therapy required for patients with INSS Stage 3 neuroblastoma and high risk features remain controversial. Procedure A retrospective cohort design was used to determine if intensive chemoradiotherapy with purged autologous bone marrow rescue (ABMT) and/or 13-cis-retinoic acid (13-cis-RA) improved outcome for patients with high-risk neuroblastoma that was not metastatic to distant sites. We identified 72 patients with INSS Stage 3 neuroblastoma enrolled between 1991 and 1996 on the Phase III CCG 3891 randomized trial. Patients were analyzed on an intent-to-treat basis using a log-rank test. Results The 5-year event-free survival (EFS) and overall survival (OS) rates for patients with Stage 3 neuroblastoma were 55 +/- 6% and 59% +/- 6%, respectively (n=72). Patients randomized to ABMT (n=20) had 5-year EFS of 65% +/- 11% and OS of 65% +/- 11% compared to 41% +/- 11 (p=0.21) and 46% +/- 11% (p=0.23) for patients randomized to CC (n=23), respectively. Patients randomized to 13-cis-RA (n=23) had 5-year EFS of 70% +/- 10% and OS of 78% +/- 9% compared to 63% +/- 12% (p=0.67) and 67% +/- 12% (p=0.55) for those receiving no further therapy (n=16), respectively. Patients randomized to both ABMT and 13-cis-RA (n=6) had a 5-year EFS of 80% ± 11% and OS of 100%. Conclusion Patients with high-risk Stage 3 neuroblastoma have an overall poor prognosis despite aggressive chemoradiotherapy. Further studies are warranted to determine if myeloablative consolidation followed by 13-cis-RA maintenance therapy statistically significantly improves outcome. PMID:18937318

  3. Do all patients in the phase I oncology trials need to be hospitalized? Domestic but outstanding issues for globalization of drug development in Japan.

    Science.gov (United States)

    Shimomura, Akihiko; Kondo, Shunsuke; Kobayashi, Noriko; Iwasa, Satoru; Kitano, Shigehisa; Tamura, Kenji; Fujiwara, Yutaka; Yamamoto, Noboru

    2017-08-01

    Most trials investigating new drugs around the world, including phase I trials, are conducted in outpatient clinics. However, in Japan, regulatory authority requirements and traditional domestic guidelines often require hospitalization of phase I study participants. Patients participating in single-agent phase I clinical trials at National Cancer Center Hospital between December 1996 and August 2014 were monitored. Toxicity requiring hospitalization is defined as toxicity that needs intensive treatment. Study designs were classified into three types: first-in-human (FIH) study, dose-escalation study (conventional dose-escalation study to determine maximum tolerated dose (MTD) in Japanese patients), and dose-finding study (to assess safety and pharmacokinetic profiles up to the MTD previously determined in the West). A total of 945 patients who participated in a variety of single-agent phase I clinical trials between December 1996 and August 2014 were included in this study. Patients participated in one of three study types: dose-escalation (n = 582, 62%), first-in-human (n = 129, 14%), or dose-finding (n = 234, 25%). A total of 76 study drugs were evaluated as part of this pool of phase I studies. Subdivided by mechanism of action, 20 (26%) were cytotoxic, 50 (66%) were molecularly targeted, and 6 (8%) were immune checkpoint inhibitor. Thirty-six patients (3.8%) had severe toxicities requiring hospitalization during the first cycle. The overall number of toxicities requiring hospitalization and/or grade 4 toxicities during any cycle was 5.0%. The frequency of severe toxicity that needs to be hospitalized was unexpectedly low. The data did not demonstrate the need for hospitalization in the phase I trials, suggesting that phase I trials in Japan could be conducted in outpatient settings.

  4. Differential effect of age on survival in advanced NSCLC in women versus men: analysis of recent Eastern Cooperative Oncology Group (ECOG) studies, with and without bevacizumab.

    Science.gov (United States)

    Wakelee, H A; Dahlberg, S E; Brahmer, J R; Schiller, J H; Perry, M C; Langer, C J; Sandler, A B; Belani, C P; Johnson, D H

    2012-06-01

    The impact of age on prognosis in advanced stage non-small cell lung cancer (NSCLC) may differ by sex. Eligible patients (N=1590) from E1594, a 4-arm platinum-based chemotherapy trial, and E4599 (carboplatin/paclitaxel ± bevacizumab) chemotherapy arm were divided into male and female cohorts and separated into age groups of women ≥60 years old treated with chemotherapy alone on E1594 and E4599 was 11.6 months versus 9.0 months for women women (younger had greater benefit), with no age effect in men. In this unplanned, exploratory subgroup analysis of advanced stage NSCLC ECOG trials, women ≥60 years old treated with chemotherapy live longer than men and younger women. In contrast, bevacizumab survival benefit was more pronounced in men of any age and in younger women on E4599. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

  5. Stereotactic Body Radiotherapy for Recurrent or Oligometastatic Uterine Cervix Cancer: A Cooperative Study of the Korean Radiation Oncology Group (KROG 14-11).

    Science.gov (United States)

    Park, Hae Jin; Chang, Ah Ram; Seo, Youngseok; Cho, Chul Koo; Jang, Won-Il; Kim, Mi Sook; Choi, Chulwon

    2015-09-01

    To evaluate local control and patient survival for recurrent or oligometastatic uterine cervical cancer treated with stereotactic body radiotherapy (SBRT) using CyberKnife, and to demonstrate the safety of SBRT. Between 2002 and 2013, 100 recurrent or oligometastatic lesions in 85 patients were treated with SBRT at three Institutions. SBRT sites were within the previous RT field in 59 and partially overlapped in nine. SBRT sites included three local recurrences, 89 lymph node metastases, and eight distant metastases. Patients were treated with a median dose of 39 Gy in three fractions, which was equivalent to a biologically effective dose (BED) of 90 Gy. The median follow-up period was 20.4 months. Local failure occurred in 17 out of 100 SBRT-treated sites. The 2-year and 5-year local progression-free survival rates were 82.5% and 78.8%, respectively. Eleven local failures occurred within the previous RT field. The 2-year and 5-year overall survival rates were 57.5% and 32.9%, respectively. BED >90 Gy (p=0.072) and >69 Gy (p=0.059) and longer disease-free interval (p=0.065) predicted marginally superior local control. Re-irradiation appeared to be related to inferior local control (p<0.001), but the SBRT BED in this group was much lower than the dose in the other group (median BED, 79 Gy vs. 90 Gy). Chronic toxicities of grade 3 or more occurred in five cases. SBRT for recurrent or oligometastatic cervical cancer resulted in excellent local control, especially with a long disease-free interval and high BED treatment, with acceptable toxicities. Therefore, SBRT can be considered a therapeutic option for these patients. Copyright© 2015 International Institute of Anticancer Research (Dr. John G. Delinassios), All rights reserved.

  6. Modernizing Clinical Trial Eligibility Criteria: Recommendations of the American Society of Clinical Oncology-Friends of Cancer Research HIV Working Group.

    Science.gov (United States)

    Uldrick, Thomas S; Ison, Gwynn; Rudek, Michelle A; Noy, Ariela; Schwartz, Karl; Bruinooge, Suanna; Schenkel, Caroline; Miller, Barry; Dunleavy, Kieron; Wang, Judy; Zeldis, Jerome; Little, Richard F

    2017-11-20

    Purpose People with HIV are living longer as a result of effective antiretroviral therapy. Cancer has become a leading cause of morbidity and mortality in this patient population. However, studies of novel cancer therapeutics have historically excluded patients with HIV. Critical review of eligibility criteria related to HIV is required to accelerate development of and access to effective therapeutics for HIV-infected patients with cancer and make studies more generalizable to this patient population. Methods From January through April 2016, the HIV Working Group conducted a series of teleconferences; a review of 46 New Drug Applications from registration studies of unique agents studied in adults with cancer that led to the initial US Food and Drug Administration approval of that agent from 2011 to 2015; and a review of HIV-related eligibility criteria from National Cancer Institute-sponsored studies. Results were discussed and refined at a multistakeholder workshop held May 12, 2016. The HIV Working Group developed recommendations for eligibility criteria that focus on pharmacologic and immunologic considerations in this patient population and that balance patient safety, access to appropriate investigational agents, and study integrity. Results Exclusion of patients with HIV remains common in most studies of novel cancer agents. Models for HIV-related eligibility criteria in National Cancer Institute-sponsored studies are instructive. HIV infection itself should no longer be an exclusion criterion for most studies. Eligibility criteria related to HIV infection that address concurrent antiretroviral therapy and immune status should be designed in a manner that is appropriate for a given cancer. Conclusion Expanding clinical trial eligibility to be more inclusive of patients with HIV is justified in most cases and may accelerate the development of effective therapies in this area of unmet clinical need.

  7. The Effects of Adjuvant Endocrine Treatment on Serum Leptin, Serum Adiponectin and Body Composition in Patients with Breast Cancer: The Izmir Oncology Group (IZOG) Study.

    Science.gov (United States)

    Akyol, Murat; Demir, Leyla; Alacacioglu, Ahmet; Ellidokuz, Hülya; Kucukzeybek, Yuksel; Yildiz, Yasar; Gumus, Zehra; Bayoglu, Vedat; Yildiz, Ibrahim; Salman, Tarık; Varol, Umut; Kucukzeybek, Betul; Demir, Lutfiye; Dirican, Ahmet; Sutcu, Recep; Tarhan, Mustafa Oktay

    2016-01-01

    A limited number of studies have been conducted on the effects of hormonal therapy with tamoxifen (TMX) or aromatase inhibitors (AIs) on plasma levels of leptin and adiponectin, as well as body composition in breast cancer (BC) patients. Therefore, we aimed to analyze the relationship between adipocytokines and body composition as well as the effects of TMX and AIs on plasma adiponectin, leptin, leptin/adiponectin ratio (LAR) and body composition. Patients were treated with either TMX or AI according to their menopausal status after adjuvant radiotherapy. Changes in body composition and serum leptin and adiponectin levels were evaluated. We recorded the type of hormonal therapy, BMI, waist/hip ratio (WHR), leptin and adiponectin levels at study entry, and after 6 and 12 months. From baseline to the 6- and 12-month follow-ups, there were statistically significant increases in WHR (p = 0.003), fat mass (p = 0.041), and serum leptin (p body composition and serum leptin and adiponectin levels were similar in TMX and AI groups. A statistically significant decrease was found in total body water and LAR (p body fat percentage increased, such increases were not statistically significant. A positive correlation was found between baseline BMI and serum leptin levels. This correlation was maintained at 6 and 12 months. The negative correlation found between serum adiponectin levels at baseline and baseline BMI did not last throughout the study. In this study, increased leptin and adiponectin levels and a decreased LAR were found in both AI and TMX groups. These changes might have occurred through both mechanisms of hormonal therapy and body composition changes. Therefore, AIs and TMX may exert their protective effects for BC patients by decreasing LAR rather than affecting leptin or adiponectin alone. © 2015 S. Karger AG, Basel.

  8. High risk Merkel cell carcinoma of the skin treated with synchronous carboplatin/etoposide and radiation: a trans-Tasman radiation oncology group study

    International Nuclear Information System (INIS)

    Poulsen, M.G.; Rischin, D.; Ainslie, J.; Walpole, E.; Harvey, J.; Mackintosh, J.; Hamilton, C.; Tripcony, L.

    2003-01-01

    The effectiveness of synchronous carboplatin, etoposide and radiation therapy was prospectively assessed in a group of patients with high risk Merkel Cell Carcinoma of the skin. Patients were eligible if they had disease localised to the primary site and nodes and were required to have at least one of the following high risk features: recurrence after initial therapy, involved nodes, primary size greater than 1 cm, gross residual disease after surgery or occult primary with nodes. Radiation was delivered to the primary site and nodes to a dose of 50 Gy in 25 fractions over 5 weeks and synchronous carboplatin (AUC 4.5) and etoposide 80 mg/M2 intravenously days 1-3 was given in weeks 1, 4, 7 and 10. The median age of the group was 67 [43-86] years and there were 39 males and 14 females. Involved nodes (stageII) were present in 33 (62%) cases. The sites involved in decreasing order were head and neck (22), occult primary (13), upper limb (8), lower limb (8) and trunk (2). Fifty-three patients were entered between 1996 and 2001.The median potential follow up was 48 months. There were no treatment related deaths. The 3 year overall survival, loco-regional control and distant control were 76%, 75% and 76% respectively. Factors that were predictive for local control and survival were tumour site and the presence of nodes. Multivariate analysis indicated that the major factor influencing survival was the presence of nodes. However this was not a significant factor in loco-regional control. High levels of loco-regional control and survival have been achieved with the addition of chemotherapy to radiation treatment for high risk Merkel cell carcinoma of skin. The role of chemo-radiotherapy for high risk MCC warrants further investigation

  9. Pediatric nuclear oncology

    International Nuclear Information System (INIS)

    Howman Giles, R.; Bernard, E.; Uren, R.

    1997-01-01

    Nuclear medicine plays an important and increasing role in the management of childhood malignancy. This is particularly true in the solid tumours of childhood. It is also helpful in the management of the complications of cancer treatment such as the infections which often accompany immune suppression in oncology patients. Scintigraphy is a complementary investigation to other radiological techniques and adds the functional dimension to anatomical investigations such as CT, MRI and ultrasound. In selected malignancies radionuclides are also used in treatment. This review discusses the technical considerations relating to children and the specific techniques relating to pediatric oncology. Specific tumours and the various applications of radionuclides are discussed in particular lymphoma, primary bone tumours, soft tissue sarcomas, neuroblastoma, Wilms' tumour, brain tumours and leukemia. Uncommon tumours are also discussed and how radionuclides are useful in the investigation of various complications which occur in oncology patients

  10. Gas Phase Chromatography of some Group 4, 5, and 6 Halides

    Energy Technology Data Exchange (ETDEWEB)

    Sylwester, Eric Robert [Univ. of California, Berkeley, CA (United States)

    1998-10-01

    Gas phase chromatography using The Heavy Element Volatility Instrument (HEVI) and the On Line Gas Apparatus (OLGA III) was used to determine volatilities of ZrBr4, HfBr4, RfBr4, NbBr5, TaOBr3, HaCl5, WBr6, FrBr, and BiBr3. Short-lived isotopes of Zr, Hf, Rf, Nb, Ta, Ha, W, and Bi were produced via compound nucleus reactions at the 88-Inch Cyclotron at Lawrence Berkeley National Laboratory and transported to the experimental apparatus using a He gas transport system. The isotopes were halogenated, separated from the other reaction products, and their volatilities determined by isothermal gas phase chromatography. Adsorption Enthalpy (ΔHa) values for these compounds were calculated using a Monte Carlo simulation program modeling the gas phase chromatography column. All bromides showed lower volatility than molecules of similar molecular structures formed as chlorides, but followed similar trends by central element. Tantalum was observed to form the oxybromide, analogous to the formation of the oxychloride under the same conditions. For the group 4 elements, the following order in volatility and ΔHa was observed: RfBr4 > ZrBr4 > HfBr4. The ΔHa values determined for the group 4, 5, and 6 halides are in general agreement with other experimental data and theoretical predictions. Preliminary experiments were performed on Me-bromides. A new measurement of the half-life of 261Rf was performed. 261Rf was produced via the 248Cm(18O, 5n) reaction and observed with a half-life of 74-6+7 seconds, in excellent agreement with the previous measurement of 78-6+11 seconds. We recommend a new half-life of 75±7 seconds for 261Rf based on these two measurements. Preliminary studies in transforming HEVI from an isothermal (constant

  11. Group theoretical arguments on the Landau theory of second-order phase transitions applied to the phase transitions in some liquid crystals

    International Nuclear Information System (INIS)

    Rosciszewski, K.

    1979-01-01

    The phase transitions between liquids and several of the simplest liquid crystalline phases (nematic, cholesteric, and the simplest types of smectic A and smectic C) were studied from the point of view of the group-theoretical arguments of Landau theory. It was shown that the only possible candidates for second-order phase transitions are those between nematic and smectic A, between centrosymmetric nematic and smectic C and between centrosymmetric smectic A and smectic C. Simple types of density functions for liquid crystalline phases are proposed. (author)

  12. Phase III randomized study of radiation and temozolomide versus radiation and nitrosourea therapy for anaplastic astrocytoma: results of NRG Oncology RTOG 9813.

    Science.gov (United States)

    Chang, Susan; Zhang, Peixin; Cairncross, J Gregory; Gilbert, Mark R; Bahary, Jean-Paul; Dolinskas, Carol A; Chakravarti, Arnab; Aldape, Kenneth D; Bell, Erica H; Schiff, David; Jaeckle, Kurt; Brown, Paul D; Barger, Geoffrey R; Werner-Wasik, Maria; Shih, Helen; Brachman, David; Penas-Prado, Marta; Robins, H Ian; Belanger, Karl; Schultz, Christopher; Hunter, Grant; Mehta, Minesh

    2017-02-01

    The primary objective of this study was to compare the overall survival (OS) of patients with anaplastic astrocytoma (AA) treated with radiotherapy (RT) and either temozolomide (TMZ) or a nitrosourea (NU). Secondary endpoints were time to tumor progression (TTP), toxicity, and the effect of IDH1 mutation status on clinical outcome. Eligible patients with centrally reviewed, histologically confirmed, newly diagnosed AA were randomized to receive either RT+TMZ (n = 97) or RT+NU (n = 99). The study closed early because the target accrual rate was not met. Median follow-up time for patients still alive was 10.1 years (1.9-12.6 y); 66% of the patients died. Median survival time was 3.9 years in the RT/TMZ arm (95% CI, 3.0-7.0) and 3.8 years in the RT/NU arm (95% CI, 2.2-7.0), corresponding to a hazard ratio (HR) of 0.94 (P = .36; 95% CI, 0.67-1.32). The differences in progression-free survival (PFS) and TTP between the 2 arms were not statistically significant. Patients in the RT+NU arm experienced more grade ≥3 toxicity (75.8% vs 47.9%, P < .001), mainly related to myelosuppression. Of the 196 patients, 111 were tested for IDH1-R132H status (60 RT+TMZ and 51 RT+NU). Fifty-four patients were IDH negative and 49 were IDH positive with a better OS in IDH-positive patients (median survival time 7.9 vs 2.8 y; P = .004, HR = 0.50; 95% CI, 0.31-0.81). RT+TMZ did not appear to significantly improve OS or TTP for AA compared with RT+ NU. RT+TMZ was better tolerated. IDH1-R132H mutation was associated with longer survival. © The Author(s) 2016. Published by Oxford University Press on behalf of the Society for Neuro-Oncology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

  13. Diagnosis and management of acquired aplastic anemia in childhood. Guidelines from the Marrow Failure Study Group of the Pediatric Haemato-Oncology Italian Association (AIEOP).

    Science.gov (United States)

    Barone, Angelica; Lucarelli, Annunziata; Onofrillo, Daniela; Verzegnassi, Federico; Bonanomi, Sonia; Cesaro, Simone; Fioredda, Francesca; Iori, Anna Paola; Ladogana, Saverio; Locasciulli, Anna; Longoni, Daniela; Lanciotti, Marina; Macaluso, Alessandra; Mandaglio, Rosalba; Marra, Nicoletta; Martire, Baldo; Maruzzi, Matteo; Menna, Giuseppe; Notarangelo, Lucia Dora; Palazzi, Giovanni; Pillon, Marta; Ramenghi, Ugo; Russo, Giovanna; Svahn, Johanna; Timeus, Fabio; Tucci, Fabio; Cugno, Chiara; Zecca, Marco; Farruggia, Piero; Dufour, Carlo; Saracco, Paola

    2015-06-01

    Acquired aplastic anemia (AA) is a rare heterogeneous disease characterized by pancytopenia and hypoplastic bone marrow. The incidence is 2-3/million inhabitants/year, in Europe, but higher in East Asia. Survival in severe aplastic anemia (SAA) has markedly improved in the past 2 decades because of advances in hematopoietic stem cell transplantation, immunosuppressive and biologic drugs, and supportive care. In SAA hematopoietic stem cell transplant (HSCT) from a matched sibling donor (MSD) is the treatment of choice. If a MSD is not available, the options include immunosuppressive therapy (IST) or unrelated donor HSCT. The objective of this guideline is to provide healthcare professionals with clear guidance on the diagnosis and management of pediatric patients with AA. A preliminary, evidence-based document issued by a group of pediatric hematologists was discussed, modified and approved during a series of "Consensus Conferences" according to procedures previously validated by the AIEOP Board. The guidelines highlight the importance of referring pediatric patients with AA to pediatric centers with long experience in diagnosis, differential diagnosis, management, supportive care and follow-up of AA. Copyright © 2015. Published by Elsevier Inc.

  14. Applications of a solid phase radioimmunoassay (SPRIA) to the micro-determination of ABO blood group

    International Nuclear Information System (INIS)

    Wu Fenqiang; Guo Jingyuan

    1995-01-01

    The authors report a simple, rapid, sensitive and accurate solid phase radioimmunoassay (SPRIA) method which has been improved. The research included the tests of its methodological parameters, sensitivity, accuracy, and the studies on its applications to the detection of blood group substances in varied forensic biological materials. The coefficient variation of intra-assay was 5.6%, and that of inter-assay was 10.15%. As to its applications to the forensic serology, the ABO blood groups of human bloodstain, hair follicular tissues and salivary stains had been tested and the results were satisfying. Later, 50 unknown type bloodly samples had been blind tested. The judging level used to identify the positive and negative wells was 800 cpm, that meant, if the radioactive count of a well were over 800 cpm, it was determined as a positive well, if that of a well were below 800 cpm, it was negative well. As SPRIA is a method of micro-determination which can micro-test the blood group antigens contained in varied forensic biological materials, it should has a good future of its applications to the forensic medicine fields

  15. Female Representation in the Academic Oncology Physician Workforce: Radiation Oncology Losing Ground to Hematology Oncology

    Energy Technology Data Exchange (ETDEWEB)

    Ahmed, Awad A. [Sylvester Comprehensive Cancer Center University of Miami Health System, Miami, Florida (United States); Hwang, Wei-Ting [Department of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, Pennsylvania (United States); Holliday, Emma B. [Division of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Chapman, Christina H.; Jagsi, Reshma [Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan (United States); Thomas, Charles R. [Department of Radiation Medicine, Knight Cancer Institute, Oregon Health & Science University, Portland, Oregon (United States); Deville, Curtiland, E-mail: cdeville@jhmi.edu [Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University, Baltimore, Maryland (United States)

    2017-05-01

    Purpose: Our purpose was to assess comparative female representation trends for trainees and full-time faculty in the academic radiation oncology and hematology oncology workforce of the United States over 3 decades. Methods and Materials: Simple linear regression models with year as the independent variable were used to determine changes in female percentage representation per year and associated 95% confidence intervals for trainees and full-time faculty in each specialty. Results: Peak representation was 48.4% (801/1654) in 2013 for hematology oncology trainees, 39.0% (585/1499) in 2014 for hematology oncology full-time faculty, 34.8% (202/581) in 2007 for radiation oncology trainees, and 27.7% (439/1584) in 2015 for radiation oncology full-time faculty. Representation significantly increased for trainees and full-time faculty in both specialties at approximately 1% per year for hematology oncology trainees and full-time faculty and 0.3% per year for radiation oncology trainees and full-time faculty. Compared with radiation oncology, the rates were 3.84 and 2.94 times greater for hematology oncology trainees and full-time faculty, respectively. Conclusion: Despite increased female trainee and full-time faculty representation over time in the academic oncology physician workforce, radiation oncology is lagging behind hematology oncology, with trainees declining in recent years in radiation oncology; this suggests a de facto ceiling in female representation. Whether such issues as delayed or insufficient exposure, inadequate mentorship, or specialty competitiveness disparately affect female representation in radiation oncology compared to hematology oncology are underexplored and require continued investigation to ensure that the future oncologic physician workforce reflects the diversity of the population it serves.

  16. Female Representation in the Academic Oncology Physician Workforce: Radiation Oncology Losing Ground to Hematology Oncology

    International Nuclear Information System (INIS)

    Ahmed, Awad A.; Hwang, Wei-Ting; Holliday, Emma B.; Chapman, Christina H.; Jagsi, Reshma; Thomas, Charles R.; Deville, Curtiland

    2017-01-01

    Purpose: Our purpose was to assess comparative female representation trends for trainees and full-time faculty in the academic radiation oncology and hematology oncology workforce of the United States over 3 decades. Methods and Materials: Simple linear regression models with year as the independent variable were used to determine changes in female percentage representation per year and associated 95% confidence intervals for trainees and full-time faculty in each specialty. Results: Peak representation was 48.4% (801/1654) in 2013 for hematology oncology trainees, 39.0% (585/1499) in 2014 for hematology oncology full-time faculty, 34.8% (202/581) in 2007 for radiation oncology trainees, and 27.7% (439/1584) in 2015 for radiation oncology full-time faculty. Representation significantly increased for trainees and full-time faculty in both specialties at approximately 1% per year for hematology oncology trainees and full-time faculty and 0.3% per year for radiation oncology trainees and full-time faculty. Compared with radiation oncology, the rates were 3.84 and 2.94 times greater for hematology oncology trainees and full-time faculty, respectively. Conclusion: Despite increased female trainee and full-time faculty representation over time in the academic oncology physician workforce, radiation oncology is lagging behind hematology oncology, with trainees declining in recent years in radiation oncology; this suggests a de facto ceiling in female representation. Whether such issues as delayed or insufficient exposure, inadequate mentorship, or specialty competitiveness disparately affect female representation in radiation oncology compared to hematology oncology are underexplored and require continued investigation to ensure that the future oncologic physician workforce reflects the diversity of the population it serves.

  17. Female Representation in the Academic Oncology Physician Workforce: Radiation Oncology Losing Ground to Hematology Oncology.

    Science.gov (United States)

    Ahmed, Awad A; Hwang, Wei-Ting; Holliday, Emma B; Chapman, Christina H; Jagsi, Reshma; Thomas, Charles R; Deville, Curtiland

    2017-05-01

    Our purpose was to assess comparative female representation trends for trainees and full-time faculty in the academic radiation oncology and hematology oncology workforce of the United States over 3 decades. Simple linear regression models with year as the independent variable were used to determine changes in female percentage representation per year and associated 95% confidence intervals for trainees and full-time faculty in each specialty. Peak representation was 48.4% (801/1654) in 2013 for hematology oncology trainees, 39.0% (585/1499) in 2014 for hematology oncology full-time faculty, 34.8% (202/581) in 2007 for radiation oncology trainees, and 27.7% (439/1584) in 2015 for radiation oncology full-time faculty. Representation significantly increased for trainees and full-time faculty in both specialties at approximately 1% per year for hematology oncology trainees and full-time faculty and 0.3% per year for radiation oncology trainees and full-time faculty. Compared with radiation oncology, the rates were 3.84 and 2.94 times greater for hematology oncology trainees and full-time faculty, respectively. Despite increased female trainee and full-time faculty representation over time in the academic oncology physician workforce, radiation oncology is lagging behind hematology oncology, with trainees declining in recent years in radiation oncology; this suggests a de facto ceiling in female representation. Whether such issues as delayed or insufficient exposure, inadequate mentorship, or specialty competitiveness disparately affect female representation in radiation oncology compared to hematology oncology are underexplored and require continued investigation to ensure that the future oncologic physician workforce reflects the diversity of the population it serves. Copyright © 2017 Elsevier Inc. All rights reserved.

  18. Vesicular monoamine transporter protein expression correlates with clinical features, tumor biology, and MIBG avidity in neuroblastoma: a report from the Children's Oncology Group

    International Nuclear Information System (INIS)

    Temple, William; Mendelsohn, Lori; Nekritz, Erin; Gustafson, W.C.; Matthay, Katherine K.; Kim, Grace E.; Lin, Lawrence; Giacomini, Kathy; Naranjo, Arlene; Van Ryn, Collin; Yanik, Gregory A.; Kreissman, Susan G.; Hogarty, Michael; DuBois, Steven G.

    2016-01-01

    Vesicular monoamine transporters 1 and 2 (VMAT1 and VMAT2) are thought to mediate MIBG uptake in adult neuroendocrine tumors. In neuroblastoma, the norepinephrine transporter (NET) has been investigated as the principal MIBG uptake protein, though some tumors without NET expression concentrate MIBG. We investigated VMAT expression in neuroblastoma and correlated expression with MIBG uptake and clinical features. We evaluated VMAT1 and VMAT2 expression by immunohistochemistry (IHC) in neuroblastoma tumors from 76 patients with high-risk metastatic disease treated in a uniform cooperative group trial (COG A3973). All patients had baseline MIBG diagnostic scans centrally reviewed. IHC results were scored as the product of intensity grading (0 - 3+) and percent of tumor cells expressing the protein of interest. The association between VMAT1 and VMAT2 scores and clinical and biological features was tested using Wilcoxon rank-sum tests. Patient characteristics were typical of high-risk neuroblastoma, though the cohort was intentionally enriched in patients with MIBG-nonavid tumors (n = 20). VMAT1 and VMAT2 were expressed in 62 % and 75 % of neuroblastoma tumors, respectively. VMAT1 and VMAT2 scores were both significantly lower in MYCN amplified tumors and in tumors with high mitotic karyorrhectic index. MIBG-avid tumors had significantly higher VMAT2 scores than MIBG-nonavid tumors (median 216 vs. 45; p = 0.04). VMAT1 expression did not correlate with MIBG avidity. VMAT1 and VMAT2 are expressed in the majority of neuroblastomas. Expression correlates with other biological features. The expression level of VMAT2 but not that of VMAT1 correlates with avidity for MIBG. (orig.)

  19. What, why, and when we image: considerations for diagnostic imaging and clinical research in the Children's Oncology Group

    Energy Technology Data Exchange (ETDEWEB)

    Reaman, Gregory H. [The George Washington University, School of Medicine and Health Sciences, Division of Hematology Oncology, Children' s National Medical Center, Washington, DC (United States)

    2009-02-15

    Success in improving treatment outcomes in childhood cancer has been achieved almost exclusively through multicenter and multidisciplinary clinical and applied research over several decades. While biologically rational as well as empirical approaches have led to combination chemotherapy and multimodality approaches to therapy, which have given rise to evidence-based practice standards, similar scientific rigor has not always been as evidently applied to modalities utilized to assess initial disease burden and, more important, response to investigational approaches to therapy. As the empirical approach to therapeutic advances has likely maximized its benefit, future progress will require translation of biologic discovery most notably from the areas of genomics and proteomics. Hence, attempts to improve efficacy of therapy will require a parallel effort to minimize collateral damage of future therapeutic approaches, and such a parallel approach will mandate the continued dependence on advances in diagnostic imaging for improvements in staging methodologies to best define risk groups for risk-adjusted therapy. In addition, anatomic and functional assessment of response and surveillance for disease recurrence will require improved understanding of the biology as well as natural history of individual diseases, which one hopes will better inform investigators in designing trials. Clinical and research expertise is urgently needed in the selection of specific imaging studies and frequencies that best assess a response as well as to define disease-free intervals. Despite limited resources to develop sufficient infrastructure, emphasis on enabling early assessment of new technology to minimize risks associated with treatment advances and with those critical diagnostic and staging procedures must continue to be a focus of pediatric cancer clinical research. (orig.)

  20. Vesicular monoamine transporter protein expression correlates with clinical features, tumor biology, and MIBG avidity in neuroblastoma: a report from the Children's Oncology Group

    Energy Technology Data Exchange (ETDEWEB)

    Temple, William; Mendelsohn, Lori; Nekritz, Erin; Gustafson, W.C.; Matthay, Katherine K. [UCSF School of Medicine, Department of Pediatrics, San Francisco, CA (United States); UCSF Benioff Children' s Hospital, San Francisco, CA (United States); Kim, Grace E. [UCSF School of Medicine, Department of Pathology, San Francisco, CA (United States); Lin, Lawrence; Giacomini, Kathy [UCSF School of Pharmacy, Department of Bioengineering and Therapeutic Sciences, San Francisco, CA (United States); Naranjo, Arlene; Van Ryn, Collin [University of Florida, Children' s Oncology Group Statistics and Data Center, Gainesville, FL (United States); Yanik, Gregory A. [University of Michigan, CS Mott Children' s Hospital, Ann Arbor, MI (United States); Kreissman, Susan G. [Duke University Medical Center, Durham, NC (United States); Hogarty, Michael [University of Pennsylvania, Children' s Hospital of Philadelphia and Perelman School of Medicine, Philadelphia, PA (United States); DuBois, Steven G. [UCSF School of Medicine, Department of Pediatrics, San Francisco, CA (United States); UCSF Benioff Children' s Hospital, San Francisco, CA (United States); UCSF School of Medicine, San Francisco, CA (United States)

    2016-03-15

    Vesicular monoamine transporters 1 and 2 (VMAT1 and VMAT2) are thought to mediate MIBG uptake in adult neuroendocrine tumors. In neuroblastoma, the norepinephrine transporter (NET) has been investigated as the principal MIBG uptake protein, though some tumors without NET expression concentrate MIBG. We investigated VMAT expression in neuroblastoma and correlated expression with MIBG uptake and clinical features. We evaluated VMAT1 and VMAT2 expression by immunohistochemistry (IHC) in neuroblastoma tumors from 76 patients with high-risk metastatic disease treated in a uniform cooperative group trial (COG A3973). All patients had baseline MIBG diagnostic scans centrally reviewed. IHC results were scored as the product of intensity grading (0 - 3+) and percent of tumor cells expressing the protein of interest. The association between VMAT1 and VMAT2 scores and clinical and biological features was tested using Wilcoxon rank-sum tests. Patient characteristics were typical of high-risk neuroblastoma, though the cohort was intentionally enriched in patients with MIBG-nonavid tumors (n = 20). VMAT1 and VMAT2 were expressed in 62 % and 75 % of neuroblastoma tumors, respectively. VMAT1 and VMAT2 scores were both significantly lower in MYCN amplified tumors and in tumors with high mitotic karyorrhectic index. MIBG-avid tumors had significantly higher VMAT2 scores than MIBG-nonavid tumors (median 216 vs. 45; p = 0.04). VMAT1 expression did not correlate with MIBG avidity. VMAT1 and VMAT2 are expressed in the majority of neuroblastomas. Expression correlates with other biological features. The expression level of VMAT2 but not that of VMAT1 correlates with avidity for MIBG. (orig.)

  1. Association of MYCN copy number with clinical features, tumor biology, and outcomes in neuroblastoma: A report from the Children's Oncology Group.

    Science.gov (United States)

    Campbell, Kevin; Gastier-Foster, Julie M; Mann, Meegan; Naranjo, Arlene H; Van Ryn, Collin; Bagatell, Rochelle; Matthay, Katherine K; London, Wendy B; Irwin, Meredith S; Shimada, Hiroyuki; Granger, M Meaghan; Hogarty, Michael D; Park, Julie R; DuBois, Steven G

    2017-11-01

    High-level MYCN amplification (MNA) is associated with poor outcome and unfavorable clinical and biological features in patients with neuroblastoma. To the authors' knowledge, less is known regarding these associations in patients with low-level MYCN copy number increases. In this retrospective study, the authors classified patients has having tumors with MYCN wild-type tumors, MYCN gain (2-4-fold increase in MYCN signal compared with the reference probe), or MNA (>4-fold increase). Tests of trend were used to investigate ordered associations between MYCN copy number category and features of interest. Log-rank tests and Cox models compared event-free survival and overall survival by subgroup. Among 4672 patients, 3694 (79.1%) had MYCN wild-type tumors, 133 (2.8%) had MYCN gain, and 845 (18.1%) had MNA. For each clinical/biological feature, the percentage of patients with an unfavorable feature was lowest in the MYCN wild-type category, intermediate in the MYCN gain category, and highest in the MNA category (PNeuroblastoma Staging System) and patients with non-high-risk disease with MYCN gain had a significantly increased risk for death, a finding confirmed on multivariable testing. Increasing MYCN copy number is associated with an increasingly higher rate of unfavorable clinical/biological features, with 11q aberration being an exception. Patients with MYCN gain appear to have inferior outcomes, especially in otherwise more favorable groups. Cancer 2017;123:4224-4235. © 2017 American Cancer Society. © 2017 American Cancer Society.

  2. Phase and group refractive index curves for electromagnet waves moving in an ionised medium (1962); Courbes des indices de phase et de groupe d'ondes electromagnetiques se propageant dans un milieu ionise (1962)

    Energy Technology Data Exchange (ETDEWEB)

    Consoli, T [Commissariat a l' Energie Atomique, Saclay (France). Centre d' Etudes Nucleaires

    1962-07-01

    The family of curves presented in this table give the phase and group refractive indexes of plane electromagnetic waves propagating along and across a static magnetic field in a plasma. (author) [French] Les courbes presentees sous formes de reseaux donnent les indices de phase et de groupe d'ondes electromagnetiques planes se propageant longitudinalement ou transversalement dans un plasma en presence d'un champ magnetique statique. (auteur)

  3. Waste area Grouping 2 Phase I task data report: Human health risk assessment

    International Nuclear Information System (INIS)

    Purucker, S.T.; Douthat, D.M.

    1996-06-01

    This report is one of five reports issued in 1996 that provide follow- up information to the Phase 1 Remedial Investigation (RI) Report for Waste Area Grouping (WAG) 2 at Oak Ridge National Laboratory (ORNL). The five reports address areas of concern that could cause potential human health risk and ecological risk within WAG2 at ORNL. The purpose of this report is to present a summary of the human health risk assessment results based on the data collected for the WAG 2 Phase 1 RI. Estimates of risk are provided based on measured concentrations in the surface water, floodplain soil, and sediment of White Oak Creek, Melton Branch, and their tributaries. The human health risk assessment methodology used in this risk assessment is based on Risk Assessment Guidance for Superfund (RAGS). First, the data for the different media are elevated to determine usability for risk assessment. Second, through the process of selecting chemicals of potential concern (COPCs), contaminants to be considered in the risk assessment are identified for each assessment of exposure potential is performed, and exposure pathways are identified. Subsequently, exposure is estimated quantitatively, and the toxicity of each of the COPCs is determined. The results of these analyses are combined and summarized in a risk characterization

  4. Angular beam width of a slit-diffracted wave with noncollinear group and phase velocities

    International Nuclear Information System (INIS)

    Lock, Edwin H

    2012-01-01

    Taking magnetostatic surface wave diffraction as an example, this paper theoretically investigates the 2D diffraction pattern arising in the far-field region of a ferrite slab in the case of a plane wave with noncollinear group and phase velocities incident on a wide, arbitrarily oriented slit in an opaque screen. A universal analytical formula for the angular width of a diffracted beam is derived, which is valid for magnetostatic and other types of waves in anisotropic media and structures (including metamaterials) in 2D geometries. It is shown that the angular width of a diffracted beam in an anisotropic medium can not only take values greater or less than λ 0 /D (where λ 0 is the incident wavelength, and D is the slit width), but can also be zero under certain conditions. (methodological notes)

  5. Significance of PIK3CA Mutations in Patients with Early Breast Cancer Treated with Adjuvant Chemotherapy: A Hellenic Cooperative Oncology Group (HeCOG Study.

    Directory of Open Access Journals (Sweden)

    George Papaxoinis

    Full Text Available The PI3K-AKT pathway is frequently activated in breast cancer. PIK3CA mutations are most frequently found in the helical (exon 9 and kinase (exon 20 domains of this protein. The aim of the present study was to examine the role of different types of PIK3CA mutations in combination with molecular biomarkers related to PI3K-AKT signaling in patients with early breast cancer.Tumor tissue samples from 1008 early breast cancer patients treated with adjuvant chemotherapy in two similar randomized trials of HeCOG were examined. Tumors were subtyped with immunohistochemistry (IHC and FISH for ER, PgR, Ki67, HER2 and androgen receptor (AR. PIK3CA mutations were analyzed by Sanger sequencing (exon 20 and qPCR (exon 9 (Sanger/qPCR mutations. In 610 cases, next generation sequencing (NGS PIK3CA mutation data were also available. PIK3CA mutations and PTEN protein expression (IHC were analyzed in luminal tumors (ER and/or PgR positive, molecular apocrine carcinomas (MAC; ER/PgR negative / AR positive and hormone receptor (ER/PgR/AR negative tumors.PIK3CA mutations were detected in 235/1008 tumors (23% with Sanger/qPCR and in 149/610 tumors (24% with NGS. Concordance between the two methods was good with a Kappa coefficient of 0.76 (95% CI 0.69-0.82. Lobular histology, low tumor grade and luminal A tumors were associated with helical domain mutations (PIK3CAhel, while luminal B with kinase domain mutations (PIK3CAkin. The overall incidence of PIK3CA mutations was higher in luminal as compared to MAC and hormone receptor negative tumors (p = 0.004. Disease-free and overall survival did not significantly differ with respect to PIK3CA mutation presence and type. However, a statistically significant interaction between PIK3CA mutation status and PTEN low protein expression with regard to prognosis was identified.The present study did not show any prognostic significance of specific PIK3CA mutations in a large group of predominantly lymph-node positive breast cancer

  6. PROSPECTIVE EVALUATION OF AN IN VITRO RADIATION RESISTANCE ASSAY IN LOCALLY ADVANCED CANCER OF THE UTERINE CERVIX: A SOUTHWEST ONCOLOGY GROUP STUDY

    Science.gov (United States)

    Randall, Leslie M; Monk, Bradley J; Moon, James; Parker, Ricardo; Al-Ghazi, Muthana; Wilczynski, Sharon; Fruehauf, John P; Markman, Maurie; Burger, Robert A

    2010-01-01

    Objectives To investigate the feasibility of performing a fresh-tissue, in vitro radiation resistance assay (IVRRA) in a cooperative group setting and to assess the association of IVRRA results with clinical outcomes. Methods Women with Stages IIB-IVA carcinoma of the uterine cervix without obvious para-aortic lymphadenopathy on imaging were eligible. Primary tumor biopsies were shipped to a central testing facility where agar-based cell suspensions were exposed to 300 cGy of RT ± cisplatin and cultured for 5 days. 3H-thymidine incorporation was used to determine percent cell inhibition (PCI) of test specimen compared to that of the untreated control. Tumors were considered to exhibit extreme radiation resistance (ERR), intermediate radiation resistance (IRR) or low radiation resistance (LRR) based on a standard data set from 39 previously studied specimens. Standardized doses of external beam radiation and intracavitary brachytherapy, when feasible, in addition to platinum-based chemotherapy were mandated. Progression-free survival (PFS) was the primary endpoint. Clinical response and overall survival (OS) were secondary endpoints. Clinical investigators were blinded to assay data and vice versa. Results Thirty-six patients were enrolled, but analysis was limited to 17 patients whose specimens were adequate for IVRRA. The median follow-up time was 40 months. There was no association between IVRRA and response. In the Cox model, IRR/ERR tumors showed worse PFS [HR=11.2 (95% CI 1.3–96, p=0.03)] and worse OS [HR=11.7 (95% CI 1.4–99.6, p=0.03)] compared to LRR tumors when IVRRA was performed with RT alone, but there were no associations between IVRRA and PFS or OS when cisplatin was added to the IVRRA. Conclusions IVRRA (RT alone) results correlated with PFS and OS in this prospective trial, but follow-up trials are indicated to address feasibility and to confirm results in an expanded cohort. If confirmed, IVRRA could potentially direct molecular identification

  7. Nasopharyngeal carcinoma in a low incidence European area. A prospective observational analysis from the Head and Neck Study Group of the Italian Society of Radiation Oncology (AIRO)

    Energy Technology Data Exchange (ETDEWEB)

    Tonoli, S.; Bruschieri, L. [Brescia University, Istituto del Radio, Brescia (Italy); Alterio, D. [European Institute of Oncology, Milan (Italy); Caspiani, O. [Isola Tiberina Hospital, Rome (Italy); Bacigalupo, A. [IRCCS A.O.U. San Martino IST Genoa, Genoa (Italy); Bunkheila, F. [S. Orsola Hospital, Bologna (Italy); Cianciulli, M. [S. Camillo Hospital, Rome (Italy); Merlotti, A. [Busto Arsizio Hospital, Busto Arsizio (Italy); Podhradska, A. [Milan University - Monza S. Gerardo Hospital, Milan (Italy); Rampino, M. [Turin University, Turin (Italy); Cante, D. [Treviglio Hospital, Treviglio (Italy); Gatta, R. [Brescia University, Istituto del Radio, Brescia (Italy); Prato Hospital, Prato (Italy); Magrini, S.M.

    2016-12-15

    To evaluate the outcomes with respect to long-term survival and toxicity in patients with nasopharyngeal carcinoma (NPC) treated in a European country with low incidence. A prospective observational study carried out by the AIRO Head and Neck group in 12 Italian institutions included 136 consecutive patients treated with radiotherapy (RT) ± chemotherapy (CHT) for NPC (without distant metastasis) between January 1, 2008 and December 31, 2010. The disease-specific survival (DSS), overall survival (OS), and disease-free survival (DFS) at 5 years were 92 (±2), 91 (±3), and 69 % (±5 %), respectively. Distant failure was the most frequent modality of relapse. The local, regional, and locoregional control at 5 years were 89 (±3), 93 (±3), and 84 % (±4 %), respectively. The incidence of acute and late toxicity and the correlations with different clinical/technical variables were analyzed. Neoadjuvant CHT prolongs radiotherapy overall treatment time (OTT) and decreases treatment adherence during concomitant chemoradiotherapy. An adequate minimum dose coverage to PTV(T) is a predictive variable well related to outcome. Our data do not substantially differ in terms of survival and toxicity outcomes from those reported in larger series of patients treated in countries with higher incidences of NPC. The T stage (TNM 2002 UICC classification) is predictive of DSS and OS. The GTV volume (T ± N) and an adequate minimum PTV(T) coverage dose (D95 %) were also identified as potential predictive variables. Sophisticated technologies of dose delivery (IMRT) with image-guided radiotherapy could help to obtain better minimum PTV(T) coverage dose with increased DFS; distant metastasis after treatment still remains an unresolved issue. (orig.) [German] Bewertung von langfristigem Ueberleben und Toxizitaet bei Patienten mit Nasopharynxkarzinom (NPC), die in einem europaeischen Land mit geringer Inzidenz behandelt wurden. Die prospektive Beobachtungsanalyse, durchgefuehrt von der

  8. Quality Assessment in Oncology

    International Nuclear Information System (INIS)

    Albert, Jeffrey M.; Das, Prajnan

    2012-01-01

    The movement to improve healthcare quality has led to a need for carefully designed quality indicators that accurately reflect the quality of care. Many different measures have been proposed and continue to be developed by governmental agencies and accrediting bodies. However, given the inherent differences in the delivery of care among medical specialties, the same indicators will not be valid across all of them. Specifically, oncology is a field in which it can be difficult to develop quality indicators, because the effectiveness of an oncologic intervention is often not immediately apparent, and the multidisciplinary nature of the field necessarily involves many different specialties. Existing and emerging comparative effectiveness data are helping to guide evidence-based practice, and the increasing availability of these data provides the opportunity to identify key structure and process measures that predict for quality outcomes. The increasing emphasis on quality and efficiency will continue to compel the medical profession to identify appropriate quality measures to facilitate quality improvement efforts and to guide accreditation, credentialing, and reimbursement. Given the wide-reaching implications of quality metrics, it is essential that they be developed and implemented with scientific rigor. The aims of the present report were to review the current state of quality assessment in oncology, identify existing indicators with the best evidence to support their implementation, and propose a framework for identifying and refining measures most indicative of true quality in oncologic care.

  9. Quality Assessment in Oncology

    Energy Technology Data Exchange (ETDEWEB)

    Albert, Jeffrey M. [Department of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Das, Prajnan, E-mail: prajdas@mdanderson.org [Department of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas (United States)

    2012-07-01

    The movement to improve healthcare quality has led to a need for carefully designed quality indicators that accurately reflect the quality of care. Many different measures have been proposed and continue to be developed by governmental agencies and accrediting bodies. However, given the inherent differences in the delivery of care among medical specialties, the same indicators will not be valid across all of them. Specifically, oncology is a field in which it can be difficult to develop quality indicators, because the effectiveness of an oncologic intervention is often not immediately apparent, and the multidisciplinary nature of the field necessarily involves many different specialties. Existing and emerging comparative effectiveness data are helping to guide evidence-based practice, and the increasing availability of these data provides the opportunity to identify key structure and process measures that predict for quality outcomes. The increasing emphasis on quality and efficiency will continue to compel the medical profession to identify appropriate quality measures to facilitate quality improvement efforts and to guide accreditation, credentialing, and reimbursement. Given the wide-reaching implications of quality metrics, it is essential that they be developed and implemented with scientific rigor. The aims of the present report were to review the current state of quality assessment in oncology, identify existing indicators with the best evidence to support their implementation, and propose a framework for identifying and refining measures most indicative of true quality in oncologic care.

  10. Nanomedicine in veterinary oncology.

    Science.gov (United States)

    Lin, Tzu-Yin; Rodriguez, Carlos O; Li, Yuanpei

    2015-08-01

    Nanomedicine is an interdisciplinary field that combines medicine, engineering, chemistry, biology and material sciences to improve disease management and can be especially valuable in oncology. Nanoparticle-based agents that possess functions such as tumor targeting, imaging and therapy are currently under intensive investigation. This review introduces the basic concept of nanomedicine and the classification of nanoparticles. Because of their favorable pharmacokinetics, tumor targeting properties, and resulting superior efficacy and toxicity profiles, nanoparticle-based agents can overcome several limitations associated with conventional diagnostic and therapeutic protocols in veterinary oncology. The two most important tumor targeting mechanisms (passive and active tumor targeting) and their dominating factors (i.e. shape, charge, size and nanoparticle surface display) are discussed. The review summarizes published clinical and preclinical studies that utilize different nanoformulations in veterinary oncology, as well as the application of nanoparticles for cancer diagnosis and imaging. The toxicology of various nanoformulations is also considered. Given the benefits of nanoformulations demonstrated in human medicine, nanoformulated drugs are likely to gain more traction in veterinary oncology. Published by Elsevier Ltd.

  11. Unilateral Muscle Artifacts due to Non-compliance During Uptake Phase of 18F-FDG PET/CT in an Oncologic Patient

    Directory of Open Access Journals (Sweden)

    William Makis

    2018-02-01

    Full Text Available A 49-year-old male patient with a prior history of poor compliance with medical appointments was referred for an 18F-fluoro-2-deoxy-D-glucose (18F-FDG positron emission tomography/computed tomography (PET/CT for the staging of a rectal squamous cell carcinoma. The PET/CT showed unilateral diffuse skeletal muscle 18F-FDG uptake as well as bilateral salivary gland uptake artifacts, suggestive of non-compliance with patient preparation instructions. The PET/CT nurse noted that during the 18F-FDG uptake phase, the patient appeared intoxicated, and she found two beer cans hidden in the waste disposal beside his chair just prior to imaging. The patient only admitted to eating a cookie approximately 30 minutes after the injection of 18F-FDG PET/CT and denied consuming alcohol during the uptake phase. We present the imaging findings of non-compliance with patient instructions during the uptake phase of 18F-FDG.

  12. Molecular imaging in oncology

    Energy Technology Data Exchange (ETDEWEB)

    Schober, Otmar; Riemann, Burkhard (eds.) [Universitaetsklinikum Muenster (Germany). Klinik fuer Nuklearmedizin

    2013-02-01

    Considers in detail all aspects of molecular imaging in oncology, ranging from basic research to clinical applications in the era of evidence-based medicine. Examines technological issues and probe design. Discusses preclinical studies in detail, with particular attention to multimodality imaging. Presents current clinical use of PET/CT, SPECT/CT, and optical imagingWritten by acknowledged experts. The impact of molecular imaging on diagnostics, therapy, and follow-up in oncology is increasing significantly. The process of molecular imaging includes key biotarget identification, design of specific molecular imaging probes, and their preclinical evaluation, e.g., in vivo using small animal studies. A multitude of such innovative molecular imaging probes have already entered clinical diagnostics in oncology. There is no doubt that in future the emphasis will be on multimodality imaging in which morphological, functional, and molecular imaging techniques are combined in a single clinical investigation that will optimize diagnostic processes. This handbook addresses all aspects of molecular imaging in oncology, ranging from basic research to clinical applications in the era of evidence-based medicine. The first section is devoted to technology and probe design, and examines a variety of PET and SPECT tracers as well as multimodality probes. Preclinical studies are then discussed in detail, with particular attention to multimodality imaging. In the third section, diverse clinical applications are presented, and the book closes by looking at future challenges. This handbook will be of value to all who are interested in the revolution in diagnostic oncology that is being brought about by molecular imaging.

  13. Molecular imaging in oncology

    International Nuclear Information System (INIS)

    Schober, Otmar; Riemann, Burkhard

    2013-01-01

    Considers in detail all aspects of molecular imaging in oncology, ranging from basic research to clinical applications in the era of evidence-based medicine. Examines technological issues and probe design. Discusses preclinical studies in detail, with particular attention to multimodality imaging. Presents current clinical use of PET/CT, SPECT/CT, and optical imagingWritten by acknowledged experts. The impact of molecular imaging on diagnostics, therapy, and follow-up in oncology is increasing significantly. The process of molecular imaging includes key biotarget identification, design of specific molecular imaging probes, and their preclinical evaluation, e.g., in vivo using small animal studies. A multitude of such innovative molecular imaging probes have already entered clinical diagnostics in oncology. There is no doubt that in future the emphasis will be on multimodality imaging in which morphological, functional, and molecular imaging techniques are combined in a single clinical investigation that will optimize diagnostic processes. This handbook addresses all aspects of molecular imaging in oncology, ranging from basic research to clinical applications in the era of evidence-based medicine. The first section is devoted to technology and probe design, and examines a variety of PET and SPECT tracers as well as multimodality probes. Preclinical studies are then discussed in detail, with particular attention to multimodality imaging. In the third section, diverse clinical applications are presented, and the book closes by looking at future challenges. This handbook will be of value to all who are interested in the revolution in diagnostic oncology that is being brought about by molecular imaging.

  14. Theoretical and practice formation in oncological infirmary for pre graduate students in Colombia

    International Nuclear Information System (INIS)

    Chalela, S; Orduz, G; Almenares C

    1999-01-01

    The cancer appears in Colombia like one of the first three causes of mortality, with growing projection from 1991. To know the reality on the teaching of the oncology in the levels of pre-graduate formation in infirmary, it is the fundamental objective of the present work, to determine the theoretical contained and the practices activities that it has more than enough the topic they become trained at the moment in the country and in a same way to establish basic limits of the duty to belong to the nurse in this area. The present study is of traverse descriptive type, and it was developed in two phases. The first of quantitative type, directed to all the academic units of Colombia with pre-graduate formation in infirmary that they had a graduated promotion at least. The total was of 21 universities, 18 of those, which the surveys responded, that included the identification of the academic unit and the hours assigned for each one of the oncology topics, in theoretical contents and activities practice. The second phase, of qualitative type, was developed using the consent Delphi methodology, with selection of a group of experts (for the study they were 11 nurses of the whole country) that had pos-grade in oncology infirmary or at least 5 years of professional experience in the oncology area. Each one qualified the importance of each oncology topic and it expressed their approach about hours in theoretical contents and in activities practice that they should become trained to the infirmary students in the pre-graduate; of the 18 analyzed academic units, 13 considered as insufficient the contents that it has more than enough oncology, this at the moment teaching to the pre-graduate students in Colombia. The work concludes with the description of the topics that at the moment they are teaching the academic units in Colombia and with the basic limits that it has more than enough oncology, the experts consider necessary for the formation in the infirmary pre-graduate in

  15. Renormalization Group and Phase Transitions in Spin, Gauge, and QCD Like Theories

    Energy Technology Data Exchange (ETDEWEB)

    Liu, Yuzhi [Univ. of Iowa, Iowa City, IA (United States)

    2013-08-01

    In this thesis, we study several different renormalization group (RG) methods, including the conventional Wilson renormalization group, Monte Carlo renormalization group (MCRG), exact renormalization group (ERG, or sometimes called functional RG), and tensor renormalization group (TRG).

  16. Waste Area Grouping 2 Remedial Investigation Phase 1 Seep Task data report: Contaminant source area assessment

    International Nuclear Information System (INIS)

    Hicks, D.S.

    1996-03-01

    This report presents the findings of the Waste Area Grouping (WAG) 2, Phase 1 Remedial Investigation (RI) Seep Task efforts during 1993 and 1994 at Oak Ridge National Laboratory (ORNL). The results presented here follow results form the first year of sampling, 1992, which are contained in the Phase 1 RI report for WAG 2 (DOE 1995a). The WAG 2 Seep Task efforts focused on contaminants in seeps, tributaries, and main streams within the White Oak Creek (WOC) watershed. This report is designed primarily as a reference for contaminants and a resource for guiding remedial decisions. Additional in-depth assessments of the Seep Task data may provide clearer understandings of contaminant transport from the different source areas in the WOC watershed. WAG 2 consists of WOC and its tributaries downstream of the ORNL main plant area, White Oak Lake, the White Oak Creek Embayment of the Clinch River, and the associated flood plains and subsurface environment. The WOC watershed encompasses ORNL and associated WAGs. WAG 2 acts as an integrator for contaminant releases from the contaminated sites at ORNL and as the conduit transporting contaminants to the Clinch River. The main objectives of the Seep Task were to identify and characterize seeps, tributaries and source areas that are responsible for the contaminant releases to the main streams in WAG 2 and to quantify their input to the total contaminant release from the watershed at White Oak Dam (WOD). Efforts focused on 90 Sr, 3 H, and 137 Cs because these contaminants pose the greatest potential human health risk from water ingestion at WOD. Bimonthly sampling was conducted throughout the WOC watershed beginning in March 1993 and ending in August 1994. Samples were also collected for metals, anions, alkalinity, organics, and other radionuclides

  17. Prognostic factors in children and adolescents with acute myeloid leukemia (excluding children with Down syndrome and acute promyelocytic leukemia): univariate and recursive partitioning analysis of patients treated on Pediatric Oncology Group (POG) Study 8821.

    Science.gov (United States)

    Chang, M; Raimondi, S C; Ravindranath, Y; Carroll, A J; Camitta, B; Gresik, M V; Steuber, C P; Weinstein, H

    2000-07-01

    The purpose of the paper was to define clinical or biological features associated with the risk for treatment failure for children with acute myeloid leukemia. Data from 560 children and adolescents with newly diagnosed acute myeloid leukemia who entered the Pediatric Oncology Group Study 8821 from June 1988 to March 1993 were analyzed by univariate and recursive partitioning methods. Children with Down syndrome or acute promyelocytic leukemia were excluded from the study. Factors examined included age, number of leukocytes, sex, FAB morphologic subtype, cytogenetic findings, and extramedullary disease at the time of diagnosis. The overall event-free survival (EFS) rate at 4 years was 32.7% (s.e. = 2.2%). Age > or =2 years, fewer than 50 x 10(9)/I leukocytes, and t(8;21) or inv(16), and normal chromosomes were associated with higher rates of EFS (P value = 0.003, 0.049, 0.0003, 0.031, respectively), whereas the M5 subtype of AML (P value = 0.0003) and chromosome abnormalities other than t(8;21) and inv(16) were associated with lower rates of EFS (P value = 0.0001). Recursive partitioning analysis defined three groups of patients with widely varied prognoses: female patients with t(8;21), inv(16), or a normal karyotype (n = 89) had the best prognosis (4-year EFS = 55.1%, s.e. = 5.7%); male patients with t(8;21), inv(16) or normal chromosomes (n = 106) had an intermediate prognosis (4-year EFS = 38.1%, s.e. = 5.3%); patients with chromosome abnormalities other than t(8;21) and inv(16) (n = 233) had the worst prognosis (4-year EFS = 27.0%, s.e. = 3.2%). One hundred and thirty-two patients (24%) could not be grouped because of missing cytogenetic data, mainly due to inadequate marrow samples. The results suggest that pediatric patients with acute myeloid leukemia can be categorized into three potential risk groups for prognosis and that differences in sex and chromosomal abnormalities are associated with differences in estimates of EFS. These results are tentative and

  18. Long-Term Treatment Sequelae After External Beam Irradiation With or Without Hormonal Manipulation for Adenocarcinoma of the Prostate: Analysis of Radiation Therapy Oncology Group Studies 85-31, 86-10, and 92-02

    International Nuclear Information System (INIS)

    Lawton, Colleen A.; Bae, Kyoungwha; Pilepich, Miljenko; Hanks, Gerald; Shipley, William

    2008-01-01

    Purpose: Late gastrointestinal (GI) and genitourinary (GU) morbidity from external beam irradiation used to treat adenocarcinoma of the prostate continue to be a concern of physicians and patients alike. In addition, for locally advanced/high-risk cancer, the appropriate use of hormonal manipulation in addition to radiation therapy (RT) may increase toxicity. We analyzed three large Radiation Therapy Oncology Group (RTOG) studies (85-31, 86-10, and 92-02) to try to address these issues. Methods and Materials: A total of 2,922 patients were accrued with a median follow-up of 10.3 years for surviving patients. The RTOG scoring scheme was used to assess GI, GU, and other toxicities. Toxicity reported was Grade 3 or higher late toxicity. Patient toxicity level was assessed by study and by treatment type combining RT only vs. RT + short-course hormone therapy (STH) vs. RT + long-term hormone therapy (LTH). Results: Multivariate analysis reveals that age >70 was statistically significantly associated with a decrease in late any Grade 3+ toxicity (hazard ratio [HR] = 0.78, p = 0.0476) adjusted for treatment type. Comparing treatment type, patients treated with RT+STH had a statistically significant lower probability of Grade 3+ GI, GU, and other toxicity compared with RT alone (p = .00006; p = 0.0037; p = 0.0127, respectively). Patients treated with RT+LTH had a statistically significant lower probability of Grade 3+ GU toxicity compared with RT alone (p = 0.023). Conclusions: These data show that external beam radiation therapy remains a safe option for locally advanced/high-risk prostate cancer, and the use of hormonal manipulation does appear to be protective for GU and GI toxicity depending upon length of treatment

  19. Results of a Quality Assurance Review of External Beam Radiation Therapy in the International Society of Paediatric Oncology (Europe) Neuroblastoma Group's High-risk Neuroblastoma Trial: A SIOPEN Study

    International Nuclear Information System (INIS)

    Gaze, Mark N.; Boterberg, Tom; Dieckmann, Karin; Hörmann, Marcus; Gains, Jennifer E.; Sullivan, Kevin P.; Ladenstein, Ruth

    2013-01-01

    Purpose: Radiation therapy is important for local control in neuroblastoma. This study reviewed the compliance of plans with the radiation therapy guidelines of the International Society of Paediatric Oncology (Europe) Neuroblastoma Group (SIOPEN) High-Risk Trial protocol. Methods and Materials: The SIOPEN trial central electronic database has sections to record diagnostic imaging and radiation therapy planning data. Individual centers may upload data remotely, but not all centers involved in the trial chose to use this system. A quality scoring system was devised based on how well the radiation therapy plan matched the protocol guidelines, to what extent deviations were justified, and whether adverse effects may result. Central review of radiation therapy planning was undertaken retrospectively in 100 patients for whom complete diagnostic and treatment sets were available. Data were reviewed and compared against protocol guidelines by an international team of radiation oncologists and radiologists. For each patient in the sample, the central review team assigned a quality assurance score. Results: It was found that in 48% of patients there was full compliance with protocol requirements. In 29%, there were deviations for justifiable reasons with no likely long-term adverse effects resulting. In 5%, deviations had occurred for justifiable reasons, but that might result in adverse effects. In 1%, there was a deviation with no discernible justification, which would not lead to long-term adverse events. In 17%, unjustified deviations were noted, with a risk of an adverse outcome resulting. Conclusions: Owing to concern over the proportion of patients in whom unjustified deviations were observed, a protocol amendment has been issued. This offers the opportunity for central review of radiation therapy plans before the start of treatment and the treating clinician a chance to modify plans.

  20. A Comparative Evaluation of Normal Tissue Doses for Patients Receiving Radiation Therapy for Hodgkin Lymphoma on the Childhood Cancer Survivor Study and Recent Children's Oncology Group Trials

    Energy Technology Data Exchange (ETDEWEB)

    Zhou, Rachel; Ng, Angela [Department of Radiation Therapy, Princess Margaret Cancer Centre, Toronto, Ontario (Canada); Constine, Louis S. [Department of Radiation Oncology, University of Rochester, Rochester, New York (United States); Stovall, Marilyn [Division of Radiation Oncology, Department of Radiation Physics, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Armstrong, Gregory T. [Epidemiology/Cancer Control Department, St. Jude Children' s Research Hospital, Memphis, Tennessee (United States); Neglia, Joseph P. [Department of Pediatrics, University of Minnesota, Minneapolis, Minnesota (United States); Friedman, Debra L. [Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, Tennessee (United States); Kelly, Kara [Division of Pediatric Hematology/Oncology/Stem Cell Transplant, Department of Pediatrics, Columbia University Medical Center, New York, New York (United States); FitzGerald, Thomas J. [Department of Radiation Oncology, University of Massachusetts Medical School, Worcester, Massachusetts (United States); Imaging and Radiation Oncology Core Group, Lincoln, Rhode Island (United States); Hodgson, David C., E-mail: David.hodgson@rmp.uhn.on.ca [Department of Radiation Oncology, University of Toronto, and Radiation Medicine Program, Princess Margaret Hospital, Toronto, Ontario (Canada)

    2016-06-01

    Purpose: Survivors of pediatric Hodgkin lymphoma (HL) are recognized to have an increased risk of delayed adverse health outcomes related to radiation therapy (RT). However, the necessary latency required to observe these late effects means that the estimated risks apply to outdated treatments. We sought to compare the normal tissue dose received by children treated for HL and enrolled in the Childhood Cancer Survivor Study (CCSS) (diagnosed 1970-1986) with that of patients treated in recent Children's Oncology Group (COG) trials (enrolled 2002-2012). Methods and Materials: RT planning data were obtained for 50 HL survivors randomly sampled from the CCSS cohort and applied to computed tomography planning data sets to reconstruct the normal tissue dosimetry. For comparison, the normal tissue dosimetry data were obtained for all 191 patients with full computed tomography–based volumetric RT planning on COG protocols AHOD0031 and AHOD0831. Results: For early-stage patients, the mean female breast dose in the COG patients was on average 83.5% lower than that for CCSS patients, with an absolute reduction of 15.5 Gy. For advanced-stage patients, the mean breast dose was decreased on average by 70% (11.6 Gy average absolute dose reduction). The mean heart dose decreased on average by 22.9 Gy (68.6%) and 17.6 Gy (56.8%) for early- and advanced-stage patients, respectively. All dose comparisons for breast, heart, lung, and thyroid were significantly lower for patients in the COG trials than for the CCSS participants. Reductions in the prescribed dose were a major contributor to these dose reductions. Conclusions: These are the first data quantifying the significant reduction in the normal tissue dose using actual, rather than hypothetical, treatment plans for children with HL. These findings provide useful information when counseling families regarding the risks of contemporary RT.

  1. A Paired, Double-Blind, Randomized Comparison of a Moisturizing Durable Barrier Cream to 10% Glycerine Cream in the Prophylactic Management of Postmastectomy Irradiation Skin Care: Trans Tasman Radiation Oncology Group (TROG) 04.01

    Energy Technology Data Exchange (ETDEWEB)

    Graham, Peter H., E-mail: peter.graham@sesiahs.health.nsw.gov.au [Cancer Care Centre, St. George Hospital, Kogarah, New South Wales (Australia); Plant, Natalie; Graham, Jennifer L.; Browne, Lois [Cancer Care Centre, St. George Hospital, Kogarah, New South Wales (Australia); Borg, Martin [Department of Radiation Oncology, Royal Adelaide Hospital (Australia); Capp, Anne [Department of Radiation Oncology, Mater Hospital, Newcastle, New South Wales (Australia); Delaney, Geoff P. [Cancer Care Centre, Liverpool Hospital, Liverpool, New South Wales (Australia); Harvey, Jennifer [Mater Hospital, South Brisbane, Queensland (Australia); Kenny, Lisbeth [Royal Brisbane Hospital, Herston, Queensland (Australia); Francis, Michael [Andrew Love Cancer Centre, Geelong (Australia); Zissiadis, Yvonne [Department of Radiation Oncology, Royal Perth Hospital, Perth (Australia)

    2013-05-01

    Purpose: A previous, unblinded study demonstrated that an alcohol-free barrier film containing an acrylate terpolymer (ATP) was effective in reducing skin reactions compared with a 10% glycerine cream (sorbolene). The different appearances of these products precluded a blinded comparison. To test the acrylate terpolymer principle in a double-blinded manner required the use of an alternative cream formulation, a moisturizing durable barrier cream (MDBC); the study was conducted by the Trans Tasman Radiation Oncology Group (TROG) as protocol 04.01. Methods and Materials: A total of 333 patients were randomized; 1 patient was ineligible and 14 patients withdrew or had less than 7 weeks' observations, leaving 318 for analysis. The chest wall was divided into medial and lateral compartments, and patients were randomized to have MDBC applied daily to the medial or lateral compartment and sorbolene to the other compartment. Weekly observations, photographs, and symptom scores (pain and pruritus) were collected to week 12 or resolution of skin reactions if earlier. Skin dose was confirmed by centrally calibrated thermoluminescent dosimeters. Results: Rates of medial and lateral compartment Common Toxicity Criteria (CTC), version 3, greater than or equal to grade 3 skin reactions were 23% and 41%, but rates by skin care product were identical at 32%. There was no significant difference between MDBC and sorbolene in the primary endpoint of peak skin reactions or secondary endpoints of area-under-the-curve skin reaction scores. Conclusions: The MDBC did not reduce the peak skin reaction compared to sorbolene. It is possible that this is related to the difference in the formulation of the cream compared with the film formulation. Skin dosimetry verification and double blinding are essential for radiation skin care comparative studies.

  2. Prospective, longitudinal assessment of quality of life in children from diagnosis to 3 months off treatment for standard risk acute lymphoblastic leukemia: Results of Children's Oncology Group study AALL0331.

    Science.gov (United States)

    Mitchell, Hannah-Rose; Lu, Xiaomin; Myers, Regina M; Sung, Lillian; Balsamo, Lyn M; Carroll, William L; Raetz, Elizabeth; Loh, Mignon L; Mattano, Leonard A; Winick, Naomi J; Devidas, Meenakshi; Hunger, Stephen P; Maloney, Kelly; Kadan-Lottick, Nina S

    2016-01-15

    Standard risk acute lymphoblastic leukemia (SR-ALL) has high cure rates, but requires 2-3 years of therapy. We aimed to (i) prospectively evaluate health-related quality of life (HRQOL) during and after SR-ALL therapy, and (ii) identify associated predictors. Parents of 160 SR-ALL patients enrolled on Children's Oncology Group (COG) therapeutic trial AALL0331 at 31 sites completed the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales (physical, emotional and social functioning) and Family Assessment Device-General Functioning (FAD-GF) at 1, 6 and 12 months after diagnosis, and 3 months post-therapy. Mean PedsQL scores in physical, emotional and social functioning were impaired 1 month after diagnosis but steadily improved. Three months post-therapy, impaired physical and social functioning was observed in 27.8 and 25.8% of patients, respectively. In repeated-measures analysis, problematic family functioning predicted emotional (OR = 1.85, 95% CI 1.03-3.34) and social (OR = 1.99, 95% CI 1.21-3.27) impairment. Larger household size was associated with social impairment (OR = 1.21, 95% CI 1.02-1.45). Adverse neurological event(s) during therapy predicted post-therapy physical (OR = 5.17, 95% CI 1.61-16.63) and social (OR = 8.17, 95% CI 1.19-56.16) impairment. HRQOL 1 month after diagnosis was not predictive of HRQOL 3 months after therapy completion. In conclusion, children with SR-ALL experience considerable impairment in HRQOL at the end of induction, but rapidly improve. However, many still experience physical and social impairment 3 months post-therapy, suggesting a role for continued family and physical functioning support. Longer follow-up is needed to determine if post-therapy deficits change over time. © 2015 UICC.

  3. A Paired, Double-Blind, Randomized Comparison of a Moisturizing Durable Barrier Cream to 10% Glycerine Cream in the Prophylactic Management of Postmastectomy Irradiation Skin Care: Trans Tasman Radiation Oncology Group (TROG) 04.01

    International Nuclear Information System (INIS)

    Graham, Peter H.; Plant, Natalie; Graham, Jennifer L.; Browne, Lois; Borg, Martin; Capp, Anne; Delaney, Geoff P.; Harvey, Jennifer; Kenny, Lisbeth; Francis, Michael; Zissiadis, Yvonne

    2013-01-01

    Purpose: A previous, unblinded study demonstrated that an alcohol-free barrier film containing an acrylate terpolymer (ATP) was effective in reducing skin reactions compared with a 10% glycerine cream (sorbolene). The different appearances of these products precluded a blinded comparison. To test the acrylate terpolymer principle in a double-blinded manner required the use of an alternative cream formulation, a moisturizing durable barrier cream (MDBC); the study was conducted by the Trans Tasman Radiation Oncology Group (TROG) as protocol 04.01. Methods and Materials: A total of 333 patients were randomized; 1 patient was ineligible and 14 patients withdrew or had less than 7 weeks' observations, leaving 318 for analysis. The chest wall was divided into medial and lateral compartments, and patients were randomized to have MDBC applied daily to the medial or lateral compartment and sorbolene to the other compartment. Weekly observations, photographs, and symptom scores (pain and pruritus) were collected to week 12 or resolution of skin reactions if earlier. Skin dose was confirmed by centrally calibrated thermoluminescent dosimeters. Results: Rates of medial and lateral compartment Common Toxicity Criteria (CTC), version 3, greater than or equal to grade 3 skin reactions were 23% and 41%, but rates by skin care product were identical at 32%. There was no significant difference between MDBC and sorbolene in the primary endpoint of peak skin reactions or secondary endpoints of area-under-the-curve skin reaction scores. Conclusions: The MDBC did not reduce the peak skin reaction compared to sorbolene. It is possible that this is related to the difference in the formulation of the cream compared with the film formulation. Skin dosimetry verification and double blinding are essential for radiation skin care comparative studies

  4. Decline in Tested and Self-Reported Cognitive Functioning After Prophylactic Cranial Irradiation for Lung Cancer: Pooled Secondary Analysis of Radiation Therapy Oncology Group Randomized Trials 0212 and 0214

    International Nuclear Information System (INIS)

    Gondi, Vinai; Paulus, Rebecca; Bruner, Deborah W.; Meyers, Christina A.; Gore, Elizabeth M.; Wolfson, Aaron; Werner-Wasik, Maria; Sun, Alexander Y.; Choy, Hak; Movsas, Benjamin

    2013-01-01

    Purpose: To assess the impact of prophylactic cranial irradiation (PCI) on self-reported cognitive functioning (SRCF), a functional scale on the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30). Methods and Materials: Radiation Therapy Oncology Group (RTOG) protocol 0214 randomized patients with locally advanced non-small cell lung cancer to PCI or observation; RTOG 0212 randomized patients with limited-disease small cell lung cancer to high- or standard-dose PCI. In both trials, Hopkins Verbal Learning Test (HVLT)-Recall and -Delayed Recall and SRCF were assessed at baseline (after locoregional therapy but before PCI or observation) and at 6 and 12 months. Patients developing brain relapse before follow-up evaluation were excluded. Decline was defined using the reliable change index method and correlated with receipt of PCI versus observation using logistic regression modeling. Fisher's exact test correlated decline in SRCF with HVLT decline. Results: Of the eligible patients pooled from RTOG 0212 and RTOG 0214, 410 (93%) receiving PCI and 173 (96%) undergoing observation completed baseline HVLT or EORTC QLQ-C30 testing and were included in this analysis. Prophylactic cranial irradiation was associated with a higher risk of decline in SRCF at 6 months (odds ratio 3.60, 95% confidence interval 2.34-6.37, P<.0001) and 12 months (odds ratio 3.44, 95% confidence interval 1.84-6.44, P<.0001). Decline on HVLT-Recall at 6 and 12 months was also associated with PCI (P=.002 and P=.002, respectively) but was not closely correlated with decline in SRCF at the same time points (P=.05 and P=.86, respectively). Conclusions: In lung cancer patients who do not develop brain relapse, PCI is associated with decline in HVLT-tested and self-reported cognitive functioning. Decline in HVLT and decline in SRCF are not closely correlated, suggesting that they may represent distinct elements of the cognitive spectrum

  5. Prospective Trial of Stereotactic Body Radiation Therapy for Both Operable and Inoperable T1N0M0 Non-Small Cell Lung Cancer: Japan Clinical Oncology Group Study JCOG0403

    Energy Technology Data Exchange (ETDEWEB)

    Nagata, Yasushi, E-mail: nagat@hiroshima-u.ac.jp [Department of Radiation Oncology, Hiroshima University, Hiroshima (Japan); Hiraoka, Masahiro [Department of Radiation Oncology and Image-Applied Therapy, Kyoto University, Kyoto (Japan); Shibata, Taro [Japan Clinical Oncology Group Data Center, Center for Research Administration and Support, National Cancer Center, Tokyo (Japan); Onishi, Hiroshi [Department of Radiology, University of Yamanashi, Chuo (Japan); Kokubo, Masaki [Department of Image-Based Medicine, Institute of Biomedical Research and Innovation, Kobe (Japan); Karasawa, Katsuyuki [Department of Radiation Oncology, Tokyo Metropolitan Komagome Hospital, Tokyo (Japan); Shioyama, Yoshiyuki [Department of Clinical Radiology, Kyushu University, Fukuoka (Japan); Onimaru, Rikiya [Department of Radiology, Hokkaido University, Sapporo (Japan); Kozuka, Takuyo [Department of Radiation Oncology, The Cancer Institute Hospital, Tokyo (Japan); Kunieda, Etsuo [Department of Radiation Oncology, Keio University, Tokyo (Japan); Saito, Tsutomu [Department of Radiology, Nihon University Itabashi Hospital, Tokyo (Japan); Nakagawa, Keiichi [Department of Radiology, The University of Tokyo Hospital, Tokyo (Japan); Hareyama, Masato [Department of Radiology, Sapporo Medical University, Sapporo (Japan); Takai, Yoshihiro [Department of Radiation Oncology, Tohoku University, Sendai (Japan); Hayakawa, Kazushige [Department of Radiology and Radiation Oncology, Kitasato University, Sagamihara (Japan); Mitsuhashi, Norio [Department of Radiation Oncology, Tokyo Women' s Medical University, Tokyo (Japan); Ishikura, Satoshi [Department of Radiology, Koshigaya Municipal Hospital, Koshigaya (Japan)

    2015-12-01

    Purpose: To evaluate, in Japan Clinical Oncology Group study 0403, the safety and efficacy of stereotactic body radiation therapy (SBRT) in patients with T1N0M0 non-small cell lung cancer (NSCLC). Methods and Materials: Eligibility criteria included histologically or cytologically proven NSCLC, clinical T1N0M0. Prescribed dose was 48 Gy at the isocenter in 4 fractions. The primary endpoint was the percent (%) 3-year overall survival. The threshold % 3-year survival to be rejected was set at 35% for inoperable patients, whereas the expected % 3-year survival was 80% for operable patients. Results: Between July 2004 and November 2008, 169 patients from 15 institutions were registered. One hundred inoperable and 64 operable patients (total 164) were eligible. Patients' characteristics were 122 male, 47 female; median age 78 years (range, 50-91 years); adenocarcinomas, 90; squamous cell carcinomas, 61; others, 18. Of the 100 inoperable patients, the % 3-year OS was 59.9% (95% confidence interval 49.6%-68.8%). Grade 3 and 4 toxicities were observed in 10 and 2 patients, respectively. No grade 5 toxicity was observed. Of the 64 operable patients, the % 3-year OS was 76.5% (95% confidence interval 64.0%-85.1%). Grade 3 toxicities were observed in 5 patients. No grade 4 and 5 toxicities were observed. Conclusions: Stereotactic body radiation therapy for stage I NSCLC is effective, with low incidences of severe toxicity. This treatment can be considered a standard treatment for inoperable stage I NSCLC. This treatment is promising as an alternative to surgery for operable stage I NSCLC.

  6. Results of a Quality Assurance Review of External Beam Radiation Therapy in the International Society of Paediatric Oncology (Europe) Neuroblastoma Group's High-risk Neuroblastoma Trial: A SIOPEN Study

    Energy Technology Data Exchange (ETDEWEB)

    Gaze, Mark N., E-mail: mark.gaze@uclh.nhs.uk [Department of Oncology, University College London Hospitals NHS Foundation Trust, London (United Kingdom); Boterberg, Tom [Department of Radiation Oncology, Ghent University Hospital, Ghent (Belgium); Dieckmann, Karin; Hoermann, Marcus [General Hospital Vienna, Medical University Vienna (Austria); Gains, Jennifer E.; Sullivan, Kevin P. [Department of Oncology, University College London Hospitals NHS Foundation Trust, London (United Kingdom); Ladenstein, Ruth [Children' s Cancer Research Institute, St. Anna Children' s Hospital, Vienna (Austria)

    2013-01-01

    Purpose: Radiation therapy is important for local control in neuroblastoma. This study reviewed the compliance of plans with the radiation therapy guidelines of the International Society of Paediatric Oncology (Europe) Neuroblastoma Group (SIOPEN) High-Risk Trial protocol. Methods and Materials: The SIOPEN trial central electronic database has sections to record diagnostic imaging and radiation therapy planning data. Individual centers may upload data remotely, but not all centers involved in the trial chose to use this system. A quality scoring system was devised based on how well the radiation therapy plan matched the protocol guidelines, to what extent deviations were justified, and whether adverse effects may result. Central review of radiation therapy planning was undertaken retrospectively in 100 patients for whom complete diagnostic and treatment sets were available. Data were reviewed and compared against protocol guidelines by an international team of radiation oncologists and radiologists. For each patient in the sample, the central review team assigned a quality assurance score. Results: It was found that in 48% of patients there was full compliance with protocol requirements. In 29%, there were deviations for justifiable reasons with no likely long-term adverse effects resulting. In 5%, deviations had occurred for justifiable reasons, but that might result in adverse effects. In 1%, there was a deviation with no discernible justification, which would not lead to long-term adverse events. In 17%, unjustified deviations were noted, with a risk of an adverse outcome resulting. Conclusions: Owing to concern over the proportion of patients in whom unjustified deviations were observed, a protocol amendment has been issued. This offers the opportunity for central review of radiation therapy plans before the start of treatment and the treating clinician a chance to modify plans.

  7. Multicenter Study of Carbon-Ion Radiation Therapy for Mucosal Melanoma of the Head and Neck: Subanalysis of the Japan Carbon-Ion Radiation Oncology Study Group (J-CROS) Study (1402 HN)

    Energy Technology Data Exchange (ETDEWEB)

    Koto, Masashi, E-mail: koto.masashi@qst.go.jp [Hospital of the National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Sciences and Technology, Chiba (Japan); Demizu, Yusuke [Department of Radiology, Hyogo Ion Beam Medical Center, Tatsuno (Japan); Saitoh, Jun-ichi [Gunma University Heavy Ion Medical Center, Maebashi (Japan); Suefuji, Hiroaki [Ion Beam Therapy Center, SAGA-HIMAT Foundation, Tosu (Japan); Tsuji, Hiroshi [Hospital of the National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Sciences and Technology, Chiba (Japan); Okimoto, Tomoaki [Department of Radiology, Hyogo Ion Beam Medical Center, Tatsuno (Japan); Ohno, Tatsuya [Gunma University Heavy Ion Medical Center, Maebashi (Japan); Shioyama, Yoshiyuki [Ion Beam Therapy Center, SAGA-HIMAT Foundation, Tosu (Japan); Takagi, Ryo [Hospital of the National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Sciences and Technology, Chiba (Japan); Nemoto, Kenji [Department of Radiation Oncology, Yamagata University Faculty of Medicine, Yamagata (Japan); Nakano, Takashi [Gunma University Heavy Ion Medical Center, Maebashi (Japan); Kamada, Tadashi [Hospital of the National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Sciences and Technology, Chiba (Japan)

    2017-04-01

    Purpose: To evaluate the efficacy and safety of carbon-ion radiation therapy (RT) for mucosal melanoma of the head and neck (MMHN) in the Japan Carbon-Ion Radiation Oncology Study Group study. Methods and Materials: Patients with MMHN with N0-1M0 status who were treated with carbon-ion RT at 4 institutions in Japan between November 2003 and December 2014 were analyzed retrospectively. Two hundred sixty patients (male, 111; female, 149; median age, 68 years) with histologically proven MMHN were enrolled. Results: Primary sites included the nasal cavity in 178 patients, paranasal sinuses in 43, oral cavity in 27, and pharynx in 12. Eighty-six patients had T3 tumors, 147 had T4a tumors, and 27 had T4b tumors. Two hundred fifty-one patients were diagnosed with N0 disease, and 9 with N1 disease. The median total dose and number of fractions were 57.6 Gy RBE (relative biological effectiveness) and 16, respectively. Chemotherapy including dimethyl traizeno imidazole carboxamide was used concurrently in 129 patients. The median follow-up duration was 22 months (range, 1-132 months). The 2-year overall survival and local control rates were 69.4% and 83.9%, respectively. Multivariate analysis showed that gross tumor volume and concurrent chemotherapy were significant prognostic factors for overall survival. Grade 3 and grade 4 late morbidities were observed in 27 and 7 patients (5 developed ipsilateral blindness, 1 mucosal ulcer, and 1 second malignant disease in the irradiated volume), respectively. No patients developed grade 5 late morbidities. Conclusion: Carbon-ion RT is a promising treatment option for MMHN.

  8. Prospective Trial of Stereotactic Body Radiation Therapy for Both Operable and Inoperable T1N0M0 Non-Small Cell Lung Cancer: Japan Clinical Oncology Group Study JCOG0403

    International Nuclear Information System (INIS)

    Nagata, Yasushi; Hiraoka, Masahiro; Shibata, Taro; Onishi, Hiroshi; Kokubo, Masaki; Karasawa, Katsuyuki; Shioyama, Yoshiyuki; Onimaru, Rikiya; Kozuka, Takuyo; Kunieda, Etsuo; Saito, Tsutomu; Nakagawa, Keiichi; Hareyama, Masato; Takai, Yoshihiro; Hayakawa, Kazushige; Mitsuhashi, Norio; Ishikura, Satoshi

    2015-01-01

    Purpose: To evaluate, in Japan Clinical Oncology Group study 0403, the safety and efficacy of stereotactic body radiation therapy (SBRT) in patients with T1N0M0 non-small cell lung cancer (NSCLC). Methods and Materials: Eligibility criteria included histologically or cytologically proven NSCLC, clinical T1N0M0. Prescribed dose was 48 Gy at the isocenter in 4 fractions. The primary endpoint was the percent (%) 3-year overall survival. The threshold % 3-year survival to be rejected was set at 35% for inoperable patients, whereas the expected % 3-year survival was 80% for operable patients. Results: Between July 2004 and November 2008, 169 patients from 15 institutions were registered. One hundred inoperable and 64 operable patients (total 164) were eligible. Patients' characteristics were 122 male, 47 female; median age 78 years (range, 50-91 years); adenocarcinomas, 90; squamous cell carcinomas, 61; others, 18. Of the 100 inoperable patients, the % 3-year OS was 59.9% (95% confidence interval 49.6%-68.8%). Grade 3 and 4 toxicities were observed in 10 and 2 patients, respectively. No grade 5 toxicity was observed. Of the 64 operable patients, the % 3-year OS was 76.5% (95% confidence interval 64.0%-85.1%). Grade 3 toxicities were observed in 5 patients. No grade 4 and 5 toxicities were observed. Conclusions: Stereotactic body radiation therapy for stage I NSCLC is effective, with low incidences of severe toxicity. This treatment can be considered a standard treatment for inoperable stage I NSCLC. This treatment is promising as an alternative to surgery for operable stage I NSCLC.

  9. A Research Agenda for Radiation Oncology: Results of the Radiation Oncology Institute's Comprehensive Research Needs Assessment

    Energy Technology Data Exchange (ETDEWEB)

    Jagsi, Reshma, E-mail: rjagsi@med.umich.edu [Department of Radiation Oncology, University of Michigan, Ann Arbor, MI (United States); Bekelman, Justin E. [Department of Radiation Oncology, University of Pennsylvania, Philadelphia, PA (United States); Brawley, Otis W. [Department of Hematology and Oncology, Emory University, and American Cancer Society, Atlanta, Georgia (United States); Deasy, Joseph O. [Department of Radiation Oncology, Memorial Sloan-Kettering Cancer Center, New York, NY (United States); Le, Quynh-Thu [Department of Radiation Oncology, Stanford University, Stanford, CA (United States); Michalski, Jeff M. [Department of Radiation Oncology, Washington University, St. Louis, MO (United States); Movsas, Benjamin [Department of Radiation Oncology, Henry Ford Health System, Detroit, MI (United States); Thomas, Charles R. [Department of Radiation Oncology, Oregon Health and Sciences University, Portland, OR (United States); Lawton, Colleen A. [Department of Radiation Oncology, Medical College of Wisconsin, Milwaukee, WI (United States); Lawrence, Theodore S. [Department of Radiation Oncology, University of Michigan, Ann Arbor, MI (United States); Hahn, Stephen M. [Department of Radiation Oncology, University of Pennsylvania, Philadelphia, PA (United States)

    2012-10-01

    Purpose: To promote the rational use of scarce research funding, scholars have developed methods for the systematic identification and prioritization of health research needs. The Radiation Oncology Institute commissioned an independent, comprehensive assessment of research needs for the advancement of radiation oncology care. Methods and Materials: The research needs assessment used a mixed-method, qualitative and quantitative social scientific approach, including structured interviews with diverse stakeholders, focus groups, surveys of American Society for Radiation Oncology (ASTRO) members, and a prioritization exercise using a modified Delphi technique. Results: Six co-equal priorities were identified: (1) Identify and develop communication strategies to help patients and others better understand radiation therapy; (2) Establish a set of quality indicators for major radiation oncology procedures and evaluate their use in radiation oncology delivery; (3) Identify best practices for the management of radiation toxicity and issues in cancer survivorship; (4) Conduct comparative effectiveness studies related to radiation therapy that consider clinical benefit, toxicity (including quality of life), and other outcomes; (5) Assess the value of radiation therapy; and (6) Develop a radiation oncology registry. Conclusions: To our knowledge, this prioritization exercise is the only comprehensive and methodologically rigorous assessment of research needs in the field of radiation oncology. Broad dissemination of these findings is critical to maximally leverage the impact of this work, particularly because grant funding decisions are often made by committees on which highly specialized disciplines such as radiation oncology are not well represented.

  10. A Research Agenda for Radiation Oncology: Results of the Radiation Oncology Institute’s Comprehensive Research Needs Assessment

    International Nuclear Information System (INIS)

    Jagsi, Reshma; Bekelman, Justin E.; Brawley, Otis W.; Deasy, Joseph O.; Le, Quynh-Thu; Michalski, Jeff M.; Movsas, Benjamin; Thomas, Charles R.; Lawton, Colleen A.; Lawrence, Theodore S.; Hahn, Stephen M.

    2012-01-01

    Purpose: To promote the rational use of scarce research funding, scholars have developed methods for the systematic identification and prioritization of health research needs. The Radiation Oncology Institute commissioned an independent, comprehensive assessment of research needs for the advancement of radiation oncology care. Methods and Materials: The research needs assessment used a mixed-method, qualitative and quantitative social scientific approach, including structured interviews with diverse stakeholders, focus groups, surveys of American Society for Radiation Oncology (ASTRO) members, and a prioritization exercise using a modified Delphi technique. Results: Six co-equal priorities were identified: (1) Identify and develop communication strategies to help patients and others better understand radiation therapy; (2) Establish a set of quality indicators for major radiation oncology procedures and evaluate their use in radiation oncology delivery; (3) Identify best practices for the management of radiation toxicity and issues in cancer survivorship; (4) Conduct comparative effectiveness studies related to radiation therapy that consider clinical benefit, toxicity (including quality of life), and other outcomes; (5) Assess the value of radiation therapy; and (6) Develop a radiation oncology registry. Conclusions: To our knowledge, this prioritization exercise is the only comprehensive and methodologically rigorous assessment of research needs in the field of radiation oncology. Broad dissemination of these findings is critical to maximally leverage the impact of this work, particularly because grant funding decisions are often made by committees on which highly specialized disciplines such as radiation oncology are not well represented.

  11. Combined carboplatin plus ifosfamide and cisplatin in patients with advanced ovarian carcinoma. A phase I-II study. GOCS (Gynecological Oncology Cooperative Study).

    Science.gov (United States)

    Lorusso, V; Leone, B; Di Vagno, G; Manzione, L; Palmeri, S; Vallejo, C; Machiavelli, M; Nacci, G; Bilancia, D; Leonardi, V; Catino, A; Gargano, G; Loverro, G; Selvaggi, L; De Lena, M

    1998-02-01

    Because of the relative lack of overlapping toxicity, carboplatin (PPL) and cisplatin (CDDP) can be easily combined for treatment of ovarian cancer to increase total platinum dose intensity. Ifosfamide (IFO), one of the most effective single agents in ovarian cancer, has a low hematological toxicity when administered in continuous infusion. From January 1991 to December 1993, 34 patients with advanced ovarian cancer, previously untreated with chemo- or radiotherapy, were enrolled in a phase I-II study with the aim of determining the maximum tolerated dose (MTD) of CDDP (on day 8 of a 28-day cycle) in combination with PPL (300 mg/m2 on day 1) and IFO (4,000 mg/m2/24 h by continuous infusion on day 1). The initial dose level of CDDP was 40 mg/m2, which was continuously increased by 10 mg/m2 up to the MTD defined as one dose level below that inducing dose-limiting toxicity (DLT) in at least two-thirds of treated patients; no dose escalation was allowed in the same patient. Grade 3-4 leukopenia and thrombocytopenia were observed in 54 and 49% of patients, respectively. The DLT was reached at 70 mg/m2 and therefore the dose recommended for the phase II study was 60 mg/m2. Complete (CR) plus partial response was observed in 88% of patients with a 21% pathological CR. With a minimum follow-up of 32 months (median 40 months), median progression-free survival and overall survival were 21 and 39 months, respectively. In conclusion, the combination of CDDP, PPL, and IFO provides an effective regimen for ovarian cancer with an acceptable toxicity profile.

  12. NRG Oncology Radiation Therapy Oncology Group 0822: A Phase 2 Study of Preoperative Chemoradiation Therapy Using Intensity Modulated Radiation Therapy in Combination With Capecitabine and Oxaliplatin for Patients With Locally Advanced Rectal Cancer

    Energy Technology Data Exchange (ETDEWEB)

    Hong, Theodore S., E-mail: tshong1@mgh.harvard.edu [Massachusetts General Hospital, Boston, Massachusetts (United States); Moughan, Jennifer [NRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania (United States); Garofalo, Michael C. [University of Maryland School of Medicine, Baltimore, Maryland (United States); Bendell, Johanna [Sarah Cannon Research Institute, Nashville, Tennessee (United States); Berger, Adam C. [Thomas Jefferson University Hospital, Philadelphia, Pennsylvania (United States); Oldenburg, Nicklas B.E. [North Main Radiation Oncology, Providence, Rhode Island (United States); Anne, Pramila Rani [Thomas Jefferson University Hospital, Philadelphia, Pennsylvania (United States); Perera, Francisco [London Regional Cancer Program/Western Ontario, London, Ontario (Canada); Lee, R. Jeffrey [Intermountain Medical Center, Salt Lake City, Utah (United States); Jabbour, Salma K. [Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey (United States); Nowlan, Adam [Piedmont Hospital, Atlanta, Georgia (United States); DeNittis, Albert [Main Line Community Clinical Oncology Program, Wynnewood, Pennsylvania (United States); Crane, Christopher [University of Texas-MD Anderson Cancer Center, Houston, Texas (United States)

    2015-09-01

    Purpose: To evaluate the rate of gastrointestinal (GI) toxicity of neoadjuvant chemoradiation with capecitabine, oxaliplatin, and intensity modulated radiation therapy (IMRT) in cT3-4 rectal cancer. Methods and Materials: Patients with localized, nonmetastatic T3 or T4 rectal cancer <12 cm from the anal verge were enrolled in a prospective, multi-institutional, single-arm study of preoperative chemoradiation. Patients received 45 Gy with IMRT in 25 fractions, followed by a 3-dimensional conformal boost of 5.4 Gy in 3 fractions with concurrent capecitabine/oxaliplatin (CAPOX). Surgery was performed 4 to 8 weeks after the completion of therapy. Patients were recommended to receive FOLFOX chemotherapy after surgery. The primary endpoint of the study was acute grade 2 to 5 GI toxicity. Seventy-one patients provided 80% probability to detect at least a 12% reduction in the specified GI toxicity with the treatment of CAPOX and IMRT, at a significance level of .10 (1-sided). Results: Seventy-nine patients were accrued, of whom 68 were evaluable. Sixty-one patients (89.7%) had cT3 disease, and 37 (54.4%) had cN (+) disease. Postoperative chemotherapy was given to 42 of 68 patients. Fifty-eight patients had target contours drawn per protocol, 5 patients with acceptable variation, and 5 patients with unacceptable variations. Thirty-five patients (51.5%) experienced grade ≥2 GI toxicity, 12 patients (17.6%) experienced grade 3 or 4 diarrhea, and pCR was achieved in 10 patients (14.7%). With a median follow-up time of 3.98 years, the 4-year rate of locoregional failure was 7.4% (95% confidence interval [CI]: 1.0%-13.7%). The 4-year rates of OS and DFS were 82.9% (95% CI: 70.1%-90.6%) and 60.6% (95% CI: 47.5%-71.4%), respectively. Conclusion: The use of IMRT in neoadjuvant chemoradiation for rectal cancer did not reduce the rate of GI toxicity.

  13. NRG Oncology-Radiation Therapy Oncology Group Study 1014: 1-Year Toxicity Report From a Phase 2 Study of Repeat Breast-Preserving Surgery and 3-Dimensional Conformal Partial-Breast Reirradiation for In-Breast Recurrence.

    Science.gov (United States)

    Arthur, Douglas W; Winter, Kathryn A; Kuerer, Henry M; Haffty, Bruce G; Cuttino, Laurie W; Todor, Dorin A; Simone, Nicole L; Hayes, Shelly B; Woodward, Wendy A; McCormick, Beryl; Cohen, Randi J; Sahijdak, Walter M; Canaday, Daniel J; Brown, Doris R; Currey, Adam D; Fisher, Christine M; Jagsi, Reshma; White, Julia

    2017-08-01

    To determine the associated toxicity, tolerance, and safety of partial-breast reirradiation. Eligibility criteria included in-breast recurrence occurring >1 year after whole-breast irradiation, 1 to ≤2 cm, and 1 >2 cm. All patients were clinically node negative. Systemic therapy was delivered in 51%. All treatment plans underwent quality review for contouring accuracy and dosimetric compliance. All treatment plans scored acceptable for tumor volume contouring and tumor volume dose-volume analysis. Only 4 (7%) scored unacceptable for organs at risk contouring and organs at risk dose-volume analysis. Treatment-related skin, fibrosis, and/or breast pain AEs were recorded as grade 1 in 64% and grade 2 in 7%, with only 1 (<2%) grade ≥3 and identified as grade 3 fibrosis of deep connective tissue. Partial-breast reirradiation with 3-dimensional conformal radiation therapy after second lumpectomy for patients experiencing in-breast failures after whole-breast irradiation is safe and feasible, with acceptable treatment quality achieved. Skin, fibrosis, and breast pain toxicity was acceptable, and grade 3 toxicity was rare. Copyright © 2017 Elsevier Inc. All rights reserved.

  14. A Phase II Study of Intensity Modulated Radiation Therapy to the Pelvis for Postoperative Patients With Endometrial Carcinoma: Radiation Therapy Oncology Group Trial 0418

    Energy Technology Data Exchange (ETDEWEB)

    Jhingran, Anuja, E-mail: ajhingra@mdanderson.org [University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Winter, Kathryn [RTOG Statistical Center, Philadelphia, Pennsylvania (United States); Portelance, Lorraine [University of Miami, Miami, Florida (United States); Miller, Brigitte [Carolinas Medical Center North East, Concord, North Carolina (United States); Salehpour, Mohammad [University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Gaur, Rakesh [St. Luke' s Hospital, Kansas City, Missouri (United States); Souhami, Luis [McGill University Health Centre, Montreal, Quebec (Canada); Small, William [Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, Illionis (United States); Berk, Lawrence [H. Lee Moffitt Cancer Center, Tampa, Florida (United States); Gaffney, David [Huntsman Cancer Hospital, Salt Lake City, Utah (United States)

    2012-09-01

    Purpose: To determine the feasibility of pelvic intensity modulated radiation therapy (IMRT) for patients with endometrial cancer in a multi-institutional setting and to determine whether this treatment is associated with fewer short-term bowel adverse events than standard radiation therapy. Methods: Patients with adenocarcinoma of the endometrium treated with pelvic radiation therapy alone were eligible. Guidelines for target definition and delineation, dose prescription, and dose-volume constraints for the targets and critical normal structures were detailed in the study protocol and a web-based atlas. Results: Fifty-eight patients were accrued by 25 institutions; 43 were eligible for analysis. Forty-two patients (98%) had an acceptable IMRT plan; 1 had an unacceptable variation from the prescribed dose to the nodal planning target volume. The proportions of cases in which doses to critical normal structures exceeded protocol criteria were as follows: bladder, 67%; rectum, 76%; bowel, 17%; and femoral heads, 33%. Twelve patients (28%) developed grade {>=}2 short-term bowel adverse events. Conclusions: Pelvic IMRT for endometrial cancer is feasible across multiple institutions with use of a detailed protocol and centralized quality assurance (QA). For future trials, contouring of vaginal and nodal tissue will need continued monitoring with good QA and better definitions will be needed for organs at risk.

  15. Early toxicity from preoperative radiotherapy with continuous infusion 5-fluorouracil for resectable adenocarcinoma of the rectum: a Phase II trial for the Trans-Tasman Radiation Oncology Group

    International Nuclear Information System (INIS)

    Ngan, Samuel Y.K.; Burmeister, Bryan H.; Fisher, Richard; Rischin, Danny; Schache, David J.; Kneebone, Andrew; MacKay, John R.; Joseph, David; Bell, Andrew; Goldstein, David

    2001-01-01

    Purpose: To assess the toxicity and the efficacy of preoperative radiotherapy with continuous infusion 5-fluorouracil (5-FU) for locally advanced adenocarcinoma of the rectum. Methods and Materials: Eligible patients had newly diagnosed localized adenocarcinoma of the rectum within 12 cm of the anal verge, Stage T3-4, and were suitable for curative resection. Eighty-two patients were treated with radiotherapy--50.4 Gy in 28 fractions in 5.6 weeks, given concurrently with continuous infusion 5-FU, using either 96-h/week infusion at 300 mg/m 2 /day or 7-days/week infusion at 225 mg/m 2 /day. Results: The median age was 59 years (range, 27-87), and 67% of patients were male. Pretreatment stages of the rectal cancer were T3, 89% and resectable T4, 11%, with endorectal ultrasound confirmation in 67% of patients. Grade 3 acute toxicity occurred in 5 of 82 patients (6%; 95% confidence interval [CI], 2-14%). Types of surgical resection were anterior resection, 61%; abdominoperineal resection, 35%; and other procedures, 4%. There was no operative mortality. Anastomotic leakage after low anterior resection occurred in 3 of 50 patients (6%; 95% CI, 1-17%). The pathologic complete response rate was 16% (95% CI, 9-26%). Pathologic Stages T2 or less occurred in 51%. Conclusion: Preoperative radiotherapy with continuous infusion 5-FU for locally advanced rectal cancer is a safe regimen, with a significant downstaging effect. It does not seem to lead to a significant increase in serious surgical complications

  16. A PHASE II STUDY OF GEMCITABINE AND CAPECITABINE IN PATIENTS WITH ADVANCED RENAL CELL CANCER (RCC): SOUTHWEST ONCOLOGY GROUP STUDY S0312

    Science.gov (United States)

    Van Veldhuizen, Peter J.; Hussey, Michael; Lara, Primo N.; Mack, Philip C.; Gandour-Edwards, Regina; Clark, Joseph I.; Lange, Marianne K.; Crawford, E. David

    2010-01-01

    Background Gemcitabine plus capecitabine has modest efficacy in patients with advanced RCC but has considerable toxicity. We evaluated the efficacy and toxicity of a modified dose-schedule of this doublet in patients with advanced unresectable or metastatic RCC. Methods Chemotherapy-naïve patients were treated with gemcitabine at 900mg/m2 on days 1,8,15 and capecitabine at 625mg/m2 twice daily on days 1 through 21, every 28 days. Eligible patients must have adequate performance status and end-organ function. The primary endpoint was tumor response rate (RR). No further evaluation of this regimen would be pursued if the RR was ≤ 5%. In an exploratory manner using archival specimens, we also evaluated potential markers of prognosis and treatment response including thymidylate synthase (TS) gene polymorphisms and tumor expression of p53, PTEN, pAKT, pmTOR, and ERCC1. Results Of 43 patients registered, 1 was ineligible and 2 were not analyzable. There was 1 confirmed complete response (CR) and three unconfirmed partial responses (PR), for an overall response rate of 10% (95% CI: 3, 24). Nineteen patients (48%) had stable disease (SD). The six-month freedom-from-treatment-failure and overall survival rates were 20% (95% CI: 8, 32) and 75% (95% CI: 62, 88), respectively. Median survival time was 23 months (95% CI: 10, 37). One patient each experienced Grade 4 neutropenia, fatigue, thrombocytopenia and hemolysis with renal failure. The most common Grade 3 toxicities were neutropenia (12 patients), fatigue (5), and leucopenia (4). Patients with a best response of stable disease or better were more likely to have a decrease in expression of PTEN and an increased expression of pmTOR. Conclusions Gemcitabine plus capecitabine at this reduced dose-schedule benefits a small percentage of patients with RCC with an acceptable toxicity profile. The combination of gemcitabine and capecitabine may serve as a base regimen for combination therapy with targeted agents in select RCC patients. PMID:19487915

  17. A prospective phase II study of adjuvant postoperative radiation therapy following nodal surgery in malignant melanoma-Trans Tasman Radiation Oncology Group (TROG) Study 96.06

    International Nuclear Information System (INIS)

    Burmeister, Bryan H.; Mark Smithers, B.; Burmeister, Elizabeth; Baumann, Kathryn; Davis, Sidney; Krawitz, Hedley; Johnson, Carol; Spry, Nigel

    2006-01-01

    Background: The role of adjuvant postoperative therapy after resection of localised malignant melanoma involving regional lymph nodes remains controversial. There are no randomised trials that confirm that postoperative radiation conveys a benefit in terms of regional control or survival. Methods: Two hundred and thirty-four patients with melanoma involving lymph nodes were registered on a prospective study to evaluate the effect of postoperative radiation therapy. The regimen consisted of 48 Gy in 20 fractions to the nodal basin using recommended treatment guidelines for each of the major node sites. The primary endpoints were regional in-field relapse and late toxicity. Secondary endpoints were adjacent relapse, distant relapse, overall survival, progression-free survival and time to in-field progression. Results: Adjuvant radiation therapy was well tolerated by all of the patients. As the first site of relapse, regional in-field relapses occurred in 16/234 patients (6.8%). The overall survival was 36% at 5 years. The progression-free survival and regional control rates were 27% and 91%, respectively, at 5 years. Patients with more than 2 nodes involved had a significantly worse outcome in terms of distant relapse, overall and progression-free survival. Conclusion: We believe that adjuvant radiation therapy following nodal surgery could offer a possible benefit in terms of regional control. These results require confirmation in a randomised trial

  18. Pet in Clinical oncology

    International Nuclear Information System (INIS)

    Hunsche, A.; Grossman, G.; Santana, M.; Santana, C.; Halkar, R.; Garcia, E.

    2003-01-01

    The utility of the PET (positron emission tomography in clinical oncology has been recognized for more than two decades, locating it as a sensible technique for the diagnosis and the prognosis stratification of the oncology patients. The sensitivity and specificity of the PET in comparation to other image studies have demonstrated to be greater. For some years, there was a restriction of PET because of the high cost of the equipment and the cyclotrons. Nevertheless, the relation of cost/benefits is considered as a priority as this technique offers important clinical information. In this article the results observed when using it in diverse types of cancer, as well as the effectiveness shown in the pre-operating evaluation, the evaluation of residual disease, diagnosis of recurrences, pursuit and prognosis stratification of the patients with cancer. (The author)

  19. Quality in radiation oncology

    International Nuclear Information System (INIS)

    Pawlicki, Todd; Mundt, Arno J.

    2007-01-01

    A modern approach to quality was developed in the United States at Bell Telephone Laboratories during the first part of the 20th century. Over the years, those quality techniques have been adopted and extended by almost every industry. Medicine in general and radiation oncology in particular have been slow to adopt modern quality techniques. This work contains a brief description of the history of research on quality that led to the development of organization-wide quality programs such as Six Sigma. The aim is to discuss the current approach to quality in radiation oncology as well as where quality should be in the future. A strategy is suggested with the goal to provide a threshold improvement in quality over the next 10 years

  20. Pediatric oncologic endosurgery.

    Science.gov (United States)

    Boo, Yoon Jung; Goedecke, Jan; Muensterer, Oliver J

    2017-08-01

    Despite increasing popularity of minimal-invasive techniques in the pediatric population, their use in diagnosis and management of pediatric malignancy is still debated. Moreover, there is limited evidence to clarify this controversy due to low incidence of each individual type of pediatric tumor, huge diversity of the disease entity, heterogeneity of surgical technique, and lack of well-designed studies on pediatric oncologic minimal-invasive surgery. However, a rapid development of medical instruments and technologies accelerated the current trend toward less invasive surgery, including oncologic endosurgery. The aim of this article is to review current literatures about the application of the minimal-invasive approach for pediatric tumors and to give an overview of the current status, indications, individual techniques, and future perspectives.

  1. Oncology PET imaging

    International Nuclear Information System (INIS)

    Inubushi, Masayuki

    2014-01-01

    At the beginning of this article, likening medical images to 'Where is Waldo?' I indicate the concept of diagnostic process of PET/CT imaging, so that medical physics specialists could understand the role of each imaging modality and infer our distress for image diagnosis. Then, I state the present situation of PET imaging and the basics (e.g. health insurance coverage, clinical significance, principle, protocol, and pitfall) of oncology FDG-PET imaging which accounts for more than 99% of all clinical PET examinations in Japan. Finally, I would like to give a wishful prospect of oncology PET that will expand to be more cancer-specific in order to assess therapeutic effects of emerging molecular targeted drugs targeting the 'hallmarks of cancer'. (author)

  2. Pediatric oncology in Slovenia.

    Science.gov (United States)

    Jereb, B; Anzic, J

    1996-01-01

    Slovenia, a new country and formerly a part of Yugoslavia, has had its Childrens Hospital in Ljubljana since 1865. This became a part of the University Hospital in 1945, and in the early 1960s the Department of Pediatric Hematology-Oncology was established. The Oncological Institute of Slovenia was established in 1938 and has developed into a modern facility for comprehensive cancer care, research, and teaching. In close cooperation, established in the 1960s, a team from these two institutions takes care of the approximately 60 children per year who develop cancer in Slovenia. Consisting of pediatricians, radiation oncologists, pathologists, cytologists, surgeons, and other ad hoc specialists, the team meets at least twice weekly to plan treatment, follow the patients, discuss the results, and teach. All patients are subject to regular follow-up indefinitely. A separate team has been formed to study the late effects of cancer treatment on survivors, who by now are mostly adults.

  3. Frequencies of Blood Group Systems MNS, Diego, and Duffy and Clinical Phases of Carrion’s Disease in Amazonas, Peru

    Directory of Open Access Journals (Sweden)

    Oscar Acosta

    2014-01-01

    Full Text Available Carrion’s disease (CD, is a human bartonellosis, that is, endemic in the Andes of Peru, Ecuador, and Colombia. Bartonella bacilliformis, a native hemotrophic bacteria, is the causative agent of CD, and the interaction with the host could have produced changes in the gene frequencies of erythrocyte antigens. The goal here is to investigate the relationship between allele frequencies of blood group systems MNS, Diego, and Duffy and the clinical phases of CD, within a genetic context. In this associative and analytical study, 76 individuals from Bagua Grande, the province of Utcubamba, and the department of Amazonas in Peru, were enrolled. Forty of them resided in Tomocho-Collicate-Vista Hermosa area (high prevalence of cases in chronic phase, verrucous, or eruptive phase, without previous acute phase. Thirty-six individuals were from the area of Miraflores (high prevalence of cases in acute phase only and were evaluated for blood group systems MNS, Diego, and Duffy. This study constitutes one of the first attempts at evaluating the genetic factors and clinical phases of CD. No significant statistical differences (P>0.05 between allele frequencies of blood groups MNS, Diego, and Duffy and the prevalence of chronic and acute phases were detected in the two areas of Amazonas, Peru.

  4. Neurologic complications in oncology

    Directory of Open Access Journals (Sweden)

    Andrea Pace

    2010-06-01

    Full Text Available Neurologic side effects related to cancer therapy are a common problem in oncology practice. These complications can negatively affect the management of the patient, because they can inhibit treatment and diminish quality of life. Therefore specific skills are required to recognise symptoms and clinical manifestations. This review focuses on the most common neurologic complications to improve physician’s familiarity in determining the aetiology of these symptoms.

  5. Integrative oncology: an overview.

    Science.gov (United States)

    Deng, Gary; Cassileth, Barrie

    2014-01-01

    Integrative oncology, the diagnosis-specific field of integrative medicine, addresses symptom control with nonpharmacologic therapies. Known commonly as "complementary therapies" these are evidence-based adjuncts to mainstream care that effectively control physical and emotional symptoms, enhance physical and emotional strength, and provide patients with skills enabling them to help themselves throughout and following mainstream cancer treatment. Integrative or complementary therapies are rational and noninvasive. They have been subjected to study to determine their value, to document the problems they ameliorate, and to define the circumstances under which such therapies are beneficial. Conversely, "alternative" therapies typically are promoted literally as such; as actual antitumor treatments. They lack biologic plausibility and scientific evidence of safety and efficacy. Many are outright fraudulent. Conflating these two very different categories by use of the convenient acronym "CAM," for "complementary and alternative therapies," confuses the issue and does a substantial disservice to patients and medical professionals. Complementary and integrative modalities have demonstrated safety value and benefits. If the same were true for "alternatives," they would not be "alternatives." Rather, they would become part of mainstream cancer care. This manuscript explores the medical and sociocultural context of interest in integrative oncology as well as in "alternative" therapies, reviews commonly-asked patient questions, summarizes research results in both categories, and offers recommendations to help guide patients and family members through what is often a difficult maze. Combining complementary therapies with mainstream oncology care to address patients' physical, psychologic and spiritual needs constitutes the practice of integrative oncology. By recommending nonpharmacologic modalities that reduce symptom burden and improve quality of life, physicians also enable

  6. Oncological image analysis.

    Science.gov (United States)

    Brady, Sir Michael; Highnam, Ralph; Irving, Benjamin; Schnabel, Julia A

    2016-10-01

    Cancer is one of the world's major healthcare challenges and, as such, an important application of medical image analysis. After a brief introduction to cancer, we summarise some of the major developments in oncological image analysis over the past 20 years, but concentrating those in the authors' laboratories, and then outline opportunities and challenges for the next decade. Copyright © 2016 Elsevier B.V. All rights reserved.

  7. Immunoscintigraphy in gynecological oncology

    International Nuclear Information System (INIS)

    Pateisky, N.

    1987-01-01

    Immunologic and radionuclide methods are used increasingly in diagnostics and therapy. This applies especially to problems of malignant diseases. Tumor localization diagnosis has gained much from immunoscintigraphy, a non-invasive method combining immunologic and nuclear medicine techniques. Activated monoclonal antibodies against tumorous antigens make it possible to show malignant tumors scintigraphically. An introduction is given to the technique as well as first results of applying immunoscintigraphy to gynecological oncology. (author)

  8. Effect of phase-encoding direction on group analysis of resting-state functional magnetic resonance imaging.

    Science.gov (United States)

    Mori, Yasuo; Miyata, Jun; Isobe, Masanori; Son, Shuraku; Yoshihara, Yujiro; Aso, Toshihiko; Kouchiyama, Takanori; Murai, Toshiya; Takahashi, Hidehiko

    2018-05-17

    Echo-planar imaging is a common technique used in functional magnetic resonance imaging (fMRI), however it suffers from image distortion and signal loss because of large susceptibility effects that are related to the phase-encoding direction of the scan. Despite this relationship, the majority of neuroimaging studies have not considered the influence of phase-encoding direction. Here, we aimed to clarify how phase-encoding direction can affect the outcome of an fMRI connectivity study of schizophrenia. Resting-state fMRI using anterior to posterior (A-P) and posterior to anterior (P-A) directions was used to examine 25 patients with schizophrenia (SC) and 37 matched healthy controls (HC). We conducted a functional connectivity analysis using independent component analysis and performed three group comparisons: A-P vs. P-A (all participants), SC vs. HC for the A-P and P-A datasets, and the interaction between phase-encoding direction and participant group. The estimated functional connectivity differed between the two phase-encoding directions in areas that were more extensive than those where signal loss has been reported. Although functional connectivity in the SC group was lower than that in the HC group for both directions, the A-P and P-A conditions did not exhibit the same specific pattern of differences. Further, we observed an interaction between participant group and the phase-encoding direction in the left temporo-parietal junction and left fusiform gyrus. Phase-encoding direction can influence the results of functional connectivity studies. Thus, appropriate selection and documentation of phase-encoding direction will be important in future resting-state fMRI studies. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  9. A phase 2 study of the first imipridone ONC201, a selective DRD2 antagonist for oncology, administered every three weeks in recurrent glioblastoma.

    Science.gov (United States)

    Arrillaga-Romany, Isabel; Chi, Andrew S; Allen, Joshua E; Oster, Wolfgang; Wen, Patrick Y; Batchelor, Tracy T

    2017-10-03

    ONC201 is an oral, small molecule selective antagonist of the G protein-coupled receptor DRD2 that causes p53-independent apoptosis in tumor cells via integrated stress response activation and Akt/ERK inactivation. We performed a Phase II study that enrolled 17 patients with recurrent, bevacizumab-naïve, IDH1/2 WT glioblastoma who received 625mg ONC201 every three weeks. Median OS was 41.6 weeks with OS6 of 71% and OS9 of 53%. Seven of 17 patients are alive. PFS6 was 11.8% with two patients remaining on study who continue to receive ONC201 for >12 months. One of these patients had a durable objective response with a secondary glioblastoma possessing a H3.3 K27M mutation, exhibiting regression by 85% in one lesion and 76% in the second lesion. The second patient who continues to receive ONC201 for >12 months remains disease-free after enrolling on this trial following a re-resection. No drug-related SAEs or treatment discontinuation due to toxicity occurred. Plasma PK at 2 hours post-dose was 2.6 ug/mL, serum prolactin induction was observed as a surrogate marker of target engagement, and DRD2 was expressed in all evaluated archival tumor specimens. In summary, ONC201 is well tolerated and may have single agent activity in recurrent glioblastoma patients.

  10. Encyclopedia of radiation oncology

    Energy Technology Data Exchange (ETDEWEB)

    Brady, Luther W. [Drexel Univ. College of Medicine, Philadelphia, PA (United States); Yaeger, Theodore E. (eds.) [Wake Forest Univ. School of Medicine, Winston-Salem, NC (United States). Dept. of Radiation Oncology

    2013-02-01

    The simple A to Z format provides easy access to relevant information in the field of radiation oncology. Extensive cross references between keywords and related articles enable efficient searches in a user-friendly manner. Fully searchable and hyperlinked electronic online edition. The aim of this comprehensive encyclopedia is to provide detailed information on radiation oncology. The wide range of entries are written by leading experts. They will provide basic and clinical scientists in academia, practice and industry with valuable information about the field of radiation oncology. Those in related fields, students, teachers, and interested laypeople will also benefit from the important and relevant information on the most recent developments. Please note that this publication is available as print only or online only or print + online set. Save 75% of the online list price when purchasing the bundle. For more information on the online version please type the publication title into the search box above, then click on the eReference version in the results list.

  11. Adjuvant chemotherapy for rectal cancer patients treated with preoperative (chemo)radiotherapy and total mesorectal excision: a Dutch Colorectal Cancer Group (DCCG) randomized phase III trial.

    Science.gov (United States)

    Breugom, A J; van Gijn, W; Muller, E W; Berglund, Å; van den Broek, C B M; Fokstuen, T; Gelderblom, H; Kapiteijn, E; Leer, J W H; Marijnen, C A M; Martijn, H; Meershoek-Klein Kranenbarg, E; Nagtegaal, I D; Påhlman, L; Punt, C J A; Putter, H; Roodvoets, A G H; Rutten, H J T; Steup, W H; Glimelius, B; van de Velde, C J H

    2015-04-01

    The discussion on the role of adjuvant chemotherapy for rectal cancer patients treated according to current guidelines is still ongoing. A multicentre, randomized phase III trial, PROCTOR-SCRIPT, was conducted to compare adjuvant chemotherapy with observation for rectal cancer patients treated with preoperative (chemo)radiotherapy and total mesorectal excision (TME). The PROCTOR-SCRIPT trial recruited patients from 52 hospitals. Patients with histologically proven stage II or III rectal adenocarcinoma were randomly assigned (1:1) to observation or adjuvant chemotherapy after preoperative (chemo)radiotherapy and TME. Radiotherapy consisted of 5 × 5 Gy. Chemoradiotherapy consisted of 25 × 1.8-2 Gy combined with 5-FU-based chemotherapy. Adjuvant chemotherapy consisted of 5-FU/LV (PROCTOR) or eight courses capecitabine (SCRIPT). Randomization was based on permuted blocks of six, stratified according to centre, residual tumour, time between last irradiation and surgery, and preoperative treatment. The primary end point was overall survival. Of 470 enrolled patients, 437 were eligible. The trial closed prematurely because of slow patient accrual. Patients were randomly assigned to observation (n = 221) or adjuvant chemotherapy (n = 216). After a median follow-up of 5.0 years, 5-year overall survival was 79.2% in the observation group and 80.4% in the chemotherapy group [hazard ratio (HR) 0.93, 95% confidence interval (CI) 0.62-1.39; P = 0.73]. The HR for disease-free survival was 0.80 (95% CI 0.60-1.07; P = 0.13). Five-year cumulative incidence for locoregional recurrences was 7.8% in both groups. Five-year cumulative incidence for distant recurrences was 38.5% and 34.7%, respectively (P = 0.39). The PROCTOR-SCRIPT trial could not demonstrate a significant benefit of adjuvant chemotherapy with fluoropyrimidine monotherapy after preoperative (chemo)radiotherapy and TME on overall survival, disease-free survival, and recurrence rate. However, this trial did not complete

  12. A phase 2 study of weekly temsirolimus and bortezomib for relapsed or refractory B-cell non-Hodgkin lymphoma: A Wisconsin Oncology Network study.

    Science.gov (United States)

    Fenske, Timothy S; Shah, Namrata M; Kim, Kyung Mann; Saha, Sandeep; Zhang, Chong; Baim, Arielle E; Farnen, John P; Onitilo, Adedayo A; Blank, Jules H; Ahuja, Harish; Wassenaar, Tim; Qamar, Rubina; Mansky, Patrick; Traynor, Anne M; Mattison, Ryan J; Kahl, Brad S

    2015-10-01

    Proteasome inhibitors and mammalian target of rapamycin inhibitors each have activity in various B-cell malignancies and affect distinct cellular pathways. Their combination has demonstrated synergy in vitro and in mouse models. The authors conducted a single-arm, phase 2 trial of combined temsirolimus and bortezomib in patients with relapsed and refractory B-cell non-Hodgkin lymphoma (NHL) using a dosing scheme that was previously tested in multiple myeloma. The patients received bortezomib and temsirolimus weekly on days 1, 8, 15, and 22 of a 35-day cycle. Of 39 patients who received treatment, 3 achieved a complete response (7.7%; 95% confidence interval [CI], 1.6%-21%), and 9 had a partial response (PR) (23%; 95% CI, 11%-39%). Thus, the overall response rate (12 of 39 patients) was 31% (95% CI, 17%-48%), and the median progression-free survival was 4.7 months (95% CI, 2.1-7.8 months; 2 months for patients with diffuse large B-cell lymphoma [n = 18], 7.5 months for those with mantle cell lymphoma [n = 7], and 16.5 months for those with follicular lymphoma [n = 9]). Two extensively treated patients with diffuse large B-cell lymphoma achieved a complete response. There were no unexpected toxicities from the combination. The current results demonstrate that the combination of a mammalian target of rapamycin inhibitor and a proteasome inhibitor is safe and has activity in patients with heavily pretreated B-cell NHL. Further studies with this combination are warranted in specific subtypes of NHL. © 2015 American Cancer Society.

  13. Continuous 5-fluorouracil infusion plus long acting octreotide in advanced well-differentiated neuroendocrine carcinomas. A phase II trial of the Piemonte Oncology Network

    International Nuclear Information System (INIS)

    Brizzi, Maria P; Ferretti, Benedetta; Alabiso, Oscar; Ciuffreda, Libero; Bertetto, Oscar; Papotti, Mauro; Dogliotti, Luigi; Berruti, Alfredo; Ferrero, Anna; Milanesi, Enrica; Volante, Marco; Castiglione, Federico; Birocco, Nadia; Bombaci, Sebastiano; Perroni, Davide

    2009-01-01

    Well-differentiated neuroendocrine carcinomas are highly vascularized and may be sensitive to drugs administered on a metronomic schedule that has shown antiangiogenic properties. A phase II study was designed to test the activity of protracted 5-fluorouracil (5FU) infusion plus long-acting release (LAR) octreotide in patients with neuroendocrine carcinoma. Twenty-nine patients with metastatic or locally advanced well-differentiated neuroendocrine carcinoma were treated with protracted 5FU intravenous infusion (200 mg/m 2 daily) plus LAR octreotide (20 mg monthly). Patients were followed for toxicity, objective response, symptomatic and biochemical response, time to progression and survival. Assessment by Response Evaluation Criteria in Solid Tumors (RECIST) criteria showed partial response in 7 (24.1%), stable disease in 20 (69.0%), and disease progression in 2 patients. Response did not significantly differ when patients were stratified by primary tumor site and proliferative activity. A biochemical (chromogranin A) response was observed in 12/25 assessable patients (48.0%); symptom relief was obtained in 9/15 symptomatic patients (60.0%). There was non significant decrease in circulating vascular epithelial growth factor (VEGF) over time. Median time to progression was 22.6 months (range, 2.7-68.5); median overall survival was not reached yet. Toxicity was mild and manageable. Continuous/metronomic 5FU infusion plus LAR octreotide is well tolerated and shows activity in patients with well-differentiated neuroendocrine carcinoma. The potential synergism between metronomic chemotherapy and antiangiogenic drugs provides a rationale for exploring this association in the future. NCT00953394

  14. Continuous 5-fluorouracil infusion plus long acting octreotide in advanced well-differentiated neuroendocrine carcinomas. A phase II trial of the Piemonte Oncology Network

    Directory of Open Access Journals (Sweden)

    Ciuffreda Libero

    2009-11-01

    Full Text Available Abstract Background Well-differentiated neuroendocrine carcinomas are highly vascularized and may be sensitive to drugs administered on a metronomic schedule that has shown antiangiogenic properties. A phase II study was designed to test the activity of protracted 5-fluorouracil (5FU infusion plus long-acting release (LAR octreotide in patients with neuroendocrine carcinoma. Methods Twenty-nine patients with metastatic or locally advanced well-differentiated neuroendocrine carcinoma were treated with protracted 5FU intravenous infusion (200 mg/m2 daily plus LAR octreotide (20 mg monthly. Patients were followed for toxicity, objective response, symptomatic and biochemical response, time to progression and survival. Results Assessment by Response Evaluation Criteria in Solid Tumors (RECIST criteria showed partial response in 7 (24.1%, stable disease in 20 (69.0%, and disease progression in 2 patients. Response did not significantly differ when patients were stratified by primary tumor site and proliferative activity. A biochemical (chromogranin A response was observed in 12/25 assessable patients (48.0%; symptom relief was obtained in 9/15 symptomatic patients (60.0%. There was non significant decrease in circulating vascular epithelial growth factor (VEGF over time. Median time to progression was 22.6 months (range, 2.7-68.5; median overall survival was not reached yet. Toxicity was mild and manageable. Conclusion Continuous/metronomic 5FU infusion plus LAR octreotide is well tolerated and shows activity in patients with well-differentiated neuroendocrine carcinoma. The potential synergism between metronomic chemotherapy and antiangiogenic drugs provides a rationale for exploring this association in the future. Trial registration NCT00953394

  15. Neoadjuvant plus adjuvant bevacizumab in early breast cancer (NSABP B-40 [NRG Oncology]): secondary outcomes of a phase 3, randomised controlled trial.

    Science.gov (United States)

    Bear, Harry D; Tang, Gong; Rastogi, Priya; Geyer, Charles E; Liu, Qing; Robidoux, André; Baez-Diaz, Luis; Brufsky, Adam M; Mehta, Rita S; Fehrenbacher, Louis; Young, James A; Senecal, Francis M; Gaur, Rakesh; Margolese, Richard G; Adams, Paul T; Gross, Howard M; Costantino, Joseph P; Paik, Soonmyung; Swain, Sandra M; Mamounas, Eleftherios P; Wolmark, Norman

    2015-09-01

    NSABP B-40 was a 3 × 2 factorial trial testing whether adding capecitabine or gemcitabine to docetaxel followed by doxorubicin plus cyclophosphamide neoadjuvant chemotherapy would improve outcomes in women with operable, HER2-negative breast cancer and whether adding neoadjuvant plus adjuvant bevacizumab to neoadjuvant chemotherapy regimens would also improve outcomes. As reported previously, addition of neoadjuvant bevacizumab increased the proportion of patients achieving a pathological complete response, which was the primary endpoint. We present secondary patient outcomes, including disease-free survival, a specified endpoint by protocol, and data for distant recurrence-free interval, and overall survival, which were not prespecified endpoints but were collected prospectively. In this randomised controlled trial (NSABP B-40), we enrolled women aged 18 years or older, with operable, HER2-non-amplified invasive adenocarcinoma of the breast, 2 cm or greater in diameter by palpation, clinical stage T1c-3, cN0, cN1, or cN2a, without metastatic disease and diagnosed by core needle biopsy. Patients received one of three docetaxel-based neoadjuvant regimens for four cycles: docetaxel alone (100 mg/m(2)) with addition of capecitabine (825 mg/m(2) oral twice daily days 1-14, 75 mg/m(2) docetaxel) or with addition of gemcitabine (1000 mg/m(2) days 1 and 8 intravenously, 75 mg/m(2) docetaxel), all followed by neoadjuvant doxorubicin and cyclophosphamide (60 mg/m(2) and 600 mg/m(2) intravenously) every 3 weeks for four cycles. Those randomly assigned to bevacizumab groups were to receive bevacizumab (15 mg/kg, every 3 weeks for six cycles) with neoadjuvant chemotherapy and postoperatively for ten doses. Randomisation was done (1:1:1:1:1:1) via a biased-coin minimisation procedure to balance the characteristics with respect to clinical nodal status, clinical tumour size, hormone receptor status, and age. Intent-to-treat analyses were done for disease-free survival and

  16. Comparison of methods for prioritizing risk in radiation oncology

    International Nuclear Information System (INIS)

    Biazotto, Bruna; Tokarski, Marcio

    2016-01-01

    Proactive risk management tools, such as Failure Mode and Effect Analysis (FEMA), were imported from engineering and have been widely used in Radiation Oncology. An important step in this process is the risk prioritization and there are many methods to do that. This paper compares the risk prioritization of computerized planning phase in interstitial implants with high dose rate brachytherapy performed with Health Care Failure Mode and Effect Analysis (HFMEA) and FMEA with guidelines given by the Task Group 100 (TG 100) of the American Association of Physicists in Medicine. Out of the 33 possible failure modes of this process, 21 require more attention when evaluated by HFMEA and 22, when evaluated by FMEA TG 100. Despite the high coincidence between the methods, the execution of HFMEA was simpler. (author)

  17. Supportive care in radiation oncology

    International Nuclear Information System (INIS)

    Rotman, M.; John, M.

    1987-01-01

    The radiation therapist, concerned with the disease process and all the technical intricacies of treatment, has usually not been involved in managing the supportive aspects of caring for the patient. Yet, of the team of medical specialists and allied health personnel required in oncology, the radiation therapist is the one most responsible for overseeing the total care of the cancer patient. At times this might include emotional support, prevention and correction of tissue dysfunction, augmentation of nutrition, metabolic and electrolyte regulation, rehabilitation, and vocational support. This chapter is a brief overview of a considerable volume of literature that has occupied the interest of a rather small group of physicians, nutritionists, and psychologists. The discussion highlights the special management problems of the normal-tissue effects of radiation, the related nutritional aspects of cancer care, and certain emotional and pathologic considerations

  18. Gamma camera based FDG PET in oncology

    International Nuclear Information System (INIS)

    Park, C. H.

    2002-01-01

    Positron Emission Tomography(PET) was introduced as a research tool in the 1970s and it took about 20 years before PET became an useful clinical imaging modality. In the USA, insurance coverage for PET procedures in the 1990s was the turning point, I believe, for this progress. Initially PET was used in neurology but recently more than 80% of PET procedures are in oncological applications. I firmly believe, in the 21st century, one can not manage cancer patients properly without PET and PET is very important medical imaging modality in basic and clinical sciences. PET is grouped into 2 categories; conventional (c) and gamma camera based ( CB ) PET. CB PET is more readily available utilizing dual-head gamma cameras and commercially available FDG to many medical centers at low cost to patients. In fact there are more CB PET in operation than cPET in the USA. CB PET is inferior to cPET in its performance but clinical studies in oncology is feasible without expensive infrastructures such as staffing, rooms and equipments. At Ajou university Hospital, CBPET was installed in late 1997 for the first time in Korea as well as in Asia and the system has been used successfully and effectively in oncological applications. Our was the fourth PET operation in Korea and I believe this may have been instrumental for other institutions got interested in clinical PET. The following is a brief description of our clinical experience of FDG CBPET in oncology

  19. Do Women With Breast Cancer Who Choose Adjunctive Integrative Oncology Care Receive Different Standard Oncologic Treatment?

    Science.gov (United States)

    Standish, Leanna J; Dowd, Fred; Sweet, Erin; Dale, Linda; Andersen, M Robyn

    2018-04-01

    To determine if women with breast cancer who choose adjunctive naturopathic oncology (NO) specialty care receive different standard oncologic treatment when compared with breast cancer patients who receive only standard care. Women with breast cancer stages 0 to 4, aged 18+ who spoke English and sought care from outpatient naturopathic doctor clinics were enrolled in an observational study of clinical and quality of life outcomes. Women who sought NO care 2 or more times within the first 2 years postdiagnosis were identified as NO cases. A matched comparison group of breast cancer patients were identified using the Western Washington Cancer Surveillance System(CSS). A longitudinal cohort design. In addition to self-report data, the CSS provided data on demographics, stage at the time of diagnosis, and initial treatment. Oncology medical records were abstracted in order to provide additional information on standard oncologic treatment for all participants. Cohorts were well matched with regard to demographic, histologic, and prognostic indicators at the time of diagnosis. Approximately 70% of women in both cohorts received standard oncologic care that met the National Comprehensive Cancer Network guidelines. There were no statistically significant differences between the cohorts in treatment received. Fewer women in the NO cohort with estrogen receptor-positive breast cancer appear to have received antiestrogen therapy. Women in both cohorts appear to receive guideline-concordant care. However, women who receive adjunctive NO care may be less likely to receive antiestrogen therapy.

  20. 78 FR 25304 - Siemens Medical Solutions, USA, Inc., Oncology Care Systems (Radiation Oncology), Including On...

    Science.gov (United States)

    2013-04-30

    ..., USA, Inc., Oncology Care Systems (Radiation Oncology), Including On-Site Leased Workers From Source... Medical Solutions, USA, Inc., Oncology Care Systems (Radiation Oncology), including on- site leased... of February 2013, Siemens Medical Solutions, USA, Inc., Oncology Care Systems (Radiation Oncology...

  1. Failure patterns by prognostic group as determined by recursive partitioning analysis (RPA) of 1547 on four radiation therapy oncology group studies in operable non-small cell lung cancer (NSCLC)

    International Nuclear Information System (INIS)

    Komaki, Ritsuko; Scott, Charles B.; Byhardt, Roger W.; Emami, Bahman; Asbell, Sucha O.; Russell, Anthony H.; Roach, Mack; Urtasun, Raul C.; Gaspar, Laurie E.

    1997-01-01

    Purpose: To identify groups of patients who might benefit from more aggressive systemic or local treatment based on failure patterns when unresectable NSCLC was treated by radiation therapy alone. Methods: 1547 patients from 4 RTOG trials treated by RT alone were analyzed for the patterns of first failure by PRA class which was defined by prognostic factors, e.g., stage, KPS, weight loss, pleural effusion, age. All patients were AJCC stage II, IIIA or IIIB with KPS of at least 50 and n previous radiotherapy or chemotherapy for their NSCLC. Progressions in the primary (within irradiated fields), thorax (outside irradiated area), brain and distant metastasis other than brain were compared (two-sided) for each failure category by RPA. Results: The RPA classes are four distinct subgroups that had significantly different median survivals of 12.6, 8.3, 6.2 and 3.3 months for classes I, II, III and IV respectively (all groups p=0.0002). Pair comparison showed that RPA I vs IV p<0.0001, I vs III p=0.006, II vs IV p<0.0001, and III vs IV p=0.06. Conclusions: These results suggest the burden of disease and physiologic compromise in class IV patients are sufficient to cause death before specific sites of failure can be discerned. Site specific treatment strategies (intensive local therapy, combination chemotherapy, prophylactic cranial irradiation) may lead to improved outcome in class I and II, but are unlikely to alter outcome in class III and IV

  2. Effectiveness of a psycho-oncology training program for oncology nurses: a randomized controlled trial.

    Science.gov (United States)

    Kubota, Yosuke; Okuyama, Toru; Uchida, Megumi; Umezawa, Shino; Nakaguchi, Tomohiro; Sugano, Koji; Ito, Yoshinori; Katsuki, Fujika; Nakano, Yumi; Nishiyama, Takeshi; Katayama, Yoshiko; Akechi, Tatsuo

    2016-06-01

    Oncology nurses are expected to play an important role in psychosocial care for cancer patients. The aim of this study was to examine whether a novel training program aimed at enhancing oncology nurses' ability to assess and manage common psychological problems in cancer patients would improve participants' self-reported confidence, knowledge, and attitudes regarding care of patients with common psychological problems (trial register: UMIN000008559). Oncology nurses were assigned randomly to either the intervention group (N = 50) or the waiting list control group (N = 46). The intervention group received a 16-h program, the content of which focused on four psychological issues: normal reactions, clinically significant distress, suicidal thoughts, and delirium. Each session included a role-play exercise, group work, and didactic lecture regarding assessment and management of each problem. Primary outcomes were changes in self-reported confidence, knowledge, and attitudes toward the common psychological problems between pre-intervention and 3 months post-intervention. Secondary outcomes were job-related stress and burnout. Intervention acceptability to participants was also assessed. In the intervention group, confidence and knowledge but not attitudes were significantly improved relative to the control group. No significant intervention effects were found for job- related stress and burnout. A high percentage (98%) of participants considered the program useful in clinical practice. This psycho-oncology training program improved oncology nurses' confidence and knowledge regarding care for patients with psychological problems. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

  3. Decline in Tested and Self-Reported Cognitive Functioning After Prophylactic Cranial Irradiation for Lung Cancer: Pooled Secondary Analysis of Radiation Therapy Oncology Group Randomized Trials 0212 and 0214

    Energy Technology Data Exchange (ETDEWEB)

    Gondi, Vinai, E-mail: vgondi@chicagocancer.org [Central Dupage Hospital Cancer Center, Warrenville, Illinois (United States); University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin (United States); Paulus, Rebecca [Radiation Therapy Oncology Group Statistical Center, Philadelphia, Pennsylvania (United States); Bruner, Deborah W. [Nell Hodgson Woodfull School of Nursing, Emory University, Atlanta, Georgia (United States); Meyers, Christina A. [University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Gore, Elizabeth M. [Medical College of Wisconsin, Milwaukee, Wisconsin (United States); Wolfson, Aaron [University of Miami School of Medicine, Miami, Florida (United States); Werner-Wasik, Maria [Thomas Jefferson University Hospital, Philadelphia, Pennsylvania (United States); Sun, Alexander Y. [Princess Margaret Hospital, Toronto, ON (Canada); Choy, Hak [University of Texas Southwestern Moncreif Cancer Center, Fort Worth, Texas (United States); Movsas, Benjamin [Henry Ford Health System, Detroit, Michigan (United States)

    2013-07-15

    Purpose: To assess the impact of prophylactic cranial irradiation (PCI) on self-reported cognitive functioning (SRCF), a functional scale on the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30). Methods and Materials: Radiation Therapy Oncology Group (RTOG) protocol 0214 randomized patients with locally advanced non-small cell lung cancer to PCI or observation; RTOG 0212 randomized patients with limited-disease small cell lung cancer to high- or standard-dose PCI. In both trials, Hopkins Verbal Learning Test (HVLT)-Recall and -Delayed Recall and SRCF were assessed at baseline (after locoregional therapy but before PCI or observation) and at 6 and 12 months. Patients developing brain relapse before follow-up evaluation were excluded. Decline was defined using the reliable change index method and correlated with receipt of PCI versus observation using logistic regression modeling. Fisher's exact test correlated decline in SRCF with HVLT decline. Results: Of the eligible patients pooled from RTOG 0212 and RTOG 0214, 410 (93%) receiving PCI and 173 (96%) undergoing observation completed baseline HVLT or EORTC QLQ-C30 testing and were included in this analysis. Prophylactic cranial irradiation was associated with a higher risk of decline in SRCF at 6 months (odds ratio 3.60, 95% confidence interval 2.34-6.37, P<.0001) and 12 months (odds ratio 3.44, 95% confidence interval 1.84-6.44, P<.0001). Decline on HVLT-Recall at 6 and 12 months was also associated with PCI (P=.002 and P=.002, respectively) but was not closely correlated with decline in SRCF at the same time points (P=.05 and P=.86, respectively). Conclusions: In lung cancer patients who do not develop brain relapse, PCI is associated with decline in HVLT-tested and self-reported cognitive functioning. Decline in HVLT and decline in SRCF are not closely correlated, suggesting that they may represent distinct elements of the cognitive spectrum.

  4. Randomized trial of 8 Gy in 1 versus 20 Gy in 5 fractions of radiotherapy for neuropathic pain due to bone metastases (Trans-Tasman Radiation Oncology Group, TROG 96.05)

    International Nuclear Information System (INIS)

    Roos, Daniel E.; Turner, Sandra L.; O'Brien, Peter C.; Smith, Jennifer G.; Spry, Nigel A.; Burmeister, Bryan H.; Hoskin, Peter J.; Ball, David L.

    2005-01-01

    Background and purpose: Despite numerous randomized trials investigating radiotherapy (RT) fractionation schedules for painful bone metastases, there are very few data on RT for bone metastases causing pain with a neuropathic component. The Trans-Tasman Radiation Oncology Group undertook a randomized trial comparing the efficacy of a single 8 Gy (8/1) with 20 Gy in 5 fractions (20/5) for this type of pain. Materials and methods: Eligible patients had radiological evidence of bone metastases from a known malignancy with no change in systemic therapy within 6 weeks before or anticipated within 4 weeks after RT, no other metastases along the distribution of the neuropathic pain and no clinical or radiological evidence of cord/cauda equina compression. All patients gave written informed consent. Primary endpoints were pain response within 2 months of commencement of RT and time to treatment failure (TTF). The hypothesis was that 8/1 is at least as effective as 20/5 and the planned sample size was 270 patients. Results: Between February 1996 and December 2002, 272 patients were randomized (8/1:20/5=137:135) from 15 centres (Australia 11, New Zealand 3, UK 1). The commonest primary cancers were lung (31%), prostate (29%) and breast (8%); index sites were spine (89%), rib (9%), other (2%); 72% of patients were males and the median age was 67 (range 29-89). The median overall survival (95% CI) for all randomized patients was 4.8 mo (4.2-5.7 mo). The intention-to-treat overall response rates (95% CI) for 8/1 vs 20/5 were 53% (45-62%) vs 61% (53-70%), P=0.18. Corresponding figures for complete response were 26% (18-34%) vs 27% (19-35%), P=0.89. The estimated median TTFs (95% CI) were 2.4 mo (2.0-3.3 mo) vs 3.7 mo (3.1-5.9 mo) respectively. The hazard ratio (95% CI) for the comparison of TTF curves was 1.35 (0.99-1.85), log-rank P=0.056. There were no statistically significant differences in the rates of re-treatment, cord compression or pathological fracture by arm

  5. Higher Biologically Effective Dose of Radiotherapy Is Associated With Improved Outcomes for Locally Advanced Non–Small Cell Lung Carcinoma Treated With Chemoradiation: An Analysis of the Radiation Therapy Oncology Group

    International Nuclear Information System (INIS)

    Machtay, Mitchell; Bae, Kyounghwa; Movsas, Benjamin; Paulus, Rebecca; Gore, Elizabeth M.; Komaki, Ritsuko; Albain, Kathy; Sause, William T.; Curran, Walter J.

    2012-01-01

    Purpose: Patients treated with chemoradiotherapy for locally advanced non–small-cell lung carcinoma (LA-NSCLC) were analyzed for local-regional failure (LRF) and overall survival (OS) with respect to radiotherapy dose intensity. Methods and Materials: This study combined data from seven Radiation Therapy Oncology Group (RTOG) trials in which chemoradiotherapy was used for LA-NSCLC: RTOG 88-08 (chemoradiation arm only), 90-15, 91-06, 92-04, 93-09 (nonoperative arm only), 94-10, and 98-01. The radiotherapeutic biologically effective dose (BED) received by each individual patient was calculated, as was the overall treatment time-adjusted BED (tBED) using standard formulae. Heterogeneity testing was done with chi-squared statistics, and weighted pooled hazard ratio estimates were used. Cox and Fine and Gray’s proportional hazard models were used for OS and LRF, respectively, to test the associations between BED and tBED adjusted for other covariates. Results: A total of 1,356 patients were analyzed for BED (1,348 for tBED). The 2-year and 5-year OS rates were 38% and 15%, respectively. The 2-year and 5-year LRF rates were 46% and 52%, respectively. The BED (and tBED) were highly significantly associated with both OS and LRF, with or without adjustment for other covariates on multivariate analysis (p < 0.0001). A 1-Gy BED increase in radiotherapy dose intensity was statistically significantly associated with approximately 4% relative improvement in survival; this is another way of expressing the finding that the pool-adjusted hazard ratio for survival as a function of BED was 0.96. Similarly, a 1-Gy tBED increase in radiotherapy dose intensity was statistically significantly associated with approximately 3% relative improvement in local-regional control; this is another way of expressing the finding that the pool-adjusted hazard ratio as a function of tBED was 0.97. Conclusions: Higher radiotherapy dose intensity is associated with improved local-regional control

  6. Prognostic value of biologic subtype and the 21-gene recurrence score relative to local recurrence after breast conservation treatment with radiation for early stage breast carcinoma: results from the Eastern Cooperative Oncology Group E2197 study.

    Science.gov (United States)

    Solin, Lawrence J; Gray, Robert; Goldstein, Lori J; Recht, Abram; Baehner, Frederick L; Shak, Steven; Badve, Sunil; Perez, Edith A; Shulman, Lawrence N; Martino, Silvana; Davidson, Nancy E; Sledge, George W; Sparano, Joseph A

    2012-07-01

    The present study was performed to evaluate the significance of biologic subtype and 21-gene recurrence score relative to local recurrence and local-regional recurrence after breast conservation treatment with radiation. Eastern Cooperative Oncology Group E2197 was a prospective randomized clinical trial that compared two adjuvant systemic chemotherapy regimens for patients with operable breast carcinoma with 1-3 positive lymph nodes or negative lymph nodes with tumor size >1.0 cm. The study population was a subset of 388 patients with known 21-gene recurrence score and treated with breast conservation surgery, systemic chemotherapy, and definitive radiation treatment. Median follow-up was 9.7 years (range = 3.7-11.6 years). The 10-year rates of local recurrence and local-regional recurrence were 5.4 % and 6.6 %, respectively. Neither biologic subtype nor 21-gene Recurrence Score was associated with local recurrence or local-regional recurrence on univariate or multivariate analyses (all P ≥ 0.12). The 10-year rates of local recurrence were 4.9 % for hormone receptor positive, HER2-negative tumors, 6.0 % for triple negative tumors, and 6.4 % for HER2-positive tumors (P = 0.76), and the 10-year rates of local-regional recurrence were 6.3, 6.9, and 7.2 %, respectively (P = 0.79). For hormone receptor-positive tumors, the 10-year rates of local recurrence were 3.2, 2.9, and 10.1 % for low, intermediate, and high 21-gene recurrence score, respectively (P = 0.17), and the 10-year rates of local-regional recurrence were 3.8, 5.1, and 12.0 %, respectively (P = 0.12). For hormone receptor-positive tumors, the 21-gene recurrence score evaluated as a continuous variable was significant for local-regional recurrence (hazard ratio 2.66; P = 0.03). The 10-year rates of local recurrence and local-regional recurrence were reasonably low in all subsets of patients. Neither biologic subtype nor 21-gene recurrence score should preclude breast conservation treatment with radiation.

  7. Low Interrater Reliability in Grading of R