WorldWideScience

Sample records for cancer institute trials

  1. Single Institution Feasibility Trials - Cancer Imaging Program

    Science.gov (United States)

    Within the CIP program, the current R21 mechanism provides potential funding for small, single institution feasibility trials. The current announcement is titled In Vivo Cancer Imaging Exploratory/Developmental Grants.

  2. Tumor induction following intraoperative radiotherapy: Late results of the National Cancer Institute canine trials

    Energy Technology Data Exchange (ETDEWEB)

    Barnes, M.; Duray, P.; DeLuca, A.; Anderson, W.; Sindelar, W.; Kinsella, T. (Fox Chase Cancer Center, Philadelphia, PA (USA))

    1990-09-01

    Intraoperative radiotherapy has been employed in human cancer research for over a decade. Since 1979, trials to assess the acute and late toxicity of IORT have been carried out at the National Cancer Institute in an adult dog model in an attempt to establish dose tolerance guidelines for a variety of organs. Of the 170 animals entered on 12 studies with a minimum follow-up of 2 years, 148 dogs received IORT; 22 control animals received only surgery. Animals were sacrificed at designated intervals following IORT, usually at 1, 6, 12, 24, and 60 month intervals. 102 of 148 irradiated dogs were sacrificed less than 24 months; 46 dogs were followed greater than or equal to 24 months after IORT. To date, 34 of the 46 animals have been sacrificed; the 12 remaining animals are to be followed to 5 years. These 12 animals have minimum follow-up of 30 months. In the irradiated group followed for greater than or equal to 24 months, 10 tumors have arisen in 9 animals. One animal developed an incidental spontaneous breast carcinoma outside the IORT port, discovered only at scheduled post-mortem exam. The remaining nine tumors arose within IORT ports. Two tumors were benign neural tumors--a neuroma and a neurofibroma. One animal had a collision tumor comprised of grade I chondrosarcoma adjacent to grade III osteosarcoma arising in lumbar vertebrae. Two other grade III osteosarcomas, one grade III fibrosarcoma, and one grade III malignant fibrous histiocytoma arose in retroperitoneal/paravertebral sites. An embryonal rhabdomyosarcoma (sarcoma botryoides) arose within the irradiated urinary bladder of one animal. No sham irradiated controls nor IORT animals sacrificed less than 24 months have developed any spontaneous or radiation-induced tumors. The time range of diagnoses of tumors was 24-58 months. The IORT dose range associated with tumor development was 20-35 Gy.

  3. Web services-based access to local clinical trial databases: a standards initiative of the Association of American Cancer Institutes.

    Science.gov (United States)

    Stahl, Douglas C; Evans, Richard M; Afrin, Lawrence B; DeTeresa, Richard M; Ko, Dave; Mitchell, Kevin

    2003-01-01

    Electronic discovery of the clinical trials being performed at a specific research center is a challenging task, which presently requires manual review of the center's locally maintained databases or web pages of protocol listings. Near real-time automated discovery of available trials would increase the efficiency and effectiveness of clinical trial searching, and would facilitate the development of new services for information providers and consumers. Automated discovery efforts to date have been hindered by issues such as disparate database schemas, vocabularies, and insufficient standards for easy intersystem exchange of high-level data, but adequate infrastructure now exists that make possible the development of applications for near real-time automated discovery of trials. This paper describes the current state (design and implementation) of the Web Services Specification for Publication and Discovery of Clinical Trials as developed by the Technology Task Force of the Association of American Cancer Institutes. The paper then briefly discusses a prototype web service-based application that implements the specification. Directions for evolution of this specification are also discussed. PMID:14728248

  4. Stereotactic body radiotherapy for localized prostate cancer: Pooled analysis from a multi-institutional consortium of prospective phase II trials

    International Nuclear Information System (INIS)

    Purpose: The effectiveness of stereotactic body radiotherapy (SBRT) for localized prostate cancer is tested. Methods and materials: A total of 1100 patients with clinically localized prostate cancer were enrolled in separate prospective phase 2 clinical trials of SBRT from 8 institutions during 2003–11 and pooled for analysis. SBRT using the CyberKnife delivered a median dose of 36.25 Gy in 4–5 fractions. Patients were low-risk (58%), intermediate-risk (30%) and high-risk (11%). A short-course of androgen deprivation therapy (ADT) was given to 14%. PSA relapse defined as a rise >2 ng/ml above nadir was analyzed with the Kaplan Meier method. Results: With a median follow-up of 36 months there were 49 patients with PSA failure (4.5%), 9 of whom were subsequently determined to be benign PSA bounces. The 5-year biochemical relapse free survival (bRFS) rate was 93% for all patients; 95%, 83% and 78% for GS ⩽6, 7 and ⩾8, respectively (p = 0.001), and 95%, 84% and 81% for low-, intermediate- and high-risk patients, respectively (p 0.2 ng/ml was noted among 16% of patients. For 135 patients possessing a minimum of 5 years follow-up, the 5-year bRFS rate for low- and intermediate-risk patients was 99% and 93%, respectively. Conclusion: PSA relapse-free survival rates after SBRT compare favorably with other definitive treatments for low and intermediate risk patients. The current evidence supports consideration of SBRT among the therapeutic options for these patients

  5. The challenge to bring personalized cancer medicine from clinical trials into routine clinical practice: the case of the Institut Gustave Roussy.

    Science.gov (United States)

    Arnedos, Monica; André, Fabrice; Farace, Françoise; Lacroix, Ludovic; Besse, Benjamin; Robert, Caroline; Soria, Jean Charles; Eggermont, Alexander M M

    2012-04-01

    Research with high throughput technologies has propitiated the segmentation of different types of tumors into very small subgroups characterized by the presence of very rare molecular alterations. The identification of these subgroups and the apparition of new agents targeting these infrequent alterations are already affecting the way in which clinical trials are being conducted with an increased need to identify those patients harboring specific molecular alterations. In this review we describe some of the currently ongoing and future studies at the Institut Gustave Roussy that aim for the identification of potential therapeutic targets for cancer patients with the incorporation of high throughput technologies into daily practice including aCGH, next generation sequencing and the creation of a software that allows for target identification specific for each tumor. The initial intention is to enrich clinical trials with cancer patients carrying certain molecular alterations in order to increase the possibility of demonstrating benefit from a targeted agent. Mid and long term aims are to facilitate and speed up the process of drug development as well as to implement the concept of personalized medicine. PMID:22483534

  6. Biweekly cetuximab and irinotecan in advanced colorectal cancer patients progressing after at least one previous line of chemotherapy: results of a phase II single institution trial

    Science.gov (United States)

    Martín-Martorell, P; Roselló, S; Rodríguez-Braun, E; Chirivella, I; Bosch, A; Cervantes, A

    2008-01-01

    This is a phase II institutional exploratory trial of biweekly irinotecan and cetuximab administration regimen in metastatic colorectal cancer patients progressing to at least one previous chemotherapy line. A total of 40 patients were treated between November 2005 and November 2007 with irinotecan 180 mg m−2 and cetuximab 500 mg m−2 q2w (every 2 weeks), in every 21-day cycles, until unacceptable toxicity or progressive disease. An overall response rate of 22.5% was obtained (two complete and seven partial responses). The disease control rate was 60%. The time to progression was 3.4 months and the overall survival was 8 months. The toxicity compared very favourably to weekly cetuximab combination schedules. Grade 3/4 adverse effects were observed in 12 patients. Overall, our results turn up very similar both in terms of toxicity and efficacy to those obtained by weekly and biweekly administration regimens. PMID:18665167

  7. Web Services-Based Access to Local Clinical Trial Databases: A Standards Initiative of the Association of American Cancer Institutes

    OpenAIRE

    Stahl, Douglas C.; Evans, Richard M.; Afrin, Lawrence B.; DeTeresa, Richard M.; Ko, Dave; MITCHELL, KEVIN

    2003-01-01

    Electronic discovery of the clinical trials being performed at a specific research center is a challenging task, which presently requires manual review of the center’s locally maintained databases or web pages of protocol listings. Near real-time automated discovery of available trials would increase the efficiency and effectiveness of clinical trial searching, and would facilitate the development of new services for information providers and consumers. Automated discovery efforts to date hav...

  8. The ALCHEMIST Lung Cancer Trial

    Science.gov (United States)

    A collection of material about the ALCHEMIST lung cancer trial that will examine tumor tissue from patients with early-stage, completely resected lung cancer for gene mutations in the EGFR and ALK genes, and a

  9. 78 FR 53154 - National Cancer Institute; Notice of Closed Meetings

    Science.gov (United States)

    2013-08-28

    ... Prevention Research; 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93... Emphasis Panel NCI Experimental Therapeutics--Clinical Trials Network with Phase 1 Emphasis. Date: November... HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Closed...

  10. Complementary and Alternative Medicine Cancer Clinical Trials

    Science.gov (United States)

    ... Introduction Cancer CAM Clinical Trials Introduction What are clinical trials? A clinical trial is one of the final ... and effective. What are the different types of clinical trials? Treatment trials test new treatments (like a new ...

  11. Prostate Cancer Research Trial Helps John Spencer Treat His Cancer

    Science.gov (United States)

    ... this page please turn Javascript on. Feature: Prostate Cancer Prostate Cancer Research Trial Helps John Spencer Treat His ... Read More "Prostate Cancer" Articles Progress Against Prostate Cancer / Prostate Cancer Research Trial Helps John Spencer Treat His ...

  12. Peralta Cancer Research Institute

    International Nuclear Information System (INIS)

    The investigators in the cell biology program at PCRI have pioneered in the development of techniques for culturing human epithelial cells. The cancer diagnosis program has been concerned with researching new techniques for early diagnosis of breast cancer in women. The cancer treatment program has been concerned with applying cell biology and biochemistry advances to improve cancer management

  13. Long-term outcomes for children with acute lymphoblastic leukemia (ALL) treated on The Cancer Institute of New Jersey ALL trial (CINJALL).

    Science.gov (United States)

    Drachtman, Richard A; Masterson, Margaret; Shenkerman, Angela; Vijayanathan, Veena; Cole, Peter D

    2016-10-01

    The Cancer Institute of New Jersey Acute Lymphoblastic Leukemia trial (CINJALL) employed a post-induction regimen centered on intensive oral antimetabolite therapy, with no intravenous methotrexate (MTX). Fifty-eight patients enrolled between 2001 and 2005. A high rate of induction death (n = 3) or induction failure (n = 1) was observed. Among those who entered remission, five-year DFS is 80 ± 8.9% for those at standard risk of relapse and 76 ± 7.8% for high-risk patients, with median follow up over six years. The estimated cumulative incidence of testicular relapse among boys was elevated (13 ± 7.2%) compared to the rate observed on contemporary protocols. We conclude that post-induction therapy using intensive oral antimetabolites for children with acute lymphoblastic leukemia (ALL) can result in overall long-term DFS comparable to that observed among children treated with regimens including intravenous MTX. However, an increased risk of late extramedullary relapse among boys was observed, supporting the prevailing opinion that high-dose MTX improves outcome for children with ALL. PMID:26879921

  14. Selected National Cancer Institute Breast Cancer Research Topics | NIH MedlinePlus the Magazine

    Science.gov (United States)

    ... For Breast Cancer Selected National Cancer Institute Breast Cancer Research Topics Past Issues / Summer 2014 Table of Contents ... Trials www.cancer.gov/clinicaltrials/Taking-Part-in-Cancer-Treatment-Research-Studies MedlinePlus tutorial www.nlm.nih.gov/medlineplus/ ...

  15. National Cancer Institute

    Science.gov (United States)

    ... Español 1-800-4-CANCER Live Chat Publications Dictionary Menu Contact Dictionary Search About Cancer Causes and Prevention Risk Factors ... Contacts Other Funding Find NCI funding for small business innovation, technology transfer, and contracts Training Cancer Training ...

  16. A Multi-institutional Clinical Trial of Rectal Dose Reduction via Injected Polyethylene-Glycol Hydrogel During Intensity Modulated Radiation Therapy for Prostate Cancer: Analysis of Dosimetric Outcomes

    International Nuclear Information System (INIS)

    Purpose: To characterize the effect of a prostate-rectum spacer on dose to rectum during external beam radiation therapy for prostate cancer and to assess for factors correlated with rectal dose reduction. Methods and Materials: Fifty-two patients at 4 institutions were enrolled into a prospective pilot clinical trial. Patients underwent baseline scans and then were injected with perirectal spacing hydrogel and rescanned. Intensity modulated radiation therapy plans were created on both scans for comparison. The objectives were to establish rates of creation of ≥7.5 mm of prostate-rectal separation, and decrease in rectal V70 of ≥25%. Multiple regression analysis was performed to evaluate the associations between preinjection and postinjection changes in rectal V70 and changes in plan conformity, rectal volume, bladder volume, bladder V70, planning target volume (PTV), and postinjection midgland separation, gel volume, gel thickness, length of PTV/gel contact, and gel left-to-right symmetry. Results: Hydrogel resulted in ≥7.5-mm prostate-rectal separation in 95.8% of patients; 95.7% had decreased rectal V70 of ≥25%, with a mean reduction of 8.0 Gy. There were no significant differences in preinjection and postinjection prostate, PTV, rectal, and bladder volumes. Plan conformities were significantly different before versus after injection (P=.02); plans with worse conformity indexes after injection compared with before injection (n=13) still had improvements in rectal V70. In multiple regression analysis, greater postinjection reduction in V70 was associated with decreased relative postinjection plan conformity (P=.01). Reductions in V70 did not significantly vary by institution, despite significant interinstitutional variations in plan conformity. There were no significant relationships between reduction in V70 and the other characteristics analyzed. Conclusions: Injection of hydrogel into the prostate-rectal interface resulted in dose reductions to rectum

  17. From Clinical Trials to the Front Line: Vinflunine for Treatment of Urothelial Cell Carcinoma at the National Cancer Institute of Naples

    Science.gov (United States)

    Facchini, Gaetano; Della Pepa, Chiara; Cavaliere, Carla; Cecere, Sabrina C.; Di Napoli, Marilena; D'Aniello, Carmine; Crispo, Anna; Iovane, Gelsomina; Maiolino, Piera; Tramontano, Teresa; Piscitelli, Raffaele; Pisconti, Salvatore; Montella, Maurizio; Berretta, Massimiliano; Sorrentino, Domenico; Perdonà, Sisto; Pignata, Sandro

    2016-01-01

    Background: The efficacy of Vinflunine, after failure of platinum-based chemotherapy in patients with metastatic or recurrent Transitional Cell Cancer of the Urothelial Tract, TCCU, has been demonstrated in an international, randomized, phase III trial comparing Vinflunine plus Best Supportive Care, BSC, with BSC alone. On the basis of that study vinflunine has been approved by the European Medicine Association, EMA, for treatment of TCCU patients after failure of a platinum treatment. However, since data in clinical trials often differ from routine clinical practice due to unselected population and less strict monitoring, “real life” experiences are very helpful to verify the efficacy of a new therapy. Methods: This was a spontaneous, observational, retrospective study involving 43 patients with metastatic TCCU treated with vinflunine at our cancer center, data about demographics, disease characteristics, and previous treatments were collected and outcome and toxicities of vinflunine were analyzed. Results: 41 of 43 patients were eligible for RR analysis, the Overall RR was 12%, the Disease Control Rate was 29%; when including only patients treated in II line the DCR rose to 33%; the median PFS and the median OS were 2.2 and 6.9 months, respectively. Conclusion: Our findings were consistent with the outcome data emerged in the phase III randomized trial and in the other observational studies conducted all around Europe in the last 2–3 years. This experience supports the use of vinflunine in patients with advanced TTCU as effective and manageable antineoplastic drug. PMID:27199753

  18. Clinical Trials | Division of Cancer Prevention

    Science.gov (United States)

    Information about actively enrolling, ongoing, and completed clinical trials of cancer prevention, early detection, and supportive care, including phase I, II, and III agent and action trials and clinical trials management. |

  19. Insight into early-phase trials for lung cancer in the United States

    OpenAIRE

    Yang, Jin-Ji; Wu, Yi-Long

    2015-01-01

    Introduction Few data have been published comparing early-phase trials for lung cancer between China and the United States (US). This study was to investigate the differences of phase 1 trials for lung cancer between these two countries. Methods In 2014, a cross-sectional survey was conducted to compare phase 1 trials for lung cancer between the Guangdong Lung Cancer Institute (GLCI), the University of Wisconsin Carbone Cancer Center (UWCCC), and the University of Texas MD Anderson Cancer Cen...

  20. Clinical Trials Management | Division of Cancer Prevention

    Science.gov (United States)

    Information for researchers about developing, reporting, and managing NCI-funded cancer prevention clinical trials. Protocol Information Office The central clearinghouse for clinical trials management within the Division of Cancer Prevention.Read more about the Protocol Information Office. | Information for researchers about developing, reporting, and managing NCI-funded cancer prevention clinical trials.

  1. ICMIC Institutions - Cancer Imaging Program

    Science.gov (United States)

    ICMIC grants facilitate interaction among scientists from a variety of fields to conduct multidisciplinary research on cellular and molecular imaging related to cancer. Pre-ICMIC planning grants have provided time and funds for investigators and institutions to prepare themselves, organizationally and scientifically, to establish ICMICs.

  2. Survival in prostate cancer prevention trial detailed

    Science.gov (United States)

    In the NCI-sponsored Prostate Cancer Prevention Trial, initial findings from a decade ago showed that the drug finasteride significantly reduced the risk of prostate cancer, but among those who did develop prostate cancer, paradoxically, the drug was asso

  3. Institutional shared resources and translational cancer research.

    Science.gov (United States)

    De Paoli, Paolo

    2009-01-01

    The development and maintenance of adequate shared infrastructures is considered a major goal for academic centers promoting translational research programs. Among infrastructures favoring translational research, centralized facilities characterized by shared, multidisciplinary use of expensive laboratory instrumentation, or by complex computer hardware and software and/or by high professional skills are necessary to maintain or improve institutional scientific competitiveness. The success or failure of a shared resource program also depends on the choice of appropriate institutional policies and requires an effective institutional governance regarding decisions on staffing, existence and composition of advisory committees, policies and of defined mechanisms of reporting, budgeting and financial support of each resource. Shared Resources represent a widely diffused model to sustain cancer research; in fact, web sites from an impressive number of research Institutes and Universities in the U.S. contain pages dedicated to the SR that have been established in each Center, making a complete view of the situation impossible. However, a nation-wide overview of how Cancer Centers develop SR programs is available on the web site for NCI-designated Cancer Centers in the U.S., while in Europe, information is available for individual Cancer centers. This article will briefly summarize the institutional policies, the organizational needs, the characteristics, scientific aims, and future developments of SRs necessary to develop effective translational research programs in oncology.In fact, the physical build-up of SRs per se is not sufficient for the successful translation of biomedical research. Appropriate policies to improve the academic culture in collaboration, the availability of educational programs for translational investigators, the existence of administrative facilitations for translational research and an efficient organization supporting clinical trial recruitment

  4. Institutional shared resources and translational cancer research

    Directory of Open Access Journals (Sweden)

    De Paoli Paolo

    2009-06-01

    Full Text Available Abstract The development and maintenance of adequate shared infrastructures is considered a major goal for academic centers promoting translational research programs. Among infrastructures favoring translational research, centralized facilities characterized by shared, multidisciplinary use of expensive laboratory instrumentation, or by complex computer hardware and software and/or by high professional skills are necessary to maintain or improve institutional scientific competitiveness. The success or failure of a shared resource program also depends on the choice of appropriate institutional policies and requires an effective institutional governance regarding decisions on staffing, existence and composition of advisory committees, policies and of defined mechanisms of reporting, budgeting and financial support of each resource. Shared Resources represent a widely diffused model to sustain cancer research; in fact, web sites from an impressive number of research Institutes and Universities in the U.S. contain pages dedicated to the SR that have been established in each Center, making a complete view of the situation impossible. However, a nation-wide overview of how Cancer Centers develop SR programs is available on the web site for NCI-designated Cancer Centers in the U.S., while in Europe, information is available for individual Cancer centers. This article will briefly summarize the institutional policies, the organizational needs, the characteristics, scientific aims, and future developments of SRs necessary to develop effective translational research programs in oncology. In fact, the physical build-up of SRs per se is not sufficient for the successful translation of biomedical research. Appropriate policies to improve the academic culture in collaboration, the availability of educational programs for translational investigators, the existence of administrative facilitations for translational research and an efficient organization

  5. IMRT credentialing for prospective trials using institutional virtual phantoms: results of a joint European Organization for the Research and Treatment of Cancer and Radiological Physics Center project

    International Nuclear Information System (INIS)

    Intensity-modulated radiotherapy (IMRT) credentialing for a EORTC study was performed using an anthropomorphic head phantom from the Radiological Physics Center (RPC; RPCPH). Institutions were retrospectively requested to irradiate their institutional phantom (INSTPH) using the same treatment plan in the framework of a Virtual Phantom Project (VPP) for IMRT credentialing. CT data set of the institutional phantom and measured 2D dose matrices were requested from centers and sent to a dedicated secure EORTC uploader. Data from the RPCPH and INSTPH were thereafter centrally analyzed and inter-compared by the QA team using commercially available software (RIT; ver.5.2; Colorado Springs, USA). Eighteen institutions participated to the VPP. The measurements of 6 (33%) institutions could not be analyzed centrally. All other centers passed both the VPP and the RPC ±7%/4 mm credentialing criteria. At the 5%/5 mm gamma criteria (90% of pixels passing), 11(92%) as compared to 12 (100%) centers pass the credentialing process with RPCPH and INSTPH (p = 0.29), respectively. The corresponding pass rate for the 3%/3 mm gamma criteria (90% of pixels passing) was 2 (17%) and 9 (75%; p = 0.01), respectively. IMRT dosimetry gamma evaluations in a single plane for a H&N prospective trial using the INSTPH measurements showed agreement at the gamma index criteria of ±5%/5 mm (90% of pixels passing) for a small number of VPP measurements. Using more stringent, criteria, the RPCPH and INSTPH comparison showed disagreement. More data is warranted and urgently required within the framework of prospective studies

  6. Multi-institutional phase II trial of intermediate risk prostate cancer treated with combination of external beam radiotherapy and high dose rate iridium brachytherapy

    International Nuclear Information System (INIS)

    A total of 84 intermediate risk prostate cancer (T2b or T2c, or 10< prostate specific antigen (PSA) ≤20 ng/ml, or Gleason score =7) patients were enrolled from five institutions. External beam radiotherapy were 3 Gy x 13 fraction =39 Gy and high dose rate iridium brachytherapy were 9 Gy x 2=18 Gy in one or two days. Primary endpoint of this study is the incidence of grade 3 late toxicity (NCI-CTC Ver.3) and secondary endpoint are acute toxicity and PSA relapse free rate. No grade 3 toxicity was observed and only one patient among 84 patients is noted PSA failure. Combined treatment of external beam radiotherapy and high dose rate iridium brachytherapy against intermediate risk of prostate cancer is safe and effective treatment. (author)

  7. A randomized phase III trial comparing concomitant chemoradiotherapy versus radiotherapy alone in advanced head and neck cancers - mature results: Yoodhvir Singh Nagar, Lucknow Cancer Institute, India

    International Nuclear Information System (INIS)

    To evaluate contribution of concomitant chemoradiotherapy (CTRT) over and above radiotherapy alone (RT) in previously untreated stage III/IV, squamous cell carcinoma of the head and neck (SCCH and N). Patients with cancers of oral cavity (OC), oropharynx (OP), supraglottis (SG) and hypopharynx (HP) were randomized into RT arm or CTRT arm. Radiotherapy was identical in both arms (70Gy/35 fractions/7 weeks). In CTRT arm concomitant cisplatin (35mg/m2) was given weekly for seven cycles. Surgery was reserved for salvage purposes when required. From May 1996 to December 1998, 155 patients (RT=78, CTRT=77) were enrolled and 139 patients (RT1,CTRT=68) were assessable. Over 90% patients in both arms completed planned treatment. The complete response rate was 51% in RT arm and 71% in CTRT arm (p=0.017). The median disease free survival (DFS) and overall survival (OS) in RT arm and CTRT arm were 3 months vs. 11 months (p=0.0009) and 9 months vs. 26 months (p=0.01) respectively. The 5-year DFS and OS in the two arms were 10% vs. 27% (p=0.000) and 16% vs. 29% (p=0.01) respectively. Acute grade III toxicity was comparable in both the arms (12% vs. 16%, p=0.74). Late grade I/II toxicity was higher in CTRT arm (70% vs. 51%, p=0.09). Serious late toxicities were not seen in both arms. On univariate analysis the favorable factors for immediate response were protocol (CTRT better), primary site (SG and OP better than OC and HP), T-stage (T1-T2 better), Nodes (N0 better than N+), Stage (III > IV), KPS (>80) and lesser overall treatment time (OTT). Multivariate analysis retained protocol, T stage, N stage and OTT as factors independently affecting the immediate response. Addition of concomitant weekly cisplatin (35mg/m2) to radiotherapy improves the likelihood of local control, DFS and OS with acceptable acute and late toxicities and can be recommended as a standard form of treatment in advanced SCCH and N

  8. Health-Related Quality of Life After Stereotactic Body Radiation Therapy for Localized Prostate Cancer: Results From a Multi-institutional Consortium of Prospective Trials

    Energy Technology Data Exchange (ETDEWEB)

    King, Christopher R., E-mail: crking@mednet.ucla.edu [Department of Radiation Oncology, University of California, Los Angeles, California (United States); Collins, Sean [Department of Radiation Oncology, Georgetown University, Washington, District of Columbia (United States); Fuller, Donald [Genesis Healthcare Partners, San Diego, California (United States); Wang, Pin-Chieh; Kupelian, Patrick; Steinberg, Michael [Department of Radiation Oncology, University of California, Los Angeles, California (United States); Katz, Alan [Flushing Radiation Oncology, Flushing, New York (United States)

    2013-12-01

    Purpose: To evaluate the early and late health-related quality of life (QOL) outcomes among prostate cancer patients following stereotactic body radiation therapy (SBRT). Methods and Materials: Patient self-reported QOL was prospectively measured among 864 patients from phase 2 clinical trials of SBRT for localized prostate cancer. Data from the Expanded Prostate Cancer Index Composite (EPIC) instrument were obtained at baseline and at regular intervals up to 6 years. SBRT delivered a median dose of 36.25 Gy in 4 or 5 fractions. A short course of androgen deprivation therapy was given to 14% of patients. Results: Median follow-up was 3 years and 194 patients remained evaluable at 5 years. A transient decline in the urinary and bowel domains was observed within the first 3 months after SBRT which returned to baseline status or better within 6 months and remained so beyond 5 years. The same pattern was observed among patients with good versus poor baseline function and was independent of the degree of early toxicities. Sexual QOL decline was predominantly observed within the first 9 months, a pattern not altered by the use of androgen deprivation therapy or patient age. Conclusion: Long-term outcome demonstrates that prostate SBRT is well tolerated and has little lasting impact on health-related QOL. A transient and modest decline in urinary and bowel QOL during the first few months after SBRT quickly recovers to baseline levels. With a large number of patients evaluable up to 5 years following SBRT, it is unlikely that unexpected late adverse effects will manifest themselves.

  9. Two-week course of preoperative chemoradiotherapy followed by delayed surgery for rectal cancer: A phase II multi-institutional clinical trial (KROG 11-02)

    International Nuclear Information System (INIS)

    Purpose: The aim of this study was to evaluate the efficacy and safety of a two-week schedule of radiotherapy with oral capecitabine in locally advanced rectal cancer. Methods and materials: Eighty patients with rectal cancer located in the mid to low rectum, staged cT3-4N0-2M0, were prospectively enrolled. They underwent preoperative chemoradiotherapy and delayed surgery 6–8 weeks after the completion of radiation therapy. A radiation dose of 33 Gy in 10 fractions was delivered to the pelvis for 2 weeks. One cycle of oral capecitabine was administered at a dose of 1650 mg/m2/day during radiotherapy. Tumor response and toxicity were the study endpoints. This study was registered at ClinicalTrials.gov (number, (NCT01431599)). Results: All included patients underwent total mesorectal excisions including 12 cases of robot assisted surgery and 50 cases of laparoscopic surgery. Of the 80 patients, 27 (33.8%) achieved downstaging (ypT0-2N0) of a rectal tumor and 11 (13.8%) had a pathologically complete response (ypCR). Downstaging rates were 45% for T classification and 65% for N classification. Sphincter saving was achieved in 73 (91.3%) of the 80 patients. Of the 80 patients, 3 (3.8%) experienced grade 3 hematologic toxicity, and 2 (2.5%) had grade 3 postoperative complications such as ileus and wound dehiscence. There was no grade 4 toxicity. Conclusion: A two-week schedule of radiotherapy with oral capecitabine in locally advanced rectal cancer patients showed low toxicity profiles and promising results in terms of tumor response

  10. Health-Related Quality of Life After Stereotactic Body Radiation Therapy for Localized Prostate Cancer: Results From a Multi-institutional Consortium of Prospective Trials

    International Nuclear Information System (INIS)

    Purpose: To evaluate the early and late health-related quality of life (QOL) outcomes among prostate cancer patients following stereotactic body radiation therapy (SBRT). Methods and Materials: Patient self-reported QOL was prospectively measured among 864 patients from phase 2 clinical trials of SBRT for localized prostate cancer. Data from the Expanded Prostate Cancer Index Composite (EPIC) instrument were obtained at baseline and at regular intervals up to 6 years. SBRT delivered a median dose of 36.25 Gy in 4 or 5 fractions. A short course of androgen deprivation therapy was given to 14% of patients. Results: Median follow-up was 3 years and 194 patients remained evaluable at 5 years. A transient decline in the urinary and bowel domains was observed within the first 3 months after SBRT which returned to baseline status or better within 6 months and remained so beyond 5 years. The same pattern was observed among patients with good versus poor baseline function and was independent of the degree of early toxicities. Sexual QOL decline was predominantly observed within the first 9 months, a pattern not altered by the use of androgen deprivation therapy or patient age. Conclusion: Long-term outcome demonstrates that prostate SBRT is well tolerated and has little lasting impact on health-related QOL. A transient and modest decline in urinary and bowel QOL during the first few months after SBRT quickly recovers to baseline levels. With a large number of patients evaluable up to 5 years following SBRT, it is unlikely that unexpected late adverse effects will manifest themselves

  11. New Cancer Prevention and Control Central Institutional Review Board Established | Division of Cancer Prevention

    Science.gov (United States)

    The NCI Central Institutional Review Board (CIRB) Initiative announced the establishment of the Cancer Prevention and Control (CPC) CIRB January 14, extending the benefits of centralized review to investigators participating in clinical trials sponsored by the Division of Cancer Prevention (DCP). |

  12. Phase 1 Trials in Pancreatic Cancer

    Directory of Open Access Journals (Sweden)

    Esther Yu

    2014-07-01

    Full Text Available Despite many clinical trials over the last two decades since the approval of gemcitabine, the survival of patients with pancreatic cancer has improved by a few only months. This disappointing reality underlines an urgent need to develop more effective drugs or better combinations. A variety of phase I trials were presented at the annual meeting of ASCO 2014 focusing on locally advanced and metastatic pancreatic cancer. We summarize four abstracts (abstracts #4116, #4123, #4026, #4138.

  13. American Institute for Cancer Research

    Science.gov (United States)

    ... Order Publications Shop AICR Health @ Work Healthy Recipes Cancer Research Update AICR eNews AICR Newsletter ScienceNow CancerResource Where ... Patients and Survivors Materials for Health Professionals Our Cancer Research Research Grants Conference Continuous Update Project Research Progress ...

  14. The Regina Elena National Cancer Institute process of accreditation according to the standards of the Organisation of European Cancer Institutes.

    Science.gov (United States)

    Canitano, Stefano; Di Turi, Annunziata; Caolo, Giuseppina; Pignatelli, Adriana C; Papa, Elena; Branca, Marta; Cerimele, Marina; De Maria, Ruggero

    2015-12-31

    The accreditation process is, on the one hand, a tool used to homogenize procedures, rendering comparable and standardized processes of care, and on the other, a methodology employed to develop a culture of quality improvement. Although not yet proven by evidence-based studies that health outcomes improve as a result of an accreditation to excellence, it is undeniable that better control of healthcare processes results in better quality and safety of diagnostic and therapeutic pathways. The Regina Elena National Cancer Institute underwent the accreditation process in accordance with the standards criteria set by the Organisation of European Cancer Institutes (OECI), and it has recently completed the process, acquiring its designation as a Comprehensive Cancer Center (CCC). This was an invaluable opportunity for the Regina Elena Institute to create a more cohesive environment, to widely establish a culture of quality, to implement an institutional information system, and to accelerate the process of patient involvement in strategic decisions. The steps of the process allowed us to evaluate the performance and the organization of the institute and put amendments in place designed to be adopted through 26 improvement actions. These actions regarded several aspects of the institute, including quality culture, information communication technology system, care, clinical trials unit, disease management team, nursing, and patient empowerment and involvement. Each area has a timeline. We chose to present the following 3 improvement actions: clinical trial center, computerized ambulatory medical record, and centrality of patient and humanization of clinical pathway. PMID:27096274

  15. Prospective study of the relationship between coffee and tea with colorectal cancer risk: The PLCO Cancer Screening Trial

    OpenAIRE

    Dominianni, C; Huang, W-Y; Berndt, S.; Hayes, R B; Ahn, J.

    2013-01-01

    Background: Coffee and tea are commonly consumed and carry potential anticancer components that could reduce the risk of colorectal cancer; however, their relationships with colorectal cancer risk remain inconsistent. Methods: A prospective analysis was carried out to examine the relationships of coffee and tea intake with colorectal cancer risk in 57 398 men and women in the intervention arm of the National Cancer Institute-Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial, a nat...

  16. 78 FR 20118 - National Cancer Institute; Notice of Closed Meeting

    Science.gov (United States)

    2013-04-03

    ... Committee: National Cancer Institute Special Emphasis Panel; Cancer Biology and Therapy. Date: April 17... Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers... HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Closed...

  17. 78 FR 25459 - National Cancer Institute; Notice of Closed Meeting

    Science.gov (United States)

    2013-05-01

    ... Committee: National Cancer Institute Special Emphasis Panel; Cancer Therapy (Omnibus). Date: June 27-28....395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93... HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Closed...

  18. 75 FR 20370 - National Cancer Institute; Notice of Closed Meetings

    Science.gov (United States)

    2010-04-19

    ....395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93...@mail.nih.gov . Name of Committee: National Cancer Institute Special Emphasis Panel, Breast Cancer... HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Closed...

  19. Central Institutional Review Board Review for an Academic Trial Network

    Science.gov (United States)

    Kaufmann, Petra; O’Rourke, P. Pearl

    2016-01-01

    Problem Translating discoveries into therapeutics is often delayed by lengthy start-up periods for multicenter clinical trials. One cause of delay can be multiple institutional review board (IRB) reviews of the same protocol. Approach When developing the Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT; hereafter, NN), the National Institute of Neurological Disorders and Stroke (NINDS) established a central IRB (CIRB) based at Massachusetts General Hospital, the academic medical center that received the NN clinical coordinating center grant. The 25 NN sites, located at U.S. academic institutions, agreed to required CIRB use for NN trials. Outcomes To delineate roles and establish legal relationships between the NN sites and the CIRB, the CIRB executed reliance agreements with the sites and their affiliates that hold federalwide assurance for the protection of human subjects (FWA); this took, on average, 84 days. The first NN protocol reviewed by the CIRB achieved full approval to allow participant enrollment within 56 days and went from grant award to the first patient visit in less than four months. The authors describe anticipated challenges related to institutional oversight responsibilities versus regulatory CIRB review as well as unanticipated challenges related to working with complex organizations that include multiple FWA-holding affiliates. Next Steps The authors anticipate that CIRB use will decrease NN trial start-up time and thus promote efficient trial implementation. They plan to collect data on timelines and costs associated with CIRB use. The NINDS plans to promote CIRB use in future initiatives. PMID:25406606

  20. Reducing cancer health disparities: Perspective of the National Cancer Institute

    OpenAIRE

    Chu, Kenneth C.; Hubbell, F. Allan

    2008-01-01

    The National Cancer Institute created the Special Population Network (SPN) to develop cancer awareness, research and training with partnerships from community and research organizations. This paper provides background information about the Pacific Islander Cancer Control Network, one of the SPNs, and about the seven research projects that are described in this Supplement.

  1. A Phase II Multi-institutional Trial of Chemoradiation Using Weekly Docetaxel and Erythropoietin for High-Risk Postoperative Head and Neck Cancer Patients

    International Nuclear Information System (INIS)

    Purpose: To determine efficacy and toxicities of postoperative concurrent chemoradiation using docetaxel in high-risk head and neck cancer. Methods and Materials: High-risk patients were enrolled 2-8 weeks after surgery. Treatment included 60 Gy for 6 weeks with weekly docetaxel 25 mg/m2 and erythropoietin alpha 40,000 U for hemoglobin ≤12 g/dL. Primary endpoints included locoregional control (LC), disease-free survival (DFS), and patterns of failure (POF). Secondary endpoints were toxicity and quality of life. Results: Eighteen patients were enrolled (14 male, 4 female), aged 24-70 years (median, 55 years). Primary site included oropharynx = 7, oral cavity 8, hypopharynx = 1, and larynx = 2. Pathologic American Joint Committee on Cancer Stage was III = 3 patients, IV = 15 patients. High-risk eligibility included ≥2 positive lymph nodes = 13, extracapsular extension = 10, positive margins = 8 (11 patients with two or more risk factors). Docetaxel was reduced to 20 mg/m2/week after 5 patients had prolonged Grade 3 or higher mucositis. Overall, number of doses delivered was 2 of 6 = 1, 3 of 6 2, 4 of 6 = 2, 5 of 6 = 4, 6 of 6 = 9 patients. With median follow-up of 30 months (range, 5-66), 10 (56%) patients are alive and have no evidence of disease (NED); POF: three local recurrences (two with distant) and 1 distant only. One-year survival was 76%, median PFS and DFS had not been reached. Three-year LC was 82%. No Grade 3 or higher late toxicities were observed, although a few cases of prolonged mucositis and taste loss (>3 months) were seen, particularly at 25 mg/m2/week. Conclusion: Postoperative radiation therapy with weekly docetaxel 20 or 25 mg/m2/week for high-risk postoperative head and neck cancer caused intolerable mucosal toxicity, prompting early study termination. Further studies should consider 15 mg/m2. Actuarial 3-year LC is 82%, similar to cisplatin-based chemoradiation regimens. Distant metastasis remains an important issue requiring additional

  2. DO CANCER CLINICAL TRIAL POPULATIONS TRULY REPRESENT CANCER PATIENTS? A COMPARISON OF OPEN CLINICAL TRIALS TO THE CANCER GENOME ATLAS

    Science.gov (United States)

    Geifman, Nophar; Butte, Atul J.

    2016-01-01

    Open clinical trial data offer many opportunities for the scientific community to independently verify published results, evaluate new hypotheses and conduct meta-analyses. These data provide a springboard for scientific advances in precision medicine but the question arises as to how representative clinical trials data are of cancer patients overall. Here we present the integrative analysis of data from several cancer clinical trials and compare these to patient-level data from The Cancer Genome Atlas (TCGA). Comparison of cancer type-specific survival rates reveals that these are overall lower in trial subjects. This effect, at least to some extent, can be explained by the more advanced stages of cancer of trial subjects. This analysis also reveals that for stage IV cancer, colorectal cancer patients have a better chance of survival than breast cancer patients. On the other hand, for all other stages, breast cancer patients have better survival than colorectal cancer patients. Comparison of survival in different stages of disease between the two datasets reveals that subjects with stage IV cancer from the trials dataset have a lower chance of survival than matching stage IV subjects from TCGA. One likely explanation for this observation is that stage IV trial subjects have lower survival rates since their cancer is less likely to respond to treatment. To conclude, we present here a newly available clinical trials dataset which allowed for the integration of patient-level data from many cancer clinical trials. Our comprehensive analysis reveals that cancer-related clinical trials are not representative of general cancer patient populations, mostly due to their focus on the more advanced stages of the disease. These and other limitations of clinical trials data should, perhaps, be taken into consideration in medical research and in the field of precision medicine. PMID:26776196

  3. Recommendations for Collection and Handling of Specimens From Group Breast Cancer Clinical Trials

    OpenAIRE

    Leyland-Jones, Brian R.; Ambrosone, Christine B.; Bartlett, John; Ellis, Matthew J. C.; Enos, Rebecca A.; Raji, Adekunle; Pins, Michael R.; Zujewski, Jo Anne; Hewitt, Stephen M.; Forbes, John F.; Abramovitz, Mark; Braga, Sofia; Cardoso, Fatima; Harbeck, Nadia; Denkert, Carsten

    2008-01-01

    Recommendations for specimen collection and handling have been developed for adoption across breast cancer clinical trials conducted by the Breast International Group (BIG)-sponsored Groups and the National Cancer Institute (NCI)-sponsored North American Cooperative Groups. These recommendations are meant to promote identifiable standards for specimen collection and handling within and across breast cancer trials, such that the variability in collection/handling practices that currently exist...

  4. Prostate Cancer Research Trial Helps John Spencer Treat His Cancer | NIH MedlinePlus the Magazine

    Science.gov (United States)

    ... this page please turn Javascript on. Feature: Prostate Cancer Prostate Cancer Research Trial Helps John Spencer Treat His Cancer ... because of timely detection and treatment of his prostate cancer. He participated in an NIH-sponsored clinical trial. ...

  5. Breast Cancer: Surgery at the South Egypt Cancer Institute

    OpenAIRE

    Salem, Ahmed A.S.; Mohamed Abou Elmagd Salem; Hamza Abbass

    2010-01-01

    Breast cancer is the most frequent malignant tumor in women worldwide. In Egypt, it is the most common cancer among women, representing 18.9% of total cancer cases (35.1% in women and 2.2% in men) among the Egypt National Cancer Institute’s (NCI) series of 10,556 patients during the year 2001, with an age-adjusted rate of 49.6 per 100,000 people. In this study, the data of all breast cancer patients presented to the surgical department of the South Egypt cancer Institute (SECI) hospital durin...

  6. Integrated Molecular Profiling in Advanced Cancers Trial

    Science.gov (United States)

    2016-06-21

    Breast Cancer; Non-small Cell Lung Cancer; Colorectal Cancer; Genitourinary Cancer; Pancreatobiliary Gastrointestinal Cancer; Upper Aerodigestive Tract Cancer; Gynecological Cancers; Melanoma Cancers; Rare Cancers; Unknown Primary Cancers

  7. 77 FR 67015 - National Cancer Institute; Notice of Closed Meetings

    Science.gov (United States)

    2012-11-08

    ... Committee: National Cancer Institute Special Emphasis Panel NCI Omnibus and Cancer Therapy. Date: November... Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397... HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Closed...

  8. 78 FR 8157 - National Cancer Institute; Notice of Closed Meetings

    Science.gov (United States)

    2013-02-05

    ... Committee: National Cancer Institute Special Emphasis Panel; Provocative Questions: Cancer Therapy and... Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397... HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Closed...

  9. 78 FR 36200 - National Cancer Institute; Notice of Closed Meetings

    Science.gov (United States)

    2013-06-17

    ... Committee: National Cancer Institute Special Emphasis Panel; Cancer Biology and Therapy. Date: June 24, 2013... Research; 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396... HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Closed...

  10. 78 FR 59362 - National Cancer Institute; Notice of Closed Meetings

    Science.gov (United States)

    2013-09-26

    ... Committee: National Cancer Institute Special Emphasis Panel Provocative Questions--Group D: Cancer Therapy... Research; 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396... HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Closed...

  11. 78 FR 50065 - National Cancer Institute; Notice of Closed Meetings

    Science.gov (United States)

    2013-08-16

    ...@mail.nih.gov . Name of Committee: National Cancer Institute Special Emphasis Panel; Cancer Therapy... Prevention Research; 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93... HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Closed...

  12. 76 FR 50487 - National Cancer Institute Notice of Closed Meetings

    Science.gov (United States)

    2011-08-15

    ... Committee: National Cancer Institute Special Emphasis Panel; NCI SPORE in Childhood ALL, Skin, Brain, Lung....395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93... HUMAN SERVICES National Institutes of Health National Cancer Institute Notice of Closed...

  13. A pilot study on the quality of data management in a cancer clinical trial

    NARCIS (Netherlands)

    Putten, E. van der; Velden, J.W. van der; Siers, A.; Hamersma, E.A.M.

    1987-01-01

    Twelve institutional data managers were asked to independently code the data from a patient chart of one patient in an ovarian cancer trial. They abstracted data from the medical record and filled out three types of trial forms (on-study, chemotherapy, and summary forms). The analysis of the process

  14. Cooperative research and development opportunities with the National Cancer Institute

    Science.gov (United States)

    Sybert, Kathleen

    1991-01-01

    The Office of Technology Development (OTD) of the National Cancer Institute (NCI) is responsible for negotiating Cooperative Research and Development Agreements (CRADAs), whereby the knowledge resulting from NCI investigators' government-sponsored research is developed in collaboration with universities and/or industry into new products of importance for the diagnosis and treatment of cancer and acquired immunodeficiency syndrome (AIDS). The NCI has recently executed a unique 'clinical trials' CRADA and is developing a model agreement based upon it for the development and commercialization of products for the diagnosis and treatment of cancer and AIDS. NCI drug screening, preclinical testing, clinical trials, and AIDS program capabilities form the basis for this new technology development/technology transfer vehicle. NCI's extensive drug screening program and 'designer foods' program serve as potential sources of investigational new drugs (INDs) and cancer preventatives. Collaborations between NCI and pharmaceutical companies having the facilities, experience, and expertise necessary to develop INDs into approved drugs available to the public are being encouraged where the companies have proprietary rights to INDs, or where NCI has proprietary rights to INDs and invites companies to respond to a collaborator announcement published in the Federal Register. The joint efforts of the NCI and the chosen collaborator are designed to generate the data necessary to obtain pharmaceutic regulatory approval from the Food and Drug Administration (FDA) to market the drugs developed, and thereby make them available to health care providers for the diagnosis and treatment of cancer and AIDS.

  15. Lethal Prostate Cancer in the PLCO Cancer Screening Trial.

    Science.gov (United States)

    Shoag, Jonathan; Mittal, Sameer; Halpern, Joshua A; Scherr, Douglas; Hu, Jim C; Barbieri, Christopher E

    2016-07-01

    The Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial randomized men to usual care or annual prostate-specific antigen (PSA) screening for 6 yr and digital rectal examination for 4 yr. This trial found no difference between the intervention and usual care arms of the study in the primary end point of prostate cancer (PCa)-specific mortality. The PLCO trial results have had a major impact on health policy and the rate of PSA screening in the United States. We analyzed the 13-yr screening and outcomes data from the 151 participants who died of PCa in the screening arm of the trial to better understand how randomization to screening failed to prevent PCa death in these men. We found that of these men, 81 (53.6%) either were never screened as part of the trial or had an initial positive screen. Only 17 (11.3%) of those who died reached year 6 of the trial with a PSA <4.0 ng/ml. The men who died in the screening arm were also older at study entry than the average PLCO participant (66 vs 62 yr; p < 0.001). Our analysis should inform the interpretation of the PLCO trial and provide insight into future trial design. PMID:27166670

  16. Institutional mistrust in the organization of pharmaceutical clinical trials

    OpenAIRE

    Fisher, Jill A.

    2008-01-01

    In this paper I explore the politics of trust in the clinical testing of pharmaceuticals in the US. Specifically, I analyze trust in terms of its institutional manifestations in the pharmaceutical clinical trials industry. In the process of testing new drugs, pharmaceutical companies must (1) protect their proprietary information from the clinicians who conduct their studies, and (2) find a way to ensure human subjects' compliance to study protocols. Concern with these two critical issues lea...

  17. 76 FR 576 - National Cancer Institute; Notice of Closed Meetings

    Science.gov (United States)

    2011-01-05

    ...-Therapy Breast Cancer Patients. Date: March 3, 2011. Time: 12 p.m. to 5 p.m. Agenda: To review and....395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93... HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Closed...

  18. 78 FR 27408 - National Cancer Institute; Notice of Closed Meetings

    Science.gov (United States)

    2013-05-10

    ... Methods for the Detection of Cancer Recurrence in Post-Therapy Breast Cancer Patients. Date: June 4, 2013... Prevention Research; 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93... HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Closed...

  19. 78 FR 58321 - National Cancer Institute; Notice of Closed Meetings

    Science.gov (United States)

    2013-09-23

    ... Emphasis Panel, Provocative Questions: Cancer Therapy & Outcomes. Date: November 7-8, 2013. Time: 8:00 a.m..., Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398... HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Closed...

  20. 75 FR 21002 - National Cancer Institute; Notice of Closed Meetings

    Science.gov (United States)

    2010-04-22

    ...; 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer... Panel, SPORE in Lymphoma and Breast Cancer. Date: June 15-16, 2010. Time: 5 p.m. to 5 p.m. Agenda: To... HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Closed...

  1. 75 FR 3239 - National Cancer Institute; Notice of Closed Meetings

    Science.gov (United States)

    2010-01-20

    ... Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398, Cancer Research... Special Emphasis Panel, Basal-like Breast Cancer Assay. Date: March 10, 2010. Time: 8 a.m. to 7 p.m... HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Closed...

  2. African American women's perceptions of cancer clinical trials

    OpenAIRE

    Haynes-Maslow, Lindsey; Godley, Paul; DiMartino, Lisa; White, Brandolyn; Odom, Janice; Richmond, Alan; Carpenter, William

    2014-01-01

    Cancer clinical trials are important for resolving cancer health disparities for several reasons; however, clinical trial participation among African Americans is significantly lower than Caucasians. This study engaged focus groups of 82 female African American cancer survivors or cancer caregivers, including those in better resourced, more urban areas and less resourced, more rural areas. Informed by an integrated conceptual model, the focus groups examined perceptions of cancer clinical tri...

  3. Most Breast Cancer Screening Trials Have a Flawed Design

    OpenAIRE

    Gurnani, Nishant; Srivastava, Anurag

    2011-01-01

    In the present article, we discuss that why most breast cancer screening trials have a flawed origin. We suggest some solutions to correct these flaws so that more valid and reliable screening trials can be conducted in the future.

  4. How Have Cancer Clinical Trial Eligibility Criteria Evolved Over Time?

    Science.gov (United States)

    Yaman, Anil; Chakrabarti, Shreya; Sen, Anando; Weng, Chunhua

    2016-01-01

    Knowledge reuse of cancer trial designs may benefit from a temporal understanding of the evolution of the target populations of cancer studies over time. Therefore, we conducted a retrospective analysis of the trends of cancer trial eligibility criteria between 1999 and 2014. The yearly distributions of eligibility concepts for chemicals and drugs, procedures, observations, and medical conditions extracted from free-text eligibility criteria of 32,000 clinical trials for 89 cancer types were analyzed. We identified the concepts that trend upwards or downwards in all or selected cancer types, and the concepts that show anomalous trends for some cancers. Later, concept trends were studied in a disease-specific manner and illustrated for breast cancer. Criteria trends observed in this study are also validated and interpreted using evidence from the existing medical literature. This study contributes a method for concept trend analysis and original knowledge of the trends in cancer clinical trial eligibility criteria. PMID:27570681

  5. The Cervix Cancer Research Network (CCRN: Increasing access to cancer clinical trials in low- and middle-income countries

    Directory of Open Access Journals (Sweden)

    Gita eSuneja

    2015-02-01

    Full Text Available Introduction: The burden of cervical cancer is large and growing in developing countries, due in large part to limited access to screening services and lack of human papillomavirus (HPV vaccination. In spite of modern advances in diagnostic and therapeutic modalities, outcomes from cervical cancer have not markedly improved in recent years. Novel clinical trials are urgently needed to improve outcomes from cervical cancer worldwide. Methods: The Cervix Cancer Research Network (CCRN, a subsidiary of the Gynecologic Cancer InterGroup (GCIG, is a multi-national, multi-institutional consortium of physicians and scientists focused on improving cervical cancer outcomes worldwide by making cancer clinical trials available in low-, middle-, and high-income countries. Standard operating procedures for participation in CCRN include a pre-qualifying questionnaire to evaluate clinical activities and research infrastructure, followed by a site visit. Once a site is approved, they may choose to participate in one of four currently accruing clinical trials.Results: To date, 13 different CCRN site visits have been performed. Of these 13 sites visited, 10 have been approved as CCRN sites including Tata Memorial Hospital, India; Bangalore, India; Trivandrum, India; Ramathibodi, Thailand; Siriaj, Thailand; Pramongkutklao, Thailand; Ho Chi Minh, Vietnam; Blokhin Russian Cancer Research Center; the Hertzen Moscow Cancer Research Institute; and the Russian Scientific Center of Roentgenoradiology. The four currently accruing clinical trials are TACO, OUTBACK, INTERLACE, and SHAPE.Discussion: The CCRN has successfully enrolled 10 sites in developing countries to participate in four randomized clinical trials. The primary objectives are to provide novel therapeutics to regions with the greatest need and to improve the validity and generalizability of clinical trial results by enrolling a diverse sample of patients.

  6. 78 FR 50064 - National Cancer Institute; Notice of Meeting

    Science.gov (United States)

    2013-08-16

    ...: 8:30 a.m. to 3:30 p.m. Agenda: Cancer Communication for Prevention: In the Digital Commons... HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Meeting Pursuant to... a meeting of the President's Cancer Panel. The meeting will be open to the public, with...

  7. 78 FR 69432 - National Cancer Institute; Notice of Meeting

    Science.gov (United States)

    2013-11-19

    ...:30 a.m. to 4:00 p.m. Agenda: Cancer Communication in the Digital Era: Opportunities and Challenges... HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Meeting Pursuant to... a meeting of the President's Cancer Panel. The meeting will be open to the public, with...

  8. Design, development of water tank-type lung phantom and dosimetric verification in institutions participating in a phase I study of stereotactic body radiation therapy in patients with T2N0M0 non-small cell lung cancer: Japan Clinical Oncology Group trial (JCOG0702)

    International Nuclear Information System (INIS)

    A domestic multicenter phase I study of stereotactic body radiotherapy (SBRT) for T2N0M0 non-small cell lung cancer in inoperable patients or elderly patients who refused surgery was initiated as the Japan Clinical Oncology Group trial (JCOG0702) in Japan. Prior to the clinical study, the accuracy of dose calculation in radiation treatment-planning systems was surveyed in participating institutions, and differences in the irradiating dose between the institutions were investigated. We developed a water tank-type lung phantom appropriate for verification of the exposure dose in lung SBRT. Using this water tank-type lung phantom, the dose calculated in the radiation treatment-planning system and the measured dose using a free air ionization chamber and dosimetric film were compared in a visiting survey of the seven institutions participating in the clinical study. In all participating institutions, differences between the calculated and the measured dose in the irradiation plan were as follows: the accuracy of the absolute dose in the center of the simulated tumor measured using a free air ionization chamber was within 2%, the mean gamma value was ≤0.47 on gamma analysis following the local dose criteria, and the pass rate was >87% for 3%/3 mm from measurement of dose distribution with dosimetric film. These findings confirmed the accuracy of delivery doses in the institutions participating in the clinical study, so that a study with integration of the institutions could be initiated

  9. Nutritional profile of pediatric cancer patients at Cancer Institute, Chennai

    Directory of Open Access Journals (Sweden)

    V Radhakrishnan

    2015-01-01

    Full Text Available Background: Malnutrition is widely prevalent in the pediatric population in India. There is paucity of data on the prevalence of malnutrition in pediatric cancer patients and the impact of cancer treatment on nutritional status of Indian children. Aims: The study was conducted to look at the prevalence of malnutrition and assess the impact of treatment on nutritional status of pediatric cancer patients. Settings And Design: This was a retrospective study. Materials And Methods: Data on the weight of pediatric cancer patients <16 years of age treated at Cancer Institute, Chennai, from January 2013 to May 2014 were analyzed at systematic time points in therapy. Patients' weight were plotted on the Centre for Disease Control (CDC growth charts. Patients were defined to be undernourished if their weight for age was ≤3rd centile in CDC growth charts and obese if their weight for age was ≥97th centile on CDC growth charts. RESULTS: A total of 295 patient case records were analyzed. Acute lymphoblastic leukemia was the most common malignancy. At diagnosis, under-nutrition was seen in 44% patients, this increased to 46% midway during treatment (end of induction in acute leukemia and completion of 50% of planned treatment in solid tumors and decreased to 27% at the end of treatment (beginning of maintenance in acute leukemia and completion of planned treatment in solid tumors (P = 0.0005. There was no significant difference in nutritional status between patients with hematological malignancies and solid tumors (P = 0.8. Conclusion: Under-nutrition is present in close to half of the pediatric cancer patients presenting to our institute. Active nutritional intervention and education were able to significantly reduce the prevalence of under-nutrition in patients at the end of treatment.

  10. The Danish randomized lung cancer CT screening trial

    DEFF Research Database (Denmark)

    Pedersen, Jesper H; Ashraf, Haseem; Dirksen, Asger;

    2009-01-01

    INTRODUCTION: Lung cancer screening with low dose computed tomography (CT) has not yet been evaluated in randomized clinical trials, although several are underway. METHODS: In The Danish Lung Cancer Screening Trial, 4104 smokers and previous smokers from 2004 to 2006 were randomized to either...

  11. Report on a Delphi process and workshop to improve accrual to cancer clinical trials

    Science.gov (United States)

    Bell, J.A.H.; Balneaves, L.G.; Kelly, M.T.; Richardson, H.

    2016-01-01

    Cancer clinical trials (ccts) are essential for furthering knowledge and developing effective interventions to improve the lives of people living with cancer in Canada. Randomized controlled trials are particularly important for developing evidence-based health care interventions. To produce robust and relevant research conclusions, timely and sufficient accrual to ccts is essential. The present report delivers the key recommendations emerging from a workshop meeting, Improve Accrual to Cancer Clinical Trials, that was hosted by the Canadian Cancer Trials Group and funded by the Canadian Institutes of Health Research. The meeting, which took place in Toronto, Ontario, in April 2012 before the Canadian Cancer Trials Group annual spring meeting, brought together key stakeholders from across Canada to explore creative strategies for improving accrual to ccts. The objectives of the workshop were to provide an opportunity for knowledge exchange with respect to the research evidence and the ethics theory related to cct accrual and to promote discussion of best practices and policies related to enhancing cct access and accrual in Canada. The workshop provided the foundation for establishing new interdisciplinary research collaborations to overcome the identified barriers to cct participation in Canada. Meeting participants also supported the development of evidence-based policies and practices to make trials more accessible to Canadians living with cancer.

  12. Immune checkpoints in cancer clinical trials

    Institute of Scientific and Technical Information of China (English)

    Elad Sharon; Howard Streicher; Priscila Goncalves; Helen XChen

    2014-01-01

    Immunology-based therapy is rapidly developing into an effective treatment option for a surprising range of cancers. We have learned over the last decade that powerful immunologic effector cells may be blocked by inhibitory regulatory pathways controlled by specific molecules often called“immune checkpoints.” These checkpoints serve to control or turn off the immune response when it is no longer needed to prevent tissue injury and autoimmunity. Cancer cells have learned or evolved to use these mechanisms to evade immune control and elimination. The development of a new therapeutic class of drugs that inhibit these inhibitory pathways has recently emerged as a potent strategy in oncology. Three sets of agents have emerged in clinical trials exploiting this strategy. These agents are antibody-based therapies targeting cytotoxic T-lymphocyte antigen4 (CTLA4), programmed cell death1 (PD-1), and programmed cell death ligand 1 (PD-L1). These inhibitors of immune inhibition have demonstrated extensive activity as single agents and in combinations. Clinical responses have been seen in melanoma, renal cellcarcinoma, non-smal celllung cancer, and several other tumor types. Despite the autoimmune or inflammatory immune-mediated adverse effects which have been seen, the responses and overall survival benefits exhibited thus far warrant further clinical development.

  13. Current Status and Challenges of Cancer Clinical Trials in Korea

    OpenAIRE

    Shim, Byoung Yong; Park, Se Hoon; Lee, Soonil; Kim, Jin-Soo; Lee, Kyoung Eun; Kang, Yoon-Koo; Ahn, Myung-Ju

    2015-01-01

    Purpose Cancer clinical trials in Korea have rapidly progressed in terms of quantity and quality during the last decade. This study evaluates the current status of cancer clinical trials in Korea and their associated problems. Materials and Methods We analyzed the clinical trials approved by the Korea Food and Drug Administration (KFDA) between 2007 and 2013. A nationwide on-line survey containing 22 questions was also performed with several cooperative study groups and individual researchers...

  14. 78 FR 36201 - National Cancer Institute; Notice of Closed Meeting

    Science.gov (United States)

    2013-06-17

    ... new diagnostics for cancer. Place: National Cancer Institute, 9609 Medical Center Drive, Room 2W908... meeting is to evaluate requests for development resources for potential new cancer diagnostics. The... of the potential diagnostics to improve the treatment of cancer. The research proposals and...

  15. Imaging in early phase childhood cancer trials

    International Nuclear Information System (INIS)

    Advances made in the treatment of childhood malignancies during the last four decades have resulted in overall cure rates of approximately 80%, but progress has slowed significantly during the last 10 years, underscoring the need for more effective and less toxic agents. Current research is focused on development of molecularly targeted agents, an era ushered in with the discovery of imatinib mesylate for the treatment of chronic myelogenous leukemia. Since imatinib's introduction into the clinic, an increasing number of tyrosine kinase inhibitors have been developed and entered into clinical trials and practice. Parallel to the initial advances made in molecularly targeted agents has been the development of a spectrum of novel imaging modalities. Future goals for imaging in childhood cancer research thus include (1) patient identification based on target identification or other biologic characteristics of the tumor, (2) assessing pharmacokinetic-pharmacodynamic (PK-PD) effects, and (3) predictive value with an early indication of patient benefit. Development and application of novel imaging modalities for children with cancer can serve to streamline development of molecularly targeted agents. (orig.)

  16. Imaging in early phase childhood cancer trials

    Energy Technology Data Exchange (ETDEWEB)

    Adamson, Peter C. [Children' s Hospital of Philadelphia, Division of Clinical Pharmacology and Therapeutics, Philadelphia, PA (United States)

    2009-02-15

    Advances made in the treatment of childhood malignancies during the last four decades have resulted in overall cure rates of approximately 80%, but progress has slowed significantly during the last 10 years, underscoring the need for more effective and less toxic agents. Current research is focused on development of molecularly targeted agents, an era ushered in with the discovery of imatinib mesylate for the treatment of chronic myelogenous leukemia. Since imatinib's introduction into the clinic, an increasing number of tyrosine kinase inhibitors have been developed and entered into clinical trials and practice. Parallel to the initial advances made in molecularly targeted agents has been the development of a spectrum of novel imaging modalities. Future goals for imaging in childhood cancer research thus include (1) patient identification based on target identification or other biologic characteristics of the tumor, (2) assessing pharmacokinetic-pharmacodynamic (PK-PD) effects, and (3) predictive value with an early indication of patient benefit. Development and application of novel imaging modalities for children with cancer can serve to streamline development of molecularly targeted agents. (orig.)

  17. The national cancer institute (NCI) and cancer biology in a 'post genome world'

    International Nuclear Information System (INIS)

    The National Cancer Institute (NCI) exists to reduce the burden of all cancers through research and discovery. Extensive restructuring of the NCI over the past year has been aimed at assuring that the institution functions in all ways to promote opportunities for discovery in the laboratory, in the clinic, and in the community. To do this well requires the difficult and almost paradoxical problem of planning for scientific discovery which, in turn is based on the freedom to pursue the unanticipated. The intellectual and structural landscape of science is changing and it places new challenges, new demands and new opportunities for facilitating discovery. The nature of cancer as a disease of genomic instability and of accumulated genetic change, coupled with a possibility of the development of new technologies for reading, utilizing, interpreting and manipulating the genome of single cells, provides unprecedented opportunities for a new type of high through-put biology that will change the nature of discovery, cancer detection, diagnosis, prognosis, therapeutic decision-making and therapeutic discovery. To capture these new opportunities will require attention to be paid to integrate the development of technology and new scientific discoveries with the ability to apply advances rapidly and efficiently through clinical trials

  18. Serum Oxidized Protein and Prostate Cancer Risk within the Prostate Cancer Prevention Trial

    OpenAIRE

    Hoque, Ashraful; Ambrosone, Christine B; Till, Cathee; Goodman, Phyllis J.; Tangen, Cathy; Kristal, Alan; Lucia, Scott; Wang, Qiao; Kappil, Maya; Thompson, Ian; Hsing, Ann W.; Parnes, Howard; Lippman, Scott M.; Santella, Regina M.

    2010-01-01

    To evaluate the role of oxidative stress in prostate cancer risk, we analyzed serum levels of protein carbonyl groups in 1808 prostate cancer cases and 1805 controls, nested in the Prostate Cancer Prevention Trial, a randomized, placebo-control trial that found finasteride decreased prostate cancer risk. There were no significant differences in protein carbonyl levels in baseline samples between those later diagnosed with prostate cancer and those without at the end of study biopsy. Adjusted ...

  19. New generation of breast cancer clinical trials implementing molecular profiling

    Institute of Scientific and Technical Information of China (English)

    Dimitrios Zardavas; Martine Piccart-Gebhart

    2016-01-01

    The implementation of molecular profiling technologies in oncology deepens our knowledge for the molecular landscapes of cancer diagnoses, identifying aberrations that could be linked with specific therapeutic vulnerabilities. In particular, there is an increasing list of molecularly targeted anticancer agents undergoing clinical development that aim to block specific molecular aberrations. This leads to a paradigm shift, with an increasing list of specific aberrations dictating the treatment of patients with cancer. This paradigm shift impacts the field of clinical trials, since the classical approach of having clinico-pathological disease characteristics dictating the patients' enrolment in oncology trials shifts towards the implementation of molecular profiling as pre-screening step. In order to facilitate the successful clinical development of these new anticancer drugs within specific molecular niches of cancer diagnoses, there have been developed new, innovative trial designs that could be classified as follows: i) longitudinal cohort studies that implement (or not) "nested" downstream trials, 2) studies that assess the clinical utility of molecular profiling, 3) "master" protocol trials, iv) "basket" trials, v) trials following an adaptive design. In the present article, we review these innovative study designs, providing representative examples from each category and we discuss the challenges that still need to be addressed in this era of new generation oncology trials implementing molecular profiling. Emphasis is put on the field of breast cancer clinical trials.

  20. 75 FR 16488 - National Cancer Institute; Notice of Closed Meeting

    Science.gov (United States)

    2010-04-01

    ... the treatment of cancer. The outcome of the evaluation will provide information to internal NCI... development of the potential therapeutic to improve the treatment of various forms of cancer. The research... of Committee: National Cancer Institute Special Emphasis Panel; NCI Experimental Therapeutics...

  1. 75 FR 60132 - National Cancer Institute; Notice of Closed Meeting

    Science.gov (United States)

    2010-09-29

    ... the treatment of cancer. The outcome of the evaluation will provide information to internal NCI... development of the potential therapeutic to improve the treatment of various forms of cancer. The research... of Committee: National Cancer Institute Special Emphasis Panel; NCI Experimental Therapeutics...

  2. 76 FR 42719 - National Cancer Institute; Notice of Closed Meeting

    Science.gov (United States)

    2011-07-19

    ... the treatment of cancer. The outcome of the evaluation will provide information to internal NCI... development of the potential therapeutic to improve the treatment of various forms of cancer. The research... of Committee: National Cancer Institute Special Emphasis Panel, NCI Experimental Therapeutics...

  3. 77 FR 43098 - National Cancer Institute; Notice of Closed Meeting

    Science.gov (United States)

    2012-07-23

    ... the treatment of cancer. The outcome of the evaluation will provide information to internal NCI... development of the potential therapeutic to improve the treatment of various forms of cancer. The research... of Committee: National Cancer Institute Special Emphasis Panel; NCI Experimental Therapeutics...

  4. 76 FR 10381 - National Cancer Institute; Notice of Closed Meeting

    Science.gov (United States)

    2011-02-24

    ... the treatment of cancer. The outcome of the evaluation will provide information to internal NCI... development of the potential therapeutic to improve the treatment of various forms of cancer. The research... of Committee: National Cancer Institute Special Emphasis Panel; NCI Experimental Therapeutics...

  5. 77 FR 15782 - National Cancer Institute; Notice of Closed Meeting

    Science.gov (United States)

    2012-03-16

    ... the treatment of cancer. The outcome of the evaluation will provide information to internal NCI... development of the potential therapeutic to improve the treatment of various forms of cancer. The research.... ] Name of Committee: National Cancer Institute Special Emphasis Panel NCI Experimental...

  6. 75 FR 33817 - National Cancer Institute; Notice of Closed Meeting

    Science.gov (United States)

    2010-06-15

    ... the treatment of cancer. The outcome of the evaluation will provide information to internal NCI... development of the potential therapeutic to improve the treatment of various forms of cancer. The research... of Committee: National Cancer Institute Special Emphasis Panel; NCI Experimental Therapeutics...

  7. 76 FR 66733 - National Cancer Institute; Notice of Closed Meeting

    Science.gov (United States)

    2011-10-27

    ... the treatment of cancer. The outcome of the evaluation will provide information to internal NCI... development of the potential therapeutic to improve the treatment of various forms of cancer. The research... of Committee: National Cancer Institute Special Emphasis Panel, NCI Experimental Therapeutics...

  8. Diet, Supplement Use, and Prostate Cancer Risk: Results From the Prostate Cancer Prevention Trial

    OpenAIRE

    Kristal, Alan R.; Arnold, Kathryn B.; Neuhouser, Marian L; Goodman, Phyllis; Platz, Elizabeth A.; Albanes, Demetrius; Thompson, Ian M

    2010-01-01

    The authors examined nutritional risk factors for prostate cancer among 9,559 participants in the Prostate Cancer Prevention Trial (United States and Canada, 1994–2003). The presence or absence of cancer was determined by prostate biopsy, which was recommended during the trial because of an elevated prostate-specific antigen level or an abnormal digital rectal examination and was offered to all men at the trial's end. Nutrient intake was assessed using a food frequency questionnaire and a str...

  9. ALCHEMIST: Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trials

    Science.gov (United States)

    ALCHEMIST represents three integrated, precision medicine trials that are designed to identify people with early-stage lung cancer who have tumors that harbor certain uncommon genetic changes and evaluate whether drug treatments targeted against those mol

  10. Trial Yields Positive Data on Pembrolizumab for Lung Cancer

    Science.gov (United States)

    Findings from an early phase clinical trial may point to a biomarker that identifies patients with advanced non-small cell lung cancer most likely to respond to the immunotherapy drug pembrolizumab (Keytruda®).

  11. European randomized lung cancer screening trials: Post NLST

    DEFF Research Database (Denmark)

    Field, JK; Klaveren, R; Pedersen, JH;

    2013-01-01

    Overview of the European randomized lung cancer CT screening trials (EUCT) is presented with regard to the implementation of CT screening in Europe; post NLST. All seven principal investigators completed a questionnaire on the epidemiological, radiological, and nodule management aspects of their ......Overview of the European randomized lung cancer CT screening trials (EUCT) is presented with regard to the implementation of CT screening in Europe; post NLST. All seven principal investigators completed a questionnaire on the epidemiological, radiological, and nodule management aspects...

  12. Is prostate cancer screening responsible for the negative results of prostate cancer treatment trials?

    Science.gov (United States)

    Prasad, Vinay

    2016-08-01

    Clinical guidelines continue to move away from routine prostate specific antigen screening (PSA), once a widespread medical practice. A curious difference exists between early prostate cancer and early breast cancer. While randomized trials of therapy in early breast cancer continue to show overall survival benefit, this is not the case in prostate cancer, where prostatectomy was no better than observation in a recent trial, and where early androgen deprivation is no better than late androgen deprivation. Here, I make the case that prostate cancer screening contributes so greatly to over diagnosis that even treatment trials yield null results due to contamination with non-life threatening disease. PMID:27372859

  13. Selenium and Prostate Cancer Prevention: Insights from the Selenium and Vitamin E Cancer Prevention Trial (SELECT)

    OpenAIRE

    Nicastro, Holly L.; Dunn, Barbara K

    2013-01-01

    The Selenium and Vitamin E Cancer Prevention Trial (SELECT) was conducted to assess the efficacy of selenium and vitamin E alone, and in combination, on the incidence of prostate cancer. This randomized, double-blind, placebo-controlled, 2 × 2 factorial design clinical trial found that neither selenium nor vitamin E reduced the incidence of prostate cancer after seven years and that vitamin E was associated with a 17% increased risk of prostate cancer compared to placebo. The null result was ...

  14. A concept for trial institutions focussing on randomised controlled trials in surgery

    Directory of Open Access Journals (Sweden)

    Büchler Markus W

    2008-01-01

    Full Text Available Abstract Background Although considered the reference standard for generating valid scientific evidence of a treatment's benefits and harms, the number of Randomised Controlled Trials (RCT comparing surgical techniques remains low. Much effort has been made in order to overcome methodological issues and improve quality of RCTs in surgery. To the present there has been, however, only little emphasis on development and maintenance of institutions for implementation of adequately designed and conducted surgical RCTs. Mehods/Design Description of the developments in surgical RCT infrastructure in Germany between 2001 and 2006. Cross sectional evaluation of completed and ongoing surgical RCTs within the German Surgical Society and the Clinical Study Centre, Department of Surgery, University of Heidelberg. Results Foundation of a national Clinical Trial Centre (CTC for the organisation of multi-centre RCTs in the surgical setting (Study Center of the German Surgical Society, SDGC. Establishment of a network of CTCs with affiliated Clinical Sites (CSs to enhance patient recruitment and shorten the duration of RCTs. Since its foundation four surgical RCTs with a total sample size of 1650 patients (1006 of these randomised have been supervised by the SDGC with 35 CSs involved in patient recruitment. Five further CTCs were set up in 2006. Together with their affiliated CSs a network has been organised providing improved conditions for the conduction of surgical RCTs. Conclusion Improvement of infrastructure substantially facilitates integration of RCTs into routine surgical practice. A network of collaborating CTCs and CSs can provide an adequate infrastructure for the conduction of multi-centre RCTs.

  15. 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.

  16. 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)

    International Nuclear Information System (INIS)

    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.

  17. Clinical Trials Node | Division of Cancer Prevention

    Science.gov (United States)

    The Division of Cancer Prevention (DCP) conducts and supports research to determine a person's risk of cancer and to find ways to reduce the risk. This knowledge is critical to making progress against cancer because risk varies over the lifespan as genetic and epigenetic changes can transform healthy tissue into invasive cancer.

  18. Consumer input into research: the Australian Cancer Trials website

    Directory of Open Access Journals (Sweden)

    Butow Phyllis N

    2011-06-01

    Full Text Available Abstract Background The Australian Cancer Trials website (ACTO was publicly launched in 2010 to help people search for cancer clinical trials recruiting in Australia, provide information about clinical trials and assist with doctor-patient communication about trials. We describe consumer involvement in the design and development of ACTO and report our preliminary patient evaluation of the website. Methods Consumers, led by Cancer Voices NSW, provided the impetus to develop the website. Consumer representative groups were consulted by the research team during the design and development of ACTO which combines a search engine, trial details, general information about trial participation and question prompt lists. Website use was analysed. A patient evaluation questionnaire was completed at one hospital, one week after exposure to the website. Results ACTO's main features and content reflect consumer input. In February 2011, it covered 1, 042 cancer trials. Since ACTO's public launch in November 2010, until the end of February 2011, the website has had 2, 549 new visits and generated 17, 833 page views. In a sub-study of 47 patient users, 89% found the website helpful for learning about clinical trials and all respondents thought patients should have access to ACTO. Conclusions The development of ACTO is an example of consumers working with doctors, researchers and policy makers to improve the information available to people whose lives are affected by cancer and to help them participate in their treatment decisions, including consideration of clinical trial enrolment. Consumer input has ensured that the website is informative, targets consumer priorities and is user-friendly. ACTO serves as a model for other health conditions.

  19. Unique perception of clinical trials by Korean cancer patients

    Directory of Open Access Journals (Sweden)

    Lee Su Jin

    2012-12-01

    Full Text Available Abstract Background In the past few years, the number of clinical trials has increased rapidly in East Asia, especially for gastric and hepatobiliary cancer that are prevalent in Asian populations. However, the actual degree of understanding or perceptions of clinical trials by cancer patients in East Asian countries have seldom been studied. Methods Between July 1st and November 30th of 2011, we conducted a prospective study to survey cancer patients regarding their awareness of, and willingness to participate in, a clinical trial. Patients with gastrointestinal/hepatobiliary cancer who visited the Hematology-Oncology outpatient clinic at Samsung Medical Center (SMC were enrolled. A total of 21 questions were asked including four questions which used the Visual analogue scale (VAS score. Results In this survey study, 1,000 patients were asked to participate and 675 patients consented to participate (67.5%. The awareness of clinical trials was substantially higher in patients who had a higher level of education (pp=0.004, and had a higher economic status (p=0.001. However, the willingness to participate in a clinical trial was not affected by the level of education or economic status of patients. The most influential factors for patient willingness to participate were a physician recommendation (n=181, 26.8%, limited treatment options (n=178, 26.4%, and expectations of effectiveness of new anti-cancer drugs (n=142, 21.0%. Patients with previous experience in clinical trials had a greater willingness to participate in clinical trials compared to patients without previous experience (p Conclusions This large patient cohort survey study showed that Korean cancer patients are more aware of clinical trials, but awareness did not translate into willingness to participate.

  20. 76 FR 1625 - National Cancer Institute; Notice of Closed Meeting

    Science.gov (United States)

    2011-01-11

    ... Committee: National Cancer Institute Initial Review Group; Subcommittee I--Career Development, Career Development. Date: February 22-23, 2011. Time: February 22, 2011, 8 a.m. to 6 p.m. Agenda: To review...

  1. 75 FR 48699 - National Cancer Institute; Notice of Closed Meeting

    Science.gov (United States)

    2010-08-11

    ... Committee: National Cancer Institute Initial Review Group, Subcommittee I--Career Development, NCI-I Career Development. Date: September 21, 2010. Time: 8 a.m. to 6 p.m. Agenda: To review and evaluate...

  2. Dana-Farber Cancer Institute | Office of Cancer Genomics

    Science.gov (United States)

    Functional Annotation of Cancer Genomes Principal Investigator: William C. Hahn, M.D., Ph.D. The comprehensive characterization of cancer genomes has and will continue to provide an increasingly complete catalog of genetic alterations in specific cancers. However, most epithelial cancers harbor hundreds of genetic alterations as a consequence of genomic instability. Therefore, the functional consequences of the majority of mutations remain unclear.

  3. A Review of Barriers to Minorities' Participation in Cancer Clinical Trials: Implications for Future Cancer Research.

    Science.gov (United States)

    Salman, Ali; Nguyen, Claire; Lee, Yi-Hui; Cooksey-James, Tawna

    2016-04-01

    To enhance nurses' awareness and competencies in practice and research by reporting the common barriers to participation of minorities in cancer clinical trials and discussing facilitators and useful strategies for recruitment. Several databases were searched for articles published in peer reviewed journals. Some of the barriers to minorities' participation in clinical trials were identified within the cultural social-context of cancer patients. The involvement of community networking was suggested as the most effective strategy for the recruitment of minorities in cancer clinical trials. Using culturally sensitive approaches to enhance ethnic minorities' participation is important for advancing cancer care and eliminating health disparities. Awareness of barriers and potential facilitators to the enrollment of ethnic minority cancer patients may contribute to enhancing nurses' competencies of recruiting ethnic minorities in nursing research, playing efficient roles in cancer clinical trials team, and providing culturally competent quality care. PMID:25822567

  4. The National Lung Screening Trial (NLST) | Division of Cancer Prevention

    Science.gov (United States)

    The National Lung Screening Trial (NLST) compared two ways of detecting lung cancer: low-dose helical computed tomography (CT) and standard chest X-ray. Both chest X-rays and low-dose helical CT scans have been used to find lung cancer early, but the effects of these screening techniques on lung cancer mortality rates had not been determined. NLST enrolled 53,454 current or former heavy smokers from 33 sites and coordinating centers across the United States. | The National Lung Screening Trial (NLST) compared two ways of detecting lung cancer: participants who received low-dose helical CT scans had a 20% lower risk of dying from lung cancer than participants who received standard chest X-rays.

  5. Online Information about Cancer Clinical Trials: Evaluating the Web Sites of Comprehensive Cancer Centers

    OpenAIRE

    Monaco, Valerie; Krills, Sandra K.

    2003-01-01

    The objective of this study was to examine the information provided on comprehensive cancer centers’ Web sites regarding clinical trials. Thirty-nine Web sites were visually inspected for four categories of variables: navigation to the clinical trial information, search functionality provided to the visitor, information content provided about trials, and the reading level of the information provided. Results indicated that for those Web sites that provided information about clinical trials, t...

  6. Recommended Patient-Reported Core Set of Symptoms and Quality-of-Life Domains to Measure in Ovarian Cancer Treatment Trials

    OpenAIRE

    Donovan, Kristine A.; Donovan, Heidi S.; Cella, David; Gaines, Martha E.; Penson, Richard T.; Plaxe, Steven C.; von Gruenigen, Vivian E.; Bruner, Deborah Watkins; Reeve, Bryce B.; Wenzel, Lari

    2014-01-01

    There is no consensus as to what symptoms or quality-of-life (QOL) domains should be measured as patient-reported outcomes (PROs) in ovarian cancer clinical trials. A panel of experts convened by the National Cancer Institute reviewed studies published between January 2000 and August 2011. The results were included in and combined with an expert consensus-building process to identify the most salient PROs for ovarian cancer clinical trials. We identified a set of PROs specific to ovarian canc...

  7. Finasteride Concentrations and Prostate Cancer Risk: Results from the Prostate Cancer Prevention Trial

    OpenAIRE

    Chau, Cindy H.; Price, Douglas K.; Cathee Till; Goodman, Phyllis J.; Xiaohong Chen; Leach, Robin J; Johnson-Pais, Teresa L.; Hsing, Ann W.; Ashraful Hoque; Tangen, Catherine M.; Lisa Chu; Parnes, Howard L.; Schenk, Jeannette M.; Reichardt, Juergen K. V.; Thompson, Ian M

    2015-01-01

    Objective In the Prostate Cancer Prevention Trial (PCPT), finasteride reduced the risk of prostate cancer by 25%, even though high-grade prostate cancer was more common in the finasteride group. However, it remains to be determined whether finasteride concentrations may affect prostate cancer risk. In this study, we examined the association between serum finasteride concentrations and the risk of prostate cancer in the treatment arm of the PCPT and determined factors involved in modifying dru...

  8. Advancing the evidence base in cancer: psychosocial multicenter trials

    Directory of Open Access Journals (Sweden)

    Sanson-Fisher Robert

    2012-09-01

    Full Text Available Abstract Background The diagnosis and treatment of cancer is associated with significant distress and psychosocial morbidity. Although psychosocial interventions have been developed in an attempt to improve psychosocial outcomes in cancer patients and survivors, there is continued debate about whether there is adequate high-level evidence to establish the effectiveness of these interventions. The evidence base is limited as a result of numerous challenges faced by those attempting to conduct psychosocial intervention trials within the health system. Barriers include insufficient participant recruitment, difficulty generalizing from single-trial studies, difficulty in building and managing research teams with multidisciplinary expertise, lack of research design expertise and a lack of incentives for researchers conducting intervention research. To strengthen the evidence base, more intervention studies employing methodologically rigorous research designs are necessary. Methods In order to advance the evidence base of interventions designed to improve psychosocial outcomes for cancer patients and survivors, we propose the formation of a collaborative trials group that conducts multicenter trials to test the effectiveness of such interventions. Results Establishment of such a group would improve the quality of the evidence base in psychosocial research in cancer patients, by increasing support for conducting intervention research and providing intervention research training opportunities. A multidisciplinary collaborative group conducting multicenter trials would have the capacity to overcome many of the barriers that currently exist. Conclusions A stronger evidence base is necessary to identify effective psychosocial interventions for cancer patients. The proposed formation of a psycho-oncology collaborative trials group that conducts multicenter trials to test the effectiveness of psychosocial interventions would assist in achieving this outcome.

  9. Clinical trials update of the European Organization for Research and Treatment of Cancer Breast Cancer Group

    International Nuclear Information System (INIS)

    The present clinical trial update consists of a review of two of eight current studies (the 10981-22023 AMAROS trial and the 10994 p53 trial) of the European Organization for Research and Treatment of Cancer Breast Cancer Group, as well as a preview of the MIND-ACT trial. The AMAROS trial is designed to prove equivalent local/regional control for patients with proven axillary lymph node metastasis by sentinel node biopsy if treated with axillary radiotherapy instead of axillary lymph node dissection, with reduced morbidity. The p53 trial started to assess the potential predictive value of p53 using a functional assay in yeast in patients with locally advanced/inflammatory or large operable breast cancer prospectively randomised to a taxane regimen versus a nontaxane regimen

  10. Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial (PLCO) | Division of Cancer Prevention

    Science.gov (United States)

    The PLCO Cancer Screening Trial was a population-based randomized trial to determine the effects of screening on cancer-related mortality and secondary endpoints in more than 150,000 men and women aged 55 to 74.  The PLCO Biorepository, accessible by the Cancer Data Access System (CDAS) web portal, contains about 2.7 million biologic specimens from intervention participants during their six trial screening years, and buccal cell specimens from control participants. The Etiology and Early Marker Studies (EEMS) component has biologic materials and risk factor information from trial participants before diagnosis of disease.  | A repository of data from a large randomized trial on the effects of screening on cancer-related mortality and secondary endpoints in men and women aged 55 to 74.

  11. DICOM Structured Reporting and Cancer Clinical Trials Results

    Directory of Open Access Journals (Sweden)

    David A. Clunie

    2007-01-01

    Full Text Available The use of biomarkers derived from radiological images as surrogate end-points in therapeutic cancer clinical trials is well established. DICOM is the ubiquitous standard for the interchange of images for both clinical use as well as research. It also has capabilities for the exchange of image-related information, including categorical and quantitative information derived from images. The use of DICOM Structured Reporting for the encoding and interchange of clinical trial results in a standard manner is reviewed.

  12. DICOM Structured Reporting and Cancer Clinical Trials Results

    OpenAIRE

    David A. Clunie

    2007-01-01

    The use of biomarkers derived from radiological images as surrogate end-points in therapeutic cancer clinical trials is well established. DICOM is the ubiquitous standard for the interchange of images for both clinical use as well as research. It also has capabilities for the exchange of image-related information, including categorical and quantitative information derived from images. The use of DICOM Structured Reporting for the encoding and interchange of clinical trial results in a standar...

  13. Selenium and Vitamin E Cancer Prevention Trial (SELECT): Questions and Answers

    Science.gov (United States)

    ... Prostate Cancer Prostate Cancer Screening Research Selenium and Vitamin E Cancer Prevention Trial (SELECT): Questions and Answers ... of prostate cancer mean to men who take vitamin E but who were not SELECT participants? The ...

  14. Prostate and Urologic Cancer Clinical Trials | Division of Cancer Prevention

    Science.gov (United States)

    The Division of Cancer Prevention (DCP) conducts and supports research to determine a person's risk of cancer and to find ways to reduce the risk. This knowledge is critical to making progress against cancer because risk varies over the lifespan as genetic and epigenetic changes can transform healthy tissue into invasive cancer.

  15. Differences in trial knowledge and motives for participation among cancer patients in phase 3 clinical trials.

    Science.gov (United States)

    Godskesen, T M; Kihlbom, U; Nordin, K; Silén, M; Nygren, P

    2016-05-01

    While participants in clinical oncology trials are essential for the advancement of cancer therapies, factors decisive for patient participation have been described but need further investigation, particularly in the case of phase 3 studies. The aim of this study was to investigate differences in trial knowledge and motives for participation in phase 3 clinical cancer trials in relation to gender, age, education levels and former trial experience. The results of a questionnaire returned from 88 of 96 patients (92%) were analysed using the Mann-Whitney U-test. There were small, barely relevant differences in trial knowledge among patients when stratified by gender, age or education. Participants with former trial experience were less aware about the right to withdraw. Male participants and those aged ≥65 years were significantly more motivated by a feeling of duty, or by the opinions of close ones. Men seem more motivated than women by external factors. With the awareness that elderly and single male participants might be a vulnerable group and participants with former trial experience are less likely to be sufficiently informed, the information consent process should focus more on these patients. We conclude that the informed consent process seems to work well, with good results within most subgroups. PMID:25904313

  16. Institutional shared resources and translational cancer research

    OpenAIRE

    De Paoli Paolo

    2009-01-01

    Abstract The development and maintenance of adequate shared infrastructures is considered a major goal for academic centers promoting translational research programs. Among infrastructures favoring translational research, centralized facilities characterized by shared, multidisciplinary use of expensive laboratory instrumentation, or by complex computer hardware and software and/or by high professional skills are necessary to maintain or improve institutional scientific competitiveness. The s...

  17. Study Protocol: A randomized controlled trial of patient navigation-activation to reduce cancer health disparities

    Directory of Open Access Journals (Sweden)

    Rousseau Sally

    2010-10-01

    Full Text Available Abstract Background Cancer health disparities affecting low-income and minority patients are well documented. Root-causes are multifactorial, including diagnostic and treatment delays, social and financial barriers, and poor communication. Patient navigation and communication coaching (activation are potential interventions to address disparities in cancer treatment. The purpose of this clinical trial is to test the effectiveness of an intervention combining patient navigation and activation to improve cancer treatment. Methods/Design The Rochester Patient Navigation Research Program (PNRP is a National Cancer Institute-sponsored, patient-level randomized trial (RCT of patient navigation and activation, targeting newly-diagnosed breast and colorectal cancer patients in Rochester, NY. The goal of the program is to decrease cancer health disparities by addressing barriers to receipt of cancer care and promoting patient self-efficacy. The intervention uses trained, paraprofessional patient navigators recruited from the target community, and a detailed training and supervisory program. Recruited patients are randomly assigned to receive either usual care (except for baseline and follow-up questionnaires and interviews or intervention. The intervention patients receive tailored assistance from their patient navigators, including phone calls, in-person meetings, and behind-the-scenes coordination of care. A total of 344 patients have been recruited. Outcomes measured at three month intervals include timeliness of care, patient adherence, patient satisfaction, quality of life, self-efficacy, health literacy, and cancer knowledge. Discussion This unique intervention combining patient navigation and patient activation is designed to address the multifactorial problem of cancer health disparities. If successful, this study will affect the design and implementation of patient navigation programs. Trials Registration clinicaltrials.gov identifier NCT

  18. Design of clinical trials for therapeutic cancer vaccines development.

    Science.gov (United States)

    Mackiewicz, Jacek; Mackiewicz, Andrzej

    2009-12-25

    Advances in molecular and cellular biology as well as biotechnology led to definition of a group of drugs referred to as medicinal products of advanced technologies. It includes gene therapy products, somatic cell therapeutics and tissue engineering. Therapeutic cancer vaccines including whole cell tumor cells vaccines or gene modified whole cells belong to somatic therapeutics and/or gene therapy products category. The drug development is a multistep complex process. It comprises of two phases: preclinical and clinical. Guidelines on preclinical testing of cell based immunotherapy medicinal products have been defined by regulatory agencies and are available. However, clinical testing of therapeutic cancer vaccines is still under debate. It presents a serious problem since recently clinical efficacy of the number of cancer vaccines has been demonstrated that focused a lot of public attention. In general clinical testing in the current form is very expensive, time consuming and poorly designed what may lead to overlooking of products clinically beneficial for patients. Accordingly regulatory authorities and researches including Cancer Vaccine Clinical Trial Working Group proposed three regulatory solutions to facilitate clinical development of cancer vaccines: cost-recovery program, conditional marketing authorization, and a new development paradigm. Paradigm includes a model in which cancer vaccines are investigated in two types of clinical trials: proof-of-principle and efficacy. The proof-of-principle trial objectives are: safety; dose selection and schedule of vaccination; and demonstration of proof-of-principle. Efficacy trials are randomized clinical trials with objectives of demonstrating clinical benefit either directly or through a surrogate. The clinical end points are still under debate. PMID:19835869

  19. Update on clinical trials: genetic targets in breast cancer.

    Science.gov (United States)

    Lim, Bora; Cream, Leah V; Harvey, Harold A

    2013-01-01

    Breast cancer is the most commonly diagnosed cancer in women in United States. From data of American Cancer Society from 2007 reported total of 178,480 women diagnosed with breast cancer. The death rate from breast cancer has decreased in North America over time, but still accounts for second highest cancer death, following lung cancer. Breast cancer is staged based on tumor size, nodal involvement, and distant metastasis like any other solid tumors. However clinical staging is not the only important factor in management of breast cancer. Various molecular features divides breast cancer into many subgroups - that act differently, and respond differently from therapy. Thus the focus of breast cancer treatment has evolved focusing on specific targets. The most important biologic markers in subtyping of breast cancer so far are hormone receptor positivity and HER2/neu protein expression. Five molecular subtypes using intrinsic gene set include Basal mRNA, HER2 + mRNA, Luminal AmRNA, Luminal B mRNA, and Normal-like mRNA. In addition, better understanding of genetic target of breast cancer has given us arsenal of personalized, and more effective treatment approach.This review will focus on examples that highlight several mechanism of tumorigenesis, giving us not just understanding of gene pathways and the molecular biology, that could lead us to therapeutic target. Several important molecular targets have been investigated in preclinical and clinical trials, others are yet to be explored. We will also describe genetic mechanisms discovery related to overcoming resistance to current targeted therapies in breast cancer, including hormone receptor expression and HER 2- neu amplification. We will also review other exciting developments in understanding of breast cancer, the tumor microenvironment and cancer stem cells, and targeting agents in that area. PMID:23288634

  20. The National Cancer Institute's PREVENT Cancer Preclinical Drug Development Program: overview, current projects, animal models, agent development strategies, and molecular targets.

    Science.gov (United States)

    Shoemaker, Robert H; Suen, Chen S; Holmes, Cathy A; Fay, Judith R; Steele, Vernon E

    2016-02-01

    The PREVENT Cancer Preclinical Drug Development Program (PREVENT) is a National Cancer Institute, Division of Cancer Prevention (NCI, DCP)-supported program whose primary goal is to bring new cancer preventive interventions (small molecules and vaccines) and biomarkers through preclinical development towards clinical trials by creating partnerships between the public sector (eg, academia, industry) and DCP. PREVENT has a formalized structure for moving interventions forward in the prevention pipeline using a stage-gate process with go/no go decision points along the critical path for development. This review describes the structure of the program, its focus areas, and provides examples of projects currently in the pipeline. PMID:26970137

  1. 78 FR 27974 - Proposed Collection; 60-Day Comment Request: National Cancer Institute (NCI) Alliance for...

    Science.gov (United States)

    2013-05-13

    ... Cancer Institute (NCI) Alliance for Nanotechnology in Cancer Platform Partnership Scientific Progress... Partnerships (CNPP) awarded by the National Cancer Institute (NCI). The CNPPs are part of the Alliance for... trans-Alliance collaboration, scientific milestones, progress towards clinical translation...

  2. TRICHOMONOSIS AND SUBSEQUENT RISK OF PROSTATE CANCER IN THE PROSTATE CANCER PREVENTION TRIAL

    OpenAIRE

    Sutcliffe, Siobhan; Alderete, John F.; Till, Cathee; Goodman, Phyllis J.; Hsing, Ann W.; Zenilman, Jonathan M; De Marzo, Angelo M.; Platz, Elizabeth A.

    2009-01-01

    We previously observed a positive association between a history of trichomonosis, a sexually transmitted infection caused by the protozoan, Trichomonas vaginalis, and prostate cancer risk in the Health Professionals Follow-up Study. To determine the reproducibility of this finding, we conducted a second, prospective investigation of trichomonosis and prostate cancer in the Prostate Cancer Prevention Trial. Participants were men ≥55 years of age with no evidence of prostate cancer at enrollmen...

  3. Serum Phospholipid Fatty Acids and Prostate Cancer Risk: Results From the Prostate Cancer Prevention Trial

    OpenAIRE

    Brasky, Theodore M.; Till, Cathee; White, Emily; Neuhouser, Marian L; Song, Xiaoling; Goodman, Phyllis; Thompson, Ian M; King, Irena B.; Albanes, Demetrius; Kristal, Alan R.

    2011-01-01

    Inflammation may be involved in prostate cancer development and progression. This study examined the associations between inflammation-related phospholipid fatty acids and the 7-year-period prevalence of prostate cancer in a nested case-control analysis of participants, aged 55–84 years, in the Prostate Cancer Prevention Trial during 1994–2003. Cases (n = 1,658) were frequency matched to controls (n = 1,803) on age, treatment, and prostate cancer family history. Phospholipid fatty acids were ...

  4. Reduction in the risk of prostate cancer: future directions after the Prostate Cancer Prevention Trial.

    Science.gov (United States)

    Crawford, E David; Andriole, Gerald L; Marberger, Michael; Rittmaster, Roger S

    2010-03-01

    The landmark Prostate Cancer Prevention Trial (PCPT) generated interest in the potential health benefits and cost of reducing prostate cancer risk--specifically, the potential role of 5alpha-reductase inhibitors. However, the PCPT raised several unanswered questions, including the cause and significance of the increased incidence of high-grade tumors associated with finasteride. In the present study, we review the PCPT findings and unanswered questions, next steps in this field, and ongoing prostate cancer prevention trials addressing these unanswered questions. Particular emphasis is placed on the design of the second large-scale trial of a 5alpha-reductase inhibitor, the REduction by DUtasteride of prostate Cancer Events (REDUCE) trial. PMID:20035983

  5. Phase I and II clinical trials for gastric cancer.

    Science.gov (United States)

    Khushalani, Nikhil I

    2012-01-01

    Gastric cancer remains a global public health problem with considerable heterogeneity in pathogenesis and clinical presentation across geographic regions. Improved understanding of the molecular biology of this disease has opened avenues for targeted intervention. An individualized treatment approach is required for optimal management of this cancer. Overcoming resistance to therapy requires combining targeted agents with the traditional options of chemotherapy/radiation therapy, and also targeting more than 1 pathway of carcinogenesis at a time. Encouraging molecular hypothesis and biomarker-driven trials will lead to improved patient outcomes and may eventually enable the therapeutic nihilism associated with gastric cancer to be overcome. PMID:22098835

  6. Creating a “culture of research” in a community hospital: Strategies and tools from the National Cancer Institute Community Cancer Centers Program

    Science.gov (United States)

    St. Germain, Diane; Nacpil, Lianne M; Zaren, Howard A; Swanson, Sandra M; Minnick, Christopher; Carrigan, Angela; Denicoff, Andrea M; Igo, Kathleen E; Acoba, Jared D; Gonzalez, Maria M; McCaskill-Stevens, Worta

    2015-01-01

    Background The value of community-based cancer research has long been recognized. In addition to the National Cancer Institute’s Community Clinical and Minority-Based Oncology Programs established in 1983, and 1991 respectively, the National Cancer Institute established the National Cancer Institute Community Cancer Centers Program in 2007 with an aim of enhancing access to high-quality cancer care and clinical research in the community setting where most cancer patients receive their treatment. This article discusses strategies utilized by the National Cancer Institute Community Cancer Centers Program to build research capacity and create a more entrenched culture of research at the community hospitals participating in the program over a 7-year period. Methods To facilitate development of a research culture at the community hospitals, the National Cancer Institute Community Cancer Centers Program required leadership or chief executive officer engagement; utilized a collaborative learning structure where best practices, successes, and challenges could be shared; promoted site-to-site mentoring to foster faster learning within and between sites; required research program assessments that spanned clinical trial portfolio, accrual barriers, and outreach; increased identification and use of metrics; and, finally, encouraged research team engagement across hospital departments (navigation, multidisciplinary care, pathology, and disparities) to replace the traditionally siloed approach to clinical trials. Limitations The health-care environment is rapidly changing while complexity in research increases. Successful research efforts are impacted by numerous factors (e.g. institutional review board reviews, physician interest, and trial availability). The National Cancer Institute Community Cancer Centers Program sites, as program participants, had access to the required resources and support to develop and implement the strategies described. Metrics are an important

  7. New Hires at the National Cancer Institute at Frederick | Poster

    Science.gov (United States)

    Fifty-one people joined the facility in November and December 2013. The National Cancer Institute welcomes… Emily Boward Emad Darvishi Shuo Gu Sanath Kumar Janaka Robert Kortum Yasmin Lachir Jinbian Liu Yang Liu Eric Ramirez Salazar Brett Shelley Li Xia Jaeho Yoon

  8. Phase 0/I/II Cancer Prevention Clinical Trials Program Clinical Trials | Division of Cancer Prevention

    Science.gov (United States)

    The Division of Cancer Prevention (DCP) conducts and supports research to determine a person's risk of cancer and to find ways to reduce the risk. This knowledge is critical to making progress against cancer because risk varies over the lifespan as genetic and epigenetic changes can transform healthy tissue into invasive cancer.

  9. Contributions of the European trials (European randomized screening group) in computed tomography lung cancer screening

    NARCIS (Netherlands)

    Heuvelmans, Marjolein A; Vliegenthart, Rozemarijn; Oudkerk, Matthijs

    2015-01-01

    Lung cancer is the leading cause of cancer-related death worldwide. In 2011, the largest lung cancer screening trial worldwide, the US National Lung Screening Trial, published a 20% decrease in lung cancer-specific mortality in the computed tomography (CT)-screened group, compared with the group scr

  10. Gastrointestinal Tumor Board: An Evolving Experience in Tehran Cancer Institute

    Directory of Open Access Journals (Sweden)

    Peiman Haddad

    2013-04-01

    Full Text Available Gastrointestinal (GI cancers are a significant source of morbidity and mortality in Iran, with stomach adenocarcinoma as the most common cancer in men and the second common cancer in women. Also, some parts of Northern Iran have one of the highest incidences of esophageal cancer in the world. Multi-disciplinary organ-based joint clinics and tumor boards are a well-recognized necessity for modern treatment of cancer and are routinely utilized in developed countries, especially in major academic centres. But this concept is relatively new in developing countries, where cancer treatment centres are burdened by huge loads of patients and have to cope with a suboptimum availability of resources and facilities. Cancer Institute of Tehran University of Medical Sciences is the oldest and the only comprehensive cancer treatment centre in Iran, with a long tradition of a general tumor board for all cancers. But with the requirements of modern oncology, there has been a very welcome attention to sub-specialized organ-based tumor boards and joint clinics here in the past few years. Considering this, we started a multi-disciplinary tumor board for GI cancers in our institute in early 2010 as the first such endeavor here. We hereby review this 2-year evolving experience. The process of establishment of a GI tumor board, participations from different oncology disciplines and related specialties, the cancers presented and discussed in the 2 years of this tumor board, the general intents of treatment for the decisions made and the development of interest in this tumor board among the Tehran oncology community will be reviewed. The GI tumor board of Tehran Cancer Institute started its work in January 2010, with routine weekly sessions. A core group of 2 physicians from each surgical, radiation and medical oncology departments plus one gastroenterologist, GI pathologist and radiologist was formed, but participation from all interested physicians was encouraged. An

  11. Black raspberries in cancer clinical trials: Past, present and future

    Science.gov (United States)

    Kresty, Laura A.; Mallery, Susan R.; Stoner, Gary D.

    2016-01-01

    BACKGROUND Black raspberries (BRB) inhibit a broad range of cancers in preclinical models, including in vivo models of oral, esophageal, colon, breast and skin cancer. Promising preclinical results have led to clinical evaluations in cancer patients or patients at increased risk for cancer development. OBJECTIVE To summarize clinical investigations targeting cancer or precancerous lesions with BRB and discuss future directions. METHODS A thorough literature search was conducted through December 1, 2015 to identify all published studies evaluating BRB in cancer focused clinical trials. RESULTS Research investigating BRB in clinical settings report positive effects on preneoplastic lesions or cancers of the oral cavity, esophagus and colon. BRB treatment resulted in: histologic regression of oral intraepithelial neoplasia associated with improved histologic grade and significantly reduced loss of heterozygosity at tumor suppressor gene loci, modulated genes linked to RNA processing and growth factor recycling; in the colon, BRB inhibited FAP-associated polyp progression, demethylated tumor suppressor genes and improved plasma cytokine profiles; in Barrett’s patients, BRB consumption increased tissue levels of GST-pi and decreased 8-isoprostane, a marker of lipid peroxidation/oxidative stress. CONCLUSIONS The precise dose, duration and optimum mode of BRB delivery for cancer inhibition remains to be fully elucidated. Common themes across studies support that BRB are anti-proliferative, anti- inflammatory, reduce oxidative stress and restore tumor suppressive activity. Future directions are included in the conclusions section.

  12. Phase 0/I/II Cancer Prevention Clinical Trials Program (Consortia) | Division of Cancer Prevention

    Science.gov (United States)

    Five cancer research centers lead multiple collaborative networks to assess potential cancer preventive agents and to conduct early clinical development of promising preventive agents. Also called the Consortia for Early Phase Prevention Trials, the studies require extensive biomarker analysis, investigation of the biologic effects of the cancer preventive agents on their intended molecular targets and on multiple endpoints associated with carcinogenesis, and correlation with clinically relevant endpoints.  | Systematic early clinical development of promising preventive agents through five major medical research centers.

  13. Improvement of pain related self management for oncologic patients through a trans institutional modular nursing intervention: protocol of a cluster randomized multicenter trial

    OpenAIRE

    Thoke-Colberg Anette; Kuss Oliver; Kukk Ene; Renz Petra; Kitzmantel Maria; Jahn Patrick; Horn Ingrid; Landenberger Margarete

    2010-01-01

    Abstract Background Pain is one of the most frequent and distressing symptoms in cancer patients. For the majority of the patients, sufficient pain relief can be obtained if adequate treatment is provided. However, pain remains often undertreated due to institutional, health care professional and patient related barriers. Patients self management skills are affected by the patients' knowledge, activities and attitude to pain management. This trial protocol is aimed to test the SCION-PAIN prog...

  14. Prevention of Prostate Cancer: Outcomes of Clinical Trials and Future Opportunities

    OpenAIRE

    Thompson, Ian; Kristal, Alan; Platz, Elizabeth A.

    2014-01-01

    Prostate cancer is an excellent target for prevention, to reduce both mortality and the burden of overdetection of potential inconsequential disease whose diagnosis increases cost, morbidity, and anxiety. The Prostate Cancer Prevention Trial has demonstrated that finasteride significantly reduces the risk of prostate cancer but only low-grade disease; overall survival is unaffected. In the Selenium and Vitamin E Cancer Prevention Trial (SELECT) clinical trial, selenium had no effect on prosta...

  15. Study design and methods for the Breast Cancer and Exercise Trial in Alberta (BETA)

    OpenAIRE

    Friedenreich, Christine M; MacLaughlin, Sarah; Neilson, Heather K.; Stanczyk, Frank Z.; Yasui, Yutaka; Duha, Aalo; Lynch, Brigid M; Kallal, Ciara; Courneya, Kerry S

    2014-01-01

    Background Exercise has favorable effects on biomarkers associated with a lower risk of breast cancer, however it is unclear if higher doses of exercise provide additional effects. No clinical trial has systematically examined how different exercise volumes influence the mechanisms underlying breast cancer etiology. The Breast Cancer and Exercise Trial in Alberta (BETA) - a follow-up study to the Alberta Physical Activity and Breast Cancer Prevention (ALPHA) Trial - is examining how a one-yea...

  16. National Lung Screening Trial (NLST)

    Science.gov (United States)

    The National Lung Screening Trial (NLST), a research study sponsored by the National Cancer Institute that used low-dose helical CT scans or chest X-ray to screen men and women at risk for lung cancer.

  17. Regulatory impediments jeopardizing the conduct of clinical trials in Europe funded by the National Institutes of Health

    DEFF Research Database (Denmark)

    Neaton, James D; Babiker, Abdel; Bohnhorst, Mark;

    2010-01-01

    A number of reports have highlighted problems of conducting publicly funded trials in Europe as a consequence of the European Union (EU) Clinical Trials Directive. The impact of the EU Directive on multi-national trials, which include sites in Europe that are funded by the US National Institutes ...

  18. Primary breast cancer: European radiotherapy trials

    International Nuclear Information System (INIS)

    For many years in Europe, surgically operable breast carcinomas have been treated by conservative treatments. There are two methods of conservative treatment: limited surgery with or without auxiliary dissection followed by irradiation and irradiation as the primary treatment. Depending on the size of the primary tumor and clinical findings in the axillae, patients were referred to either of the two treatment alternatives. Generally, limited surgery and irradiation was performed in patients with early breast carcinomas, while irradiation as the primary treatment was used for more locally advanced cancers. Since 1960, conservative treatments with megavoltage for patients with invasive breast carcinomas have been used more and more frequently. These conservation methods have been used hoping to achieve long-term survival comparable to that obtained by mastectomy and breast preservation with good cosmetic results. This chapter reviews results at 5 and 10 years obtained in Europe by several authors concerning early breast infiltration carcinomas treated by limited surgery or without axillary dissection followed by irradiation

  19. Sample size re-estimation in a breast cancer trial

    Science.gov (United States)

    Hade, Erinn; Jarjoura, David; Wei, Lai

    2016-01-01

    Background During the recruitment phase of a randomized breast cancer trial, investigating the time to recurrence, we found evidence that the failure probabilities used at the design stage were too high. Since most of the methodological research involving sample size re-estimation has focused on normal or binary outcomes, we developed a method which preserves blinding to re-estimate sample size in our time to event trial. Purpose A mistakenly high estimate of the failure rate at the design stage may reduce the power unacceptably for a clinically important hazard ratio. We describe an ongoing trial and an application of a sample size re-estimation method that combines current trial data with prior trial data or assumes a parametric model to re-estimate failure probabilities in a blinded fashion. Methods Using our current blinded trial data and additional information from prior studies, we re-estimate the failure probabilities to be used in sample size re-calculation. We employ bootstrap resampling to quantify uncertainty in the re-estimated sample sizes. Results At the time of re-estimation data from 278 patients was available, averaging 1.2 years of follow up. Using either method, we estimated an increase of 0 for the hazard ratio proposed at the design stage. We show that our method of blinded sample size re-estimation preserves the Type I error rate. We show that when the initial guess of the failure probabilities are correct; the median increase in sample size is zero. Limitations Either some prior knowledge of an appropriate survival distribution shape or prior data is needed for re-estimation. Conclusions In trials when the accrual period is lengthy, blinded sample size re-estimation near the end of the planned accrual period should be considered. In our examples, when assumptions about failure probabilities and HRs are correct the methods usually do not increase sample size or otherwise increase it by very little. PMID:20392786

  20. Competing events and costs of clinical trials: Analysis of a randomized trial in prostate cancer

    International Nuclear Information System (INIS)

    Background: Clinical trial costs may be reduced by identifying enriched subpopulations of patients with favorable risk profiles for the events of interest. However, increased selectivity affects accrual rates, with uncertain impact on clinical trial cost. Methods: We conducted a secondary analysis of Southwest Oncology Group (SWOG) 8794 randomized trial of adjuvant radiotherapy for high-risk prostate cancer. The primary endpoint was metastasis-free survival (MFS), defined as time to metastasis or death from any cause (competing mortality). We used competing risks regression models to identify an enriched subgroup at high risk for metastasis and low risk for competing mortality. We applied a cost model to estimate the impact of enrichment on trial cost and duration. Results: The treatment effect on metastasis was similar in the enriched subgroup (HR, 0.42; 95% CI, 0.23–0.76) compared to the whole cohort (HR, 0.50; 95% CI, 0.30–0.81) while the effect on competing mortality was not significant in the subgroup or the whole cohort (HR 0.70; 95% CI 0.39–1.23, vs. HR 0.94; 95% CI, 0.68–1.31). Due to the higher incidence of metastasis relative to competing mortality in the enriched subgroup, the treatment effect on MFS was greater in the subgroup compared to the whole cohort (HR 0.55; 95% CI 0.36–0.82, vs. HR 0.77; 95% CI, 0.58–1.01). Trial cost was 75% less in the subgroup compared to the whole cohort ($1.7 million vs. $6.8 million), and the trial duration was 30% shorter (8.4 vs. 12.0 years). Conclusion: Competing event enrichment can reduce clinical trial cost and duration, without sacrificing generalizability

  1. Relation between breast cancer mortality and screening effectiveness: systematic review of the mammography trials

    DEFF Research Database (Denmark)

    Gøtzsche, Peter C

    2011-01-01

    The mammography screening trials have shown varying results. This could be because screening was better in some trials than in others at advancing the time of diagnosis. If so, more cancers would be identified in such trials relative to the control group, and fewer of the cancers would have reached...... an advanced stage. I performed a systematic review of the mammography screening trials using metaregression. Finding many cancers was not related to the size of the reduction in breast cancer mortality (p = 0.19 after seven and p = 0.73 after 13 years of follow-up). In contrast, finding few cancers...

  2. Understanding and Reducing Obstacles in a Collaboration between a Minority Institution and a Cancer Center

    OpenAIRE

    Thompson, Beti; O’Connell, Mary; Löest, Helena; Anderson, Jennifer; Westcott, Rick

    2013-01-01

    Reducing the cancer incidence and mortality rates of underserved populations will require multidisciplinary efforts involving teams of diverse investigators. We describe a collaborative program between a National Cancer Institute-designated cancer center and a minority-serving institution. The organizations worked together to discover institutional and cultural barriers and facilitators to productive collaboration.

  3. Cryotherapy for Primary Treatment of Prostate Cancer: Intermediate Term Results of a Prospective Study from a Single Institution

    OpenAIRE

    S. Alvarez Rodríguez; Arias Fúnez, F.; Bueno Bravo, C.; Rodríguez-Patrón Rodríguez, R.; Sanz Mayayo, E.; V. Hevia Palacios; Burgos Revilla, F. J.

    2014-01-01

    Purpose. Published data about cryotherapy for prostate cancer (PC) treatment are based on case series with a lack of clinical trials and the inexistence of a validated definition of biochemical failure. A prospective study with standardized followup protocol was conducted in our institution. Material and Methods. Prospective study of a series of cases including 108 patients diagnosed with localized PC at clinical stage T1c-T2c treated by primary cryoablation and median followup of 61 months. ...

  4. Northeast Regional Cancer Institute's Cancer Surveillance and Risk Factor Program

    Energy Technology Data Exchange (ETDEWEB)

    Lesko, Samuel M.

    2007-07-31

    OBJECTIVES The Northeast Regional Cancer Institute is conducting a program of ongoing epidemiologic research to address cancer disparities in northeast Pennsylvania. Of particular concern are disparities in the incidence of, stage at diagnosis, and mortality from colorectal cancer. In northeast Pennsylvania, age-adjusted incidence and mortality rates for colorectal cancer are higher, and a significantly smaller proportion of new colorectal cancer cases are diagnosed with local stage disease than is observed in comparable national data. Further, estimates of the prevalence of colorectal cancer screening in northeast Pennsylvania are lower than the US average. The Northeast Regional Cancer Institute’s research program supports surveillance of common cancers, investigations of cancer risk factors and screening behaviors, and the development of resources to further cancer research in this community. This project has the following specific objectives: I. To conduct cancer surveillance in northeast Pennsylvania. a. To monitor incidence and mortality for all common cancers, and colorectal cancer, in particular, and b. To document changes in the stage at diagnosis of colorectal cancer in this high-risk, underserved community. II. To conduct a population-based study of cancer risk factors and screening behavior in a six county region of northeast Pennsylvania. a. To monitor and document changes in colorectal cancer screening rates, and b. To document the prevalence of cancer risk factors (especially factors that increase the risk of colorectal cancer) and to identify those risk factors that are unusually common in this community. APPROACH Cancer surveillance was conducted using data from the Northeast Regional Cancer Institute’s population-based Regional Cancer Registry, the Pennsylvania Cancer Registry, and NCI’s SEER program. For common cancers, incidence and mortality were examined by county within the region and compared to data for similar populations in the US

  5. The Prostate Cancer Intervention Versus Observation Trial: VA/NCI/AHRQ Cooperative Studies Program #407 (PIVOT): design and baseline results of a randomized controlled trial comparing radical prostatectomy with watchful waiting for men with clinically localized prostate cancer.

    Science.gov (United States)

    Wilt, Timothy J

    2012-12-01

    Prostate cancer is the most common noncutaneous malignancy and the second leading cause of cancer death in men. In the United States, 90% of men with prostate cancer are more than age 60 years, diagnosed by early detection with the prostate-specific antigen (PSA) blood test, and have disease believed confined to the prostate gland (clinically localized). Common treatments for clinically localized prostate cancer include watchful waiting (WW), surgery to remove the prostate gland (radical prostatectomy), external-beam radiation therapy and interstitial radiation therapy (brachytherapy), and androgen deprivation. Little is known about the relative effectiveness and harms of treatments because of the paucity of randomized controlled trials. The Department of Veterans Affairs/National Cancer Institute/Agency for Healthcare Research and Quality Cooperative Studies Program Study #407:Prostate Cancer Intervention Versus Observation Trial (PIVOT), initiated in 1994, is a multicenter randomized controlled trial comparing radical prostatectomy with WW in men with clinically localized prostate cancer. We describe the study rationale, design, recruitment methods, and baseline characteristics of PIVOT enrollees. We provide comparisons with eligible men declining enrollment and men participating in another recently reported randomized trial of radical prostatectomy vs WW conducted in Scandinavia. We screened 13 022 men with prostate cancer at 52 US medical centers for potential enrollment. From these, 5023 met initial age, comorbidity, and disease eligibility criteria, and a total of 731 men agreed to participate and were randomized. The mean age of enrollees was 67 years. Nearly one-third were African American. Approximately 85% reported that they were fully active. The median PSA was 7.8ng/mL (mean 10.2ng/mL). In three-fourths of men, the primary reason for biopsy leading to a diagnosis of prostate cancer was a PSA elevation or rise. Using previously developed tumor risk

  6. Prostate cancer - evidence of exercise and nutrition trial (PrEvENT):Study protocol for a randomised controlled feasibility trial

    OpenAIRE

    Hackshaw-McGeagh, Lucy; Lane, J. Athene; Persad, Raj; Gillatt, David; Holly, Jeff M P; Koupparis, Anthony; Rowe, Edward; Johnston, Lyndsey; Cloete, Jenny; Shiridzinomwa, Constance; Abrams, Paul; Penfold, Chris M; Bahl, Amit; Oxley, Jon; Perks, Claire M.

    2016-01-01

    Background: A growing body of observational evidence suggests that nutritional and physical activity interventions are associated with beneficial outcomes for men with prostate cancer, including brisk walking, lycopene intake, increased fruit and vegetable intake and reduced dairy consumption. However, randomised controlled trial data are limited. The 'Prostate Cancer: Evidence of Exercise and Nutrition Trial' investigates the feasibility of recruiting and randomising men diagnosed with local...

  7. Launching a novel preclinical infrastructure: comparative oncology trials consortium directed therapeutic targeting of TNFalpha to cancer vasculature.

    Directory of Open Access Journals (Sweden)

    Melissa C Paoloni

    Full Text Available BACKGROUND: Under the direction and sponsorship of the National Cancer Institute, we report on the first pre-clinical trial of the Comparative Oncology Trials Consortium (COTC. The COTC is a novel infrastructure to integrate cancers that naturally develop in pet dogs into the development path of new human drugs. Trials are designed to address questions challenging in conventional preclinical models and early phase human trials. Large animal spontaneous cancer models can be a valuable addition to successful studies of cancer biology and novel therapeutic drug, imaging and device development. METHODOLOGY/PRINCIPAL FINDINGS: Through this established infrastructure, the first trial of the COTC (COTC001 evaluated a targeted AAV-phage vector delivering tumor necrosis factor (RGD-A-TNF to alphaV integrins on tumor endothelium. Trial progress and data was reviewed contemporaneously using a web-enabled electronic reporting system developed for the consortium. Dose-escalation in cohorts of 3 dogs (n = 24 determined an optimal safe dose (5x10(12 transducing units intravenous of RGD-A-TNF. This demonstrated selective targeting of tumor-associated vasculature and sparing of normal tissues assessed via serial biopsy of both tumor and normal tissue. Repetitive dosing in a cohort of 14 dogs, at the defined optimal dose, was well tolerated and led to objective tumor regression in two dogs (14%, stable disease in six (43%, and disease progression in six (43% via Response Evaluation Criteria in Solid Tumors (RECIST. CONCLUSIONS/SIGNIFICANCE: The first study of the COTC has demonstrated the utility and efficiency of the established infrastructure to inform the development of new cancer drugs within large animal naturally occurring cancer models. The preclinical evaluation of RGD-A-TNF within this network provided valuable and necessary data to complete the design of first-in-man studies.

  8. Intelligent Application of Breast Cancer Trials Data in the Clinic

    OpenAIRE

    Joanne Frankli; Sunil Verma; Sibylle Loibl; Pierfranco Conte; Peter Schmid; Christos Sotiriou

    2015-01-01

    This meeting commenced with a talk from Prof Loibl on neoadjuvant and adjuvant strategies for HER2positive (human epidermal growth factor receptor 2-positive) early breast cancer (EBC), which featured a précis on the most pertinent, recent trial data and how these data may shape future treatment decisions in clinical practice. Prof Conte moved the discussion forward by addressing how recent studies may lead towards a new standard of care (SoC) and treatment paradigms in patients with metastat...

  9. Cancer complementary and alternative medicine research at the US National Cancer Institute.

    Science.gov (United States)

    Jia, Libin

    2012-05-01

    The United States National Cancer Institute (NCI) supports complementary and alternative medicine (CAM) research which includes different methods and practices (such as nutrition therapies) and other medical systems (such as Chinese medicine). In recent years, NCI has spent around $120 million each year on various CAM-related research projects on cancer prevention, treatment, symptom/side effect management and epidemiology. The categories of CAM research involved include nutritional therapeutics, pharmacological and biological treatments, mind-body interventions, manipulative and body based methods, alternative medical systems, exercise therapies, spiritual therapies and energy therapies on a range of types of cancer. The NCI Office of Cancer Complementary and Alternative Medicine (OCCAM) supports various intramural and extramural cancer CAM research projects. Examples of these cancer CAM projects are presented and discussed. In addition, OCCAM also supports international research projects. PMID:22241505

  10. 78 FR 53763 - Proposed Collection; 60-day Comment Request Cancer Trials Support Unit (CTSU) (NCI)

    Science.gov (United States)

    2013-08-30

    ... Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, 9609 Medical Center Drive... Cancer Therapy Evaluation Program (CTEP) establishes and supports programs to facilitate the... HUMAN SERVICES National Institutes of Health Proposed Collection; 60-day Comment Request Cancer...

  11. Uncaria tomentosa—Adjuvant Treatment for Breast Cancer: Clinical Trial

    Directory of Open Access Journals (Sweden)

    Maria do Carmo Santos Araújo

    2012-01-01

    Full Text Available Breast cancer is the most frequent neoplasm affecting women worldwide. Some of the recommended treatments involve chemotherapy whose toxic effects include leukopenia and neutropenia. This study assessed the effectiveness of Uncaria tomentosa (Ut in reducing the adverse effects of chemotherapy through a randomized clinical trial. Patients with Invasive Ductal Carcinoma—Stage II, who underwent a treatment regimen known as FAC (Fluorouracil, Doxorubicin, Cyclophosphamide, were divided into two groups: the UtCa received chemotherapy plus 300 mg dry Ut extract per day and the Ca group that only received chemotherapy and served as the control experiment. Blood samples were collected before each one of the six chemotherapy cycles and blood counts, immunological parameters, antioxidant enzymes, and oxidative stress were analyzed. Uncaria tomentosa reduced the neutropenia caused by chemotherapy and was also able to restore cellular DNA damage. We concluded that Ut is an effective adjuvant treatment for breast cancer.

  12. Association of Symptomatic Benign Prostatic Hyperplasia and Prostate Cancer: Results from the Prostate Cancer Prevention Trial

    OpenAIRE

    Schenk, Jeannette M.; Kristal, Alan R.; Arnold, Kathryn B.; Tangen, Catherine M.; Neuhouser, Marian L; Lin, Daniel W; White, Emily; Thompson, Ian M

    2011-01-01

    This study examined the association between symptomatic benign prostatic hyperplasia (BPH) and prostate cancer risk in 5,068 placebo-arm participants enrolled in the Prostate Cancer Prevention Trial (1993–2003). These data include 1,225 men whose cancer was detected during the 7-year trial—556 detected for cause (following abnormal prostate-specific antigen or digital rectal examination) and 669 detected not for cause (without indication), as well as 3,843 men who had biopsy-proven absence of...

  13. Finasteride concentrations and prostate cancer risk: results from the Prostate Cancer Prevention Trial.

    Directory of Open Access Journals (Sweden)

    Cindy H Chau

    Full Text Available In the Prostate Cancer Prevention Trial (PCPT, finasteride reduced the risk of prostate cancer by 25%, even though high-grade prostate cancer was more common in the finasteride group. However, it remains to be determined whether finasteride concentrations may affect prostate cancer risk. In this study, we examined the association between serum finasteride concentrations and the risk of prostate cancer in the treatment arm of the PCPT and determined factors involved in modifying drug concentrations.Data for this nested case-control study are from the PCPT. Cases were drawn from men with biopsy-proven prostate cancer and matched controls. Finasteride concentrations were measured using a liquid chromatography-mass spectrometry validated assay. The association of serum finasteride concentrations with prostate cancer risk was determined by logistic regression. We also examine whether polymorphisms in the enzyme target and metabolism genes of finasteride are related to drug concentrations using linear regression.Among men with detectable finasteride concentrations, there was no association between finasteride concentrations and prostate cancer risk, low-grade or high-grade, when finasteride concentration was analyzed as a continuous variable or categorized by cutoff points. Since there was no concentration-dependent effect on prostate cancer, any exposure to finasteride intake may reduce prostate cancer risk. Of the twenty-seven SNPs assessed in the enzyme target and metabolism pathway, five SNPs in two genes, CYP3A4 (rs2242480; rs4646437; rs4986910, and CYP3A5 (rs15524; rs776746 were significantly associated with modifying finasteride concentrations. These results suggest that finasteride exposure may reduce prostate cancer risk and finasteride concentrations are affected by genetic variations in genes responsible for altering its metabolism pathway.ClinicalTrials.gov NCT00288106.

  14. Intelligent Application of Breast Cancer Trials Data in the Clinic

    Directory of Open Access Journals (Sweden)

    Joanne Frankli

    2015-11-01

    Full Text Available This meeting commenced with a talk from Prof Loibl on neoadjuvant and adjuvant strategies for HER2positive (human epidermal growth factor receptor 2-positive early breast cancer (EBC, which featured a précis on the most pertinent, recent trial data and how these data may shape future treatment decisions in clinical practice. Prof Conte moved the discussion forward by addressing how recent studies may lead towards a new standard of care (SoC and treatment paradigms in patients with metastatic breast cancer. Prof Schmid gave an overview of potential strategies that could be used to prevent or overcome endocrine therapy resistance in patients with hormone receptor-positive breast cancer. The session was concluded with a presentation on ‘Precision Medicine for Metastatic Breast Cancer’ by Prof Sotiriou, in which he highlighted the potential applications of precision medicine and some of the different approaches that have been used in metastatic breast cancer. Prof Verma, the meeting chair, opened the symposium and facilitated the discussion sessions. The contents of the presentations and discussions are summarised herein.

  15. COLOR II. A randomized clinical trial comparing laparoscopic and open surgery for rectal cancer

    DEFF Research Database (Denmark)

    2009-01-01

    INTRODUCTION: Laparoscopic resection of rectal cancer has been proven efficacious but morbidity and oncological outcome need to be investigated in a randomized clinical trial. Trial design: Non-inferiority randomized clinical trial. METHODS: The COLOR II trial is an ongoing international randomized...... clinical trial. Currently 27 hospitals from Europe, South Korea and Canada are including patients. The primary endpoint is loco-regional recurrence rate three years post-operatively. Secondary endpoints cover quality of life, overall and disease free survival, post-operative morbidity and health economy...... II trial. Completion of inclusion is expected by the end of 2009. Trial registration: Clinicaltrials.gov, identifier: NCT00297791 (www.clinicaltrials.gov)....

  16. Intraoperative photodynamic therapy of bladder cancer with alasens (results of multicenter trial

    Directory of Open Access Journals (Sweden)

    E. V. Filonenko

    2014-01-01

    Full Text Available The results of multicenter prospective trial for efficacy of combined modality treatment: transurethral resection (TUR + photodynamic therapy (PDT with alasens for bladder cancer are represented in the article. Trials were organized by Research Institute of Organic Intermediates and Dyes and conducted according to clinical protocol approved by Ministry of Health of Russia, at the sites of leading Russian cancer clinical centers. The trial included 45 subjects with verified diagnosis of non-muscle-invasive bladder cancer. Patients underwent TUR of bladder with simultaneous PDT as anti-relapse treatment. Alasens was administered to patients as intravesicular instillation of 3% solution in volume of 50 ml with 1.5–2h exposure (prior to TUR. TUR was performed after instillation. PDT session was conducted immediately after the completion of TUR on a single occasion by means of combined local irradiation on tumor bed with diffuse irradiation on whole urinary bladder mucosa (light dose of local irradiation – 100 J/cm2, diffuse irradiation – 20 J/cm2. Good tolerance of the treatment was noticed, there were no complications. Among 45 patients included in the trial, 35 (78% completed 12 month protocol follow-up without relapse. The recurrence of bladder tumor was registered in 10 (22% cases 6–12 months after TUR+PDT including 3 patients with recurrence 6 months after treatment, 3–9 months and 4–12 months. These patients underwent repeated TUR, whereafter their follow-up in the settings of the clinical trial was disposed. Thus, PDT with alasens after TUR allowed to decrease the recurrence rate of non-muscle-invasive bladder cancer for 1st year after treatment to 22% versus 40–80% for TUR as monotherapy according to literature data. The obtained results were comparable by efficiency with TUR combined with methods of adjuvant treatment for bladder tumors (the recurrence rates for 1-year follow-up after TUR+chemotherapy – 36–44%, after TUR

  17. Demographic pattern of male breast cancer: an institutional based study

    International Nuclear Information System (INIS)

    Background: Male breast cancer incidence rises with age with peak in the sixth and seventh decade. It is one of the rare diseases and accounts for less than 1% of all malignancies worldwide. It is usually diagnosed in the late stage with poor prognosis. Objective: The purpose of this study was to know the demographic pattern and tumour characteristic of breast cancer in men reported at Institute of Radiotherapy and Nuclear Medicine (IRNUM), Peshawar. Methods: Retrospective data was collected from the (IRNUM), Peshawar for a period of three years (2006-2008). The evaluation was done from the histopathological reports of mastectomy and biopsy specimens. All male patients in the age group 26 -86 year with breast cancer were included in the study. The age of the patients and tumour characteristics recorded were size, grade, type, skin involvement and stage. Results: Total number of male patients with breast cancer were 31 (2.1%) out of the total patients with breast malignancy during the study period with the mean age of 58.3 years. Tumour size ranged from 2 to 12 Cm. with average of 3.6 Cm. Invasive ductal carcinoma was found in 87% , papillary carcinoma in 6.5%, each of malignant fibrous histocytoma and sarcoma in 3.2% cases. Maximum number of patients was of grade II (41%). Patients in whom stage of the disease was know n were 22 cases with 45.5% had stage III disease and 32% had stage IV disease. Skin involvement was found positive in 8 (25.8%). Conclusion: Due to poor health care system breast cancer is diagnosed in a late stage of the disease and prognosis is poor. (author)

  18. Locally advanced cervix cancer: chemotherapy prior to definitive surgery or radiotherapy. A single institutional experience

    International Nuclear Information System (INIS)

    Primary or neoadjuvant chemotherapy prior to definitive local therapy has potential advantages for locally advanced cervix cancer. It can down stage a cancer and allow definitive local therapy to be technically possible (surgery), or potentially more effective (radiotherapy). It can also eradicate subclinical systemic metastases. This report reviews a single institution's experience of neoadjuvant chemotherapy prior to definitive local therapy for cervix cancer over a 13-year period. One hundred and six patients were treated with this intent. The patients were analysed for their response to chemotherapy, treatment received, survival, relapse and toxicity. The chemotherapy was feasible and the majority of patients had a complete or partial response (58.5%). Eight patients did not proceed to local treatment. Forty-six patients had definitive surgery and 52 had definitive radiotherapy. The 5-year overall survival was 27% and the majority of patients died with disease. The first site of relapse was usually in the pelvis (46.2%). Late complications that required ongoing medical therapy (n = 6) or surgical intervention (n = 2) were recorded in eight patients (7.5%). On univariate analysis stage (P= 0.04), tumour size (P = 0.01), lymph node status (P=0.003), response to chemotherapy (P = 0.045) and treatment (P = 0.003) were all significant predictors of survival. On multivariate analysis, tumour size (P < 0.0001) and nodal status (P = 0.02) were significant predictors of survival. Despite the impressive responses to chemotherapy of advanced cervix cancer, there is evidence from randomized trials that it does not improve or compromise survival prior to radiotherapy. As its role prior to surgery remains unclear, it should not be used in this setting outside a prospective randomized trial. Copyright (2001) Blackwell Science Pty Ltd

  19. A message of hope: creation of the Faces of Lung Cancer project for increasing awareness of clinical trials.

    Science.gov (United States)

    Quinn, G P; Bell-Ellison, B A; Bell, M Y; Caraway, V D; Conforte, D; Graci, L B; Lewandowski, A; Reynolds, B; Shaffer, A; Powell-Stafford, V L; Sapp, A L; Shimizu, C O; Vadaparampil, S; Vaughn, E J; Williams, C; Bepler, G

    2008-11-01

    In 2002, the Thoracic Oncology Advocacy Program at H. Lee Moffitt Cancer Center and Research Institute was created with a mission to contribute to the prevention and cure of lung cancer by embracing the patient perspective. In an effort to increase awareness of clinical trials (CTs) and to humanize the CT process, members of the advocacy programme were involved in the creation of the Faces of Lung Cancer project. Twelve lung cancer patients who participated in a CT, four caregivers of patients who had been on a trial and four thoracic health care professionals were interviewed and photographed by a professional photographer with prior experience in photo-documentary work. Preliminary results indicate just the process of participating in the Faces of Lung Cancer project and creating the photo essay has had a positive impact on the lives of cancer patients and their caregivers. Formal evaluation of the Faces of Lung Cancer project is underway; however, preliminary results indicate that the project is viewed as successful in terms of conveying a message of hope and increasing awareness. By including visual displays, in conjunction with patient interviews, the photo essay is able to generate and blend powerful information and images that provide a richer, more complete portrayal of the context of a patient's experience. PMID:18771536

  20. 75 FR 51830 - National Cancer Institute's Best Practices for Biospecimen Resources

    Science.gov (United States)

    2010-08-23

    ... HUMAN SERVICES National Institutes of Health National Cancer Institute's Best Practices for Biospecimen... best practices, the National Cancer Institute (NCI) is seeking public comment on a revised version of the NCI Best Practices for Biospecimen Resources. This revised version of the NCI Best Practices...

  1. Randomization to screening for prostate, lung, colorectal and ovarian cancers and thyroid cancer incidence in two large cancer screening trials.

    Directory of Open Access Journals (Sweden)

    Thomas J O'Grady

    Full Text Available Thyroid cancer incidence has increased significantly over the past three decades due, in part, to incidental detection. We examined the association between randomization to screening for lung, prostate, colorectal and/or ovarian cancers and thyroid cancer incidence in two large prospective randomized screening trials.We assessed the association between randomization to low-dose helical CT scan versus chest x-ray for lung cancer screening and risk of thyroid cancer in the National Lung Screening Trial (NLST. In the Prostate Lung Colorectal and Ovarian Cancer Screening Trial (PLCO, we assessed the association between randomization to regular screening for said cancers versus usual medical care and thyroid cancer risk. Over a median 6 and 11 years of follow-up in NLST and PLCO, respectively, we identified 60 incident and 234 incident thyroid cancer cases. Cox proportional hazards regression was used to calculate the cause specific hazard ratios (HR and 95% confidence intervals (CI for thyroid cancer.In NLST, randomization to lung CT scan was associated with a non-significant increase in thyroid cancer risk (HR = 1.61; 95% CI: 0.96-2.71. This association was stronger during the first 3 years of follow-up, during which participants were actively screened (HR = 2.19; 95% CI: 1.07-4.47, but not subsequently (HR = 1.08; 95% CI: 0.49-2.37. In PLCO, randomization to cancer screening compared with usual care was associated with a significant decrease in thyroid cancer risk for men (HR = 0.61; 95% CI: 0.49-0.95 but not women (HR = 0.91; 95% CI: 0.66-1.26. Similar results were observed when restricting to papillary thyroid cancer in both NLST and PLCO.Our study suggests that certain medical encounters, such as those using low-dose helical CT scan for lung cancer screening, may increase the detection of incidental thyroid cancer.

  2. Randomization to Screening for Prostate, Lung, Colorectal and Ovarian Cancers and Thyroid Cancer Incidence in Two Large Cancer Screening Trials

    Science.gov (United States)

    O'Grady, Thomas J.; Kitahara, Cari M.; DiRienzo, A. Gregory; Boscoe, Francis P.; Gates, Margaret A.

    2014-01-01

    Background Thyroid cancer incidence has increased significantly over the past three decades due, in part, to incidental detection. We examined the association between randomization to screening for lung, prostate, colorectal and/or ovarian cancers and thyroid cancer incidence in two large prospective randomized screening trials. Methods We assessed the association between randomization to low-dose helical CT scan versus chest x-ray for lung cancer screening and risk of thyroid cancer in the National Lung Screening Trial (NLST). In the Prostate Lung Colorectal and Ovarian Cancer Screening Trial (PLCO), we assessed the association between randomization to regular screening for said cancers versus usual medical care and thyroid cancer risk. Over a median 6 and 11 years of follow-up in NLST and PLCO, respectively, we identified 60 incident and 234 incident thyroid cancer cases. Cox proportional hazards regression was used to calculate the cause specific hazard ratios (HR) and 95% confidence intervals (CI) for thyroid cancer. Results In NLST, randomization to lung CT scan was associated with a non-significant increase in thyroid cancer risk (HR  = 1.61; 95% CI: 0.96–2.71). This association was stronger during the first 3 years of follow-up, during which participants were actively screened (HR  = 2.19; 95% CI: 1.07–4.47), but not subsequently (HR  = 1.08; 95% CI: 0.49–2.37). In PLCO, randomization to cancer screening compared with usual care was associated with a significant decrease in thyroid cancer risk for men (HR  = 0.61; 95% CI: 0.49–0.95) but not women (HR  = 0.91; 95% CI: 0.66–1.26). Similar results were observed when restricting to papillary thyroid cancer in both NLST and PLCO. Conclusion Our study suggests that certain medical encounters, such as those using low-dose helical CT scan for lung cancer screening, may increase the detection of incidental thyroid cancer. PMID:25192282

  3. Tribulations of a prostate cancer trial - lessons learned from TOAD, a cancer council Victoria and Transtasman Radiation Oncology Group Trial

    International Nuclear Information System (INIS)

    Full text: From 2004-2009 a total of 226 out of a target of 750 prostate cancer patients have been randomised into the Timing of Androgen Deprivation trial between immediate and delayed androgen deprivation. A screening log was kept by participating centres for the first 928 patients, which documented the reasons for non-entry into the trial; 42.7% of screened patients were ineligible and a further 33.0% were not entered for other reasons. Fewer than 10% of patients cited not wanting to be part of a clinical trial as a reason for non-entry. Strategies to improve recruitment included broadening the eligibility criteria, encouraging international collaboration, the use and support of research nurses in the private health care environment, and the use of phone follow-up. Recruitment will be completed at the number originally intended to inform the interim analysis designed to test the validity of the statistical assumptions, and a combined survival analysis with the Canadian study is planned.

  4. Issues Related to Implementing a Smoking Cessation Clinical Trial for Cancer Patients1

    OpenAIRE

    Martinez, Elisa; Tatum, Kristina L.; Weber, Dorothy M.; Kuzla, Natalie; Pendley, Anna B.S.; Campbell, Kirsten; Ridge, John A; Langer, Corey; Miyamoto, Curtis; Schnoll, Robert A.

    2008-01-01

    Given high rates of smoking among cancer patients, smoking cessation treatment is crucial, yet limited data exist to guide integration of such trials into the oncologic context. To determine the feasibility of conducting smoking cessation clinical trials with cancer patients, screening and baseline data from a large randomized placebo-controlled pharmacotherapy trial were analyzed. Descriptive statistics and regression analyses were used to compare enrollees to decliners, describe program enr...

  5. 5-Alpha reductase inhibitor use and prostate cancer survival in the Finnish Prostate Cancer Screening Trial.

    Science.gov (United States)

    Murtola, Teemu J; Karppa, Elina K; Taari, Kimmo; Talala, Kirsi; Tammela, Teuvo Lj; Auvinen, Anssi

    2016-06-15

    Randomized clinical trials have shown that use of 5α-reductase inhibitors (5-ARIs) lowers overall prostate cancer (PCa) risk compared to placebo, while the proportion of Gleason 8-10 tumors is elevated. It is unknown whether this affects PCa-specific survival. We studied disease-specific survival by 5-ARI usage in a cohort of 6,537 prostate cancer cases diagnosed in the Finnish Prostate Cancer Screening Trial and linked to the national prescription database for information on medication use. Cox proportional hazards regression was used to estimate hazard ratios and 95% confidence intervals for prostate cancer-specific deaths. For comparison, survival among alpha-blocker users was also evaluated. During the median follow-up of 7.5 years after diagnosis a total of 2,478 men died; 617 due to prostate cancer and 1,861 due to other causes. The risk of prostate cancer death did not differ between 5-ARI users and nonusers (multivariable adjusted HR 0.94, 95% CI 0.72-1.24 and HR 0.98, 95% CI 0.69-1.41 for usage before and after the diagnosis, respectively). Alpha-blocker usage both before and after diagnosis was associated with increased risk of prostate cancer death (HR 1.29, 95% CI 1.08-1.54 and HR 1.56, 95% CI 1.30-1.86, respectively). The risk increase vanished in long-term alpha-blocker usage. Use of 5-ARIs does not appear to affect prostate cancer mortality when used in management of benign prostatic hyperplasia. Increased risk associated with alpha-blocker usage should prompt further exploration on the prognostic role of lower urinary tract symptoms. PMID:26804670

  6. Selenium and Prostate Cancer Prevention: Insights from the Selenium and Vitamin E Cancer Prevention Trial (SELECT

    Directory of Open Access Journals (Sweden)

    Holly L. Nicastro

    2013-04-01

    Full Text Available The Selenium and Vitamin E Cancer Prevention Trial (SELECT was conducted to assess the efficacy of selenium and vitamin E alone, and in combination, on the incidence of prostate cancer. This randomized, double-blind, placebo-controlled, 2 × 2 factorial design clinical trial found that neither selenium nor vitamin E reduced the incidence of prostate cancer after seven years and that vitamin E was associated with a 17% increased risk of prostate cancer compared to placebo. The null result was surprising given the strong preclinical and clinical evidence suggesting chemopreventive activity of selenium. Potential explanations for the null findings include the agent formulation and dose, the characteristics of the cohort, and the study design. It is likely that only specific subpopulations may benefit from selenium supplementation; therefore, future studies should consider the baseline selenium status of the participants, age of the cohort, and genotype of specific selenoproteins, among other characteristics, in order to determine the activity of selenium in cancer prevention.

  7. PI3K inhibitors as new cancer therapeutics: implications for clinical trial design

    Directory of Open Access Journals (Sweden)

    Massacesi C

    2016-01-01

    Full Text Available Cristian Massacesi,1 Emmanuelle Di Tomaso,2 Patrick Urban,3 Caroline Germa,4 Cornelia Quadt,5 Lucia Trandafir,1 Paola Aimone,3 Nathalie Fretault,1 Bharani Dharan,4 Ranjana Tavorath,4 Samit Hirawat4 1Novartis Oncology, Paris, France; 2Novartis Institutes for BioMedical Research Inc, Cambridge, MA, USA; 3Novartis Pharma AG, Basel, Switzerland; 4Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA; 5Novartis Pharmaceuticals KK, Tokyo, Japan Abstract: The PI3K–AKT–mTOR pathway is frequently activated in cancer. PI3K inhibitors, including the pan-PI3K inhibitor buparlisib (BKM120 and the PI3Kα-selective inhibitor alpelisib (BYL719, currently in clinical development by Novartis Oncology, may therefore be effective as anticancer agents. Early clinical studies with PI3K inhibitors have demonstrated preliminary antitumor activity and acceptable safety profiles. However, a number of unanswered questions regarding PI3K inhibition in cancer remain, including: what is the best approach for different tumor types, and which biomarkers will accurately identify the patient populations most likely to benefit from specific PI3K inhibitors? This review summarizes the strategies being employed by Novartis Oncology to help maximize the benefits of clinical studies with buparlisib and alpelisib, including stratification according to PI3K pathway activation status, selective enrollment/target enrichment (where patients with PI3K pathway-activated tumors are specifically recruited, nonselective enrollment with mandatory tissue collection, and enrollment of patients who have progressed on previous targeted agents, such as mTOR inhibitors or endocrine therapy. An overview of Novartis-sponsored and Novartis-supported trials that are utilizing these approaches in a range of cancer types, including breast cancer, head and neck squamous cell carcinoma, non-small cell lung carcinoma, lymphoma, and glioblastoma multiforme, is also described. Keywords: PI3K

  8. Controlled clinical trial in the advanced primary lung cancer

    International Nuclear Information System (INIS)

    The results of a controlled clinical trial in the treatment of advanced primary lung cancer are presented. There were 39 patients who entered the present study that was conducted at the Thoracic Surgery Departament of the A.C. Camargo Hospital of the Antonio Prudente Foundation of Sao Paulo, Brazil. The patients were divided in two groups 1) - Radiotherapy with Cobalt 60 plus Chemotherapy. 2) - Chemotherapy only. The radiotherapy was provided by the split dose technic (6.000 rads in 3 cycles of 2.000 rads each). The chemotherapy consisted of the following drugs (5 FU, Metil hidrazina, Methotrexate, Actinomycin D, Oncovin, Cytoxan) administered in 16 cycles, aiming the synchronous funtional blockade. There was no statistically significant difference in survival of the two groups, ie, the first with 19,3 weeks and the second group with 14,6 weeks. (Author)

  9. Designing phase II trials in cancer: a systematic review and guidance

    OpenAIRE

    Brown, S R; Gregory, W. M.; Twelves, C. J.; M. Buyse; Collinson, F; Parmar, M; Seymour, M T; J M Brown

    2011-01-01

    Background: Literature reviews of cancer trials have highlighted the need for better understanding of phase II statistical designs. Understanding the key elements associated with phase II design and knowledge of available statistical designs is necessary to enable appropriate phase II trial design. Methods: A systematic literature review was performed to identify phase II trial designs applicable to oncology trials. The results of the review were used to create a library of currently availabl...

  10. Long-term survival of participants in the prostate cancer prevention trial

    OpenAIRE

    Silberstein, Jonathan L.; Sartor, Oliver

    2014-01-01

    The Prostate Cancer Prevention Trial (PCPT) is a seminal study in the field of urology. More than 10 years after its initial publication, updated data from this trial continue to shape our understanding of prostate cancer. Among the major findings from the PCPT has been the demonstration that prostate cancer is common in men with prostate-specific antigen (PSA) once thought to be in the normal range,1 finasteride prevents the development of benign prostatic hypertrophy,2 it increases the sens...

  11. Reasons why patients fail screening in Indian breast cancer trials

    Directory of Open Access Journals (Sweden)

    P Mahajan

    2015-01-01

    Full Text Available Introduction: An increased number of screen failure patients in a clinical trial increases time and cost required for the recruitment. Assessment of reasons for screen failure can help reduce screen failure rates and improve recruitment. Materials and Methods: We collected retrospective data of human epidermal growth factor receptor (HER2 positive Indian breast cancer patients, who failed screening for phase 3 clinical trials and ascertained their reasons for screen failure from screening logs. Statistical comparison was done to ascertain if there are any differences between private and public sites. Results: Of 727 patients screened at 14 sites, 408 (56.1% failed screening. The data on the specific reasons for screen failures was not available at one of the public sites (38 screen failures out of 83 screened patients. Hence, after excluding that site, further analysis is based on 644 patients, of which 370 failed screening. Of these, 296 (80% screen failure patients did not meet selection criteria. The majority -266 were HER2 negative. Among logistical issues, 39 patients had inadequate breast tissue sample. Sixteen patients withdrew their consent at private sites as compared to six at public sites. The difference between private and public sites for the above three reasons was statistically significant. Conclusion: Use of prescreening logs to reduce the number of patients not meeting selection criteria and protocol logistics, and patient counseling to reduce consent withdrawals could be used to reduce screen failure rate.

  12. The Impact of Concomitant Medication Use on Patient Eligibility for Phase I Cancer Clinical Trials

    Directory of Open Access Journals (Sweden)

    Mitesh J. Borad, Kelly K. Curtis, Hani M. Babiker, Martin Benjamin, Raoul Tibes, Ramesh K. Ramanathan, Karen Wright, Amylou C. Dueck, Gayle Jameson, Daniel D. Von Hoff

    2012-01-01

    Full Text Available Concomitant medication (CM use may result in Phase I cancer clinical trial ineligibility due to concern for potential CM-investigational drug interactions or alteration of investigational drug absorption. Few studies have examined the impact of CM use on trial eligibility. Methods: We reviewed records of 274 patients on Phase I trials at a single academic institution. Demographics, CM identities and classes, CM discontinuation, reasons, and incidence of CM substitution were recorded. CM-investigational drug cytochrome P450 (CYP enzyme interactions were documented. Statistical analysis was performed using descriptive statistics. Results: 273 of 274 patients (99.6%, 95% confidence interval [CI] 98.9-100% took CM, with a median of 8 CM per patient (range 0 - 42. CM discontinuation occurred in 67 cases (25%, 95% CI 19-30%. The most common CM classes discontinued were herbal (17 cases, 25%, 95% CI 16-37% and proton pump inhibitors (15 cases, 22%, 95% CI 12-32%. CM discontinuation reasons were: protocol prohibition (32 cases, 48%, 95% CI 36-60%; potential CM-investigational drug interaction (25 cases, 37%, 95% CI 26-49%; other (10 cases, 15%, 95% CI 6-23%. A potential CM-investigational drug CYP interaction was noted in 122 cases (45%, 95% CI 39-50%. CM potentially weakly decreased investigational drug metabolism in 52 cases (43%, 95% CI 34-51%, and potentially strongly decreased investigational drug metabolism in 17 cases (14%, 95% CI 8-20%. Investigational drug potentially weakly decreased CM metabolism in 39 cases (32%, 95% CI 24-40%, and potentially strongly decreased CM metabolism in 28 cases (23%, 95% CI 15-30%. CM substitution occurred in 36/67 cases (54%, 95% CI 41-66% where CM were discontinued to allow for eventual participation in clinical trials. Overall in 2 cases (0.7%, 95% CI 0.1-2.6%, patients were protocol ineligible because CM could not be discontinued or substituted. Conclusions: This study highlights the high prevalence of

  13. Image Quality Assurance in the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial Network of the National Lung Screening Trial

    OpenAIRE

    Moore, Stephen M.; Gierada, David S.; Clark, Kenneth W.; Blaine, G. James

    2005-01-01

    The National Lung Screening Trial is evaluating the effectiveness of low-dose spiral CT and conventional chest X-ray as screening tests for persons who are at high risk for developing lung cancer. This multicenter trial requires quality assurance (QA) for the image quality and technical parameters of the scans. The electronic system described here helps manage the QA process. The system includes a workstation at each screening center that de-identifies the data, a DICOM storage service at the...

  14. CPTAC Establishes Formal Relationships with Two Academic Institutions in Taiwan - Office of Cancer Clinical Proteomics Research

    Science.gov (United States)

    The National Cancer Institute's Clinical Proteomic Tumor Analysis Consortium (CPTAC) has entered into memorandum of understandings (MOUs) with Chang Gung University and Academia Sinica, in Taipei, Taiwan.

  15. Phase III Multi-Institutional Trial of Adjuvant Chemotherapy With Paclitaxel, Estramustine, and Oral Etoposide Combined With Long-Term Androgen Suppression Therapy and Radiotherapy Versus Long-Term Androgen Suppression Plus Radiotherapy Alone for High-Risk Prostate Cancer: Preliminary Toxicity Analysis of RTOG 99-02

    International Nuclear Information System (INIS)

    Purpose: Long-term androgen suppression plus radiotherapy (AS+RT) is standard treatment of high-risk prostate cancer. A randomized trial, Radiation Therapy Oncology Group trial 9902, was undertaken to determine whether adjuvant chemotherapy with paclitaxel, estramustine, and etoposide (TEE) plus AS+RT would improve disease outcomes with acceptable toxicity. Methods and Materials: High-risk (prostate-specific antigen 20-100 ng/mL and Gleason score ≥7; or Stage T2 or greater, Gleason score 8, prostate-specific antigen level <100 ng/mL) nonmetastatic prostate cancer patients were randomized to AS+RT (Arm 1) vs. AS+RT plus four cycles of TEE (Arm 2). TEE was delivered 4 weeks after RT. AS continued for 2 years for both treatment arms. RT began after 8 weeks of AS began. Results: The Radiation Therapy Oncology Group 9902 trial opened January 11, 2000. Excess thromboembolic toxicity was noted, leading to study closure October 4, 2004. A total of 397 patients were accrued, and the data for 381 were analyzable. An acute and long-term toxicity analysis was performed. The worst overall toxicities during treatment were increased for Arm 2. Of the 192 patients, 136 (71%) on Arm 2 had RTOG Grade 3 or greater toxicity compared with 70 (37%) of 189 patients on Arm 1. Statistically significant increases in hematologic toxicity (p < 0.0001) and gastrointestinal toxicity (p = 0.017) but not genitourinary toxicity (p = 0.07) were noted during treatment. Two Grade 5 complications related to neutropenic infection occurred in Arm 2. Three cases of myelodysplasia/acute myelogenous leukemia were noted in Arm 2. At 2 and 3 years after therapy completion, excess long-term toxicity was not observed in Arm 2. Conclusion: TEE was associated with significantly increased toxicity during treatment. The toxicity profiles did not differ at 2 and 3 years after therapy. Toxicity is an important consideration in the design of trials using adjuvant chemotherapy for prostate cancer

  16. Improvement of pain related self management for oncologic patients through a trans institutional modular nursing intervention: protocol of a cluster randomized multicenter trial

    Directory of Open Access Journals (Sweden)

    Thoke-Colberg Anette

    2010-03-01

    Full Text Available Abstract Background Pain is one of the most frequent and distressing symptoms in cancer patients. For the majority of the patients, sufficient pain relief can be obtained if adequate treatment is provided. However, pain remains often undertreated due to institutional, health care professional and patient related barriers. Patients self management skills are affected by the patients' knowledge, activities and attitude to pain management. This trial protocol is aimed to test the SCION-PAIN program, a multi modular structured intervention to improve self management in cancer patients with pain. Methods 240 patients with diagnosed malignancy and pain > 3 days and average pain ≥ 3/10 will participate in a cluster randomized trial on 18 wards in 2 German university hospitals. Patients from the intervention wards will receive, additionally to standard pain treatment, the SCION-PAIN program consisting of 3 modules: pharmacologic pain management, nonpharmacologic pain management and discharge management. The intervention will be conducted by specially trained oncology nurses and includes components of patient education, skills training and counseling to improve self care regarding pain management beginning with admission followed by booster session every 3rd day and one follow up telephone counseling within 2 to 3 days after discharge. Patients in the control group will receive standard care. Primary endpoint is the group difference in patient related barriers to management of cancer pain (BQII, 7 days after discharge. Secondary endpoints are: pain intensity & interference, adherence, coping and HRQoL. Discussion The study will determine if the acquired self management skills of the patients continue to be used after discharge from hospital. It is hypothesized that patients who receive the multi modular structured intervention will have less patient related barriers and a better self management of cancer pain. Trial Registration ClinicalTrials NCT

  17. Gaining control over breast cancer risk: Transforming vulnerability, uncertainty, and the future through clinical trial participation - a qualitative study.

    Science.gov (United States)

    Holmberg, Christine; Whitehouse, Katie; Daly, Mary; McCaskill-Stevens, Worta

    2015-11-01

    Concepts of disease risk and its management are central to processes of medicalisation and pharmaceuticalisation. Through a narrative perspective, this paper aims to understand how such macro-level developments may (or may not) be experienced individually, and how an algorithm that is used for recruitment into a clinical trial may structure individual notions of being 'at risk' and 'in need of treatment'. We interviewed 31 women participating in the Study of Tamoxifen and Raloxifene (STAR), a chemoprevention trial conducted in the US between 1999 and 2006. Interviews were thematically analysed. Women in the study had experienced the threat of breast cancer and felt vulnerable to developing the disease prior to STAR participation. The diagnosis of 'being at risk' for cancer through an algorithm that determined risk-eligibility for STAR, opened up the possibility for the women to heal. The trial became a means to recognise and collectivise the women's experiences of vulnerability. Through medication intake, being cared for by study coordinators, and the sense of community with other STAR participants, trial participation worked to transform women's lives. Such transformative experiences may nevertheless have been temporary, enduring only as long as the close links to the medical institution through trial participation lasted. PMID:26235092

  18. CMEA cooperative trials in chemotherapy of lung cancer patients

    International Nuclear Information System (INIS)

    TA comparative analysis of the immediate and short-term results of chemo- and radiotherapy of 174 patients with well differentiated inoperable lung cancer has been performed. The data were presented by the participants of the CMEA cooperative trial (the Hungarian People's Reg public, the USSR and the Czechoslovak Socialist Republic over the period of 1976-1980). Comparative analysis has shown that the use of adjuvant chemotherapy tends to improve an immediate therapeutic effect. In well differentiated squamous cell carcinoma, a marked positive effect was obtained in 48.6% of the patients as compared to 31.2% in radiotherapy alone. However, judging by the survival rates such differences in favor of chemotherapy were not revealed. After conservative treatment (radio- and chemotherapy) of patients with differentiated lung cancer in the inoperable stage 55.7% survived for 1, 17.27% for 2, 8.55% for 3 yrs. Direct correlation between the immediate effect of radio- and chemotherapy and the survival of the patients was revealed. Of 67 patients with a marked immediate effect 49 (73.1%) lived over 1 year, 8 out of 9 patients lived for 3 yrs

  19. Barriers to Recruitment of Rural Patients in Cancer Clinical Trials

    OpenAIRE

    Virani, Shamsuddin; Burke, Lola; Remick, Scot C.; Abraham, Jame

    2011-01-01

    Rates of clinical trial participation are lower among patients in rural areas. Oncologists should be trained to address patient concerns regarding clinical trial availability, utility, and accessibility.

  20. Healthcare costs in the Danish randomised controlled lung cancer CT-screening trial

    DEFF Research Database (Denmark)

    Rasmussen, J.F.; Siersma, V.; Pedersen, Jesper H.;

    2014-01-01

    OBJECTIVES: Low dose computerised tomography (CT) screening for lung cancer can reduce lung-cancer-specific mortality. The objective of this study was to analyse healthcare costs and healthcare utilisation of participants in the Danish lung cancer CT-screening trial (DLCST). MATERIALS AND METHODS...

  1. The PLCO Cancer Screening Trial: Background, Goals, Organization, Operations, Results.

    Science.gov (United States)

    Gohagan, John K; Prorok, Philip C; Greenwald, Peter; Kramer, Barnett S

    2015-01-01

    The randomized PLCO trial was designed to answer four primary questions: does screening for these cancers using often promoted tests reduce cancer-specific mortality? Nearly 155,000 men and women were allocated to screening or usual care arms in a 1:1 ratio under a centralized, secure randomization algorithm at ten competitively selected screening centers nationwide. Screened men received PSA blood tests and digital rectal examinations. Screened women received CA125 blood tests and trans-vaginal ultrasound. Both men and women in the screened arm received anterolateral view chest x-ray and 60 cm flexible sigmoidoscopy. Blood specimens were collected at each screening visit and buccal cell DNA was collected once from the usual care participants. Histology slides were collected for cancer cases. Participants completed a baseline questionnaire covering health and risk factors and a dietary questionnaire. Data collected on standardized machine-readable forms were scanned remotely at screening and laboratory sites utilizing PLCO dedicated, NCI provided and configured computer systems for quality checks, archiving, and analysis. Comprehensive quality assurance was implemented over recruitment, consenting, randomization, screening, data management, records keeping, patient-specific screening results reporting, follow-up, and data analysis. Performance and data quality were monitored on-site and remotely by data edits, site visits, and random record audits. Specially trained and certified professionals performed screening procedures and medical record abstracting. An independent committee of medical specialists reviewed and certified case-specific cause of death. Scientific leadership was provided by NCI Project Officers, PLCO principal investigators, external consultants, and an independent data and safety monitoring board. PMID:26238115

  2. Serum estrogen levels and prostate cancer risk in the prostate cancer prevention trial: a nested case–control study

    OpenAIRE

    Yao, Song; Till, Cathee; Kristal, Alan R.; Goodman, Phyllis J.; Hsing, Ann W.; Tangen, Catherine M.; Platz, Elizabeth A.; Stanczyk, Frank Z.; Reichardt, Juergen K. V.; Tang, Li; Neuhouser, Marian L; Santella, Regina M.; William D Figg; Price, Douglas K.; Parnes, Howard L.

    2011-01-01

    Objective Finasteride reduces prostate cancer risk by blocking the conversion of testosterone to dihydrotestosterone. However, whether finasteride affects estrogens levels or change in estrogens affects prostate cancer risk is unknown. Methods These questions were investigated in a case–control study nested within the prostate cancer prevention trial (PCPT) with 1,798 biopsy-proven prostate cancer cases and 1,798 matched controls. Results Among men on placebo, no relationship of serum estroge...

  3. HUMAN PAPILLOMAVIRUS TYPES 16, 18 AND 31 SEROSTATUS AND PROSTATE CANCER RISK IN THE PROSTATE CANCER PREVENTION TRIAL

    OpenAIRE

    Sutcliffe, Siobhan; Viscidi, Raphael P.; Till, Cathee; Goodman, Phyllis J.; Hoque, Ashraful M.; Hsing, Ann W.; Thompson, Ian M; Zenilman, Jonathan M; De Marzo, Angelo M.; Platz, Elizabeth A.

    2010-01-01

    Since human papillomavirus (HPV) infection was first identified as a risk factor for cervical cancer, several seroepidemiologic and tissue-based studies have investigated HPV in relation to prostate cancer, another common genitourinary malignancy, with mixed results. To further inform this potential association, we conducted a large, prospective investigation of HPV types 16, 18, and 31 in relation to risk of prostate cancer in the Prostate Cancer Prevention Trial (PCPT). Cases were a sample ...

  4. Proton Therapy for Breast Cancer After Mastectomy: Early Outcomes of a Prospective Clinical Trial

    International Nuclear Information System (INIS)

    Purpose: Dosimetric planning studies have described potential benefits for the use of proton radiation therapy (RT) for locally advanced breast cancer. We report acute toxicities and feasibility of proton delivery for 12 women treated with postmastectomy proton radiation with or without reconstruction. Methods and Materials: Twelve patients were enrolled in an institutional review board-approved prospective clinical trial. The patients were assessed for skin toxicity, fatigue, and radiation pneumonitis during treatment and at 4 and 8 weeks after the completion of therapy. All patients consented to have photographs taken for documentation of skin toxicity. Results: Eleven of 12 patients had left-sided breast cancer. One patient was treated for right-sided breast cancer with bilateral implants. Five women had permanent implants at the time of RT, and 7 did not have immediate reconstruction. All patients completed proton RT to a dose of 50.4 Gy (relative biological effectiveness [RBE]) to the chest wall and 45 to 50.4 Gy (RBE) to the regional lymphatics. No photon or electron component was used. The maximum skin toxicity during radiation was grade 2, according to the Common Terminology Criteria for Adverse Events (CTCAE). The maximum CTCAE fatigue was grade 3. There have been no cases of RT pneumonitis to date. Conclusions: Proton RT for postmastectomy RT is feasible and well tolerated. This treatment may be warranted for selected patients with unfavorable cardiac anatomy, immediate reconstruction, or both that otherwise limits optimal RT delivery using standard methods

  5. Recruitment strategies for a lung cancer chemoprevention trial involving ex-smokers.

    Science.gov (United States)

    Kye, Steve H; Tashkin, Donald P; Roth, Michael D; Adams, Bradley; Nie, Wen-Xian; Mao, Jenny T

    2009-09-01

    The ability to recruit qualified subjects who are willing to adhere to the study protocol in clinical trials is an essential component of translational research. Such tasks can be particularly challenging for chemoprevention studies when the targeted study population is healthy, at risk individuals who do not have signs or symptoms of the disease, and the study participation involves complex scheduling and invasive procedures such as bronchoscopy. In this report, we describe the recruitment process and evaluated the effectiveness of various recruitment strategies utilized in our National Cancer Institute sponsored lung cancer chemoprevention study with celecoxib. Heavy ex-smokers were recruited into the study through various methods such as radio advertisements, print media, mass mailings, flyers, internet postings and others. The number of inquiries, on-site screenees and randomization generated by each method determined the efficacy of that recruitment strategy. We prescreened 4470 individuals, invited 323 people for on-site screening and randomized 137 subjects. Radio advertisements (ads) generated the most inquiries (71.1%), followed by internet posting (11.8%), print media (6.0%), posted and racked flyers (4.4%), mass mailings (2.7%) and other strategies such as referrals from friends or family members or health care providers (2.3%). Radio ads, although costly, yielded the most subjects for on-site screening and randomization. Moreover, among the various types of radio stations, news radio stations were by far the most successful. Our results suggest that advertising on news radio is a highly effective recruitment method for successful accrual of ex-smokers into lung cancer chemoprevention trials. PMID:19508900

  6. Clinical trial designs for rare diseases: Studies developed and discussed by the International Rare Cancers Initiative

    Science.gov (United States)

    Bogaerts, Jan; Sydes, Matthew R.; Keat, Nicola; McConnell, Andrea; Benson, Al; Ho, Alan; Roth, Arnaud; Fortpied, Catherine; Eng, Cathy; Peckitt, Clare; Coens, Corneel; Pettaway, Curtis; Arnold, Dirk; Hall, Emma; Marshall, Ernie; Sclafani, Francesco; Hatcher, Helen; Earl, Helena; Ray-Coquard, Isabelle; Paul, James; Blay, Jean-Yves; Whelan, Jeremy; Panageas, Kathy; Wheatley, Keith; Harrington, Kevin; Licitra, Lisa; Billingham, Lucinda; Hensley, Martee; McCabe, Martin; Patel, Poulam M.; Carvajal, Richard; Wilson, Richard; Glynne-Jones, Rob; McWilliams, Rob; Leyvraz, Serge; Rao, Sheela; Nicholson, Steve; Filiaci, Virginia; Negrouk, Anastassia; Lacombe, Denis; Dupont, Elisabeth; Pauporté, Iris; Welch, John J.; Law, Kate; Trimble, Ted; Seymour, Matthew

    2015-01-01

    Background The past three decades have seen rapid improvements in the diagnosis and treatment of most cancers and the most important contributor has been research. Progress in rare cancers has been slower, not least because of the challenges of undertaking research. Settings The International Rare Cancers Initiative (IRCI) is a partnership which aims to stimulate and facilitate the development of international clinical trials for patients with rare cancers. It is focused on interventional – usually randomised – clinical trials with the clear goal of improving outcomes for patients. The key challenges are organisational and methodological. A multi-disciplinary workshop to review the methods used in ICRI portfolio trials was held in Amsterdam in September 2013. Other as-yet unrealised methods were also discussed. Results The IRCI trials are each presented to exemplify possible approaches to designing credible trials in rare cancers. Researchers may consider these for use in future trials and understand the choices made for each design. Interpretation Trials can be designed using a wide array of possibilities. There is no ‘one size fits all’ solution. In order to make progress in the rare diseases, decisions to change practice will have to be based on less direct evidence from clinical trials than in more common diseases. PMID:25542058

  7. NEOadjuvant therapy monitoring with PET and CT in Esophageal Cancer (NEOPEC-trial)

    International Nuclear Information System (INIS)

    Surgical resection is the preferred treatment of potentially curable esophageal cancer. To improve long term patient outcome, many institutes apply neoadjuvant chemoradiotherapy. In a large proportion of patients no response to chemoradiotherapy is achieved. These patients suffer from toxic and ineffective neoadjuvant treatment, while appropriate surgical therapy is delayed. For this reason a diagnostic test that allows for accurate prediction of tumor response early during chemoradiotherapy is of crucial importance. CT-scan and endoscopic ultrasound have limited accuracy in predicting histopathologic tumor response. Data suggest that metabolic changes in tumor tissue as measured by FDG-PET predict response better. This study aims to compare FDG-PET and CT-scan for the early prediction of non-response to preoperative chemoradiotherapy in patients with potentially curable esophageal cancer. Prognostic accuracy study, embedded in a randomized multicenter Dutch trial comparing neoadjuvant chemoradiotherapy for 5 weeks followed by surgery versus surgery alone for esophageal cancer. This prognostic accuracy study is performed only in the neoadjuvant arm of the randomized trial. In 6 centers, 150 consecutive patients will be included over a 3 year period. FDG-PET and CT-scan will be performed before and 2 weeks after the start of the chemoradiotherapy. All patients complete the 5 weeks regimen of neoadjuvant chemoradiotherapy, regardless the test results. Pathological examination of the surgical resection specimen will be used as reference standard. Responders are defined as patients with < 10% viable residual tumor cells (Mandard-score). Difference in accuracy (area under ROC curve) and negative predictive value between FDG-PET and CT-scan are primary endpoints. Furthermore, an economic evaluation will be performed, comparing survival and costs associated with the use of FDG-PET (or CT-scan) to predict tumor response with survival and costs of neoadjuvant

  8. The Missing Pieces in Reporting of Randomized Controlled Trials of External Beam Radiation Therapy Dose Escalation for Prostate Cancer.

    Science.gov (United States)

    Zaorsky, Nicholas G; Egleston, Brian L; Horwitz, Eric M; Dicker, Adam P; Nguyen, Paul L; Showalter, Timothy N; Den, Robert B

    2016-08-01

    Randomized controlled trials (RCTs) are the most rigorous way of determining whether a cause-effect relation exists between treatment and outcome and for assessing the cost-effectiveness of a treatment. For many patients, cancer is a chronic illness; RCTs evaluating treatments for indolent cancers must evolve to facilitate medical decision-making, as "concrete" patient outcomes (eg, survival) will likely be excellent independent of the intervention, and detecting a difference between trial arms may be impossible. In this commentary, we articulate 9 recommendations that we hope future clinical trialists and funding agencies (including those under the National Cancer Institute) will take into consideration when planning RCTs to help guide subsequent interpretation of results and clinical decision making, based on RCTs of external beam radiation therapy dose escalation for the most common indolent cancer in men, that is, prostate cancer. We recommend routinely reporting: (1) race; (2) medical comorbidities; (3) psychiatric comorbidities; (4) insurance status; (5) education; (6) marital status; (7) income; (8) sexual orientation; and (9) facility-related characteristics (eg, number of centers involved, type of facilities, yearly hospital volumes). We discuss how these factors independently affect patient outcomes and toxicities; future clinicians and governing organizations should consider this information to plan RCTs accordingly (to maximize patient accrual and total n), select appropriate endpoints (eg, toxicity, quality of life, sexual function), actively monitor RCTs, and report results so as to identify the optimal treatment among subpopulations. PMID:27322694

  9. Impact of institutional experience on survival outcome of patients undergoing combined chemoradiation therapy for inoperable non-small-cell lung cancer

    International Nuclear Information System (INIS)

    Purpose: Clinical experience of both physicians and institutions has been shown to significantly influence the outcome of patients. We conducted this retrospective cohort study to examine its impact on the outcome of patients undergoing combined chemoradiation therapy for the treatment of locally advanced inoperable non-small-cell lung cancer. Methods and Materials: We compared the clinical data from 239 patients who were enrolled in two consecutive Radiation Therapy Oncology Group (RTOG) trials (RTOG 91-06, RTOG 92-04) according to the number of patients enrolled from each institution in either trial alone or the two trials combined. Results: Overall, patients treated at the institutions that enrolled ≥5 patients survived longer than those treated at the institutions that enrolled <5 patients (median survival 20.5 vs. 13.4 months, p=0.0006) with a more than doubling of the 2- and 3-year survival rates (45% and 31% vs. 20% and 13%, respectively). Multivariate analyses confirmed that the number of patients enrolled from each institution was an important prognostic factor for the entire group (p=0.001) and also for RTOG 91-06 (p=0.05) and RTOG 92-04 (p=0.004) when the data were analyzed separately. Conclusion: Institutional experience has a significant impact on the survival outcome of patients undergoing combined chemoradiation therapy for inoperable non-small cell lung cancer

  10. Clinical trial designs for rare diseases: studies developed and discussed by the International Rare Cancers Initiative.

    OpenAIRE

    Bogaerts, Jan; Sydes, Matthew R; Keat, Nicola; McConnell, Andrea; Benson, Al; Ho, Alan; Roth, Arnaud; Fortpied, Catherine; Eng, Cathy; Peckitt, Clare; Coens, Corneel; Pettaway, Curtis; Arnold, Dirk; Hall, Emma; Marshall, Ernie

    2015-01-01

    Background The past three decades have seen rapid improvements in the diagnosis and treatment of most cancers and the most important contributor has been research. Progress in rare cancers has been slower, not least because of the challenges of undertaking research. Settings The International Rare Cancers Initiative (IRCI) is a partnership which aims to stimulate and facilitate the development of international clinical trials for patients with rare cancers. It is focused on interven...

  11. A New Ethical Challenge for Institutional Review Boards (IRBs/Ethics Committees (ECs in the Assessment of Pediatric Clinical Trials

    Directory of Open Access Journals (Sweden)

    Klaus Rose

    2015-05-01

    Full Text Available Both the US and EU have introduced pediatric pharmaceutical legislation to facilitate clinical trials in children and development of better medicines for children. The first concerns were published in 2014 that the European Medicines Agency (EMA’s Pediatric Committee (PDCO may be over-enthusiastic and has compelled questionable pediatric clinical trials from pharmaceutical companies. Numerous clinical trials are mandated in rare conditions for which not enough patients exist for even one trial. Furthermore, where these trials are mandated in adolescent patients, the legal age limit of the 18th birthday is confused with a medical age limit and can result in separate clinical trials in adolescent patients that neither make medical nor scientific sense nor will ever recruit enough patients for a meaningful outcome. To confirm our concerns we searched the registry clinicaltrials.gov and found examples for PDCO-triggered unethical trials. We conclude that such trials should not be accepted by institutional review boards (IRBs/ethics committees (ECs and that clinical trials resulting from negotiations with EMA’s PDCO need extra careful scrutiny by IRBs/ECs in order to prevent unethical studies and damage to pediatric research and unnecessary risks to pediatric patients.

  12. 75 FR 992 - National Cancer Institute; Notice of Meeting

    Science.gov (United States)

    2010-01-07

    ... personal privacy. Name of Committee: National Cancer Advisory Board; Ad Hoc Subcommittee on Experimental Therapeutics. Open: February 8, 2010, 6:30 p.m. to 8 p.m. Agenda: Discussion on cancer experimental... Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research;...

  13. 78 FR 28235 - National Cancer Institute; Notice of Closed Meetings

    Science.gov (United States)

    2013-05-14

    ... Toolkit for Cancer Diagnosis, Staging, and Treatment. Date: May 29, 2013. Time: 12:00 p.m. to 2:00 p.m... Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398, Cancer Research... Diagnostic Assay to Detect Basal- like Breast Cancer. Date: June 13, 2013. Time: 12:00 p.m. to 1:00...

  14. Biorepositories for the Breast Cancer Prevention Trial (BCPT) and the Study of Tamoxifen and Raloxifene (STAR) | Division of Cancer Prevention

    Science.gov (United States)

    The National Surgical Adjuvant Breast and Bowel Project (NSABP) has a serum and lymphocyte bank with specimens on more than 90% of the 33,000 women in the Breast Cancer Prevention Trial (BCPT) and Study of Tamoxifen and Raloxifene (STAR). They also have tumor blocks on the majority of the breast cancers that have occurred in women on these studies. |

  15. Lost in translation: animal models and clinical trials in cancer treatment

    OpenAIRE

    Mak, Isabella WY; Evaniew, Nathan; Ghert, Michelle

    2014-01-01

    Due to practical and ethical concerns associated with human experimentation, animal models have been essential in cancer research. However, the average rate of successful translation from animal models to clinical cancer trials is less than 8%. Animal models are limited in their ability to mimic the extremely complex process of human carcinogenesis, physiology and progression. Therefore the safety and efficacy identified in animal studies is generally not translated to human trials. Animal mo...

  16. Prostate Cancer: Prognostic factors, markers of outcome and design of clinical trials

    OpenAIRE

    Collette, Lau

    2006-01-01

    textabstractPhase III clinical trials to assess the clinical benefit of new treatment options often require large patient numbers and long follow-up, in particular in diseases with a long natural history, such as prostate cancer. In this thesis, we argue that in order to improve the efficiency of phase III prostate cancer clinical trials, a thorough understanding of prognostic factors of outcome is needed, as well as an exploration of potential predictive factors that might affect treatment b...

  17. Randomised controlled trial of effects of coordinating care for terminally ill cancer patients.

    OpenAIRE

    Addington-Hall, J M; MacDonald, L D; Anderson, H R; Chamberlain, J.; Freeling, P.; Bland, J. M.; Raftery, J

    1992-01-01

    OBJECTIVES--To measure effects on terminally ill cancer patients and their families of coordinating the services available within the NHS and from local authorities and the voluntary sector. DESIGN--Randomised controlled trial. SETTING--Inner London health district. PATIENTS--Cancer patients were routinely notified from 1987 to 1990. 554 patients expected to survive less than one year entered the trial and were randomly allocated to a coordination or a control group. INTERVENTION--All patient...

  18. A Multi-Method Process Evaluation for a Skin Cancer Prevention Diffusion Trial

    OpenAIRE

    Escoffery, Cam; Glanz, Karen; Hall, Dawn; Elliott, Tom

    2009-01-01

    This article describes process evaluation methods for the Pool Cool Diffusion Trial across four years. Pool Cool is a skin cancer prevention program that was found to improve behaviors and environments for sun protection at swimming pools in a randomized efficacy trial, which was followed by a national Diffusion Trial. The process evaluation focus shifted from measuring program satisfaction to assessing widespread program implementation, barriers and facilitators to implementation, and progra...

  19. About the Community Oncology and Prevention Trials Research Group | Division of Cancer Prevention

    Science.gov (United States)

    The Community Oncology and Prevention Trials Research Group supports clinical oncology trials in cancer prevention and control in community settings. The group also supports investigator-initiated research projects in supportive, palliative and end-of-life care, and coordinates clinical oncology research projects with other NCI programs to be done in the community setting. |

  20. Recommended patient-reported core set of symptoms to measure in adult cancer treatment trials

    NARCIS (Netherlands)

    B.B. Reeve; S.A. Mitchell; A.C. Dueck; E. Basch; D. Cella; C. Miller Reilly; L.M. Minasian; A.M. Denicoff; A.M. O'Mara; M.J. Fisch; C. Chauhan; N.K. Aaronson; C. Coens; D. Watkins Bruner

    2014-01-01

    Background: The National Cancer Institute’s Symptom Management and Health-Related Quality of Life Steering Committee held a clinical trials planning meeting (September 2011) to identify a core symptom set to be assessed across oncology trials for the purposes of better understanding treatment effica

  1. Randomized Controlled Trial of Pulmonary Metastasectomy in Colorectal Cancer: PulMiCC International Is Open in Italy

    OpenAIRE

    Migliore, Marcello; Lees, Belinda; Treasure, Tom; Fallowfield, Lesley J

    2013-01-01

    Advocates of the Pulmonary Metastasectomy in Colorectal Cancer trial describe trial design and goals, in agreement with others that such a trial is necessary to solve the question of whether or not surgery is beneficial in patients with metastatic colorectal cancer and, ultimately, to assist patients and clinical teams in deciding for or against pulmonary metastectomy.

  2. Serum IgE and risk of pancreatic cancer in the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial (PLCO)

    OpenAIRE

    Olson, Sara H.; Hsu, Meier; Wiemels, Joseph L; Paige M Bracci; ZHOU, MI; Patoka, Joseph; Reisacher, William I.; Wang, Julie; Robert C Kurtz; Silverman, Debra T.; Stolzenberg-Solomon, Rachael Z

    2014-01-01

    Epidemiologic studies have consistently found that self-reported allergies are associated with reduced risk of pancreatic cancer. Our aim was to prospectively assess the relationship between serum IgE, a marker of allergy, and risk. This nested case-control study within the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial (PLCO) included subjects enrolled in 1994-2001 and followed through 2010. There were 283 cases of pancreatic cancer and 544 controls matched on age, gender, ra...

  3. Bioequivalence and Bioavailability Clinical Trials: A Status Report from the National Institutes of Health ClinicalTrials.gov Registry

    OpenAIRE

    Stockmann, Chris; Spigarelli, Michael G.; Ampofo, Krow; Sherwin, Catherine MT

    2013-01-01

    Drug development is an expensive process that is marked by a high-failure rate. For this reason early stage bioequivalence and pharmacokinetic studies are essential in determining the fate of new drug products. In this study, we sought to systematically assess the current trends of ongoing and recently completed bioequivalence and bioavailability trials that have been registered within a national clinical trials registry. All bioequivalence and bioavailability studies registered in the United...

  4. Adaptive Radiotherapy for Head-and-Neck Cancer: Initial Clinical Outcomes From a Prospective Trial

    International Nuclear Information System (INIS)

    Purpose: To present pilot toxicity and survival outcomes for a prospective trial investigating adaptive radiotherapy (ART) for oropharyngeal squamous cell carcinoma. Methods and Materials: A total of 24 patients were enrolled in an institutional review board–approved clinical trial; data for 22 of these patients were analyzed. Daily CT-guided setup and deformable image registration permitted serial mapping of clinical target volumes and avoidance structures for ART planning. Primary site was base of tongue in 15 patients, tonsil in 6 patient, and glossopharyngeal sulcus in 1 patient. Twenty patients (91%) had American Joint Committee on Cancer (AJCC) Stage IV disease. T stage distribution was 2 T1, 12 T2, 3 T3, 5 T4. N stage distribution was 1 N0, 2 N1, 5 N2a, 12 N2b, and 2 N2c. Of the patients, 21 (95%) received systemic therapy. Results: With a 31-month median follow-up (range, 13–45 months), there has been no primary site failure and 1 nodal relapse, yielding 100% local and 95% regional disease control at 2 years. Baseline tumor size correlated with absolute volumetric treatment response (p = 0.018). Parotid volumetric change correlated with duration of feeding tube placement (p = 0.025). Acute toxicity was comparable to that observed with conventional intensity-modulated radiotherapy (IMRT). Chronic toxicity and functional outcomes beyond 1 year were tabulated. Conclusion: This is the first prospective evaluation of morbidity and survival outcomes in patients with locally advanced head-and-neck cancer treated with automated adaptive replanning. ART can provide dosimetric benefit with only one or two mid-treatment replanning events. Our preliminary clinical outcomes document functional recovery and preservation of disease control at 1-year follow-up and beyond.

  5. Adaptive Radiotherapy for Head-and-Neck Cancer: Initial Clinical Outcomes From a Prospective Trial

    Energy Technology Data Exchange (ETDEWEB)

    Schwartz, David L., E-mail: dschwartz3@nshs.edu [Department of Radiation Medicine, Hofstra North Shore-Long Island Jewish School of Medicine, New Hyde Park, NY (United States); Feinstein Institute for Medical Research, Manhasset, NY (United States); Department of Radiation Oncology, University of Texas M.D. Anderson Cancer Center, Houston, TX (United States); Garden, Adam S.; Thomas, Jimmy [Department of Radiation Oncology, University of Texas M.D. Anderson Cancer Center, Houston, TX (United States); Chen Yipei; Zhang Yongbin [Department of Radiation Physics, University of Texas M.D. Anderson Cancer Center, Houston, TX (United States); Lewin, Jan; Chambers, Mark S. [Department of Head and Neck Surgery, University of Texas M.D. Anderson Cancer Center, Houston, TX (United States); Dong, Lei [Department of Radiation Physics, University of Texas M.D. Anderson Cancer Center, Houston, TX (United States)

    2012-07-01

    Purpose: To present pilot toxicity and survival outcomes for a prospective trial investigating adaptive radiotherapy (ART) for oropharyngeal squamous cell carcinoma. Methods and Materials: A total of 24 patients were enrolled in an institutional review board-approved clinical trial; data for 22 of these patients were analyzed. Daily CT-guided setup and deformable image registration permitted serial mapping of clinical target volumes and avoidance structures for ART planning. Primary site was base of tongue in 15 patients, tonsil in 6 patient, and glossopharyngeal sulcus in 1 patient. Twenty patients (91%) had American Joint Committee on Cancer (AJCC) Stage IV disease. T stage distribution was 2 T1, 12 T2, 3 T3, 5 T4. N stage distribution was 1 N0, 2 N1, 5 N2a, 12 N2b, and 2 N2c. Of the patients, 21 (95%) received systemic therapy. Results: With a 31-month median follow-up (range, 13-45 months), there has been no primary site failure and 1 nodal relapse, yielding 100% local and 95% regional disease control at 2 years. Baseline tumor size correlated with absolute volumetric treatment response (p = 0.018). Parotid volumetric change correlated with duration of feeding tube placement (p = 0.025). Acute toxicity was comparable to that observed with conventional intensity-modulated radiotherapy (IMRT). Chronic toxicity and functional outcomes beyond 1 year were tabulated. Conclusion: This is the first prospective evaluation of morbidity and survival outcomes in patients with locally advanced head-and-neck cancer treated with automated adaptive replanning. ART can provide dosimetric benefit with only one or two mid-treatment replanning events. Our preliminary clinical outcomes document functional recovery and preservation of disease control at 1-year follow-up and beyond.

  6. Psychological distress of cancer and clinical trial participation: a review of the literature.

    Science.gov (United States)

    Kelly, C; Ghazi, F; Caldwell, K

    2002-03-01

    The House of Commons Select Committee on Science and Technology 2000 state that currently less than 5% of adult patients with solid tumours are entered into clinical trials. They recommend that increasing the number of adult cancer patients entering clinical trials must become a high priority. Health-care providers need to prepare themselves for this proposed increase in trial participants by assessing the current status of care and implementing changes within the current infrastructure to provide optimal holistic care. Cancer can change a patient's life either for better or for worse. At one extreme, having cancer leads to enhanced appreciation of life and closer bonds with others. However, at the other extreme, cancer combined with its treatment is viewed as an event that evokes distress and emotional anguish taxing the individual's ability to cope. In the last 25 years, owing to the advent of clinical trials, progress has been made in cancer treatment. Clinical trials may be hailed as the saviour to many therapeutic dilemmas. Treatments are now available which can offer patients hope of cure. Nevertheless, many participants may fear, for the purpose of research, that they may be assigned to less than optimal therapy or that their care will be carried out in a sterile scientific atmosphere devoid of humane and personal consideration. These and other reasons may cause unacceptable personal distress that overrides the potential therapeutic gain. Cancer diagnosis coupled with the ramifications of clinical trial involvement can have significant psychological implications. They may trigger the onset of a mood disorder or exacerbate a present symptom. This article will identify mood disorders in the cancer population, focus on the participants' needs in the clinical trial arena and investigate the influence trial participation has on psychological status. PMID:11966830

  7. Prevalence of bone marrow necrosis in Egyptian cancer patients referring to the National Cancer Institute

    International Nuclear Information System (INIS)

    Bone marrow necrosis; Egyptian cancer patients Abstract Background: Bone marrow necrosis is a relatively rare entity which has been associated with a poor prognosis. It is most commonly found in patients with neoplastic disorders and severe infections. Methods: study comprised examination of 5043 bone marrow biopsy specimens performed at the National Cancer Institute, Cairo University, over 7 years period (March 2004-March 2011). It included 5 years retrospective (2867 archived samples) and 2 years prospective (2176 samples). Results: Bone marrow necrosis was diagnosed in fifteen out of 5043 examined specimens with a percentage of 0.3% and ranged from mild to massive according to semiquantitative estimation. Prognosis of all patients was poor with survival not exceeding 6 months from the date of marrow necrosis diagnosis. Conclusion: In Egyptian patients, bone marrow necrosis in association with malignancy is a rare disorder which is accompanied by a poor outcome

  8. Clinicopathological Characteristics of Colon Cancer Diagnosed at Primary Health Care Institutions

    OpenAIRE

    Park, Sang Hyun; Song, Chi Wook; Kim, Yun Bae; Kim, Young Sun; Chun, Hwang Rae; Lee, Jung Hyun; Seol, Won Jong; Yoon, Hyung Sun; Lee, Myung Kwon; Lee, Jong Hyup; Bhang, Choon Sang; Park, Jae Hyung; Park, Ji Young; Do, Byung Hun; Park, Young Dae

    2014-01-01

    Background/Aims The purpose of this study was to evaluate the clinicopathologic characteristics of colon cancers detected at the SOK Sokpeynhan Internal Medical Network, a nationwide system of primary health care institutions. Methods We analyzed 579 colon cancer patients diagnosed using colonoscopy at the SOK network from January 2011 through December 2012. Cancers from the rectum to the splenic flexure were classified as left colon cancer. Patients over 65 were classified as senior. Results...

  9. 75 FR 26267 - National Cancer Institute; Notice of Meeting

    Science.gov (United States)

    2010-05-11

    ... personal privacy. Name of Committee: National Cancer Advisory Board Ad hoc Subcommittee on Experimental Therapeutics. Open: June 21, 2010, 6:30 p.m. to 8 p.m. Agenda: Discussion on Experimental Therapeutics. Place... Prevention Research; 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research;...

  10. Nutritional Science Clinical Trials | Division of Cancer Prevention

    Science.gov (United States)

    The Division of Cancer Prevention (DCP) conducts and supports research to determine a person's risk of cancer and to find ways to reduce the risk. This knowledge is critical to making progress against cancer because risk varies over the lifespan as genetic and epigenetic changes can transform healthy tissue into invasive cancer.

  11. Community Oncology and Prevention Trials Staff | Division of Cancer Prevention

    Science.gov (United States)

    The Division of Cancer Prevention (DCP) conducts and supports research to determine a person's risk of cancer and to find ways to reduce the risk. This knowledge is critical to making progress against cancer because risk varies over the lifespan as genetic and epigenetic changes can transform healthy tissue into invasive cancer.

  12. Community Oncology and Prevention Trials Clinical Trials | Division of Cancer Prevention

    Science.gov (United States)

    The Division of Cancer Prevention (DCP) conducts and supports research to determine a person's risk of cancer and to find ways to reduce the risk. This knowledge is critical to making progress against cancer because risk varies over the lifespan as genetic and epigenetic changes can transform healthy tissue into invasive cancer.

  13. Sipjeondaebo-tang in patients with cancer with anorexia: a protocol for a pilot, randomised, controlled trial

    Science.gov (United States)

    Cheon, Chunhoo; Park, Sunju; Park, Yu Lee; Huang, Ching-Wen; Ko, Youme; Jang, Bo-Hyoung; Shin, Yong-Cheol; Ko, Seong-Gyu

    2016-01-01

    Introduction Cancer-related anorexia is the loss of appetite or desire to eat in patients with cancer. Although treatments for cancer-related anorexia do exist, patients have sought complementary and alternative medicine including herbal remedies, due to safety concerns. Sipjeondaebo-tang is one among other popular herbal medicines that are beneficial to management of anorexia in Korea. The purpose of this study is to examine the feasibility for a full randomised clinical trial of Sipjeondaebo-tang for cancer-related anorexia. Methods and analysis This study is a randomised, double-blinded and placebo-controlled trial of Sipjeondaebo-tang. For the study, 40 patients with cancer, aged 20–80 years, who reported anorexia, will be recruited. The participants will receive either 3 g of Sipjeondaebo-tang or a placebo, 3 times a day for 4 weeks. The primary end point is a change in the anorexia/cachexia subscale (A/CS) of Functional Assessment of Anorexia/Cachexia Therapy (FAACT). The secondary end points include changes in the visual analogue scale (VAS) of appetite, cortisol and ghrelin. The outcomes will be measured on every visit. Each participant will visit once a week during 4 weeks. Ethics and dissemination The present study has been approved by the Institutional Review Board of the Dunsan Korean Medicine Hospital of Daejeon University (reference DJDSKH-15-03-2 (V.2.0)). The results will be disseminated in a peer-reviewed journal and scientific conference. Trial registration number NCT02468141; Pre-results. PMID:27173813

  14. Volumetric computed tomography screening for lung cancer : three rounds of the NELSON trial

    NARCIS (Netherlands)

    Horeweg, Nanda; van der Aalst, Carlijn M.; Vliegenthart, Rozemarijn; Zhao, Yingru; Xie, Xueqian; Scholten, Ernst Th; Mali, Willem; Thunnissen, Erik; Weenink, Carla; Groen, Harry J. M.; Lammers, Jan-Willem J.; Nackaerts, Kristiaan; van Rosmalen, Joost; Oudkerk, Matthijs; de Koning, Harry J.

    2013-01-01

    Several medical associations recommended lung cancer screening by low-dose computed tomography scanning for high-risk groups. Counselling of the candidates on the potential harms and benefits and their lung cancer risk is a prerequisite for screening. In the NELSON trial, screenings are considered p

  15. Brief Behavioral Activation and Problem-Solving Therapy for Depressed Breast Cancer Patients: Randomized Trial

    Science.gov (United States)

    Hopko, Derek R.; Armento, Maria E. A.; Robertson, Sarah M. C.; Ryba, Marlena M.; Carvalho, John P.; Colman, Lindsey K.; Mullane, Christen; Gawrysiak, Michael; Bell, John L.; McNulty, James K.; Lejuez, Carl W.

    2011-01-01

    Objective: Major depression is the most common psychiatric disorder among breast cancer patients and is associated with substantial impairment. Although some research has explored the utility of psychotherapy with breast cancer patients, only 2 small trials have investigated the potential benefits of behavior therapy among patients with…

  16. Nutrition and cancer: Review of epidemiological studies and clinical trials

    OpenAIRE

    Demosthenes Panagiotakos; Georgia Georgiou; Niki Kontou

    2010-01-01

    Risk factors of cancer include unhealthy dietary habits, physical inactivity, smoking, various genetic and environmental factors. Cancer is the second cause of death after cardiovascular diseases with increased incidence; moreover, 80% of gastrointestinal, breast and prostate cancers are attributed to unhealthy eating habits. Many surveys have investigated the role of diet in cancer prevention. Here we summarized current knowledge about dietary factors associated with cancer incidence. There ...

  17. Inverse treatment planning for spinal robotic radiosurgery: an international multi-institutional benchmark trial.

    Science.gov (United States)

    Blanck, Oliver; Wang, Lei; Baus, Wolfgang; Grimm, Jimm; Lacornerie, Thomas; Nilsson, Joakim; Luchkovskyi, Sergii; Palazon Cano, Isabel; Shou, Zhenyu; Ayadi, Myriam; Treuer, Harald; Viard, Romain; Siebert, Frank-Andre; Chan, Mark K H; Hildebrandt, Guido; Dunst, Jürgen; Imhoff, Detlef; Wurster, Stefan; Wolff, Robert; Romanelli, Pantaleo; Lartigau, Eric; Semrau, Robert; Soltys, Scott G; Schweikard, Achim

    2016-01-01

    Stereotactic radiosurgery (SRS) is the accurate, conformal delivery of high-dose radiation to well-defined targets while minimizing normal structure doses via steep dose gradients. While inverse treatment planning (ITP) with computerized optimization algorithms are routine, many aspects of the planning process remain user-dependent. We performed an international, multi-institutional benchmark trial to study planning variability and to analyze preferable ITP practice for spinal robotic radiosurgery. 10 SRS treatment plans were generated for a complex-shaped spinal metastasis with 21 Gy in 3 fractions and tight constraints for spinal cord (V14Gy 95%). The resulting plans were rated on a scale from 1 to 4 (excellent-poor) in five categories (constraint compliance, optimization goals, low-dose regions, ITP complexity, and clinical acceptability) by a blinded review panel. Additionally, the plans were mathemati-cally rated based on plan indices (critical structure and target doses, conformity, monitor units, normal tissue complication probability, and treatment time) and compared to the human rankings. The treatment plans and the reviewers' rankings varied substantially among the participating centers. The average mean overall rank was 2.4 (1.2-4.0) and 8/10 plans were rated excellent in at least one category by at least one reviewer. The mathematical rankings agreed with the mean overall human rankings in 9/10 cases pointing toward the possibility for sole mathematical plan quality comparison. The final rankings revealed that a plan with a well-balanced trade-off among all planning objectives was preferred for treatment by most par-ticipants, reviewers, and the mathematical ranking system. Furthermore, this plan was generated with simple planning techniques. Our multi-institutional planning study found wide variability in ITP approaches for spinal robotic radiosurgery. The participants', reviewers', and mathematical match on preferable treatment plans and ITP

  18. Recommended patient-reported core set of symptoms and quality-of-life domains to measure in ovarian cancer treatment trials.

    Science.gov (United States)

    Donovan, Kristine A; Donovan, Heidi S; Cella, David; Gaines, Martha E; Penson, Richard T; Plaxe, Steven C; von Gruenigen, Vivian E; Bruner, Deborah Watkins; Reeve, Bryce B; Wenzel, Lari

    2014-07-01

    There is no consensus as to what symptoms or quality-of-life (QOL) domains should be measured as patient-reported outcomes (PROs) in ovarian cancer clinical trials. A panel of experts convened by the National Cancer Institute reviewed studies published between January 2000 and August 2011. The results were included in and combined with an expert consensus-building process to identify the most salient PROs for ovarian cancer clinical trials. We identified a set of PROs specific to ovarian cancer: abdominal pain, bloating, cramping, fear of recurrence/disease progression, indigestion, sexual dysfunction, vomiting, weight gain, and weight loss. Additional PROs identified in parallel with a group charged with identifying the most important PROs across cancer types were anorexia, cognitive problems, constipation, diarrhea, dyspnea, fatigue, nausea, neuropathy, pain, and insomnia. Physical and emotional domains were considered to be the most salient domains of QOL. Findings of the review and consensus process provide good support for use of these ovarian cancer-specific PROs in ovarian cancer clinical trials. PMID:25006190

  19. Development and trial operation of a site-wide computerized material accounting system at Kurchatov Institute

    International Nuclear Information System (INIS)

    Since August 1994 Kurchatov Institute in cooperation with several US Department of Energy Laboratories has been developing a site-wide computerized material accounting system for nuclear materials. In 1994 a prototype system was put into trial operation at two Kurchatov facilities. Evaluation of this prototype led to the development of a new computerized material accounting system named KI-MACS, which has been operational since 1996. This system is a site-wide local secure computer network with centralized database capable of dealing with strictly confidential data and performing near-real time accountancy. It utilizes a Microsoft Windows NT operating system with SQL Server and Visual Basic, and has a 'star'-like network architecture. KI-MACS is capable of dealing with materials in itemized and bulk form, and can perform statistical evaluations of measurements and material balance. KI-MACS is fully integrated with bar code equipment, electronic scales, gamma-ray spectrometers and an Active Well Coincidence Counter, thus providing almost on-line evaluation and utilization of results of measurements, item identification and accounting. At present KI-MACS is being used in Physical Inventory Taking at the Kurchatov Central Storage Facility, and by the end of 1997 will be installed at twelve Kurchatov nuclear facilities

  20. Development and trial operation of a site-wide computerized material accounting system at Kurchatov Institute

    Energy Technology Data Exchange (ETDEWEB)

    Roumiantsev, A.N.; Ostroumov, Y.A.; Yevstropov, A.V. [Kurchatov Institute RRC, Moscow (Russian Federation)] [and others

    1997-11-01

    Since August 1994 Kurchatov Institute in cooperation with several US Department of Energy Laboratories has been developing a site-wide computerized material accounting system for nuclear materials. In 1994 a prototype system was put into trial operation at two Kurchatov facilities. Evaluation of this prototype led to the development of a new computerized material accounting system named KI-MACS, which has been operational since 1996. This system is a site-wide local secure computer network with centralized database capable of dealing with strictly confidential data and performing near-real time accountancy. It utilizes a Microsoft Windows NT operating system with SQL Server and Visual Basic, and has a `star`-like network architecture. KI-MACS is capable of dealing with materials in itemized and bulk form, and can perform statistical evaluations of measurements and material balance. KI-MACS is fully integrated with bar code equipment, electronic scales, gamma-ray spectrometers and an Active Well Coincidence Counter, thus providing almost on-line evaluation and utilization of results of measurements, item identification and accounting. At present KI-MACS is being used in Physical Inventory Taking at the Kurchatov Central Storage Facility, and by the end of 1997 will be installed at twelve Kurchatov nuclear facilities.

  1. Nutrition and cancer: Review of epidemiological studies and clinical trials

    Directory of Open Access Journals (Sweden)

    Demosthenes Panagiotakos

    2010-07-01

    Full Text Available Risk factors of cancer include unhealthy dietary habits, physical inactivity, smoking, various genetic and environmental factors. Cancer is the second cause of death after cardiovascular diseases with increased incidence; moreover, 80% of gastrointestinal, breast and prostate cancers are attributed to unhealthy eating habits. Many surveys have investigated the role of diet in cancer prevention. Here we summarized current knowledge about dietary factors associated with cancer incidence. There is a strong correlation of the protective effect of fruits and vegetables with colon cancer and the negative effect of red meat and the protective effect of milk on colorectal cancer. High alcohol consumption is related to higher incidence of mouth and esophageal cancers, with hot drinks playing a role in mouth or even gastrointestinal cancers. High fat consumption seems to play a negative role in colorectal cancer, where sugar and salt might be negatively related to stomach cancer. Beyond nutrition, physical inactivity and body fat seems to play an important role in cancer, where there are strong evidence that the first protects against colorectal cancer and the second increases the incidence of breast cancer after menopause. Data for the role of micronutrients, vitamins and minerals lead to the suggestion that dietary supplements should be avoided and all nutritional needs should be covered through a well balanced diet.

  2. Written emotional disclosure for women with ovarian cancer and their partners: randomised controlled trial

    OpenAIRE

    Arden-Close, Emily; Gidron, Yori; Bayne, Louise; Moss-Morris, Rona

    2013-01-01

    Objective: written emotional disclosure for 15–20?min a day over 3 to 4?days improves physical and psychological health and may benefit cancer patients. However, no studies have tested the effectiveness of guided writing in cancer patients and their partners. A randomised controlled trial tested whether writing about the patient's diagnosis and treatment of ovarian cancer using the Guided Disclosure Protocol (GDP) is effective in reducing perceived stress and improving quality of life (QoL) i...

  3. The post hoc use of randomised controlled trials to explore drug associated cancer outcomes

    DEFF Research Database (Denmark)

    Stefansdottir, Gudrun; Zoungas, Sophia; Chalmers, John;

    2013-01-01

    on public health before proper regulatory action can be taken. This paper aims to discuss challenges of exploring drug-associated cancer outcomes by post-hoc analyses of Randomised controlled trials (RCTs) designed for other purposes. METHODOLOGICAL CHALLENGES TO CONSIDER: We set out to perform a post......INTRODUCTION: Drug-induced cancer risk is of increasing interest. Both observational studies and data from clinical trials have linked several widely used treatments to cancer. When a signal for a potential drug-cancer association is generated, substantiation is required to assess the impact...... challenges must be addressed to enhance the likelihood of reliable conclusions. Advantages of post-hoc analyses of RCTs include quality of data collected and sometimes randomisation to exposure of interest. Limitations include confounding and sample size, which is fixed to suit the purposes of the trial...

  4. Short-course radiotherapy followed by neo-adjuvant chemotherapy in locally advanced rectal cancer – the RAPIDO trial

    International Nuclear Information System (INIS)

    Current standard for most of the locally advanced rectal cancers is preoperative chemoradiotherapy, and, variably per institution, postoperative adjuvant chemotherapy. Short-course preoperative radiation with delayed surgery has been shown to induce tumour down-staging in both randomized and observational studies. The concept of neo-adjuvant chemotherapy has been proven successful in gastric cancer, hepatic metastases from colorectal cancer and is currently tested in primary colon cancer. Patients with rectal cancer with high risk features for local or systemic failure on magnetic resonance imaging are randomized to either a standard arm or an experimental arm. The standard arm consists of chemoradiation (1.8 Gy x 25 or 2 Gy x 25 with capecitabine) preoperatively, followed by selective postoperative adjuvant chemotherapy. Postoperative chemotherapy is optional and may be omitted by participating institutions. The experimental arm includes short-course radiotherapy (5 Gy x 5) followed by full-dose chemotherapy (capecitabine and oxaliplatin) in 6 cycles before surgery. In the experimental arm, no postoperative chemotherapy is prescribed. Surgery is performed according to TME principles in both study arms. The hypothesis is that short-course radiotherapy with neo-adjuvant chemotherapy increases disease-free and overall survival without compromising local control. Primary end-point is disease-free survival at 3 years. Secondary endpoints include overall survival, local control, toxicity profile, and treatment completion rate, rate of pathological complete response and microscopically radical resection, and quality of life. Following the advances in rectal cancer management, increased focus on survival rather than only on local control is now justified. In an experimental arm, short-course radiotherapy is combined with full-dose chemotherapy preoperatively, an alternative that offers advantages compared to concomitant chemoradiotherapy with or without postoperative

  5. Redesigning Radiotherapy Quality Assurance: Opportunities to Develop an Efficient, Evidence-Based System to Support Clinical Trials—Report of the National Cancer Institute Work Group on Radiotherapy Quality Assurance

    International Nuclear Information System (INIS)

    Purpose: In the context of national calls for reorganizing cancer clinical trials, the National Cancer Institute sponsored a 2-day workshop to examine challenges and opportunities for optimizing radiotherapy quality assurance (QA) in clinical trial design. Methods and Materials: Participants reviewed the current processes of clinical trial QA and noted the QA challenges presented by advanced technologies. The lessons learned from the radiotherapy QA programs of recent trials were discussed in detail. Four potential opportunities for optimizing radiotherapy QA were explored, including the use of normal tissue toxicity and tumor control metrics, biomarkers of radiation toxicity, new radiotherapy modalities such as proton beam therapy, and the international harmonization of clinical trial QA. Results: Four recommendations were made: (1) to develop a tiered (and more efficient) system for radiotherapy QA and tailor the intensity of QA to the clinical trial objectives (tiers include general credentialing, trial-specific credentialing, and individual case review); (2) to establish a case QA repository; (3) to develop an evidence base for clinical trial QA and introduce innovative prospective trial designs to evaluate radiotherapy QA in clinical trials; and (4) to explore the feasibility of consolidating clinical trial QA in the United States. Conclusion: Radiotherapy QA can affect clinical trial accrual, cost, outcomes, and generalizability. To achieve maximum benefit, QA programs must become more efficient and evidence-based.

  6. Responding to a Significant Recruitment Challenge within Three Nationwide Psycho-Educational Trials for Cancer Patients

    Science.gov (United States)

    Stanton, Annette L.; Morra, Marion E.; Miller, Suzanne M.; Diefenbach, Michael A.; Slevin-Perocchia, Rosemarie; Raich, Peter C.; Fleisher, Linda; Wen, Kuang-Yi; Tran, Zung Vu; Mohamed, Nihal E.; George, Roshini; Bright, Mary Anne; Marcus, Alfred C.

    2013-01-01

    Purpose When faced with a significant recruitment challenge for three nationwide psycho-educational trials targeting prostate and breast cancer patients, the Cancer Information Service Research Consortium initiated outreach efforts to increase accrual. Recruitment is reported by major outreach strategy to inform the use of similar campaigns, either as primary recruitment efforts or to supplement “in-reach” recruitment within oncology settings. Methods During a 33-month period, recruitment was tracked from the National Cancer Institute’s Cancer Information Service (CIS), the American Cancer Society (ACS), Dr. Susan Love Research Foundation’s Love/Avon Army of Women (AOW), Internet advertising, press releases, radio/television interviews, recruitment materials in community venues, and outreach to churches and cancer support organizations. Results Across projects, the majority (89%) of recruited participants (N = 2,134) was obtained from the CIS (n = 901, 19 months of recruitment), AOW (n = 869, 18 months), and ACS (n = 123, 12 months). Other efforts showed minimal gain in recruitment. Conclusions Cancer information programs (e.g., CIS, ACS) and registries of individuals willing to participate in cancer-related research (e.g., AOW) can represent exceptional resources for outreach recruitment of cancer patients, especially when the eligibility criteria are highly restrictive. However, these resources do not yield samples representative of the larger population of adults diagnosed with cancer, and conclusions from such trials must be tempered accordingly. Implications for cancer survivors Inadequate recruitment to randomized controlled trials limits the creation of useful interventions for cancer survivors. By enrolling in cancer registries and taking part in research, cancer survivors can contribute to the development of effective resources for the survivor population. PMID:23595235

  7. The REDUCE trial: chemoprevention in prostate cancer using a dual 5alpha-reductase inhibitor, dutasteride.

    Science.gov (United States)

    Musquera, Mireia; Fleshner, Neil E; Finelli, Antonio; Zlotta, Alexandre R

    2008-07-01

    Dutasteride, a dual 5alpha-reductase inhibitor, is used in the treatment of benign prostatic hyperplasia (BPH). It reduces serum prostate-specific antigen levels by approximately 50% at 6 months and total prostate volume by 25% after 2 years. Randomized placebo-controlled trials in BPH patients have shown the efficacy of dutasteride in symptomatic relief, improvements in quality of life and peak urinary flow rate. Side effects occurring with dutasteride are decreased libido, erectile dysfunction, ejaculation disorders and gynecomastia. Preliminary data from placebo-controlled BPH trials have shown a decrease in the detection of prostate cancer in patients treated with dutasteride, although these studies were not designed to look at this issue. Dutasteride differs from finasteride in that it inhibits both isoenzymes of 5alpha-reductase, type I and type II. The landmark Prostate Cancer Prevention Trial at the end of the 7-year study demonstrated a 24.8% reduction in the incidence of prostate cancer in the finasteride group compared with placebo. However, a 25.5% increase in the prevalence of high-grade Gleason tumors has been observed, the clinical significance of which has been debated. Preliminary data suggest a decrease in prostate cancer incidence in dutasteride-treated patients and demonstrate type I alphareductase enzyme expression in prostate cancer. As a result, dutasteride is being investigated for prostate cancer prevention in the ongoing Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial, which is discussed here. PMID:18588452

  8. A randomized trial of laparoscopic versus open surgery for rectal cancer

    DEFF Research Database (Denmark)

    Bonjer, H Jaap; Deijen, Charlotte L; Abis, Gabor A; Cuesta, Miguel A; van der Pas, Martijn H G M; de Lange-de Klerk, Elly S M; Lacy, Antonio M; Bemelman, Willem A; Andersson, John; Angenete, Eva; Rosenberg, Jacob; Fuerst, Alois; Haglind, Eva

    2015-01-01

    BACKGROUND: Laparoscopic resection of colorectal cancer is widely used. However, robust evidence to conclude that laparoscopic surgery and open surgery have similar outcomes in rectal cancer is lacking. A trial was designed to compare 3-year rates of cancer recurrence in the pelvic or perineal ar...... of locoregional recurrence and disease-free and overall survival similar to those for open surgery. (Funded by Ethicon Endo-Surgery Europe and others; COLOR II ClinicalTrials.gov number, NCT00297791.).......BACKGROUND: Laparoscopic resection of colorectal cancer is widely used. However, robust evidence to conclude that laparoscopic surgery and open surgery have similar outcomes in rectal cancer is lacking. A trial was designed to compare 3-year rates of cancer recurrence in the pelvic or perineal area...... (locoregional recurrence) and survival after laparoscopic and open resection of rectal cancer. METHODS: In this international trial conducted in 30 hospitals, we randomly assigned patients with a solitary adenocarcinoma of the rectum within 15 cm of the anal verge, not invading adjacent tissues, and without...

  9. Patient representatives' views on patient information in clinical cancer trials

    DEFF Research Database (Denmark)

    Dellson, Pia; Nilbert, Mef; Carlsson, Christina

    2016-01-01

    future simplified and more attractive informed consent forms. CONCLUSIONS: The emotional and cognitive responses to written patient information reported by patient representatives provides a basis for revised formats in future trials and add to the body of information that support use of plain language......, structured text and illustrations to improve the informed consent process and thereby patient enrolment into clinical trials....

  10. Cancer in human immunodeficiency virus-infected children : A case series from the Children's Cancer Group and the National Cancer Institute

    NARCIS (Netherlands)

    Granovsky, MO; Mueller, BU; Nicholson, HS; Rosenberg, PS; Rabkin, CS

    1998-01-01

    Purpose: To describe the spectrum of malignancies in human immunodeficiency virus (HIV)-infected children and the clinical outcome of patients with these tumors. Methods: We retrospectively surveyed the Children's Cancer Group (CCG) and the National Cancer institute (NCI) for cases of cancer that oc

  11. Adherence to the World Cancer Research Fund/American Institute for Cancer Research lifestyle recommendations in colorectal cancer survivors : Results of the PROFILES registry

    NARCIS (Netherlands)

    Winkels, Renate M; van Lee, Linde; Beijer, Sandra; Bours, Martijn J; van Duijnhoven, Fränzel J B; Geelen, Anouk; Hoedjes, Meeke; Mols, F.; de Vries, Jeanne; Weijenberg, Matty P; Kampman, Ellen

    2016-01-01

    We examined adherence to the eight The World Cancer Research Foundation/American Institute for Cancer Research (WCRF/AICR) recommendations on diet, physical activity, and body weight among colorectal cancer survivors, and whether adherence was associated with intention to eat healthy and with the ne

  12. 77 FR 51032 - National Cancer Institute; Notice of Closed Meetings

    Science.gov (United States)

    2012-08-23

    ... patentable material, and personal information concerning individuals associated with the grant applications... & Conference Center 5701 Marinelli Road Bethesda, MD 20852. Contact Person: Jeannette F. Korczak, Ph.D... Nos. 93.392, Cancer Construction; 93.393, Cancer Cause and Prevention Research; 93.394,...

  13. 77 FR 29674 - National Cancer Institute; Notice of Closed Meetings

    Science.gov (United States)

    2012-05-18

    ... property such as patentable material, and personal information concerning individuals associated with the... evaluate grant applications. Place: Bethesda North Marriott Hotel Conference & Center, 5701 Marinelli Road.... (Catalogue of Federal Domestic Assistance Program Nos. 93.392, Cancer Construction; 93.393, Cancer Cause...

  14. 77 FR 56215 - National Cancer Institute; Notice of Closed Meetings

    Science.gov (United States)

    2012-09-12

    ... patentable material, and personal information concerning individuals associated with the grant applications.... Place: Bethesda North Marriott Hotel & Conference Center, 5701 Marinelli Road, Bethesda, MD 20852... Federal Domestic Assistance Program Nos. 93.392, Cancer Construction; 93.393, Cancer Cause and...

  15. 76 FR 64090 - National Cancer Institute; Notice of Closed Meetings

    Science.gov (United States)

    2011-10-17

    ... commercial property such as patentable material, and personal information concerning individuals associated... Conference & Center Hotel, 5701 Marinelli Road, Bethesda, MD 20852. Contact Person: Clifford W Schweinfest... Nos. 93.392, Cancer Construction; 93.393, Cancer Cause and Prevention Research; 93.394,...

  16. 75 FR 66770 - National Cancer Institute; Notice of Closed Meeting

    Science.gov (United States)

    2010-10-29

    ... patentable material, and personal information concerning individuals associated with the grant applications... applications. Place: Bethesda North Marriott Hotel & Conference Center, 5701 Marinelli Road, Bethesda, MD 20852... Program Nos. 93.392, Cancer Construction; 93.393, Cancer Cause and Prevention Research; 93.394,...

  17. 78 FR 66373 - National Cancer Institute; Notice of Closed Meeting

    Science.gov (United States)

    2013-11-05

    ... new diagnostics for cancer. Place: NCI Shady Grove, 9609 Medical Center Drive, Room 3W030, Rockville... diagnostics. The outcome of the evaluation will be information for consideration by an internal NCI committee... development of the potential diagnostics to improve the treatment of cancer. The research proposals and...

  18. Trends in Research on Energy Balance Supported by the National Cancer Institute

    OpenAIRE

    Ballard-Barbash, Rachel; Siddiqi, Sameer M.; Berrigan, David A.; Ross, Sharon A.; Nebeling, Linda C.; Dowling, Emily C.

    2013-01-01

    Over the past decade, the body of research linking energy balance to the incidence, development, progression and treatment of cancer has grown substantially. No prior NIH portfolio analyses have focused on energy balance within one institute. This portfolio analysis describes the growth of National Cancer Institute (NCI) grant research on energy balance–related conditions and behaviors from 2004 to 2010 following the release of an NCI research priority statement in 2003 on energy balance and ...

  19. Efficacy of an educational material on second primary cancer screening practice for cancer survivors: a randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Dong Wook Shin

    Full Text Available BACKGROUND: Cancer surivors have limited knowledge about second primary cancer (SPC screening and suboptimal rates of completion of screening practices for SPC. Our objective was to test the efficacy of an educational material on the knowledge, attitudes, and screening practices for SPC among cancer survivors. METHODS: Randomized, controlled trial among 326 cancer survivors from 6 oncology care outpatient clinics in Korea. Patients were randomized to an intervention or an attention control group. The intervention was a photo-novel, culturally tailored to increase knowledge about SPC screening. Knowledge and attitudes regarding SPC screening were assessed two weeks after the intervention, and screening practices were assessed after one year. RESULTS: At two weeks post-intervention, the average knowledge score was significantly higher in the intervention compared to the control group (0.81 vs. 0.75, P<0.01, with no significant difference in their attitude scores (2.64 vs. 2.57, P = 0.18. After 1 year of follow-up, the completion rate of all appropriate cancer screening was 47.2% in both intervention and control groups. CONCLUSION: While the educational material was effective for increasing knowledge of SPC screening, it did not promote cancer screening practice among cancer survivors. More effective interventions are needed to increase SPC screening rates in this population. TRIAL REGISTRATION: ClinicalTrial.gov NCT00948337.

  20. A clinicoepidemiological study of esophageal cancer patients at the National Cancer Institute, Cairo University, Egypt

    Institute of Scientific and Technical Information of China (English)

    Soumaya Ezzat; Hisham El Hossieny; Mohamed Abd Alla; Azza Nasr; Nagwan Anter; Ahmed Adel

    2016-01-01

    Objective The purposes of this study were to (1) assess the clinicoepidemiological characteristics of esopha-geal cancer patients, (2) analyze the prognostic factors determining treatment failure and survival, and (3) evaluate the results of various treatment modalities for locoregional and disseminated disease and their ef ect on disease-free survival and overal survival (OS). Methods Clinicoepidemiological retrospective data from 81 esophageal cancer patients treated at the Na-tional Cancer Institute of Cairo between 2007 and 2011 were evaluated. Results The study showed that patients with esophageal cancer commonly present with local y advanced disease (87.7% had T-stage 3 and 12.3% had T-stage 4). There was a significant correlation between surgery and survival; patients who received radical surgery and postoperative radiation had a better median survival than patients who received radical radiotherapy (20 months vs. 16 months, respectively; P = 0.04). There was also a significant statistical correlation between radical concomitant chemoradiotherapy (NCRT) and pal iative treatment. Patients who received radical NCRT had a better median survival than patients who received pal-liative radiotherapy (16 months vs. 10 months, respectively; P = 0.001). The median fol ow-up period for al patients was 7 months. The median OS of the whole group was 12 months. The OS after 1 and 2 years was 57.8% and 15%, respectively. Conclusion High-dose NCRT is an acceptable alternative for patients unfit for surgery or with inoperable disease. High-dose radiation is more ef ective than low-dose radiation in terms of local control, time to relapse, and OS. Further study using a larger series of patients and introducing new treatment protocols is necessary for a final evaluation.

  1. Patient-reported outcomes (PRO) in ovarian cancer clinical trials-lost opportunities and lessons learned.

    Science.gov (United States)

    Friedlander, M; Mercieca-Bebber, R L; King, M T

    2016-04-01

    Despite increased recognition of the value of including patient-reported outcomes (PROs) as important end points in phase III clinical trials, there has been a lack of pre-specified PRO hypotheses and shortcomings with the analyses and interpretation of PROs in many ovarian cancer trials. This paper discusses and provides examples of the so-called lost opportunities in ovarian cancer trials. These include: (i) no clear pre-specified PRO hypotheses; (ii) PRO end points not included; (iii) insensitive PRO end point selection; (iv) collection of poor-quality PRO data not suitable for analysis; (v) differences in PROs between treatment arms ignored; and (vi) poor reporting quality. We can learn from the past and with relatively little additional effort, improve the collection and interpretation of PRO data in future ovarian cancer trials. The importance of doing so is underpinned by recent initiatives to improve the standard and usefulness of PRO data in clinical trials. These include the Food and Drug Administration (FDA) Guidance for PROs to support labelling claims, the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO MCBS), the International Society for Quality-of-Life Research PRO reporting guidance and the Consolidated Standards of Reporting Clinical Trials (CONSORT)-PRO-extension statement which includes a checklist of recommended items to include in PRO sections of trial protocols. Promoting the importance of hypothesis-driven PROs in ovarian cancer clinical trials will lead to improvements in the design of these trials and the interpretation of their results. PMID:27141076

  2. Towards optimised information about clinical trials; identification and validation of key issues in collaboration with cancer patient advocates

    DEFF Research Database (Denmark)

    Dellson, P; Nilbert, M; Bendahl, P-O;

    2011-01-01

    in three clinical trials for breast cancer. Primary data collection was done in focus group interviews with breast cancer patient advocates. Content analysis identified three major themes: comprehensibility, emotions and associations, and decision making. Based on the advocates' suggestions for...

  3. Summary of Dissimilar Metal Joining Trials Conducted by Edison Welding Institute

    Energy Technology Data Exchange (ETDEWEB)

    MJ Lambert

    2005-11-18

    Under the direction of the NASA-Glenn Research Center, the Edison Welding Institute (EWI) in Columbus, OH performed a series of non-fusion joining experiments to determine the feasibility of joining refractory metals or refractory metal alloys to Ni-based superalloys. Results, as reported by EWI, can be found in the project report for EWI Project 48819GTH (Attachment A, at the end of this document), dated October 10, 2005. The three joining methods used in this investigation were inertia welding, magnetic pulse welding, and electro-spark deposition joining. Five materials were used in these experiments: Mo-47Re, T-111, Hastelloy X, Mar M-247 (coarse-grained, 0.5 mm to several millimeter average grain size), and Mar M-247 (fine-grained, approximately 50 {micro}m average grain size). Several iterative trials of each material combination with each joining method were performed to determine the best practice joining method. Mo-47Re was found to be joined easily to Hastelloy X via inertia welding, but inertia welding of the Mo-alloy to both Mar M-247 alloys resulted in inconsistent joint strength and large reaction layers between the two metals. T-111 was found to join well to Hastelloy X and coarse-grained Mar M-247 via inertia welding, but joining to fine-grained Mar M-247 resulted in low joint strength. Magnetic pulse welding (MPW) was only successful in joining T-111 tubing to Hastelloy X bar stock. The joint integrity and reaction layer between the metals were found to be acceptable. This single joining trial, however, caused damage to the electromagnetic concentrators used in this process. Subsequent design efforts to eliminate the problem resulted in a loss of power imparted to the accelerating work piece, and results could not be reproduced. Welding trials of Mar M-247 to T-111 resulted in catastrophic failure of the bar stock, even at lower power. Electro-spark deposition joining of Mo-47Re, in which the deposited material was Hastelloy X, did not have a

  4. Summary of Dissimilar Metal Joining Trials Conducted by Edison Welding Institute

    International Nuclear Information System (INIS)

    Under the direction of the NASA-Glenn Research Center, the Edison Welding Institute (EWI) in Columbus, OH performed a series of non-fusion joining experiments to determine the feasibility of joining refractory metals or refractory metal alloys to Ni-based superalloys. Results, as reported by EWI, can be found in the project report for EWI Project 48819GTH (Attachment A, at the end of this document), dated October 10, 2005. The three joining methods used in this investigation were inertia welding, magnetic pulse welding, and electro-spark deposition joining. Five materials were used in these experiments: Mo-47Re, T-111, Hastelloy X, Mar M-247 (coarse-grained, 0.5 mm to several millimeter average grain size), and Mar M-247 (fine-grained, approximately 50 (micro)m average grain size). Several iterative trials of each material combination with each joining method were performed to determine the best practice joining method. Mo-47Re was found to be joined easily to Hastelloy X via inertia welding, but inertia welding of the Mo-alloy to both Mar M-247 alloys resulted in inconsistent joint strength and large reaction layers between the two metals. T-111 was found to join well to Hastelloy X and coarse-grained Mar M-247 via inertia welding, but joining to fine-grained Mar M-247 resulted in low joint strength. Magnetic pulse welding (MPW) was only successful in joining T-111 tubing to Hastelloy X bar stock. The joint integrity and reaction layer between the metals were found to be acceptable. This single joining trial, however, caused damage to the electromagnetic concentrators used in this process. Subsequent design efforts to eliminate the problem resulted in a loss of power imparted to the accelerating work piece, and results could not be reproduced. Welding trials of Mar M-247 to T-111 resulted in catastrophic failure of the bar stock, even at lower power. Electro-spark deposition joining of Mo-47Re, in which the deposited material was Hastelloy X, did not have a

  5. 'Pragmatic randomized controlled trial of individually prescribed exercise versus usual care in a heterogeneous cancer survivor population': A feasibility study PEACH Trial: Prescribed exercise after chemotherapy

    Directory of Open Access Journals (Sweden)

    Guinan Emer

    2010-02-01

    Full Text Available Abstract Background Many cancer survivors suffer a range of physical and psychological symptoms which may persist for months or years after cessation of treatment. Despite the known benefits of exercise and its potential to address many of the adverse effects of treatment, the role of exercise as well as optimum duration, frequency, and intensity in this population has yet to be fully elucidated. Many cancer rehabilitation programmes presented in the literature are very long and have tight eligibility criteria which make them non-applicable to the majority of cancer survivors. This paper presents the protocol of a novel 8-week intervention which aims to increase fitness, and address other physical symptoms in a heterogeneous cancer survivor population. Methods/design The aim is to recruit 64 cancer survivors 2-6 months after completion of chemotherapy, usually adjuvant, with curative intent. Subjects will be recruited through oncology clinics in a single institution and randomised to usual care or an exercise intervention. The exercise intervention consists of two specifically tailored supervised moderate intensity aerobic exercise sessions weekly over 8-weeks. All participants will be assessed at baseline (0 weeks, at the end of the intervention (8 weeks, and at 3-month follow-up. The primary outcome measure is fitness, and secondary patient-related outcome measures include fatigue, quality of life, and morphological outcomes. A further secondary outcome is process evaluation including adherence to and compliance with the exercise program. Discussion This study will provide valuable information about the physical outcomes of this 8-week supervised aerobic programme. Additionally, process information and economic evaluation will inform the feasibility of implementing this program in a heterogeneous population post cessation of chemotherapy. Trial Registration NCT01030887

  6. 78 FR 25281 - National Cancer Institute; Notice of Closed Meeting

    Science.gov (United States)

    2013-04-30

    ... patentable material, and personal information concerning individuals associated with the grant applications... grant applications. Place: Bethesda North Marriott Hotel & Conference Center, 5701 Marinelli Road...@mail.nih.gov . (Catalogue of Federal Domestic Assistance Program Nos. 93.392, Cancer Construction;...

  7. Video Helps Prepare Patients to Participate in Cancer Trials

    Science.gov (United States)

    Patients who took part in a tailored, video-based educational program had a better understanding of and fewer concerns about participating in clinical trials than patients who received text-based educational.

  8. 77 FR 12600 - National Cancer Institute; Notice of Closed Meetings

    Science.gov (United States)

    2012-03-01

    ...; Quantitative Imaging for Evaluation of Responses to Cancer Therapies. Date: March 8, 2012. Time: 1 p.m. to 5 p... Emphasis Panel Cancer Imaging. Date: March 6, 2012. Time: 11 a.m. to 3 p.m. Agenda: To review and evaluate... Phase IIB Bridge Awards. Date: March 20, 2012. Time: 11 a.m. to 4 p.m. Agenda: To review and...

  9. Breast cancer epidemiology according to recognized breast cancer risk factors in the Prostate, Lung, Colorectal and Ovarian (PLCO Cancer Screening Trial Cohort

    Directory of Open Access Journals (Sweden)

    Leitzmann Michael F

    2009-03-01

    Full Text Available Abstract Background Multidisciplinary attempts to understand the etiology of breast cancer are expanding to increasingly include new potential markers of disease risk. Those efforts may have maximal scientific and practical influence if new findings are placed in context of the well-understood lifestyle and reproductive risk factors or existing risk prediction models for breast cancer. We therefore evaluated known risk factors for breast cancer in a cancer screening trial that does not have breast cancer as a study endpoint but is large enough to provide numerous analytic opportunities for breast cancer. Methods We evaluated risk factors for breast cancer (N = 2085 among 70,575 women who were randomized in the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial. Using Poisson regression, we calculated adjusted relative risks [RRs, with 95% confidence intervals (CIs] for lifestyle and reproductive factors during an average of 5 years of follow-up from date of randomization. Results As expected, increasing age, nulliparity, positive family history of breast cancer, and use of menopausal hormone therapy were positively associated with breast cancer. Later age at menarche (16 years or older vs. 2 35 or more vs. 18.5–24.9: RR = 1.21, 95% CI, 1.02–1.43] was statistically significantly associated with breast cancer. Conclusion The ongoing PLCO trial offers continued opportunities for new breast cancer investigations, but these analyses suggest that the associations between breast cancer and age at menarche, age at menopause, and obesity might be changing as the underlying demographics of these factors change. Clinical Trials Registration http://www.clinicaltrials.gov, NCT00002540.

  10. The National Cancer Institute's Physical Sciences - Oncology Network

    Science.gov (United States)

    Espey, Michael Graham

    In 2009, the NCI launched the Physical Sciences - Oncology Centers (PS-OC) initiative with 12 Centers (U54) funded through 2014. The current phase of the Program includes U54 funded Centers with the added feature of soliciting new Physical Science - Oncology Projects (PS-OP) U01 grant applications through 2017; see NCI PAR-15-021. The PS-OPs, individually and along with other PS-OPs and the Physical Sciences-Oncology Centers (PS-OCs), comprise the Physical Sciences-Oncology Network (PS-ON). The foundation of the Physical Sciences-Oncology initiative is a high-risk, high-reward program that promotes a `physical sciences perspective' of cancer and fosters the convergence of physical science and cancer research by forming transdisciplinary teams of physical scientists (e.g., physicists, mathematicians, chemists, engineers, computer scientists) and cancer researchers (e.g., cancer biologists, oncologists, pathologists) who work closely together to advance our understanding of cancer. The collaborative PS-ON structure catalyzes transformative science through increased exchange of people, ideas, and approaches. PS-ON resources are leveraged to fund Trans-Network pilot projects to enable synergy and cross-testing of experimental and/or theoretical concepts. This session will include a brief PS-ON overview followed by a strategic discussion with the APS community to exchange perspectives on the progression of trans-disciplinary physical sciences in cancer research.

  11. A Semantic Web-based System for Mining Genetic Mutations in Cancer Clinical Trials.

    Science.gov (United States)

    Priya, Sambhawa; Jiang, Guoqian; Dasari, Surendra; Zimmermann, Michael T; Wang, Chen; Heflin, Jeff; Chute, Christopher G

    2015-01-01

    Textual eligibility criteria in clinical trial protocols contain important information about potential clinically relevant pharmacogenomic events. Manual curation for harvesting this evidence is intractable as it is error prone and time consuming. In this paper, we develop and evaluate a Semantic Web-based system that captures and manages mutation evidences and related contextual information from cancer clinical trials. The system has 2 main components: an NLP-based annotator and a Semantic Web ontology-based annotation manager. We evaluated the performance of the annotator in terms of precision and recall. We demonstrated the usefulness of the system by conducting case studies in retrieving relevant clinical trials using a collection of mutations identified from TCGA Leukemia patients and Atlas of Genetics and Cytogenetics in Oncology and Haematology. In conclusion, our system using Semantic Web technologies provides an effective framework for extraction, annotation, standardization and management of genetic mutations in cancer clinical trials. PMID:26306257

  12. Clinical trial enrollment, patient characteristics, and survival differences in prospectively registered metastatic colorectal cancer patients

    DEFF Research Database (Denmark)

    Sorbye, Halfdan; Pfeiffer, Per; Cavalli-Björkman, Nina;

    2009-01-01

    oncological consideration at 3 hospitals in Scandinavia covering defined populations were registered consecutively during 2003 to 2006. Clinical trial enrollment, patient characteristics, and treatment were recorded prospectively, and the follow-up was complete. RESULTS: Palliative chemotherapy was initiated...... was then only 2.1 months. The median survival for all 760 nonresectable mCRC patients was 10.7 months. CONCLUSIONS: mCRC patients enrolled into clinical trials differ in characteristics from patients receiving chemotherapy outside protocol and have better survival, even when given the same treatment. Although......BACKGROUND: Trial accrual patterns were examined to determine whether metastatic colorectal cancer (mCRC) patients enrolled in trials are representative of a general cancer population concerning patient characteristics and survival. METHODS: A total of 760 mCRC patients referred for their first...

  13. Participation bias in a randomised trial of screening for lung cancer

    DEFF Research Database (Denmark)

    Hestbech, Mie Sara; Siersma, Volkert; Dirksen, Asger;

    2011-01-01

    following socio-demographic aspects: social group, living alone, gender, age and geographical area. DLCST participants reported less negative psychosocial aspects than the comparable population sample. CONCLUSION: The present study has shown substantial socio-demographic and psychosocial participation bias......INTRODUCTION: Participation bias might affect the results and the representability of randomised controlled trials. We investigated the degree of socio-demographic and psychosocial participation bias in the Danish Lung Cancer Screening Trial (DLCST). METHODS: In DLCST the questionnaire COS...

  14. DNA repair genotype and lung cancer risk in the beta-carotene and retinol efficacy trial

    OpenAIRE

    Doherty, Jennifer A; Sakoda, Lori C.; Loomis, Melissa M; Barnett, Matt J.; Julianto, Liberto; Thornquist, Mark D; Neuhouser, Marian L; Weiss, Noel S.; Goodman, Gary E.; Chen, Chu

    2013-01-01

    Many carcinogens in tobacco smoke cause DNA damage, and some of that damage can be mitigated by the actions of DNA repair enzymes. In a case-control study nested within the Beta-Carotene and Retinol Efficacy Trial, a randomized chemoprevention trial in current and former heavy smokers, we examined whether lung cancer risk was associated with variation in 26 base excision repair, mismatch repair, and homologous recombination repair genes. Analyses were limited to Caucasians (744 cases, 1477 co...

  15. Cryotherapy for primary treatment of prostate cancer: intermediate term results of a prospective study from a single institution.

    Science.gov (United States)

    Rodríguez, S Alvarez; Arias Fúnez, F; Bueno Bravo, C; Rodríguez-Patrón Rodríguez, R; Sanz Mayayo, E; Palacios, V Hevia; Burgos Revilla, F J

    2014-01-01

    Purpose. Published data about cryotherapy for prostate cancer (PC) treatment are based on case series with a lack of clinical trials and the inexistence of a validated definition of biochemical failure. A prospective study with standardized followup protocol was conducted in our institution. Material and Methods. Prospective study of a series of cases including 108 patients diagnosed with localized PC at clinical stage T1c-T2c treated by primary cryoablation and median followup of 61 months. Criteria of biochemical recurrence were unified according to the American Society for Therapeutic Radiology and Oncology (ASTRO). End points were biochemical progression-free survival (BPFS), cancer-specific survival, and overall survival. Rate of complications was reported. Results. The BPFS for low-, medium-, and high-risk patients was 96.4%, 91.2%, and 62.2%, respectively. Cancer-specific survival was 98.1%. Overall survival reached 94.4%. Complications included incontinence in 5.6%, urinary tract obstruction in 1.9%, urethral sloughing in 5.6%, haematuria in 1.9%, perineal pain in 11.1%, and prostatorectal fistula in 0.9%. Erectile disfunction was found in 98.1%. Conclusions. Cryotherapy is an effective and minimally invasive treatment for primary PC in well-selected cases, with low surgical risk and good results in terms of BPFS, cancer-specific survival, and overall survival. PMID:24693437

  16. The Appalachian Tri-State Node Experiences with the National Institute on Drug Abuse Clinical Trials Network

    OpenAIRE

    Kelly, Thomas M.; Daley, Dennis C; Byrne, Mimmie; DeMarzo, Larry; Smith, Doris; Madl, Stephanie

    2011-01-01

    The National Institute on Drug Abuse (NIDA)-sponsored Clinical Trial Network (CTN) recently celebrated 10 years of conducting “real world” research into the treatment of addiction. This article reviews the history and results of the most recent CTN studies and describes the experiences of one of the 13 participating research affiliates, the Appalachian Tri-State (ATS) Node. We discuss our “bidirectional” collaboration with multiple community treatment programs (CTPs) on research and dissemina...

  17. 药物临床试验机构的管理%Management of clinical trial institution

    Institute of Scientific and Technical Information of China (English)

    曹彩; 熊宁宁

    2011-01-01

    我国药物临床试验必须在通过国家食品药品监督管理局和卫生部组织的资格认定的医疗机构中进行.药物临床试验机构与研究者在GCP中共同承担研究方的角色,两者之间是管理者与被管理者的关系.药物临床试验机构的主要职责,一是医疗机构从事药物临床试验的医疗与研究条件的系统管理,包括理化检查相关科室和实验室的质量管理、研究用药品的管理、源文件和源数据的现场管理;二是对所承担的临床试验项目的管理,包括立项评估、接受监查/稽查,并对监查的质量进行评估.%Clinical trials can only be done in the State Food and Drug Adminstration (SFDA) certified investigator sites. Clinical trial institution and investigator servers jointly as the "investigator/institution" mentioned in good clinical practice (GCP). The relationship between institution and investigator is supervisor and supervisee. The major responsibilities of a clinical trial institution are as follows .? Maintaining and management of system srelated to medical service and facilitating the clinical research conditions, including quality management of related physical and chemical examination department, management of clinical research medicines , site management of source files and source documents; clinical trial project management, including feasibility assessment, receiving monitoring/audit , and quality evaluation of monitoring activities.

  18. What if Institutional Review Boards (IRBs treated healthy volunteers in clinical trials as their clients?

    Directory of Open Access Journals (Sweden)

    Martin Tolich

    2010-12-01

    Full Text Available Objectives: To understand the motivations of university students volunteering for clinical trials in New Zealand and their comprehension of risk. Methods: An ethnography using both direct observation and unstructured interviews of student volunteers in two New Zealand clinical trial companies.Subjects: Eighteen volunteers who participated in one of three separate clinical trials were interviewed. Thirteen of the eighteen trialists had been involved in previous clinical trials. Results: 1 These university students share similarities with economically disadvantaged minorities – they do not actively engage with the informed consent process, and they arrive at the trial ready to consent. 2 Word of mouth endorsements from incumbent trialists are the main factor influencing students’ decision-making process. 3 The trialists’ assessment of harm focused more on the food they were required to ingest than on the research drug.Discussion: Economic disadvantage is not a necessary precondition for volunteers to arrive at a clinical trial ready to consent. These university students were motivated to consent via informal networks sharing information about these lucrative trials. Trialists’ definition of harm may be broader than that of ethics committees. Ethics committees could employ a post-study questionnaire to evaluate healthy volunteers’ experience of the trial.

  19. Validation of Cancer Institute Quality of Life Questionnaire Version II for cancer patients in India

    Directory of Open Access Journals (Sweden)

    E Vidhubala

    2011-01-01

    Full Text Available Background: The Quality of Life (QOL questionnaire version I consisted of 38 items that were validated using 392 patients. The experiences gained through the interaction with the patients during the administration of the questionnaire provided a lot of inputs for the improvization of the tool. Aim: The current study is aimed at certain modifications of the QOL questionnaire version I and standardization of the same. Materials and Methods: The modifications of version I QOL scale included the change of verbatim, splitting, deleting, and adding of new items. Finally, version II included 42 items. It was administered to 183 cancer patients irrespective of their demographic details for further standardization. Statistics: The principal component method with varimax rotation was used. Spearman′s product moment correlation and Cronbach′s alpha coefficient were used for reliability analysis. Results: The data were subjected to factor analysis to explore the factors. Eleven factors emerged with the eigenvalue ranging from 8.03 to 1.10 and accounted for 66.7% variance. The first factor contributed maximally, 19.5%, and the remaining 10 factors contributed a total of 46.2% variance on QOL. They are general well-being, physical well-being, psychological well-being, familial relationship, sexual and personal ability, cognitive well-being, optimism and belief, economical well-being, information support, patient-physician relationship, and body image. The Cronbach alpha of 0.90 and split-half reliability of 0.80 indicated a high reliability of the tool. Conclusion: The factor structure showed that QOL is a multidimensional concept having different aspects. The Cancer Institute QOL Questionnaire version II for cancer patients is found to be a valid and reliable tool and feasible to administer at the clinical settings.

  20. Patient-Reported Outcomes in Metastatic Breast Cancer: A Review of Industry-Sponsored Clinical Trials

    Science.gov (United States)

    Krohe, Meaghan; Hao, Yanni; Lamoureux, Roger E.; Galipeau, Nina; Globe, Denise; Foley, Catherine; Mazar, Iyar; Solomon, Jeffrey; Shields, Alan L.

    2016-01-01

    INTRODUCTION Patient-reported outcome (PRO) measures serve to capture vital patient information not otherwise obtained by primary study endpoints. This paper examines how PROs are utilized as endpoints in industry-sponsored metastatic breast cancer clinical trials. METHODS A search was conducted in the clinicaltrials.gov web site for trials involving common treatments for metastatic breast cancer. Thirty-eight clinical trials were identified which included a PRO endpoint in the study, and data were extracted and summarized. RESULTS Overall, 17 unique PRO questionnaires and 14 concepts of measurement were identified as secondary or exploratory endpoints. The Functional Assessment of Cancer Therapy—Breast was the most frequently utilized questionnaire, commonly implemented to assess quality of life. The EORTC QLQ-C30 was also frequently used to measure quality of life or pain. CONCLUSION This review shares insights into the role of PROs in trials for metastatic breast cancer from which treatment developers and other stakeholders can enhance successful implementation of the patient voice into future trials. PMID:27441001

  1. Meeting the Information Needs of Lower Income Cancer Survivors: Results of a Randomized Control Trial Evaluating the American Cancer Society’s “I Can Cope”

    OpenAIRE

    Martin, Michelle Y.; Evans, Mary B; KRATT, POLLY; Pollack, Lori A.; Smith, Judith Lee; Oster, Robert; Dignan, Mark; Prayor-Patterson, Heather; Watson, Christopher; HOUSTON, PETER; ANDREWS, SHIQUINA; LIWO, AMANDIY; TSENG, TUNG SUNG; HULLETT, SANDRAL; OLIVER, JOANN

    2014-01-01

    The American Cancer Society is a leader in the development of cancer survivorship resources. One resource of the American Cancer Society is the I Can Cope program, an educational program for cancer survivors and their families. Evaluations of this program indicate that cancer patients highly rate its objectives. Yet, there are gaps in the understanding of the full impact of the program on diverse cancer survivors. In this study, the authors used a randomized trial to evaluate the program. Par...

  2. A phase 3 trial of bevacizumab in ovarian cancer

    DEFF Research Database (Denmark)

    Perren, Timothy J; Swart, Ann Marie; Pfisterer, Jacobus;

    2011-01-01

    Angiogenesis plays a role in the biology of ovarian cancer. We examined the effect of bevacizumab, the vascular endothelial growth factor inhibitor, on survival in women with this disease.......Angiogenesis plays a role in the biology of ovarian cancer. We examined the effect of bevacizumab, the vascular endothelial growth factor inhibitor, on survival in women with this disease....

  3. Phase 1 Trial of Neoadjuvant Radiation Therapy Before Prostatectomy for High-Risk Prostate Cancer

    Energy Technology Data Exchange (ETDEWEB)

    Koontz, Bridget F., E-mail: Bridget.Koontz@duke.edu [Department of Radiation Oncology, Duke Cancer Institute, Durham, North Carolina (United States); Duke Prostate Center, Duke Cancer Institute, Durham, North Carolina (United States); Quaranta, Brian P. [21st Century Oncology, Asheville, North Carolina (United States); Pura, John A. [Division of Biostatistics, Duke Cancer Institute, Durham, North Carolina (United States); Lee, W.R.; Vujaskovic, Zeljko [Department of Radiation Oncology, Duke Cancer Institute, Durham, North Carolina (United States); Duke Prostate Center, Duke Cancer Institute, Durham, North Carolina (United States); Gerber, Leah [Duke Prostate Center, Duke Cancer Institute, Durham, North Carolina (United States); Haake, Michael [Southeast Radiation Oncology, Charlotte, North Carolina (United States); Anscher, Mitchell S. [Department of Radiation Oncology, Virginia Commonwealth University, Richmond, Virginia (United States); Robertson, Cary N.; Polascik, Thomas J.; Moul, Judd W. [Department of Surgery, Duke Cancer Institute, Durham, North Carolina (United States); Duke Prostate Center, Duke Cancer Institute, Durham, North Carolina (United States)

    2013-09-01

    Purpose: To evaluate, in a phase 1 study, the safety of neoadjuvant whole-pelvis radiation therapy (RT) administered immediately before radical prostatectomy in men with high-risk prostate cancer. Methods and Materials: Twelve men enrolled and completed a phase 1 single-institution trial between 2006 and 2010. Eligibility required a previously untreated diagnosis of localized but high-risk prostate cancer. Median follow-up was 46 months (range, 14-74 months). Radiation therapy was dose-escalated in a 3 × 3 design with dose levels of 39.6, 45, 50.4, and 54 Gy. The pelvic lymph nodes were treated up to 45 Gy with any additional dose given to the prostate and seminal vesicles. Radical prostatectomy was performed 4-8 weeks after RT completion. Primary outcome measure was intraoperative and postoperative day-30 morbidity. Secondary measures included late morbidity and oncologic outcomes. Results: No intraoperative morbidity was seen. Chronic urinary grade 2+ toxicity occurred in 42%; 2 patients (17%) developed a symptomatic urethral stricture requiring dilation. Two-year actuarial biochemical recurrence-free survival was 67% (95% confidence interval 34%-86%). Patients with pT3 or positive surgical margin treated with neoadjuvant RT had a trend for improved biochemical recurrence-free survival compared with a historical cohort with similar adverse factors. Conclusions: Neoadjuvant RT is feasible with moderate urinary morbidity. However, oncologic outcomes do not seem to be substantially different from those with selective postoperative RT. If this multimodal approach is further evaluated in a phase 2 setting, 54 Gy should be used in combination with neoadjuvant androgen deprivation therapy to improve biochemical outcomes.

  4. Early Outcomes From Three Prospective Trials of Image-Guided Proton Therapy for Prostate Cancer

    International Nuclear Information System (INIS)

    Purpose: To report early outcomes with image-guided proton therapy for prostate cancer. Methods and Materials: We accrued 211 prostate cancer patients on prospective Institutional Review Board-approved trials of 78 cobalt gray equivalent (CGE) in 39 fractions for low–risk disease, dose escalation from 78 to 82 CGE for intermediate-risk disease, and 78 CGE with concomitant docetaxel followed by androgen deprivation for high-risk disease. Minimum follow-up was 2 years. Results: One intermediate-risk patient and 2 high-risk patients had disease progression. Pretreatment genitourinary (GU) symptom management was required in 38% of patients. A cumulative 88 (42%) patients required posttreatment GU symptom management. Four transient Grade 3 GU toxicities occurred, all among patients requiring pretreatment GU symptom management. Multivariate analysis showed correlation between posttreatment GU 2+ symptoms and pretreatment GU symptom management (p < 0.0001) and age (p = 0.0048). Only 1 Grade 3+ gastrointestinal (GI) symptom occurred. The prevalence of Grade 2+ GI symptoms was 0 (0%), 10 (5%), 12 (6%), and 8 (4%) at 6, 12, 18, and 24 months, with a cumulative incidence of 20 (10%) patients at 2 years after proton therapy. Univariate and multivariate analyses showed significant correlation between Grade 2+ rectal bleeding and proctitis and the percentage of rectal wall (rectum) receiving doses ranging from 40 CGE (10 CGE) to 80 CGE. Conclusions: Early outcomes with image-guided proton therapy suggest high efficacy and minimal toxicity with only 1.9% Grade 3 GU symptoms and <0.5% Grade 3 GI toxicities.

  5. Supportive care for men with prostate cancer:why are the trials not working? A systematic review and recommendations for future trials

    OpenAIRE

    Moore, Theresa H M; King, Anna J L; Evans, Maggie A; Sharp, Debbie J; Persad, Rajendra A; Huntley, Alyson L.

    2015-01-01

    Men with prostate cancer are likely to have a long illness and experience psychological distress for which supportive care may be helpful. This systematic review describes the evidence for effectiveness and cost-effectiveness of supportive care for men with prostate cancer, taking into account treatment pathway and components of interventions. MEDLINE, EMBASE, CINAHL, CENTRAL, and Psychinfo were searched from inception––July 2013 for randomized controlled trials and controlled trials. Two aut...

  6. Image quality assurance in the prostate, lung, colorectal, and ovarian cancer screening trial network of the National Lung Screening Trial.

    Science.gov (United States)

    Moore, Stephen M; Gierada, David S; Clark, Kenneth W; Blaine, G James

    2005-09-01

    The National Lung Screening Trial is evaluating the effectiveness of low-dose spiral CT and conventional chest X-ray as screening tests for persons who are at high risk for developing lung cancer. This multicenter trial requires quality assurance (QA) for the image quality and technical parameters of the scans. The electronic system described here helps manage the QA process. The system includes a workstation at each screening center that de-identifies the data, a DICOM storage service at the QA Coordinating Center, and Web-based systems for presenting images and QA evaluation forms to the QA radiologists. Quality assurance data are collated and analyzed by an independent statistical organization. We describe the design and implementation of this electronic QA system, emphasizing issues relating to data security and privacy, the various obstacles encountered in the installation of a common system at different participating screening centers, and the functional success of the system deployed. PMID:15924251

  7. A prospective phase II trial of EGCG in treatment of acute radiation-induced esophagitis for stage III lung cancer

    International Nuclear Information System (INIS)

    Background: Acute radiation-induced esophagitis (ARIE) is one of main toxicities complicated by thoracic radiotherapy, influencing patients’ quality of life and radiotherapy proceeding seriously. It is difficult to be cured rapidly so far. Our phase I trial preliminarily showed that EGCG may be a promising strategy in the treatment of ARIE. Materials and methods: We prospectively enrolled patients with stage III lung cancer from the Shandong Tumor Hospital & Institute in China from January 2013 to September 2014. All patients received concurrent or sequential chemo-radiotherapy, or radiotherapy only. EGCG was administrated once ARIE appeared. EGCG was given with the concentration of 440 μmol/L during radiotherapy and additionally two weeks after radiotherapy. RTOG score, dysphagia and pain related to esophagitis were recorded every week. Results: Thirty-seven patients with stage IIIA and IIIB lung cancer were enrolled in this trial. In comparison to the original, the RTOG score in the 1st, 2nd, 3rd, 4th, 5th week after EGCG prescription and the 1st, 2nd week after radiotherapy decreased significantly (P = 0.002, 0.000, 0.000, 0.001, 0.102, 0.000, 0.000, respectively). The pain score of each week was significantly lower than the baseline (P = 0.000, 0.000, 0.000, 0.000, 0.006, 0.000, 0.000, respectively). Conclusion: This trial confirmed that the oral administration of EGCG is an effective and safe method to deal with ARIE. A phase III randomized controlled trial is expected to further corroborate the consequence of EGCG in ARIE treatment

  8. What we have learned from randomized trials of prostate cancer screening

    Institute of Scientific and Technical Information of China (English)

    Richard M Hoffman; Anthony Y Smith

    2011-01-01

    The introduction of prostate-specific antigen (PSA) for prostate cancer screening in the late 1980s led to an epidemic of prostate cancer, particularly in developed countries. However, the first valid reports from randomized controlled trials on the efficacy of screening were not published until 2009. Men in the screening group in the European Randomized Study of Screening for Prostate Cancer were 20% less likely than those in the control group to die from prostate cancer. The absolute difference was only 0.7/1000, implying that over 1400 men needed to be screened to prevent one prostate cancer death. Screening was also associated with a 70% increased risk for being diagnosed with prostate cancer. The American Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial found no survival benefit for screening. Results were not conclusive because a substantial proportion of study subjects had previously undergone PSA testing, over half of the control group had PSA testing, follow-up was relatively short, and fewer than 100 subjects died from prostate cancer. Balancing the potential survival benefit from screening is the risk of overdiagnosis-finding cancers that would not otherwise cause clinical problems-and the risk of treatment complications, including urinary, sexual and bowel dysfunction. Prostate cancer screening efforts would benefit from improved biomarkers, which more readily identify clinically important cancers. Cancer control efforts might also need to include chemoprevention, though currently available agents are controversial. In the meantime, patients need to be supported in achieving informed decisions on whether to be screened for prostate cancer.

  9. Credentialing of radiotherapy centres for a clinical trial of adaptive radiotherapy for bladder cancer (TROG 10.01)

    International Nuclear Information System (INIS)

    Background: Daily variations in bladder filling make conformal treatment of bladder cancer challenging. On-line adaptive radiotherapy with a choice of plans has been demonstrated to reduce small bowel irradiation in single institution trials. In order to support a multicentre feasibility clinical trial on adaptive radiotherapy for bladder cancer (TROG 10.01) a credentialing programme was developed for centres wishing to participate. Methods: The credentialing programme entails three components: a facility questionnaire; a planning exercise which tests the ability of centres to create three adaptive plans based on a planning and five cone beam CTs; and a site visit during which image quality, imaging dose and image guidance procedures are assessed. Image quality and decision making were tested using customised inserts for a Perspex phantom (Modus QUASAR) that mimic different bladder sizes. Dose was assessed in the same phantom using thermoluminescence dosimetry (TLD). Results: All 12 centres participating in the full credentialing programme were able to generate appropriate target volumes in the planning exercise and identify the correct target volume and position the bladder phantom in the phantom within 3 mm accuracy. None of the imaging doses exceeded the limit of 5 cGy with a CT on rails system having the lowest overall dose. Conclusion: A phantom mimicking the decision making process for adaptive radiotherapy was found to be well suited during site visits for credentialing of centres participating in a clinical trial of adaptive radiotherapy for bladder cancer. Combined with a planning exercise the site visit allowed testing the ability of centres to create adaptive treatment plans and make appropriate decisions based on the volumetric images acquired at treatment.

  10. Advancing Survivors’ Knowledge (ASK) about skin cancer study: study protocol for a randomized controlled trial

    OpenAIRE

    Daniel, Casey L.; Armstrong, Gregory T.; Keske, Robyn R; Davine, Jessica A; McDonald, Aaron J; Sprunck-Harrild, Kim M; Coleman, Catherine; Haneuse, Sebastien J.; Mertens, Ann C.; Emmons, Karen M; Marghoob, Ashfaq A.; Elkin, Elena B.; Dusza, Stephen W.; Robison, Leslie L.; Alan C. Geller

    2015-01-01

    Background Advances in treatment have increased childhood cancer 5-year survival rates to greater than 80%. However, children previously treated with radiation are at significantly increased risk of developing subsequent neoplasms, the most common of which are skin cancers. The National Cancer Institute and Children’s Oncology Group have issued recommendations for survivors treated with radiation to perform monthly skin self-examinations and receive a physician skin examination at least annua...

  11. Advancing Survivors’ Knowledge (ASK) about skin cancer study: study protocol for a randomized controlled trial

    OpenAIRE

    Daniel, Casey L.; Armstrong, Gregory T.; Keske, Robyn R; Davine, Jessica A; McDonald, Aaron J; Sprunck-Harrild, Kim M; Coleman, Catherine; Haneuse, Sebastien J.; Mertens, Ann C.; Emmons, Karen M; Marghoob, Ashfaq A.; Elkin, Elena B.; Dusza, Stephen W.; Robison, Leslie L.; Alan C. Geller

    2015-01-01

    Background: Advances in treatment have increased childhood cancer 5-year survival rates to greater than 80%. However, children previously treated with radiation are at significantly increased risk of developing subsequent neoplasms, the most common of which are skin cancers. The National Cancer Institute and Children’s Oncology Group have issued recommendations for survivors treated with radiation to perform monthly skin self-examinations and receive a physician skin examination at least annu...

  12. Long-term effect of aspirin on cancer risk in carriers of hereditary colorectal cancer: an analysis from the CAPP2 randomised controlled trial

    DEFF Research Database (Denmark)

    Burn, John; Gerdes, Anne-Marie; Macrae, Finlay;

    2011-01-01

    Observational studies report reduced colorectal cancer in regular aspirin consumers. Randomised controlled trials have shown reduced risk of adenomas but none have employed prevention of colorectal cancer as a primary endpoint. The CAPP2 trial aimed to investigate the antineoplastic effects of as...

  13. Routine follow up of breast cancer in primary care: randomised trial.

    OpenAIRE

    Grunfeld, E.; Mant, D.; Yudkin, P; Adewuyi-Dalton, R; Cole, D; Stewart, J; Fitzpatrick, R.; Vessey, M.

    1996-01-01

    OBJECTIVE: To assess the effect on time to diagnosis of recurrence and on quality of life of transferring primary responsibility for follow up of women with breast cancer in remission from hospital to general practice. DESIGN: Randomised controlled trial with 18 month follow up in which women received routine follow up either in hospital or in general practice. SUBJECTS AND SETTING: 296 women with breast cancer in remission receiving regular follow up care at district general hospitals in Eng...

  14. Clinical Trial Design for Testing the Stem Cell Model for the Prevention and Treatment of Cancer

    International Nuclear Information System (INIS)

    The cancer stem cell model introduces new strategies for the prevention and treatment of cancers. In cancers that appear to follow the stem cell model, pathways such as Wnt, Notch and Hedgehog may be targeted with natural compounds such as curcumin or drugs to reduce the risk of initiation of new tumors. Disease progression of established tumors could also potentially be inhibited by targeting the tumorigenic stem cells alone, rather than aiming to reduce overall tumor size. These new approaches mandate a change in the design of clinical trials and biomarkers chosen for efficacy assessment for preventative, neoadjuvant, adjuvant, and palliative treatments. Cancer treatments could be evaluated by assessing stem cell markers before and after treatment. Targeted stem cell specific treatment of cancers may not result in “complete” or “partial” responses radiologically, as stem cell targeting may not reduce the tumor bulk, but eliminate further tumorigenic potential. These changes are discussed using breast, pancreatic, and lung cancer as examples

  15. Clinical Trial Design for Testing the Stem Cell Model for the Prevention and Treatment of Cancer

    Energy Technology Data Exchange (ETDEWEB)

    Reddy, Rishindra M., E-mail: reddyrm@med.umich.edu [Medical Center, University of Michigan, 1500 E. Medical Center Drive, 2120 Taubman Center, Ann Arbor, MI 48109 (United States); Kakarala, Madhuri; Wicha, Max S. [Comprehensive Cancer Center, University of Michigan, 1500 E. Medical Center Drive, Ann Arbor, MI 48109 (United States)

    2011-06-20

    The cancer stem cell model introduces new strategies for the prevention and treatment of cancers. In cancers that appear to follow the stem cell model, pathways such as Wnt, Notch and Hedgehog may be targeted with natural compounds such as curcumin or drugs to reduce the risk of initiation of new tumors. Disease progression of established tumors could also potentially be inhibited by targeting the tumorigenic stem cells alone, rather than aiming to reduce overall tumor size. These new approaches mandate a change in the design of clinical trials and biomarkers chosen for efficacy assessment for preventative, neoadjuvant, adjuvant, and palliative treatments. Cancer treatments could be evaluated by assessing stem cell markers before and after treatment. Targeted stem cell specific treatment of cancers may not result in “complete” or “partial” responses radiologically, as stem cell targeting may not reduce the tumor bulk, but eliminate further tumorigenic potential. These changes are discussed using breast, pancreatic, and lung cancer as examples.

  16. Stakeholder perspectives on implementing the National Cancer Institute's patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).

    Science.gov (United States)

    Bruner, Deborah Watkins; Hanisch, Laura J; Reeve, Bryce B; Trotti, Andy M; Schrag, Deborah; Sit, Laura; Mendoza, Tito R; Minasian, Lori; O'Mara, Ann; Denicoff, Andrea M; Rowland, Julia H; Montello, Michael; Geoghegan, Cindy; Abernethy, Amy P; Clauser, Steven B; Castro, Kathleen; Mitchell, Sandra A; Burke, Laurie; Trentacosti, Ann Marie; Basch, Ethan M

    2011-03-01

    The National Cancer Institute (NCI) is developing a patient-reported version of its Common Terminology Criteria for Adverse Events, called the "PRO-CTCAE." The PRO-CTCAE consists of a library of patient-reported items which can be administered in clinical trials to directly capture the patient experience of adverse events during cancer treatment, as well as a software platform for administering these items via computer or telephone. In order to better understand the impressions of stakeholders involved in cancer clinical research about the potential value of the PRO-CTCAE approach to capturing adverse event information in clinical research, as well as their perspectives about barriers and strategies for implementing the PRO-CTCAE in NCI-sponsored cancer trials, a survey was conducted. A survey including structured and open-ended questions was developed to elicit perceptions about the use of patient-reported outcomes (PROs) for adverse event reporting, and to explore logistical considerations for implementing the PRO-CTCAE in cancer trials. The survey was distributed electronically and by paper to a convenience sample of leadership and committee members in the NCI's cooperative group network, including principal investigators, clinical investigators, research nurses, data managers, patient advocates, and representatives of the NCI and Food and Drug Administration. Between October, 2008 through February, 2009, 727 surveys were collected. Most respondents (93%) agreed that patient reporting of adverse symptoms would be useful for improving understanding of the patient experience with treatment in cancer trials, and 88%, 80%, and 76%, respectively, endorsed that administration of PRO-CTCAE items in clinical trials would improve the completeness, accuracy, and efficiency of symptom data collection. More than three fourths believed that patient reports would be useful for informing treatment dose modifications and towards FDA regulatory evaluation of drugs. Eighty

  17. Vitamin E and C supplementation and risk of cancer in men: posttrial follow-up in the Physicians’ Health Study II randomized trial1234

    OpenAIRE

    Wang, Lu; Sesso, Howard D.; Glynn, Robert J.; Christen, William G.; Bubes, Vadim; Manson, JoAnn E.; Buring, Julie E; Gaziano, J. Michael

    2014-01-01

    Background: Recent posttrial analysis of a completed randomized trial found an increased risk of prostate cancer among healthy men taking high-dose vitamin E supplements. Trials that examined the effect of vitamin C supplements on cancer risk are few.

  18. Challenges in DCIS Risk Communication and Decision-Making: Report from an American Cancer Society and National Cancer Institute Workshop

    OpenAIRE

    Partridge, Ann H.; Elmore, Joann G.; Saslow, Debbie; McCaskill-Stevens, Worta; Schnitt, Stuart J.

    2012-01-01

    In September 2010, the American Cancer Society and National Cancer Institute convened a conference to review current issues in DCIS risk communication and decision-making and to identify directions for future research. Specific topics included patient and healthcare provider knowledge and attitudes about DCIS and its treatment, how to explain DCIS to patients given the heterogeneity of the disease, consideration of nomenclature changes, and the utility of decision tools/aids. This report desc...

  19. Patient representatives' views on patient information in clinical cancer trials

    DEFF Research Database (Denmark)

    Dellson, Pia; Nilbert, Mef; Carlsson, Christina

    2016-01-01

    of future simplified and more attractive informed consent forms. CONCLUSIONS: The emotional and cognitive responses to written patient information reported by patient representatives provides a basis for revised formats in future trials and add to the body of information that support use of plain language...

  20. Trials of bevacizumab in breast cancer - a safety review

    DEFF Research Database (Denmark)

    Kümler, Iben; Nielsen, Dorte Lisbet

    2012-01-01

    Introduction: Despite the significant gains in the treatment of breast cancer over the last decade, further improvements in survival using traditional chemotherapeutic agents have begun to plateau. Bevacizumab, a monoclonal antibody targeting vascular endothelial growth factor, has provided promise...... for continued gains in therapy efficacy. Areas covered: The authors review Phase III data concerning the safety of bevacizumab in breast cancer, summarize data on efficacy and discuss the risk:benefit ratio of the drug. The data for this review were obtained by searching in the PubMed database. This...... review enables the reader to overview current knowledge on the efficacy and safety of bevacizumab in breast cancer. Expert opinion: Insight into complex risk-benefit calculations for bevacizumab is missing. In unselected patients with HER2-negative metastatic breast cancer, the risk of serious side...

  1. Brain Cancer Treatment Shows Promise in Early Trial

    Science.gov (United States)

    ... 2016 WEDNESDAY, June 1, 2016 (HealthDay News) -- An experimental viral treatment may extend the lives of patients with a hard-to-treat brain cancer, researchers say. For the phase 1 study, patients ...

  2. Early clinical cancer trials: Proof of concept and beyond

    OpenAIRE

    Konings, Inge

    2011-01-01

    textabstractOver the last few decades clinical cancer research has developed at accelerating speed, resulting in a tremendous increase of knowledge with regard to tumour biology, hypotheses to interfere with tumour growth and the subsequent development of anticancer therapies. Obviously, the ultimate aim of cancer research is to identify treatment approaches improving overall survival with a good quality of life. Novel anticancer therapies mostly arise from scientifi c insights in preclinical...

  3. Advancing the evidence base in cancer: psychosocial multicenter trials

    OpenAIRE

    Sanson-Fisher Robert; Mackenzie Lisa; Butow Phyllis; Rankin Nicole; Paul Christine

    2012-01-01

    Abstract Background The diagnosis and treatment of cancer is associated with significant distress and psychosocial morbidity. Although psychosocial interventions have been developed in an attempt to improve psychosocial outcomes in cancer patients and survivors, there is continued debate about whether there is adequate high-level evidence to establish the effectiveness of these interventions. The evidence base is limited as a result of numerous challenges faced by those attempting to conduct ...

  4. Clinical trials of cancer screening in the developing world and their impact on cancer healthcare.

    Science.gov (United States)

    Sankaranarayanan, R; Sauvaget, C; Ramadas, K; Ngoma, T; Teguete, I; Muwonge, R; Naud, P; Nessa, A; Kuhaprema, T; Qiao, Y

    2011-11-01

    Several research and training initiatives were organized by the International Agency for Research on Cancer (IARC) in collaboration with national institutions in countries such as Angola, Brazil, Burkina Faso, China, Republic of Congo, Guinea, India, Mali, Mauritania, Nepal, Niger, Peru, Tanzania and Thailand among others, to address feasible and effective means of early detection and prevention of cervical, breast and oral cancers. The impact of these activities, that involved over 600 000 participants and more than 1200 healthcare personnel trained on strengthening the local health services in terms of infrastructure, human resources and service delivery aspects in host countries and other regions, is addressed here. These studies, inbuilt in appropriate health services platforms, have resulted in the development and sustenance of several continuing point of care services of screening and treatment in most host countries, particularly in sub-Saharan Africa, and have catalysed regional early detection programmes in India, China and Thailand. The IARC collaborative studies have evolved into major focal points of training and extending services in many countries. The large evidence base, resulting from ours and other studies is likely, in due course, to facilitate much wider scaling up of screening and treatment services through organised programmes. PMID:22039141

  5. Lower Breast Cancer Risk among Women following the World Cancer Research Fund and American Institute for Cancer Research Lifestyle Recommendations: EpiGEICAM Case-Control Study

    OpenAIRE

    Adela Castelló; Miguel Martín; Amparo Ruiz; Casas, Ana M.; Baena-Cañada, Jose M; Virginia Lope; Silvia Antolín; Pedro Sánchez; Manuel Ramos; Antonio Antón; Montserrat Muñoz; Begoña Bermejo; Ana De Juan-Ferré; Carlos Jara; José I Chacón

    2015-01-01

    Background According to the “World Cancer Research Fund” and the “American Institute of Cancer Research” (WCRF/AICR) one in four cancer cases could be prevented through a healthy diet, weight control and physical activity. Objective To explore the association between the WCRF/AICR recommendations and risk of breast cancer. Methods During the period 2006 to 2011 we recruited 973 incident cases of breast cancer and 973 controls from 17 Spanish Regions. We constructed a score based on 9 of the W...

  6. Cost-effectiveness of oral cancer screening: results from a cluster randomized controlled trial in India

    Directory of Open Access Journals (Sweden)

    Sujha Subramanian

    2009-03-01

    Full Text Available OBJECTIVE: To evaluate oral cancer screening by visual inspection. METHODS: A cluster randomized controlled trial was initiated in Trivandrum district, Kerala, India. Of 13 population clusters, seven were randomly allocated to three rounds of screening between 1996 and 2004, while standard care was provided in six (control arm. An activity-based approach was employed to calculate costs associated with various components of the screening trial. Information on the resources used and on clinical events in each trial arm was derived from trial databases. Total costs for each cluster were estimated in 2004 United States dollars (US$. The incremental cost per life-year saved was calculated for all eligible individuals and for high-risk individuals (i.e. tobacco or alcohol users. FINDINGS: The proportion of oral cancers detected at an early stage (i.e. stage I or II was higher in the intervention arm than the control arm (42% versus 24%, respectively. The incremental cost per life-year saved was US$ 835 for all individuals eligible for screening and US$ 156 for high-risk individuals. Oral cancer screening by visual inspection was performed for under US$ 6 per person. CONCLUSION: The most cost-effective approach to oral cancer screening by visual inspection is to offer it to the high-risk population. Targeted screening of this group will ensure that screening can be offered at a reasonable cost in a limited-resource setting.

  7. Cancer Screening Knowledge Changes: Results from a Randomized Control Trial of Women with Developmental Disabilities

    Science.gov (United States)

    Parish, Susan L.; Rose, Roderick A.; Luken, Karen; Swaine, Jamie G.; O'Hare, Lindsey

    2012-01-01

    Background: Women with developmental disabilities are much less likely than nondisabled women to receive cervical and breast cancer screening according to clinical guidelines. One barrier to receipt of screenings is a lack of knowledge about preventive screenings. Method: To address this barrier, we used a randomized control trial (n = 175 women)…

  8. TAILORx Trial Shows Some Women with Breast Cancer May Forgo Chemotherapy

    Science.gov (United States)

    A summary of results from the Trial Assigning Individualized Options for Treatment, or TAILORx, finds that women with early-stage hormone receptor-positive breast cancer have a low risk of recurrence based on a test for the expression of 21 genes.

  9. Salvage ablative therapy in prostate cancer: International multidisciplinary consensus on trial design

    NARCIS (Netherlands)

    Bos, W.; Muller, B.G.; Bruin, D.M. de; Abreu, A.L. de Castro; Chaussy, C.; Coleman, J.A.; Finelli, A.; Gill, I.S.; Gross, M.E.; Jenniskens, S.F.M.; Kahmann, F.; Laguna-Pes, M.P.; Rastinehad, A.R.; Simmons, L.A.; Sulser, T.; Villers, A.; Ward, J.F.; Rosette, J.J.M.C.H. de la

    2015-01-01

    INTRODUCTION: Salvage ablative therapy (SAT) has been developed as a form of localized treatment for localized recurrence of prostate cancers following radiation therapy. To better address the utility of SAT, prospective clinical trials must address the aspects of accepted standards in the initial e

  10. Magnetic-mediated hyperthermia for cancer treatment: Research progress and clinical trials

    International Nuclear Information System (INIS)

    Research progress and frontiers of magnetic-mediated hyperthermia (MMH) are presented, along with clinical trials in Germany, the US, Japan, and China. Special attention is focused on MMH mediated by magnetic nanoparticles, and multifunctional magnetic devices for cancer multimodality treatment are also introduced. (topical review - magnetism, magnetic materials, and interdisciplinary research)

  11. A randomized controlled trial of Human Papillomavirus (HPV) testing for cervical cancer screening: trial design and preliminary results (HPV FOCAL Trial)

    International Nuclear Information System (INIS)

    In the HPV FOCAL trial, we will establish the efficacy of hr-HPV DNA testing as a stand-alone screening test followed by liquid based cytology (LBC) triage of hr-HPV-positive women compared to LBC followed by hr-HPV triage with ≥ CIN3 as the outcome. HPV-FOCAL is a randomized, controlled, three-armed study over a four year period conducted in British Columbia. It will recruit 33,000 women aged 25-65 through the province's population based cervical cancer screening program. Control arm: LBC at entry and two years, and combined LBC and hr-HPV at four years among those with initial negative results and hr-HPV triage of ASCUS cases; Two Year Safety Check arm: hr-HPV at entry and LBC at two years in those with initial negative results with LBC triage of hr-HPV positives; Four Year Intervention Arm: hr-HPV at entry and combined hr-HPV and LBC at four years among those with initial negative results with LBC triage of hr-HPV positive cases To date, 6150 participants have a completed sample and epidemiologic questionnaire. Of the 2019 women enrolled in the control arm, 1908 (94.5%) were cytology negative. Women aged 25-29 had the highest rates of HSIL (1.4%). In the safety arm 92.2% of women were hr-HPV negative, with the highest rate of hr-HPV positivity found in 25-29 year old women (23.5%). Similar results were obtained in the intervention arm HPV FOCAL is the first randomized trial in North America to examine hr-HPV testing as the primary screen for cervical cancer within a population-based cervical cancer screening program. International Standard Randomised Controlled Trial Number Register, ISRCTN79347302

  12. L-Carnitine-supplementation in advanced pancreatic cancer (CARPAN) - a randomized multicentre trial

    OpenAIRE

    Kraft Matthias; Kraft Kathleen; Gärtner Simone; Mayerle Julia; Simon Peter; Weber Eckhard; Schütte Kerstin; Stieler Jens; Koula-Jenik Heide; Holzhauer Peter; Gröber Uwe; Engel Georg; Müller Cornelia; Feng You-Shan; Aghdassi Ali

    2012-01-01

    Abstract Background Cachexia, a >10% loss of body-weight, is one factor determining the poor prognosis of pancreatic cancer. Deficiency of L-Carnitine has been proposed to cause cancer cachexia. Findings We screened 152 and enrolled 72 patients suffering from advanced pancreatic cancer in a prospective, multi-centre, placebo-controlled, randomized and double-blinded trial to receive oral L-Carnitine (4 g) or placebo for 12 weeks. At entry patients reported a mean weight loss of 12 ± 2,5 (SEM)...

  13. Decline of Cosmetic Outcomes Following Accelerated Partial Breast Irradiation Using Intensity Modulated Radiation Therapy: Results of a Single-Institution Prospective Clinical Trial

    Energy Technology Data Exchange (ETDEWEB)

    Liss, Adam L. [Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan (United States); Ben-David, Merav A. [Department of Radiation Oncology, The Sheba Medical Center, Ramat Gan (Israel); Jagsi, Reshma; Hayman, James A. [Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan (United States); Griffith, Kent A. [Biostatistics Unit, University of Michigan, Ann Arbor, Michigan (United States); Moran, Jean M.; Marsh, Robin B. [Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan (United States); Pierce, Lori J., E-mail: ljpierce@umich.edu [Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan (United States)

    2014-05-01

    Purpose: To report the final cosmetic results from a single-arm prospective clinical trial evaluating accelerated partial breast irradiation (APBI) using intensity modulated radiation therapy (IMRT) with active-breathing control (ABC). Methods and Materials: Women older than 40 with breast cancer stages 0-I who received breast-conserving surgery were enrolled in an institutional review board-approved prospective study evaluating APBI using IMRT administered with deep inspiration breath-hold. Patients received 38.5 Gy in 3.85-Gy fractions given twice daily over 5 consecutive days. The planning target volume was defined as the lumpectomy cavity with a 1.5-cm margin. Cosmesis was scored on a 4-category scale by the treating physician. Toxicity was scored according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE version 3.0). We report the cosmetic and toxicity results at a median follow-up of 5 years. Results: A total of 34 patients were enrolled. Two patients were excluded because of fair baseline cosmesis. The trial was terminated early because fair/poor cosmesis developed in 7 of 32 women at a median follow-up of 2.5 years. At a median follow-up of 5 years, further decline in the cosmetic outcome was observed in 5 women. Cosmesis at the time of last assessment was 43.3% excellent, 30% good, 20% fair, and 6.7% poor. Fibrosis according to CTCAE at last assessment was 3.3% grade 2 toxicity and 0% grade 3 toxicity. There was no correlation of CTCAE grade 2 or greater fibrosis with cosmesis. The 5-year rate of local control was 97% for all 34 patients initially enrolled. Conclusions: In this prospective trial with 5-year median follow-up, we observed an excellent rate of tumor control using IMRT-planned APBI. Cosmetic outcomes, however, continued to decline, with 26.7% of women having a fair to poor cosmetic result. These results underscore the need for continued cosmetic assessment for patients treated with APBI by technique.

  14. Decline of Cosmetic Outcomes Following Accelerated Partial Breast Irradiation Using Intensity Modulated Radiation Therapy: Results of a Single-Institution Prospective Clinical Trial

    International Nuclear Information System (INIS)

    Purpose: To report the final cosmetic results from a single-arm prospective clinical trial evaluating accelerated partial breast irradiation (APBI) using intensity modulated radiation therapy (IMRT) with active-breathing control (ABC). Methods and Materials: Women older than 40 with breast cancer stages 0-I who received breast-conserving surgery were enrolled in an institutional review board-approved prospective study evaluating APBI using IMRT administered with deep inspiration breath-hold. Patients received 38.5 Gy in 3.85-Gy fractions given twice daily over 5 consecutive days. The planning target volume was defined as the lumpectomy cavity with a 1.5-cm margin. Cosmesis was scored on a 4-category scale by the treating physician. Toxicity was scored according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE version 3.0). We report the cosmetic and toxicity results at a median follow-up of 5 years. Results: A total of 34 patients were enrolled. Two patients were excluded because of fair baseline cosmesis. The trial was terminated early because fair/poor cosmesis developed in 7 of 32 women at a median follow-up of 2.5 years. At a median follow-up of 5 years, further decline in the cosmetic outcome was observed in 5 women. Cosmesis at the time of last assessment was 43.3% excellent, 30% good, 20% fair, and 6.7% poor. Fibrosis according to CTCAE at last assessment was 3.3% grade 2 toxicity and 0% grade 3 toxicity. There was no correlation of CTCAE grade 2 or greater fibrosis with cosmesis. The 5-year rate of local control was 97% for all 34 patients initially enrolled. Conclusions: In this prospective trial with 5-year median follow-up, we observed an excellent rate of tumor control using IMRT-planned APBI. Cosmetic outcomes, however, continued to decline, with 26.7% of women having a fair to poor cosmetic result. These results underscore the need for continued cosmetic assessment for patients treated with APBI by technique

  15. Adjuvant radiotherapy of regional lymph nodes in breast cancer - a meta-analysis of randomized trials

    International Nuclear Information System (INIS)

    Radiotherapy (RT) improves overall survival (OS) of breast cancer patients after breast conserving surgery and after mastectomy in patients with involved lymph nodes (LN). The contribution of RT to the regional LN to this survival benefit was poorly understood. Recently, the results of three large randomized trials addressing this question have become available. The published abstracts (full publication pending) of the MA.20 (n=1832) and the EORTC 22922–10925 (EORTC) (n=4004) trial and the full publication of the French trial (n=1334) were basis of the meta-analysis. Main eligibility criteria were positive axillary LN (all trials), LN negative disease with high risk for recurrence (MA.20), and medial/central tumor location (French, EORTC). The MA.20 and the EORTC trial tested the effect of additional regional RT to the internal mammary (IM) LN and medial supraclavicular (MS) LN, whereas in the French trial all patients received RT to the MS-LN and solely RT to the IM-LN was randomized. Primary endpoint was OS. Secondary endpoints were disease-free survival (DFS) and distant metastasis free survival (DMFS). Regional RT of the MS-LN and the IM-LN (MA.20 and EORTC) resulted in a significant improvement of OS (Hazard Ratio (HR) 0.85 (95% CL 0.75 - 0.96)). Adding the results of the French trial and using the random effects model to respect the different design of the French trial, the effect on OS of regional radiotherapy was still significant (HR 0.88 (95% CL 0.80 - 0.97)). The absolute benefits in OS were 1.6% in the MA.20 trial at 5 years, 1.6% in the EORTC trial at 10 years, and 3.3% in the French trial at 10 years (not significant in single trials). Regional radiotherapy of the MS-LN and the IM-LN (MA.20 and EORTC) was associated with a significant improvement of DFS (HR 0.85 (95% CL 0.77 - 0.94)) and DMFS (HR 0.82 (95% CL 0.73 - 0.92)). The effect sizes were not significantly different between trials for any end point. Additional regional radiotherapy to the

  16. Intraoperative Radiotherapy for Parotid Cancer: A Single-Institution Experience

    International Nuclear Information System (INIS)

    Purpose: Our practice policy has been to provide intraoperative radiotherapy (IORT) at resection to patients with head-and-neck malignancies considered to be at high risk of recurrence. The purpose of the present study was to review our experience with the use of IORT for primary or recurrent cancer of the parotid gland. Methods and Materials: Between 1982 and 2007, 96 patients were treated with gross total resection and IORT for primary or recurrent cancer of the parotid gland. The median age was 62.9 years (range, 14.3–88.1). Of the 96 patients, 33 had previously undergone external beam radiotherapy as a component of definitive therapy. Also, 34 patients had positive margins after surgery, and 40 had perineural invasion. IORT was administered as a single fraction of 15 or 20 Gy with 4–6-MeV electrons. The median follow-up period was 5.6 years. Results: Only 1 patient experienced local recurrence, 19 developed regional recurrence, and 12 distant recurrence. The recurrence-free survival rate at 1, 3, and 5 years was 82.0%, 68.5%, and 65.2%, respectively. The 1-, 3-, and 5-year overall survival rate after surgery and IORT was 88.4%, 66.1%, and 56.2%, respectively. No perioperative fatalities occurred. Complications developed in 26 patients and included vascular complications in 7, trismus in 6, fistulas in 4, radiation osteonecrosis in 4, flap necrosis in 2, wound dehiscence in 2, and neuropathy in 1. Of these 26 patients, 12 had recurrent disease, and 8 had undergone external beam radiotherapy before IORT. Conclusions: IORT results in effective local disease control at acceptable levels of toxicity and should be considered for patients with primary or recurrent cancer of the parotid gland.

  17. The Impacts of Inclusion in Clinical Trials on Outcomes among Patients with Metastatic Breast Cancer (MBC.

    Directory of Open Access Journals (Sweden)

    Ji Yun Lee

    Full Text Available Metastatic breast cancer (MBC remains a devastating and incurable disease. Over the past decade, the implementation of clinical trials both with and without molecular targeted therapeutics has impacted the daily clinical treatment of patients with MBC. In this study, we determine whether including MBC patients in clinical trials affects clinical outcomes.We retrospectively reviewed data for a total of 863 patients diagnosed with initial or recurrent (after receiving adjuvant systemic treatments following surgery metastatic disease between January 2000 and December 2013. Data were obtained from the breast cancer database of Samsung Medical Center.Among the 806 patients selected for inclusion, 188 (23% had participated in clinical trials. A total of 185 clinical trials were conducted from 2000 to 2014. When compared with earlier periods (n = 10 for 2000-2004, clinical trial enrollment significantly increased over time (n = 103 for 2005-2009, P = 0.024; n = 110 for 2010-2014, P = 0.046. Multivariate analyses revealed that biologic subtype, distant recurrence free interval (DRFI, and clinical trial enrollment were independent predictors of overall survival. Patients who participated in clinical trials showed improved survival, with a hazard ratio of 0.75 (95% CI, 0.59-0.95, which was associated with a 25% reduction in the risk of death. However, subgroup analysis showed that this improved survival benefit was not maintained in patients with triple negative breast cancer (TNBC.Although not conclusive, we could speculate that there were differences in the use of newer agents or regimens over time, and these differences appear to be associated with improved survival.

  18. Generation of "virtual" control groups for single arm prostate cancer adjuvant trials.

    Directory of Open Access Journals (Sweden)

    Zhenyu Jia

    Full Text Available It is difficult to construct a control group for trials of adjuvant therapy (Rx of prostate cancer after radical prostatectomy (RP due to ethical issues and patient acceptance. We utilized 8 curve-fitting models to estimate the time to 60%, 65%, … 95% chance of progression free survival (PFS based on the data derived from Kattan post-RP nomogram. The 8 models were systematically applied to a training set of 153 post-RP cases without adjuvant Rx to develop 8 subsets of cases (reference case sets whose observed PFS times were most accurately predicted by each model. To prepare a virtual control group for a single-arm adjuvant Rx trial, we first select the optimal model for the trial cases based on the minimum weighted Euclidean distance between the trial case set and the reference case set in terms of clinical features, and then compare the virtual PFS times calculated by the optimum model with the observed PFSs of the trial cases by the logrank test. The method was validated using an independent dataset of 155 post-RP patients without adjuvant Rx. We then applied the method to patients on a Phase II trial of adjuvant chemo-hormonal Rx post RP, which indicated that the adjuvant Rx is highly effective in prolonging PFS after RP in patients at high risk for prostate cancer recurrence. The method can accurately generate control groups for single-arm, post-RP adjuvant Rx trials for prostate cancer, facilitating development of new therapeutic strategies.

  19. Sunitinib treatment in patients with advanced renal cell cancer: the Brazilian National Cancer Institute (INCA) experience

    Science.gov (United States)

    Coelho, Rafael Corrêa; Reinert, Tomás; Campos, Franz; Peixoto, Fábio Affonso; de Andrade, Carlos Augusto; Castro, Thalita; Herchenhorn, Daniel

    2016-01-01

    ABSTRACT Purpose: The aim of this study was to assess the impact of sunitinib treatment in a non-screened group of patients with metastatic renal cell cancer (mRCC) treated by the Brazilian Unified Health System (SUS) at a single reference institution. Material and Methods: Retrospective cohort study, which evaluated patients with mRCC who received sunitinib between May 2010 and December 2013. Results: Fifty-eight patients were eligible. Most patients were male 41 (71%), with a median age of 58 years. Nephrectomy was performed in 41 (71%) patients with a median interval of 16 months between the surgery and initiation of sunitinib. The most prevalent histological subtype was clear cell carcinoma, present in 52 (91.2%) patients. In 50 patients (86%), sunitinib was the first line of systemic treatment. The main adverse effects were fatigue (57%), hypothyroidism (43%), mucositis (33%) and diarrhea (29%). Grade 3 and 4 adverse effects were infrequent: fatigue (12%), hypertension (12%), thrombocytopenia (7%), neutropenia (5%) and hand-foot syndrome (5%). Forty percent of patients achieved a partial response and 35% stable disease, with a disease control rate of 75%. Median progression free survival was 7.6 months and median overall survival was 14.1 months. Conclusion: Sunitinib treatment was active in the majority of patients, especially those with low and intermediate risk by MSKCC score, with manageable toxicity. Survival rates were inferior in this non-screened population with mRCC treated in the SUS. PMID:27564279

  20. Standard versus prosocial online support groups for distressed breast cancer survivors: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Golant Mitch

    2011-08-01

    Full Text Available Abstract Background The Internet can increase access to psychosocial care for breast cancer survivors through online support groups. This study will test a novel prosocial online group that emphasizes both opportunities for getting and giving help. Based on the helper therapy principle, it is hypothesized that the addition of structured helping opportunities and coaching on how to help others online will increase the psychological benefits of a standard online group. Methods/Design A two-armed randomized controlled trial with pretest and posttest. Non-metastatic breast cancer survivors with elevated psychological distress will be randomized to either a standard facilitated online group or to a prosocial facilitated online group, which combines online exchanges of support with structured helping opportunities (blogging, breast cancer outreach and coaching on how best to give support to others. Validated and reliable measures will be administered to women approximately one month before and after the interventions. Self-esteem, positive affect, and sense of belonging will be tested as potential mediators of the primary outcomes of depressive/anxious symptoms and sense of purpose in life. Discussion This study will test an innovative approach to maximizing the psychological benefits of cancer online support groups. The theory-based prosocial online support group intervention model is sustainable, because it can be implemented by private non-profit or other organizations, such as cancer centers, which mostly offer face-to-face support groups with limited patient reach. Trial Registration ClinicalTrials.gov: NCT01396174

  1. Iodine-125 seed brachytherapy for early stage prostate cancer: a single-institution review

    OpenAIRE

    Zuber, Simon; Weiß, Susan; Baaske, Dieter; Schöpe, Michael; Stevens, Simon; Bodis, Stephan; Zwahlen, Daniel R.

    2015-01-01

    Purpose We are reporting the five-year biochemical control, toxicity profile and dosimetric parameters using iodine-125 low dose rate brachytherapy (BT) as monotherapy for early stage prostate cancer at a single institution. Material and methods Between April 2006 and December 2010, 169 men with early stage prostate cancer were treated with BT. Biochemical failure was defined using the Phoenix definition (nadir + 2 ng/mL). Treatment-related morbidities, including urinary, rectal and sexual fu...

  2. Iodine-125 seed brachytherapy for early stage prostate cancer: a single-institution review

    OpenAIRE

    Zuber, Simon; Weiß, Susan; Baaske, Dieter; Schöpe, Michael; Stevens, Simon; Bodis, Stephan; Zwahlen, Daniel R.

    2015-01-01

    PURPOSE: We are reporting the five-year biochemical control, toxicity profile and dosimetric parameters using iodine-125 low dose rate brachytherapy (BT) as monotherapy for early stage prostate cancer at a single institution. MATERIAL AND METHODS: Between April 2006 and December 2010, 169 men with early stage prostate cancer were treated with BT. Biochemical failure was defined using the Phoenix definition (nadir + 2 ng/mL). Treatment-related morbidities, including urinary, rectal and sexu...

  3. Multi-Institutional Analysis of Early Glottic Cancer from 2000 to 2005

    OpenAIRE

    Hirasawa Naoki; Itoh Yoshiyuki; Naganawa Shinji; Ishihara Shunichi; Suzuki Kazunori; Koyama Kazuyuki; Murao Takayuki; Asano Akiko; Nomoto Yoshihito; Horikawa Yoshimi; Sasaoka Masahiro; Obata Yasunori

    2012-01-01

    Abstract Background The purpose of this study is to analyze the outcome of patients with early glottic cancer (GC) treated with radiotherapy (RT) with or without chemotherapy at 10 institutions in the Tokai District, Japan. Methods Ten institutions combined data from 279 patients with T1-T2 GC treated with RT with or without chemotherapy between 2000 and 2005. The overall survival rate, disease-specific survival rate, and local control rate were evaluated in 270 patients, except for incomplet...

  4. Management of Ontario children with acute lymphoblastic leukemia by the Dana-Farber Cancer Institute protocols.

    OpenAIRE

    Desai, S J; Barr, R D; Andrew, M.; deVeber, L L; Pai, M K

    1989-01-01

    There is ample evidence of the value of intensive therapeutic strategies in the management of acute lymphoblastic leukemia (ALL), the commonest form of malignant disease in children. Such a program, devised at the Dana-Farber Cancer Institute (DFCI), Boston, and incorporating high-dose L-asparaginase, was adopted in 1984 by the Children's Hospital at Chedoke-McMaster, Hamilton, Ont., and the Children's Hospital of Western Ontario, London. We describe the experience of these institutions in th...

  5. Comparison of Eligibility Criteria Between Protocols, Registries, and Publications of Cancer Clinical Trials.

    Science.gov (United States)

    Zhang, Sheng; Liang, Fei; Li, Wenfeng; Tannock, Ian

    2016-11-01

    Trial registration and public accessibility of appended or published protocols of phase III randomized clinical trials (RCTs) allow comparison of reported research with essential aspects of trial design. We determined how eligibility criteria of participants specified in protocols were described in trial registries and articles of 255 cancer RCTs published in leading journals. The mean proportion of matching eligibility criteria between protocols and publications per trial (the primary endpoint) was 44.0% (95% confidence interval [CI] = 40.8% to 47.3%). Almost all discrepancies in eligibility criteria (96.7%, 95% CI = 96.1% to 97.3%) suggested to readers of articles that a broader study population was included. The mean proportion of matching eligibility criteria between protocols and registries was 72.9% (95% CI = 68.2% to 77.7%, the secondary endpoint). We conclude that there are substantial differences in eligibility criteria between trial protocols, registries and articles. Inaccurate reporting of eligibility criteria may prevent appropriate assessment of the applicability of trial results. PMID:27226519

  6. Safety and radiosensitizing efficacy of sanazole (AK 2123 in oropharyngeal cancers: Randomized controlled double blind clinical trial

    Directory of Open Access Journals (Sweden)

    Pai MRSM

    2006-01-01

    Full Text Available Oropharynx is an important site of cancer in India. Global comparison indicates higher incidences in India. Radiotherapy remains an important treatment modality. Efforts to improve loco-regional treatment and prolong survival are areas of focus. Radiosensitizers in hypoxic tumors have shown promise. Aim:0 To study the safety and radiosensitizing efficacy of sanazole in oropharyngeal squamous cell carcinoma (stage T2-4, N0-3, M0 as phase-II double blind controlled trial in patients treated with conventional radiotherapy. SETTINGS AND DESIGN: Single institutional, randomized, double-blind, placebo-controlled trial. MATERIALS AND METHODS: Group 1 (control; n =23 received normal saline infusion, group 2 (test; n =23 received sanazole biweekly 1.25 g intravenous infusion 15 minutes before radiotherapy. Surrogate end points of efficacy were tumor and nodal size; safety parameters were mucositis, salivary and skin reactions, dysphagia, vomiting, dysgeusia and neurological deficit. Investigators blinded to the trial evaluated patients, weekly during treatment for six weeks and thereafter monthly for three months. STATISTICAL METHODS: Non-parametric, Friedman′s, Chi square, Mann-Whitney U tests. RESULTS: In the test, 15 (65% patients had complete response, five (22% partial/no response, two (9% died, one (4% lost to follow up. In the control, five (22% patients had complete response, 16 (70% partial/no response, one (4% died, one (4% lost to follow up. Short-term loco-regional response was better in the test ( DF = 3 , 95% Confidence Interval 0.418, 0.452, P=0.0048 . In the test group significant vomiting and one case of grade 3 neurological deficit was observed. CONCLUSION: The study validates the usefulness of sanazole for initial loco-regional control in oropharyngeal cancers.

  7. The Childhood Cancer Survivor Study: a National Cancer Institute-supported resource for outcome and intervention research.

    Science.gov (United States)

    Robison, Leslie L; Armstrong, Gregory T; Boice, John D; Chow, Eric J; Davies, Stella M; Donaldson, Sarah S; Green, Daniel M; Hammond, Sue; Meadows, Anna T; Mertens, Ann C; Mulvihill, John J; Nathan, Paul C; Neglia, Joseph P; Packer, Roger J; Rajaraman, Preetha; Sklar, Charles A; Stovall, Marilyn; Strong, Louise C; Yasui, Yutaka; Zeltzer, Lonnie K

    2009-05-10

    Survival for childhood cancer has increased dramatically over the last 40 years with 5-year survival rates now approaching 80%. For many diagnostic groups, rapid increases in survival began in the 1970s with the broader introduction of multimodality approaches, often including combination chemotherapy with or without radiation therapy. With this increase in rates of survivorship has come the recognition that survivors are at risk for adverse health and quality-of-life outcomes, with risk being influenced by host-, disease-, and treatment-related factors. In 1994, the US National Cancer Institute funded the Childhood Cancer Survivor Study, a multi-institutional research initiative designed to establish a large and extensively characterized cohort of more than 14,000 5-year survivors of childhood and adolescent cancer diagnosed between 1970 and 1986. This ongoing study, which reflects the single most comprehensive body of information ever assembled on childhood and adolescent cancer survivors, provides a dynamic framework and resource to investigate current and future questions about childhood cancer survivors. PMID:19364948

  8. Phase I/II trial evaluating carbon ion radiotherapy for the treatment of recurrent rectal cancer: the PANDORA-01 trial

    Directory of Open Access Journals (Sweden)

    Combs Stephanie E

    2012-04-01

    × 3 Gy E will be applied. The primary endpoint in the Phase I part is toxicity, the primary endpoint in the Phase II part is progression-free survival. Discussion With conventional photon irradiation treatment of recurrent rectal cancer is limited, and the clinical effect is only moderate. With carbon ions, an improved outcome can be expected due to the physical and biological characteristics of the carbon ion beam. However, the optimal dose applicable in this clincial situation as re-irradiation still has to be determined. This, as well as efficacy, is to be evaluated in the present Phase I/II trial. Trial registration NCT01528683

  9. Outcome and treatment strategy in female lung cancer: a single institution experience

    International Nuclear Information System (INIS)

    Purpose: To assess the survival rate of female lung cancer treated at the Institute of Oncology of the Vilnius University, Lithuania during the period between 1996-2005. Materials and Methods: During the period between 1996-2005, 471 women diagnosed with lung cancer were treated at the Department of Thoracic Surgery and Oncology of the Institute of Oncology, Vilnius University. Data on morphology, stage and treatment was collected from the medical records. All lung cancer cases by histology were classified in two groups: non-small cell lung cancer (includes squamous cell carcinoma, large cell carcinoma, adenocarcinoma and other less common types) and small cell lung cancer. The vital status of the study group was assessed as of December 31, 2007, by passive follow-up, using data from the population registry. It was found that 411 (87.3%) of the patients had died. Survival was estimated according to the Kaplan-Meier method. Results: The median survival of female lung cancer diagnosed during 1996-2005 in Lithuania show to be 8.7 months (8.4 (95% CI 7.2-10.8) months with non-small cell lung cancer and 9.3 (95% CI 6.3-13.0) months with small-cell lung cancer). Survival was more than 20 months in resectable non-small cell lung cancer (stages I, II, IIIA). Non-small cell lung cancer survival in advanced stages was less than 7 months. Small-cell lung cancer patients median survival at limited and extended stages of the disease were 9.5 (95% CI 2.9-18.4) compared to 9.2 (95% CI 6.2-13.7) months. Non-small cell lung cancer patients most frequently were treated by surgery (27.0%), surgery and chemotherapy or radiotherapy (19.6%). Small cell lung cancer patient treatment included chemo and radiotherapy (27.0%), chemotherapy (19.0%), radiotherapy (17.5%), surgery (27.9%). Conclusions: The single center study of female lung cancer diagnosed during 1996-2005 in Lithuania show a significantly better chance of survival in resectable non-small cell lung cancer. Advanced stages of

  10. Physical Activity during Cancer Treatment (PACT Study: design of a randomised clinical trial

    Directory of Open Access Journals (Sweden)

    de Wit G Ardine

    2010-06-01

    Full Text Available Abstract Background Fatigue is a major problem of cancer patients. Thirty percent of cancer survivors report serious fatigue three years after finishing treatment. There is evidence that physical exercise during cancer treatment reduces fatigue. This may also lead to an improvement of quality of life. Such findings may result in a decrease of healthcare related expenditures and societal costs due to sick leave. However, no studies are known that investigated these hypotheses. Therefore, the primary aim of our study is to assess the effect of exercise during cancer treatment on reducing complaints of fatigue and on reducing health service utilisation and sick leave. Methods/Design The Physical Activity during Cancer Treatment study is a multicentre randomised controlled trial in 150 breast and 150 colon cancer patients undergoing cancer treatment. Participants will be randomised to an exercise or a control group. In addition to the usual care, the exercise group will participate in an 18-week supervised group exercise programme. The control group will be asked to maintain their habitual physical activity pattern. Study endpoints will be assessed after 18 weeks (short term and after 9 months (long term. Validated questionnaires will be used. Primary outcome: fatigue (Multidimensional Fatigue Inventory and Fatigue Quality List and cost-effectiveness, health service utilisation and sick leave. Secondary outcome: health related quality of life (European Organisation Research and Treatment of Cancer-Quality of Life questionnaire-C30, Short Form 36 healthy survey, impact on functioning and autonomy (Impact on functioning and autonomy questionnaire, anxiety and depression (Hospital Anxiety and Depression Scale, physical fitness (aerobic peak capacity, muscle strength, body composition and cognitive-behavioural aspects. To register health service utilisation and sick leave, participants will keep diaries including the EuroQuol-5D. Physical activity level

  11. Breast Cancer Clinical Trials: Past Half Century Moving Forward Advancing Patient Outcomes.

    Science.gov (United States)

    Kuerer, Henry M; van la Parra, Raquel F D

    2016-10-01

    Clinical trials in breast cancer have contributed immensely to the advancements of modern multimodal breast cancer treatment. Due to improved screening methods and more effective biologic-based tailored systemic therapies, the extent of surgery necessary for local and systemic control of disease is decreasing. Sequential trials for ductal carcinoma in situ (DCIS) have changed the management of this disease and are culminating in randomized active surveillance studies in an effort potentially to prevent overtreatment of low- and intermediate-grade disease. For patients with initial node-positive disease, clipping and marking of the biopsy-proven nodal metastases before the start of neoadjuvant chemotherapy can allow for selective node dissection based on the axillary response. With the current advances in primary systemic therapy, feasibility trials are beginning to investigate the potential of nonoperative therapy for invasive cancers with percutaneously documented pathologic complete response. This article presents a review and update on landmark clinical trials related to DCIS, the extent of axillary surgery in node-positive disease, and the integration of systemic therapy with local therapy. PMID:27364503

  12. Health-related quality of life and cancer clinical trials

    OpenAIRE

    Osoba, David

    2011-01-01

    The measurement of patient-reported outcomes, including health-related quality of life, is a new initiative which has emerged and grown over the past four decades. Following the development of reliable and valid self-report questionnaires, health-related quality of life has been assessed in tens of thousands of patients and a wide variety of cancers. This review is based on a selection of data published in the last decade and is intended primarily for healthcare professionals. The assessments...

  13. Epidemiology of epithelial ovarian cancer, a single institution-based study in India

    Directory of Open Access Journals (Sweden)

    Surendra Kumar Saini

    2016-01-01

    Full Text Available Background: Ovarian cancer is the leading cause of mortality among all cancers of female genital tract in countries where effective cervical cancer screening program exists. As the world's population ages, remarkable increase in the total number of ovarian cancer cases are expected. This is preliminary epidemiological study to decide priorities in ovarian cancer research. Materials and Methods: A retrospective study was conducted with primary epithelial ovarian cancer cases registered in J. K. Cancer Institute, Kanpur (Uttar Pradesh, from 2007 to 2009. Patients' age at diagnosis, clinical feature, parity of patients, tumor histological type, Federation of Gynecology and Obstetrics stage, chemotherapy regimens, and overall survival data were collected and analyzed. Results: One hundred and sixty-three cases of primary ovarian epithelial cancer were analyzed. Patients' mean age at diagnosis was 55.98 ± 9.24 (median = 55. Serous adenocarcinoma (49.69% was the most prevalent type of histopathology followed by endometroid (19.1%, mucinous (10.42% and clear cell (4.29%. Combination of taxane and platin was most commonly used first line regimen in newly diagnosed as well as in relapsed patients post 1 year. Survival was not significantly different in various histopathology (log-rank P = 0.7406, but advancing stage demonstrated gradually poor survival (log-rank P < 0.05 when compared with early stage disease. Conclusion: Research efforts should be in the direction to find early diagnostic and effective screening tools as well as better therapeutic approaches for advanced epithelial ovarian cancer.

  14. Active Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial Grants | Division of Cancer Prevention

    Science.gov (United States)

    The Division of Cancer Prevention (DCP) conducts and supports research to determine a person's risk of cancer and to find ways to reduce the risk. This knowledge is critical to making progress against cancer because risk varies over the lifespan as genetic and epigenetic changes can transform healthy tissue into invasive cancer.

  15. Lung and Upper Aerodigestive Cancer Clinical Trials | Division of Cancer Prevention

    Science.gov (United States)

    The Division of Cancer Prevention (DCP) conducts and supports research to determine a person's risk of cancer and to find ways to reduce the risk. This knowledge is critical to making progress against cancer because risk varies over the lifespan as genetic and epigenetic changes can transform healthy tissue into invasive cancer.

  16. Local microwave hyperthermia and irradiation in cancer therapy: preliminary observations and directions for future clinical trials

    Energy Technology Data Exchange (ETDEWEB)

    Perez, C.A.; Kopecky, W.; Venkata Rao, D.; Baglan, R.; Mann, J.

    1981-06-01

    This report outlies the preliminary experience at the Mallinckrodt Institute of Radiology with hyperthermia and irradiation. Twenty-nine lesions were treated with 400 rad fractions given every 72 hours (twice weekly) for a total dose of 2000 to 4000 rad followed by hyperthermia (2450 MHz or 915 MHz microwaves, 42.0/sup 0/ to 43/sup 0/C, 90 minutes, every 72 hours.) in addition, 6 lesions were treated with three doses of 500 rad followed by hyperthermia and 12 with irradiation alone (three doses of 600, 700 or 800 rad every 72 h). In the lesions treated with 2000 to 4000 rad and heat, nine of 12 recurrent epidermoid carcinomas of the head and neck showed complete regression (75%) and one more than 50% response. Four of five metastatic melanoma nodules showed complete regression of the tumors and one over 80% response. Of nine recurrent adenocarcinoma of the breast nodules in the chest wall treated with 3200 to 4000 rad, five lesions exhibited complete regression and two others about 80%. Four of five metastatic melanoma nodules and three soft tissue sarcomas had complete tumor regression. Of the six lesions treated with 1500 rad and hyperthermia, two metastatic melanomas showed complete regression (CR), and three tumors exhibited partial regression. Despite the fact that the majority of the patients had been previously treated with definitive radiotherapy, the retreatment with moderate doses of irradiation and heat has been well tolerated. Of the 35 sites treated, four (11%) developed blisters, seven (20%) erythema only, three (8%) moist desquamation and 27 (77%) dry desquamation. There has been one instance of severe necrosis of soft tissues in the upper neck, in a patient previously treated with 5000 rad and surgery. Additional clinical trials are warranted to assess the potential value of hyperthermia alone or combined with irradiation in the treatment of selected cancer patients.

  17. 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)

    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)

  18. 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.

  19. Five-Year Outcomes from 3 Prospective Trials of Image-Guided Proton Therapy for Prostate Cancer

    Energy Technology Data Exchange (ETDEWEB)

    Mendenhall, Nancy P., E-mail: menden@shands.ufl.edu [University of Florida Proton Therapy Institute, Jacksonville, Florida (United States); Hoppe, Bradford S.; Nichols, Romaine C.; Mendenhall, William M.; Morris, Christopher G.; Li, Zuofeng; Su, Zhong [University of Florida Proton Therapy Institute, Jacksonville, Florida (United States); Williams, Christopher R.; Costa, Joseph [Division of Urology, College of Medicine, University of Florida, Jacksonville, Florida (United States); Henderson, Randal H. [University of Florida Proton Therapy Institute, Jacksonville, Florida (United States)

    2014-03-01

    Purpose: To report 5-year clinical outcomes of 3 prospective trials of image-guided proton therapy for prostate cancer. Methods and Materials: A total of 211 prostate cancer patients (89 low-risk, 82 intermediate-risk, and 40 high-risk) were treated in institutional review board-approved trials of 78 cobalt gray equivalent (CGE) in 39 fractions for low-risk disease, 78 to 82 CGE for intermediate-risk disease, and 78 CGE with concomitant docetaxel therapy followed by androgen deprivation therapy for high-risk disease. Toxicities were graded according to Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Median follow-up was 5.2 years. Results: Five-year rates of biochemical and clinical freedom from disease progression were 99%, 99%, and 76% in low-, intermediate-, and high-risk patients, respectively. Actuarial 5-year rates of late CTCAE, version 3.0 (or version 4.0) grade 3 gastrointestinal and urologic toxicity were 1.0% (0.5%) and 5.4% (1.0%), respectively. Median pretreatment scores and International Prostate Symptom Scores at >4 years posttreatment were 8 and 7, 6 and 6, and 9 and 8, respectively, among the low-, intermediate-, and high-risk patients. There were no significant changes between median pretreatment summary scores and Expanded Prostate Cancer Index Composite scores at >4 years for bowel, urinary irritative and/or obstructive, and urinary continence. Conclusions: Five-year clinical outcomes with image-guided proton therapy included extremely high efficacy, minimal physician-assessed toxicity, and excellent patient-reported outcomes. Further follow-up and a larger patient experience are necessary to confirm these favorable outcomes.

  20. Five-Year Outcomes from 3 Prospective Trials of Image-Guided Proton Therapy for Prostate Cancer

    International Nuclear Information System (INIS)

    Purpose: To report 5-year clinical outcomes of 3 prospective trials of image-guided proton therapy for prostate cancer. Methods and Materials: A total of 211 prostate cancer patients (89 low-risk, 82 intermediate-risk, and 40 high-risk) were treated in institutional review board-approved trials of 78 cobalt gray equivalent (CGE) in 39 fractions for low-risk disease, 78 to 82 CGE for intermediate-risk disease, and 78 CGE with concomitant docetaxel therapy followed by androgen deprivation therapy for high-risk disease. Toxicities were graded according to Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Median follow-up was 5.2 years. Results: Five-year rates of biochemical and clinical freedom from disease progression were 99%, 99%, and 76% in low-, intermediate-, and high-risk patients, respectively. Actuarial 5-year rates of late CTCAE, version 3.0 (or version 4.0) grade 3 gastrointestinal and urologic toxicity were 1.0% (0.5%) and 5.4% (1.0%), respectively. Median pretreatment scores and International Prostate Symptom Scores at >4 years posttreatment were 8 and 7, 6 and 6, and 9 and 8, respectively, among the low-, intermediate-, and high-risk patients. There were no significant changes between median pretreatment summary scores and Expanded Prostate Cancer Index Composite scores at >4 years for bowel, urinary irritative and/or obstructive, and urinary continence. Conclusions: Five-year clinical outcomes with image-guided proton therapy included extremely high efficacy, minimal physician-assessed toxicity, and excellent patient-reported outcomes. Further follow-up and a larger patient experience are necessary to confirm these favorable outcomes

  1. Adjuvant radiotherapy for pathologically advanced prostate cancer a randomized clinical trial

    Energy Technology Data Exchange (ETDEWEB)

    Ian, M.; Thompson, J.R.; Catherine, M.; Tangen, P.H.; Paradelo, J.; Scott Lucia, M.; Miller, G.; Troyer, D.; Messing, E.; Forman, J.; Chin, J.; Swanson, G.; Canby-Hagino, E.; Crawford, E.D

    2008-01-15

    Context - Despite a stage-shift to earlier cancer stages and lower tumor volumes for prostate cancer, pathologically advanced disease is detected at radical prostatectomy in 38% to 52% of patients. However, the optimal management of these patients after radical prostatectomy is unknown. Objective - To determine whether adjuvant radiotherapy improves metastasis-free survival in patients with stage pT3 NO MO prostate cancer. Design, Setting, and Patients - Randomized, prospective, multi-institutional, US clinical trial with enrollment between August 15, 1988, and January 1, 1997 (with database frozen for statistical analysis on September 21, 2005). Patients were 425 men with pathologically advanced prostate cancer who had undergone radical prostatectomy. Intervention - Men were randomly assigned to receive 60 to 64 Gy of external beam radiotherapy delivered to the prostatic fossa (n = 214) or usual care plus observation (n = 211). Main Outcome Measures - Primary outcome was metastasis-free survival, defined as time to first occurrence of metastatic disease or death due to any cause. Secondary outcomes included prostate-specific antigen (PSA) relapse, recurrence-free survival, overall survival, freedom from hormonal therapy, and postoperative complications. Results - Among the 425 men, median follow-up was 10.6 years (inter-quartile range, 9.2-12.7 years). For metastasis-free survival,76 (35.5%) of 214 men in the adjuvant radiotherapy group were diagnosed with metastatic disease or died (median metastasis-free estimate, 14.7 years), compared with 91 (43.1%) of 211 (median metastasis-free estimate, 13.2 years) of those in the observation group (hazard ratio [HR], 0.75; 95% CI, 0.55-1.02; P = .06). There were no significant between-group differences for overall survival (71 deaths, median survival of 14.7 years for radiotherapy vs 83 deaths, median survival of 13.8 years for observation; HR, 0.80; 95% Cl, 0.58-1.09; P =.16). PSA relapse (median PSA relapse-free survival

  2. Fruit and vegetable intakes and risk of colorectal cancer and incident and recurrent adenomas in the PLCO cancer screening trial.

    Science.gov (United States)

    Kunzmann, Andrew T; Coleman, Helen G; Huang, Wen-Yi; Cantwell, Marie M; Kitahara, Cari M; Berndt, Sonja I

    2016-04-15

    The roles of fruits and vegetables in colorectal cancer development are unclear. Few prospective studies have assessed the association with adenoma, a known precursor to colorectal cancer. Our aim was to evaluate the association between fruit and vegetable intake and colorectal cancer development by evaluating the risk of incident and recurrent colorectal adenoma and colorectal cancer. Study participants were identified from the intervention arm of the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial. Fruit and vegetable intake was measured using a self-reported dietary questionnaire. Total fruit and vegetable intake was not associated with reduced incident or recurrent adenoma risk overall, but a protective association was observed for multiple adenomas (Odds ratio 3rd tertile vs. 1st tertile  = 0.61, 95% confidence interval (CI): 0.38, 1.00). Higher fruit and vegetable intakes were associated with a borderline reduced risk of colorectal cancer (Hazard ratio (HR) 3rd tertile vs. 1st tertile  = 0.82, 95% CI: 0.67, 1.01), which reached significance amongst individuals with high processed meat intakes (HR = 0.74, 95% CI: 0.55, 0.99). Our results suggest that increased fruit and vegetable intake may protect against multiple adenoma development and may reduce the detrimental effects of high processed meat intakes on colorectal cancer risk. PMID:26559156

  3. The eCALM Trial-eTherapy for cancer appLying mindfulness: online mindfulness-based cancer recovery program for underserved individuals living with cancer in Alberta: protocol development for a randomized wait-list controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Zernicke Kristin A

    2013-02-01

    Full Text Available Abstract Background Elevated stress can exacerbate cancer symptom severity, and after completion of primary cancer treatments, many individuals continue to have significant distress. Mindfulness-Based Cancer Recovery (MBCR is an 8-week group psychosocial intervention consisting of training in mindfulness meditation and yoga designed to mitigate stress, pain, and chronic illness. Efficacy research shows face-to-face (F2F MBCR programs have positive benefits for cancer patients; however barriers exist that impede participation in F2F groups. While online MBCR groups are available to the public, none have been evaluated. Primary objective: determine whether underserved patients are willing to participate in and complete an online MBCR program. Secondary objectives: determine whether online MBCR will mirror previous efficacy findings from F2F MBCR groups on patient-reported outcomes. Method/design The study includes cancer patients in Alberta, exhibiting moderate distress, who do not have access to F2F MBCR. Participants will be randomized to either online MBCR, or waiting for the next available group. An anticipated sample size of 64 participants will complete measures online pre and post treatment or waiting period. Feasibility will be tracked through monitoring numbers eligible and participating through each stage of the protocol. Discussion 47 have completed/completing the intervention. Data suggest it is possible to conduct a randomized waitlist controlled trial of online MBCR to reach underserved cancer survivors. Trial registration Clinical Trials.gov Identifier: NCT01476891

  4. A multi-institute case-control study on the risk factors of developing pancreatic cancer.

    Science.gov (United States)

    Mizuno, S; Watanabe, S; Nakamura, K; Omata, M; Oguchi, H; Ohashi, K; Ohyanagi, H; Fujiki, T; Motojima, K

    1992-08-01

    A multi-institute, hospital-based, case-control study on pancreatic cancer was carried out to examine its association with preceding diseases, cigarette smoking, alcohol drinking and dietary factors. Analyses were based on 124 newly diagnosed exocrine pancreatic cancer cases and sex-, age- and institute-matched hospital controls in seven hospitals in Japan. Cigarette smoking showed a positive association with the risk of developing pancreatic cancer. Especially among smokers, a risk enhancing effect of involuntary/passive smoking prior to twenty years of age was observed (P tea or alcohol consumption. Among dietary factors, favoring food of a salty taste and drinking green tea five cups per day or more were positively associated with the risk. Drinking milk and eating fish everyday were inversely associated with the risk. PMID:1434027

  5. Profile of patients with lung cancer assisted at the National Cancer Institute, according to their smoking status, from 2000 to 2007

    OpenAIRE

    Mirian Carvalho de Souza; Ana Glória Godoi Vasconcelos; Marise Souto Rebelo; Paulo Antonio de Paiva Rebelo; Oswaldo Gonçalves Cruz

    2014-01-01

    INTRODUCTION: Tobacco use is directly related to the future incidence of lung cancer. In Brazil, a growing tendency in age-adjusted lung cancer mortality rates was observed in recent years. OBJECTIVE: To describe the profile of patients with lung cancer diagnosed and treated at the National Cancer Institute (INCA) in Rio de Janeiro, Brazil, between 2000 and 2007 according to their smoking status. METHODS: An observational study was conducted using INCA's database of cancer cases. To ...

  6. Genetic polymorphisms of the GNRH1 and GNRHR genes and risk of breast cancer in the National Cancer Institute Breast and Prostate Cancer Cohort Consortium (BPC3

    Directory of Open Access Journals (Sweden)

    Lund Eiliv

    2009-07-01

    Full Text Available Abstract Background Gonadotropin releasing hormone (GNRH1 triggers the release of follicle stimulating hormone and luteinizing hormone from the pituitary. Genetic variants in the gene encoding GNRH1 or its receptor may influence breast cancer risk by modulating production of ovarian steroid hormones. We studied the association between breast cancer risk and polymorphisms in genes that code for GNRH1 and its receptor (GNRHR in the large National Cancer Institute Breast and Prostate Cancer Cohort Consortium (NCI-BPC3. Methods We sequenced exons of GNRH1 and GNRHR in 95 invasive breast cancer cases. Resulting single nucleotide polymorphisms (SNPs were genotyped and used to identify haplotype-tagging SNPs (htSNPS in a panel of 349 healthy women. The htSNPs were genotyped in 5,603 invasive breast cancer cases and 7,480 controls from the Cancer Prevention Study-II (CPS-II, European Prospective Investigation on Cancer and Nutrition (EPIC, Multiethnic Cohort (MEC, Nurses' Health Study (NHS, and Women's Health Study (WHS. Circulating levels of sex steroids (androstenedione, estradiol, estrone and testosterone were also measured in 4713 study subjects. Results Breast cancer risk was not associated with any polymorphism or haplotype in the GNRH1 and GNRHR genes, nor were there any statistically significant interactions with known breast cancer risk factors. Polymorphisms in these two genes were not strongly associated with circulating hormone levels. Conclusion Common variants of the GNRH1 and GNRHR genes are not associated with risk of invasive breast cancer in Caucasians.

  7. Genetic polymorphisms of the GNRH1 and GNRHR genes and risk of breast cancer in the National Cancer Institute Breast and Prostate Cancer Cohort Consortium (BPC3)

    International Nuclear Information System (INIS)

    Gonadotropin releasing hormone (GNRH1) triggers the release of follicle stimulating hormone and luteinizing hormone from the pituitary. Genetic variants in the gene encoding GNRH1 or its receptor may influence breast cancer risk by modulating production of ovarian steroid hormones. We studied the association between breast cancer risk and polymorphisms in genes that code for GNRH1 and its receptor (GNRHR) in the large National Cancer Institute Breast and Prostate Cancer Cohort Consortium (NCI-BPC3). We sequenced exons of GNRH1 and GNRHR in 95 invasive breast cancer cases. Resulting single nucleotide polymorphisms (SNPs) were genotyped and used to identify haplotype-tagging SNPs (htSNPS) in a panel of 349 healthy women. The htSNPs were genotyped in 5,603 invasive breast cancer cases and 7,480 controls from the Cancer Prevention Study-II (CPS-II), European Prospective Investigation on Cancer and Nutrition (EPIC), Multiethnic Cohort (MEC), Nurses' Health Study (NHS), and Women's Health Study (WHS). Circulating levels of sex steroids (androstenedione, estradiol, estrone and testosterone) were also measured in 4713 study subjects. Breast cancer risk was not associated with any polymorphism or haplotype in the GNRH1 and GNRHR genes, nor were there any statistically significant interactions with known breast cancer risk factors. Polymorphisms in these two genes were not strongly associated with circulating hormone levels. Common variants of the GNRH1 and GNRHR genes are not associated with risk of invasive breast cancer in Caucasians

  8. The effectiveness of group positive psychotherapy on depression and happiness in breast cancer patients: A randomized controlled trial

    OpenAIRE

    Dowlatabadi, Mohammad Mehdi; Ahmadi, Seyed Mojtaba; Sorbi, Mohammad Hossein; Beiki, Omid; Razavi, Tayebeh Khademeh; Bidaki, Reza

    2016-01-01

    Background Breast cancer is one of the most prevalent cancers in women in the world. It causes fear, despair, and takes a tremendous toll on psychological status. Objective To determine the effectiveness of group positive psychotherapy on the depression and happiness of breast cancer patients. Methods This randomized controlled trial was conducted with 42 breast cancer patients in The Oncology Center at Kermanshah, Iran in 2015. The Data were gathered before intervention and ten weeks afterwa...

  9. Who participates in a randomized trial of mindfulness-based stress reduction (MBSR) after breast cancer?

    DEFF Research Database (Denmark)

    Würtzen, Hanne; Oksbjerg Dalton, Susanne; Kaae Andersen, Klaus;

    2013-01-01

    BACKGROUND: Discussion regarding the necessity to identify patients with both the need and motivation for psychosocial intervention is ongoing. Evidence for an effect of mindfulness-based interventions among cancer patients is based on few studies with no systematic enrollment. METHODS: We used...... Danish population-based registries and clinical databases to determine differences in demographics, breast cancer and co-morbidity among 1208 women eligible for a randomized controlled trial (www.clinicaltrials.gov identifier: NCT00990977) of mindfulness-based stress reduction MBSR. RESULTS: Participants...

  10. A Randomized Controlled Trial of Hospital-based Case Management in Cancer Care

    DEFF Research Database (Denmark)

    Wulff, Christian N; Vedsted, Peter; Søndergaard, Jens

    2012-01-01

    BACKGROUND: Case management (CM) models based on experienced nurses are increasingly used to improve coordination and continuity of care for patients with complex health care needs. Anyway, little is known about the effects of hospital-based CM in cancer care.Aim.To analyse the effects of hospital......-based CM on (i) GPs' evaluation of information from the hospital and collaboration with the hospital staff and (ii) patients' contacts with GPs during daytime and out of hours. DESIGN: A randomized controlled trial allocated 280 colorectal cancer patients 1:1 to either a control group or CM intervention...

  11. Intake of meat, meat mutagens, and iron and the risk of breast cancer in the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial

    OpenAIRE

    Ferrucci, L.M.; Cross, A J; Graubard, B.I. (Barry I.); Brinton, L A; McCarty, C A; Ziegler, R. G.; Ma, X; Mayne, S T; R. Sinha

    2009-01-01

    Background: Epidemiological evidence on meat intake and breast cancer is inconsistent, with little research on potentially carcinogenic meat-related exposures. We investigated meat subtypes, cooking practices, meat mutagens, iron, and subsequent breast cancer risk. Methods: Among 52 158 women (aged 55–74 years) in the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial, who completed a food frequency questionnaire, 1205 invasive breast cancer cases were identified. We estimated mea...

  12. A Pilot Randomized Controlled Trial of Brief Cognitive-Behavioral Therapy for Anxiety in Patients with Terminal Cancer

    OpenAIRE

    Greer, Joseph A.; Traeger, Lara; Bemis, Heather; Solis, Jessica; Hendriksen, Ellen S.; Park, Elyse R; Pirl, William F.; Temel, Jennifer S.; Prigerson, Holly G.; Safren, Steven A.

    2012-01-01

    This article presents a pilot randomized controlled trial that examined the feasibility and potential efficacy of brief cognitive-behavioral therapy to reduce anxiety in patients with terminal cancer.

  13. Feasibility of a randomized trial on adjuvant radio-iodine therapy in differentiated thyroid cancer.

    OpenAIRE

    Dragoiescu, C.; Hoekstra, O S; Kuik, D J; Lips, P.T.A.M.; Plaizier, MA; Rodrigus, PT; Huijsmans, DA; Ribot, JG; Kuijpens, J; Coebergh, J. W.; Teule, G.J.J.

    2003-01-01

    BACKGROUND: Justification for adjuvant radio-iodine (I-131) therapy in differentiated thyroid cancer (DTC) is purely based on retrospective data. This is true for ablative therapy and even more so for high-dosage adjuvant schedules. Randomized trials on the latter application are considered impossible due to anticipated formidable sample sizes required in a disease with an overall excellent prognosis like DTC. OBJECTIVE: To develop and validate a model that could stratify for risk of recurren...

  14. Accessibility and Quality of Online Cancer-Related Clinical Trial Information for Naïve Searchers.

    Science.gov (United States)

    Abel, Gregory A; Cronin, Angel M; Earles, Kristofer; Gray, Stacy W

    2015-10-01

    Although the Internet may help to increase cancer patients' awareness of clinical trials, little is known about the accessibility and quality of online clinical trial information. We simulated the experience of a naïve cancer patient without clinical trial knowledge by searching three popular search engines for treatment information for breast, lung, and prostate cancer, and myelodysplastic syndromes (MDS). Two coders independently evaluated website content for accessibility and quality. We screened 120 websites and identified 40 unique sites for analysis. Overall, 85% [95% confidence interval (CI), 70%-94%] of sites mentioned clinical trials on the landing page and 68% (51%-81%) included links to specific trials. Overall readability was poor. Approximately half of websites (36%-68%) included information on the potential benefits and risks of clinical trials and 40% provided information about when the site had been updated (25%-57%). Among sites with links to specific clinical trials, only 44% (25%-65%) provided an interactive interface that would allow patients to customize search results; breast (100%) and prostate (50%) sites were more interactive than lung (25%) and MDS (14%; P = 0.007). Although cancer clinical trial information is widely available on the Internet, its quality is highly variable. Given the fact that many emerging cancer therapeutics are personalized based on disease or genomic characteristics, interactive web-based interfaces could serve as powerful vehicles to help patients locate appropriate clinical trials. Without enhanced efforts to ensure greater interactivity of cancer treatment websites, patient awareness of relevant clinical trials may remain low. PMID:26265204

  15. Effect of Mindfulness-Based Stress Reduction on Sleep Quality among Breast Cancer Patients - Results from a Randomized Controlled Trial

    OpenAIRE

    Andersen, Signe Ravn

    2012-01-01

    Context and Objective: The prevalence of sleep disturbance is high among cancer patients, and the sleep problems tend to last for years after end of treatment. As part of a large randomized controlled clinical trial (The MICA trial) evaluating the impact of Mindfulness-Based Stress Reduction (MBSR) on psychological and somatic symptoms among breast cancer patients, the aim of the current study was to evaluate the effect of MBSR on the secondary outcome measure ‘sleep quality’. A secondary pur...

  16. Irrefutable evidence for the use of docetaxel in newly diagnosed metastatic prostate cancer: results from the STAMPEDE and CHAARTED trials

    OpenAIRE

    Soest, Robert Jan; de Wit, Ronald

    2015-01-01

    textabstractAndrogen deprivation therapy (ADT) has been used in the treatment of metastatic prostate cancer since the first description of its hormonal dependence in 1941. In 2004, docetaxel chemotherapy became the mainstay of treatment in metastatic castration-resistant prostate cancer (mCRPC), following robust, albeit modest, survival benefit in two randomized phase 3 trials. The recently published CHAARTED trial was the first to show that combining ADT with docetaxel in men with hormone-na...

  17. An Open Letter to the Cancer Community Regarding Community Clinical Trials

    Science.gov (United States)

    The National Cancer Institute (NCI) is in the process of combining its two community-based research networks to create a single network that builds on the strengths of the Community Clinical Oncology Program/Minority-Based Community Clinical Oncology Prog

  18. A Novel Cross-Disciplinary Multi-Institute Approach to Translational Cancer Research: Lessons Learned from Pennsylvania Cancer Alliance Bioinformatics Consortium (PCABC

    Directory of Open Access Journals (Sweden)

    Ashokkumar A. Patel

    2007-01-01

    property/tech transfer agreements, and material transfer agreements that have been approved by each of the member institutions. This was the foundational work that has led to the development of a centralized data warehouse that has met each of the institutions’ IRB/HIPAA standards.Results: Currently, this “virtual biorepository” has over 58,000 annotated samples from 11,467 cancer patients available for research purposes. The clinical annotation of tissue samples is either done manually over the internet or semiautomated batch modes through mapping of local data elements with PCABC common data elements. The database currently holds information on 7188 cases (associated with 9278 specimens and 46,666 annotated blocks and blood samples of prostate cancer, 2736 cases (associated with 3796 specimens and 9336 annotated blocks and blood samples of breast cancer and 1543 cases (including 1334 specimens and 2671 annotated blocks and blood samples of melanoma. These numbers continue to grow, and plans to integrate new tumor sites are in progress. Furthermore, the group has also developed a central web-based tool that allows investigators to share their translational (genomics/proteomics experiment data on research evaluating potential biomarkers via a central location on the Consortium’s web site.Conclusions: The technological achievements and the statewide informatics infrastructure that have been established by the Consortium will enable robust and efficient studies of biomarkers and their relevance to the clinical course of cancer. Studies resulting from the creation of the Consortium may allow for better classification of cancer types, more accurate assessment of disease prognosis, a better ability to identify the most appropriate individuals for clinical trial participation, and better surrogate markers of disease progression and/or response to therapy.

  19. Surgical-site infections and postoperative complications: agreement between the Danish Gynecological Cancer Database and a randomized clinical trial

    DEFF Research Database (Denmark)

    Antonsen, Sofie L; Meyhoff, Christian Sylvest; Lundvall, Lene; Høgdall, Claus Kim

    2011-01-01

    : Evaluation study. SETTING: Danish Gynecological Cancer Database (DGCD) and the Danish multicenter trial on perioperative oxygen and surgical-site infections (PROXI). SAMPLE: Paired data from 222 patients who participated in the PROXI trial taking place at Copenhagen University Hospital, Rigshospitalet...

  20. Challenges of conducting clinical trials of natural products to combat cancer.

    Science.gov (United States)

    Paller, Channing J; Denmeade, Samuel R; Carducci, Michael A

    2016-06-01

    Numerous drugs that the US Food and Drug Administration (FDA) has approved for use in cancer therapy are derived from plants, including taxanes such as paclitaxel and vinca alkaloids such as vinblastine. Dietary supplements are another category of natural products that are widely used by patients with cancer, but without the FDA-reviewed evidence of safety and efficacy--be it related to survival, palliation, symptom mitigation, and/or immune system enhancement-that is required for therapy approval. Nearly half of patients in the United States with cancer report that they started taking new dietary supplements after being given a diagnosis of cancer. Oncologists are challenged in providing advice to patients about which supplements are safe and effective to use to treat cancer or the side effects of cancer therapy, and which supplements are antagonistic to standard treatment with chemotherapy, radiation, and/or immunotherapy. Despite the large number of trials that have been launched, the FDA has not approved any dietary supplement or food to prevent cancer, halt its growth, or prevent its recurrence. In this article, we review the primary challenges faced by researchers attempting to conduct rigorous trials of natural products, including shortages of funding due to lack of patentability, manufacturing difficulties, contamination, and lack of product consistency. We also highlight the methods used by dietary supplement marketers to persuade patients that a supplement is effective (or at least safe) even without FDA approval, as well as the efforts of the US government to protect the health and safety of its citizens by ensuring that the information used to market natural products is accurate. We close with a summary of the most widely used databases of information about the safety, efficacy, and interactions of dietary supplements. PMID:27379814

  1. A comparative study of breast cancer mass screening using ultrasonography and mammography at a single institution

    International Nuclear Information System (INIS)

    In order to evaluate the effectiveness of ultrasonic screening for breast cancer (US group) in comparison with mammographic screening (MMG group), we analyzed 78,214 breast screening examinees presenting between 2007 and 2008 at our institution. The cancer detection rate in the US group was lower than that in the MMG group. However, the average age in the US group was significantly younger than that in the MMG group, and the rate of annual screening was significantly higher in the former than in the latter. In the US subgroup who underwent annual screening, the recall rate and the cancer detection rate were significantly lower, and the rate of detection of early breast cancers was significantly higher than that in the subgroup who underwent screening biennially or at longer intervals, and there was no significant inter-group difference in the cancer detection rate between women in their 40s and those aged 50 or above who underwent annual screening. The proportion of early breast cancers detected was almost the same in the both groups. In summary, US screening as well as MMG screening seems to be useful for detection of early breast cancer. Although a high recall rate for US screening has been reported previously, annual screening and sufficient quality control based on the guidelines proposed by the Japan Association of Breast and Thyroid Sonology (JABTS) are considered to reduce the recall rate. (author)

  2. Recruitment for 'A pilot study of randomized controlled trial to evaluate the efficacy of lung cancer screening by thoracic CT'

    International Nuclear Information System (INIS)

    The objective of this study was to evaluate the efficacy of lung cancer screening by thoracic computed tomography (CT), a randomized controlled trial was planned in Japan. The randomized trial was designed as follows: participants were randomly assigned into 2 groups, CT group and XP group; XP group would receive 10 times of lung cancer screening by chest x-ray annually for 10 years; smokers in CT group would receive 10 times of lung cancer screening by thoracic CT annually for 10 years; non-smokers in CT group would receive 3 times of lung cancer screening by thoracic CT and 7 times of chest x-ray during 10 years. A pilot study was performed to evaluate the feasibility of the trial. A letter for recruitment to participate in the above trial was mailed to the citizens in Hakui City, who were 50-64 years old and underwent regular lung cancer screening using chest x-ray this year. In the letter we explained that the efficacy of lung cancer screening by thoracic CT had not been proved yet; only half of the participants could undergo thoracic CT screening; thoracic CT screening might cause unfavorable consequences like radiation exposure, false positives or overdiagnosis. Of 329 persons who received the letter of recruitment, 117 replied. After meeting with us for detailed explanation, 111 persons participated in the above randomized trial. The compliance of recruitment is high (approximately one third) and the above trial may be feasible. (author)

  3. African American Participation in Oncology Clinical Trials-Focus on Prostate Cancer: Implications, Barriers, and Potential Solutions.

    Science.gov (United States)

    Ahaghotu, Chiledum; Tyler, Robert; Sartor, Oliver

    2016-04-01

    In the United States, the incidence and mortality rates of many cancers, especially prostate cancer, are disproportionately high among African American men compared with Caucasian men. Recently, mortality rates for prostate cancer have declined more rapidly in African American versus Caucasian men, but prostate cancer is still the most common cancer and the second leading cause of cancer deaths in African American men in the United States. Compared with Caucasian men, prostate cancer occurs at younger ages, has a higher stage at diagnosis, and is more likely to progress after definitive treatments in African American men. Reasons for racial discrepancies in cancer are multifactorial and potentially include socioeconomic, cultural, nutritional, and biologic elements. In addition to improving access to novel therapies, clinical trial participation is essential to adequately establish the risks and benefits of treatments in African American populations. Considering the disproportionately high mortality rates noted in these groups, our understanding of the natural history and responses to therapies is limited. This review will explore African American underrepresentation in clinical trials with a focus on prostate cancer, and potentially effective strategies to engage African American communities in prostate cancer research. Solutions targeting physicians, investigators, the community, and health care systems are identified. Improvement of African American participation in prostate cancer clinical trials will benefit all stakeholders. PMID:26786562

  4. Integrating biomarkers in colorectal cancer trials in the West and China.

    Science.gov (United States)

    Tejpar, Sabine; Shen, Lin; Wang, Xicheng; Schilsky, Richard L

    2015-09-01

    The discovery of biomarkers that provide information on drug efficacy is recognized as essential for successful and cost-effective treatment of cancer. However, biomarker discovery is difficult, and requires multiple independent studies to identify a target that serves as a suitable predictor of efficacy and to ensure appropriate biomarker validation. Clinical trials that are performed, sometimes sequentially, in Europe, the USA or Asia, are often similar in their design, in part owing to regulatory, marketing, or safety considerations. We believe some of these trials offer additional unique opportunities for biomarker discovery or validation. There are multiple hurdles to overcome, such as homogenous tissue acquisition and analysis, defining and aligning biomarker hypotheses across trials, and the need to adapt sample sizes and trial designs. Nevertheless, we believe that a collaborative engagement of the academic, regulatory and pharmaceutical community can go a long way in addressing these issues and producing more-rapid results in the field of personalized medicine. In this Perspectives, we describe our views on the current fragmented approach to biomarker discovery and validation in relevant trials run within our own regions-that is, Europe, China, and the USA-and hope this article serves as a base for further reflection. PMID:25963094

  5. Supportive care for men with prostate cancer: why are the trials not working? A systematic review and recommendations for future trials.

    Science.gov (United States)

    Mazzarello Moore, Theresa Helen; King, Anna Jyoti Louise; Evans, Maggie; Sharp, Debbie; Persad, Raj; Huntley, Alyson Louise

    2015-08-01

    Men with prostate cancer are likely to have a long illness and experience psychological distress for which supportive care may be helpful. This systematic review describes the evidence for effectiveness and cost-effectiveness of supportive care for men with prostate cancer, taking into account treatment pathway and components of interventions. MEDLINE, EMBASE, CINAHL, CENTRAL, and Psychinfo were searched from inception--July 2013 for randomized controlled trials and controlled trials. Two authors independently assessed risk of bias and extracted data. Twenty-six studies were included (2740 participants). Interventions were delivered pre and during (n = 12), short-term (n = 8), and longer term (18 months) (n = 5) after primary treatment. No interventions were delivered beyond this time. Few trials recruited ethnic minorities and none recruited men in same sex relationships. Intervention components included information, education, health professional discussion, homework, peer discussion, buddy support, cognitive behavioral therapy, cognitive restructuring, psychoeducation, Reiki and relaxation. Most interventions were delivered for 5-10 weeks. Risk of bias of trials was assessed as unclear for most domains due to lack of information. The majority of trials measuring quality of life and depression found no effect. Relatively few trials measured anxiety, coping skills and self-efficacy, and the majority found no effect. No cost data were available. Trials of supportive care for men with prostate cancer cover a range of interventions but are limited by population diversity, inconsistent measurement and reporting of outcomes, and inability to assess risk of bias. Recommendations on design and conduct of future trials are presented. PMID:25828811

  6. High-Dose-Rate Brachytherapy as a Monotherapy for Favorable-Risk Prostate Cancer: A Phase II Trial

    International Nuclear Information System (INIS)

    Purpose: There are multiple treatment options for favorable-risk prostate cancer. High-dose-rate (HDR) brachytherapy as a monotherapy is appealing, but its use is still investigational. A Phase II trial was undertaken to explore the value of such treatment in low-to-intermediate risk prostate cancer. Methods and Materials: This was a single-institution, prospective study. Eligible patients had low-risk prostate cancer features but also Gleason scores of 7 (51% of patients) and stage T2b to T2c cancer. Treatment with HDR brachytherapy with a single implant was administered over 2 days. One of four fractionation schedules was used in a dose escalation study design: 3 fractions of 10, 10.5, 11, or 11.5 Gy. Patients were assessed with the Common Terminology Criteria for Adverse Events version 2.0 for urinary toxicity, the Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer scoring schema for rectal toxicity, and the Expanded Prostate Cancer Index Composite (EPIC) questionnaire to measure patient-reported health-related quality of life. Biochemical failure was defined as a prostate-specific antigen (PSA) nadir plus 2 ng/ml. Results: Between 2003 and 2008, 79 patients were enrolled. With a median follow-up of 39.5 months, biochemical relapse occurred in 7 patients. Three- and 5-year actuarial biochemical control rates were 88.4% (95% confidence interval [CI], 78.0-96.2%) and 85.1% (95% CI, 72.5-94.5%), respectively. Acute grade 3 urinary toxicity was seen in only 1 patient. There was no instance of acute grade 3 rectal toxicity. Rates of late grade 3 rectal toxicity, dysuria, hematuria, urinary retention, and urinary incontinence were 0%, 10.3%, 1.3%, 9.0%, and 0%, respectively. No grade 4 or greater toxicity was recorded. Among the four (urinary, bowel, sexual, and hormonal) domains assessed with the EPIC questionnaire, only the sexual domain did not recover with time. Conclusions: HDR brachytherapy as a monotherapy for favorable

  7. High-Dose-Rate Brachytherapy as a Monotherapy for Favorable-Risk Prostate Cancer: A Phase II Trial

    Energy Technology Data Exchange (ETDEWEB)

    Barkati, Maroie [Division of Radiation Oncology, Peter MacCallum Cancer Centre, East Melbourne (Australia); Williams, Scott G., E-mail: scott.williams@petermac.org [Division of Radiation Oncology, Peter MacCallum Cancer Centre, East Melbourne (Australia); Department of Pathology, University of Melbourne, Melbourne (Australia); Foroudi, Farshad; Tai, Keen Hun; Chander, Sarat [Division of Radiation Oncology, Peter MacCallum Cancer Centre, East Melbourne (Australia); Department of Pathology, University of Melbourne, Melbourne (Australia); Dyk, Sylvia van [Division of Radiation Oncology, Peter MacCallum Cancer Centre, East Melbourne (Australia); See, Andrew [Ballarat Austin Radiation Oncology Centre, Ballarat (Australia); Duchesne, Gillian M. [Division of Radiation Oncology, Peter MacCallum Cancer Centre, East Melbourne (Australia); Department of Pathology, University of Melbourne, Melbourne (Australia)

    2012-04-01

    Purpose: There are multiple treatment options for favorable-risk prostate cancer. High-dose-rate (HDR) brachytherapy as a monotherapy is appealing, but its use is still investigational. A Phase II trial was undertaken to explore the value of such treatment in low-to-intermediate risk prostate cancer. Methods and Materials: This was a single-institution, prospective study. Eligible patients had low-risk prostate cancer features but also Gleason scores of 7 (51% of patients) and stage T2b to T2c cancer. Treatment with HDR brachytherapy with a single implant was administered over 2 days. One of four fractionation schedules was used in a dose escalation study design: 3 fractions of 10, 10.5, 11, or 11.5 Gy. Patients were assessed with the Common Terminology Criteria for Adverse Events version 2.0 for urinary toxicity, the Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer scoring schema for rectal toxicity, and the Expanded Prostate Cancer Index Composite (EPIC) questionnaire to measure patient-reported health-related quality of life. Biochemical failure was defined as a prostate-specific antigen (PSA) nadir plus 2 ng/ml. Results: Between 2003 and 2008, 79 patients were enrolled. With a median follow-up of 39.5 months, biochemical relapse occurred in 7 patients. Three- and 5-year actuarial biochemical control rates were 88.4% (95% confidence interval [CI], 78.0-96.2%) and 85.1% (95% CI, 72.5-94.5%), respectively. Acute grade 3 urinary toxicity was seen in only 1 patient. There was no instance of acute grade 3 rectal toxicity. Rates of late grade 3 rectal toxicity, dysuria, hematuria, urinary retention, and urinary incontinence were 0%, 10.3%, 1.3%, 9.0%, and 0%, respectively. No grade 4 or greater toxicity was recorded. Among the four (urinary, bowel, sexual, and hormonal) domains assessed with the EPIC questionnaire, only the sexual domain did not recover with time. Conclusions: HDR brachytherapy as a monotherapy for favorable

  8. Designing the selenium and bladder cancer trial (SELEBLAT, a phase lll randomized chemoprevention study with selenium on recurrence of bladder cancer in Belgium

    Directory of Open Access Journals (Sweden)

    Goossens Maria E

    2012-03-01

    Full Text Available Abstract Background In Belgium, bladder cancer is the fifth most common cancer in males (5.2% and the sixth most frequent cause of death from cancer in males (3.8%. Previous epidemiological studies have consistently reported that selenium concentrations were inversely associated with the risk of bladder cancer. This suggests that selenium may also be suitable for chemoprevention of recurrence. Method The SELEBLAT study opened in September 2009 and is still recruiting all patients with non-invasive transitional cell carcinoma of the bladder on TURB operation in 15 Belgian hospitals. Recruitment progress can be monitored live at http://www.seleblat.org. Patients are randomly assigned to selenium yeast (200 μg/day supplementation for 3 years or matching placebo, in addition to standard care. The objective is to determine the effect of selenium on the recurrence of bladder cancer. Randomization is stratified by treatment centre. A computerized algorithm randomly assigns the patients to a treatment arm. All study personnel and participants are blinded to treatment assignment for the duration of the study. Design The SELEnium and BLAdder cancer Trial (SELEBLAT is a phase III randomized, placebo-controlled, academic, double-blind superior trial. Discussion This is the first report on a selenium randomized trial in bladder cancer patients. Trial registration ClinicalTrials.gov identifier: NCT00729287

  9. Targeting histone methyltransferases and demethylases in clinical trials for cancer therapy.

    Science.gov (United States)

    Morera, Ludovica; Lübbert, Michael; Jung, Manfred

    2016-01-01

    The term epigenetics is defined as heritable changes in gene expression that are not due to alterations of the DNA sequence. In the last years, it has become more and more evident that dysregulated epigenetic regulatory processes have a central role in cancer onset and progression. In contrast to DNA mutations, epigenetic modifications are reversible and, hence, suitable for pharmacological interventions. Reversible histone methylation is an important process within epigenetic regulation, and the investigation of its role in cancer has led to the identification of lysine methyltransferases and demethylases as promising targets for new anticancer drugs. In this review, we describe those enzymes and their inhibitors that have already reached the first stages of clinical trials in cancer therapy, namely the histone methyltransferases DOT1L and EZH2 as well as the demethylase LSD1. PMID:27222667

  10. Initial LDCT appearance of incident lung cancers in the ITALUNG trial

    International Nuclear Information System (INIS)

    Highlights: • 85% of screen-detected incident lung cancers show focal abnormalities in prior LDCTs. • These tumors can initially show a non-nodular shape. • Persistent focal pulmonary abnormalities need to be monitored in screening LDCTs. - Abstract: Objectives: To characterize early features of lung cancers detected with low-dose computed tomography (LDCT) screening. Materials and methods: Two radiologists reviewed prior LDCTs in 20 incident cancers diagnosed at annual repeat screening rounds and 83 benign nodules observed in the ITALUNG trial. Results: No abnormality was observed in 3 cancers. Focal abnormalities in prior LDCT were identified in 17(85%) cancers (14 adenocarcinomas; 14 stage I). Initial abnormalities were intra-pulmonary in 10, subpleural in 4 and perifissural in 3. Average mean diameter was 9 mm (range 4.5–18 mm). Nine exhibited solid, 4 part-solid and 4 non-solid density. The margins were smooth and regular in 5 cases, lobulated in 6, irregular with spiculations in 3 and blurred in 3. Ten (59%) initial focal abnormalities had a round or oval nodular shape, but 7(41%) had a non-nodular complex (n = 5) or “stripe-like” (n = 2) shape. Bronchus sign was observed in 3 cases and association with cystic airspace in 2 cases. Non-solid density, complex or “stripe-like” shape, bronchus sign and association with cystic airspace had a specificity higher than 90%, but positive predictive value of every feature of incident lung cancers was low (range 10.4–50%). Conclusions: The vast majority of cancers diagnosed at annual repeat show corresponding focal lung abnormalities in prior LDCTs. Perifissural location and non-nodular shape do not exclude the possibility of early lung cancer. Since specificity of the early features of incident lung cancer is incomplete and their positive predictive value is low, all focal pulmonary abnormalities detected in screened subjects should be re-evaluated in subsequent LDCTs

  11. Initial LDCT appearance of incident lung cancers in the ITALUNG trial

    Energy Technology Data Exchange (ETDEWEB)

    Mascalchi, Mario, E-mail: m.mascalchi@dfc.unifi.it [Quantitative and Functional Radiology Research Programs at Meyer Children Hospital and Careggi Hospital of Florence, Florence (Italy); “Mario Serio” Department of Experimental and Clinical Biomedical Sciences, University of Florence, Florence (Italy); Picozzi, Giulia [Institute for Oncological Study and Prevention, Florence (Italy); Falchini, Massimo [“Mario Serio” Department of Experimental and Clinical Biomedical Sciences, University of Florence, Florence (Italy); Vella, Alessandra [Nuclear Medicine Unit, Le Scotte University Hospital, Siena (Italy); Diciotti, Stefano [Department of Electrical, Electronic, and Information Engineering “Guglielmo Marconi”, University of Bologna, Cesena (Italy); Carrozzi, Laura [Cardiopulmonary Department University Hospital, Pisa (Italy); Pegna, Andrea Lopes [Pneumonology Department, Careggi Hospital, Florence (Italy); Falaschi, Fabio [2nd RadiologyUnit Cisanello University Hospital of Pisa, Pisa (Italy)

    2014-11-15

    Highlights: • 85% of screen-detected incident lung cancers show focal abnormalities in prior LDCTs. • These tumors can initially show a non-nodular shape. • Persistent focal pulmonary abnormalities need to be monitored in screening LDCTs. - Abstract: Objectives: To characterize early features of lung cancers detected with low-dose computed tomography (LDCT) screening. Materials and methods: Two radiologists reviewed prior LDCTs in 20 incident cancers diagnosed at annual repeat screening rounds and 83 benign nodules observed in the ITALUNG trial. Results: No abnormality was observed in 3 cancers. Focal abnormalities in prior LDCT were identified in 17(85%) cancers (14 adenocarcinomas; 14 stage I). Initial abnormalities were intra-pulmonary in 10, subpleural in 4 and perifissural in 3. Average mean diameter was 9 mm (range 4.5–18 mm). Nine exhibited solid, 4 part-solid and 4 non-solid density. The margins were smooth and regular in 5 cases, lobulated in 6, irregular with spiculations in 3 and blurred in 3. Ten (59%) initial focal abnormalities had a round or oval nodular shape, but 7(41%) had a non-nodular complex (n = 5) or “stripe-like” (n = 2) shape. Bronchus sign was observed in 3 cases and association with cystic airspace in 2 cases. Non-solid density, complex or “stripe-like” shape, bronchus sign and association with cystic airspace had a specificity higher than 90%, but positive predictive value of every feature of incident lung cancers was low (range 10.4–50%). Conclusions: The vast majority of cancers diagnosed at annual repeat show corresponding focal lung abnormalities in prior LDCTs. Perifissural location and non-nodular shape do not exclude the possibility of early lung cancer. Since specificity of the early features of incident lung cancer is incomplete and their positive predictive value is low, all focal pulmonary abnormalities detected in screened subjects should be re-evaluated in subsequent LDCTs.

  12. Relationship of ZNF423 and CTSO with breast cancer risk in two randomised tamoxifen prevention trials.

    Science.gov (United States)

    Brentnall, Adam R; Cuzick, Jack; Byers, Helen; Segal, Corrinne; Reuter, Caroline; Detre, Simone; Sestak, Ivana; Howell, Anthony; Powles, Trevor J; Newman, William G; Dowsett, Mitchell

    2016-08-01

    A case-control study from two randomised breast cancer prevention trials of tamoxifen and raloxifene (P-1 and P-2) identified single-nucleotide polymorphisms (SNPs) in or near genes ZNF423 and CTSO as factors which predict which women will derive most anti-cancer benefit from selective oestrogen receptor modulator (SERM) therapy. In this article, we further examine this question using blood samples from two randomised tamoxifen prevention trials: the International Breast Cancer Intervention Study I (IBIS-I) and the Royal Marsden trial (Marsden). A nested case-control study was designed with 2:1 matching in IBIS-I and 1:1 matching in Marsden. The OncoArray was used for genotyping and included two SNPs previously identified (rs8060157 in ZNF423 and rs10030044 near CTSO), and 102 further SNPs within the same regions. Overall, there were 369 cases and 662 controls, with 148 cases and 268 controls from the tamoxifen arms. Odds ratios were estimated by conditional logistic regression, with Wald 95 % confidence intervals. In the tamoxifen arms, the per-allele odds ratio for rs8060157 was 0.99 (95 %CI 0.73-1.34) and 1.00 (95 %CI 0.76-1.33) for rs10030044. In the placebo arm, the odds ratio was 1.10 (95 %CI 0.87-1.40) for rs8060157 and 1.01 (95 %CI 0.79-1.29) for rs10030044. There was no evidence to suggest that other SNPs in the surrounding regions of these SNPs might predict response to tamoxifen. Results from these two prevention trials do not support the earlier findings. rs8060157 in ZNF423 and rs10030044 near CTSO do not appear to predict response to tamoxifen. PMID:27400912

  13. Frequency format diagram and probability chart for breast cancer risk communication: a prospective, randomized trial

    Directory of Open Access Journals (Sweden)

    Wahner-Roedler Dietlind

    2008-10-01

    Full Text Available Abstract Background Breast cancer risk education enables women make informed decisions regarding their options for screening and risk reduction. We aimed to determine whether patient education regarding breast cancer risk using a bar graph, with or without a frequency format diagram, improved the accuracy of risk perception. Methods We conducted a prospective, randomized trial among women at increased risk for breast cancer. The main outcome measurement was patients' estimation of their breast cancer risk before and after education with a bar graph (BG group or bar graph plus a frequency format diagram (BG+FF group, which was assessed by previsit and postvisit questionnaires. Results Of 150 women in the study, 74 were assigned to the BG group and 76 to the BG+FF group. Overall, 72% of women overestimated their risk of breast cancer. The improvement in accuracy of risk perception from the previsit to the postvisit questionnaire (BG group, 19% to 61%; BG+FF group, 13% to 67% was not significantly different between the 2 groups (P = .10. Among women who inaccurately perceived very high risk (≥ 50% risk, inaccurate risk perception decreased significantly in the BG+FF group (22% to 3% compared with the BG group (28% to 19% (P = .004. Conclusion Breast cancer risk communication using a bar graph plus a frequency format diagram can improve the short-term accuracy of risk perception among women perceiving inaccurately high risk.

  14. Protocol for the OUTREACH trial: a randomised trial comparing delivery of cancer systemic therapy in three different settings - patient's home, GP surgery and hospital day unit

    Directory of Open Access Journals (Sweden)

    McCrone Paul

    2011-10-01

    Full Text Available Abstract Background The national Cancer Reform Strategy recommends delivering care closer to home whenever possible. Cancer drug treatment has traditionally been administered to patients in specialist hospital-based facilities. Technological developments mean that nowadays, most treatment can be delivered in the out-patient setting. Increasing demand, care quality improvements and patient choice have stimulated interest in delivering some treatment to patients in the community, however, formal evaluation of delivering cancer treatment in different community settings is lacking. This randomised trial compares delivery of cancer treatment in the hospital with delivery in two different community settings: the patient's home and general practice (GP surgeries. Methods/design Patients due to receive a minimum 12 week course of standard intravenous cancer treatment at two hospitals in the Anglia Cancer Network are randomised on a 1:1:1 basis to receive treatment in the hospital day unit (control arm, or their own home, or their choice of one of three neighbouring GP surgeries. Overall patient care, treatment prescribing and clinical review is undertaken according to standard local practice. All treatment is dispensed by the local hospital pharmacy and treatment is delivered by the hospital chemotherapy nurses. At four time points during the 12 week study period, information is collected from patients, nursing staff, primary and secondary care teams to address the primary end point, patient-perceived benefits (using the emotional function domain of the EORTC QLQC30 patient questionnaire, as well as secondary end points: patient satisfaction, safety and health economics. Discussion The Outreach trial is the first randomised controlled trial conducted which compares delivery of out-patient based intravenous cancer treatment in two different community settings with standard hospital based treatment. Results of this study may better inform all key

  15. Some radiation protection problems in a cancer hospital and associated research institute

    International Nuclear Information System (INIS)

    Experience gained at the Royal Marsden Hospital and Institute of Cancer Research has shown that with attention to the design of facilities and procedures and an active personnel monitoring policy, relatively large scale radiation commitments can proceed with individual whole body doses to staff being held well below 15 mSv/annum. In spite of detailed attention to control of radiation work, traumatic radiation incidents may still occur. (H.K.)

  16. Architectural and engineering design work for the Nevada Cancer Institute facility

    International Nuclear Information System (INIS)

    The purpose of this project was to complete the architectural and engineering design, program planning, and other preliminary work necessary to construct the new Nevada Cancer Institute facility. These goals were accomplished with the construction of a new building of approximately 119,000 gross square feet. The facility houses the diagnostic and radio therapeutic treatment laboratories, radiation oncology treatment facility, physician offices, and clinical research areas

  17. Treatment outcomes of female germ cell tumors: The Egyptian National Cancer Institute experience

    OpenAIRE

    Saber, Magdy M; Zeeneldin, Ahmed A.; Mosaad M. El Gammal; Salem E. Salem; Amira D. Darweesh; Alshaymaa A. Abdelaziz; Manar Monir

    2014-01-01

    Introduction: Female germ cell tumors (GCTS) are rare tumors that carry a good prognosis. Aim: To report the experience of the Egyptian National Cancer Institute (ENCI) in managing female GCTs. Methods: This retrospective study included 19 females with ovarian GCTs presenting to the ENCI between 2006 and 2010. Results: The median age was 23 years. Ovaries were the primary site in all patients. Dysgerminoma and teratoma were the predominant pathologies followed by mixed GCT in females...

  18. Cabozantinib-Induced Thyroid Dysfunction: A Review of Two Ongoing Trials for Metastatic Bladder Cancer and Sarcoma

    OpenAIRE

    Yavuz, Sahzene; Apolo, Andrea B.; Kummar, Shivaani; del Rivero, Jaydira; Madan, Ravi A.; Shawker, Thomas; Reynolds, James; Celi, Francesco S

    2014-01-01

    Background: Thyroid dysfunction is a common adverse event associated with tyrosine kinase inhibitors (TKI), but its underlying pathophysiology is unclear. Cabozantinib is a novel TKI currently Food and Drug Administration approved for advanced medullary thyroid cancer and tested in clinical trials on solid tumors including prostate, liver, bladder, breast, and ovarian cancer.

  19. Long-term clinical outcomes of 420 consecutive prostate cancer patients in a single institute.

    Directory of Open Access Journals (Sweden)

    Edamura,Kohei

    2005-10-01

    Full Text Available

    This study was undertaken to reveal the trends of prostate cancer and the outcome of treatment modalities for each disease stage in patients in a single institute over a 10-year period. From January 1994 through December 2003, 420 consecutive patients with previously untreated and histologically confirmed prostate cancer were analyzed for annual distributions of disease stages and treatment modalities and for long-term clinical progression-free survival, prostate cancer-specific survival, and prostate-specific antigen (PSA failure-free survival rates for each stage and treatment modality. Annual trends showed that the number of patients, especially those with clinically localized cancer, increased dramatically. The 5-year disease-specific survival rates for patients with clinically localized disease were 100 percent for all treatment modalities, including hormonal therapy alone. Patients with PSA levels less than 10 ng/ml showed an 81 percent 5-year PSA failure-free survival rate with radical prostatectomy. Stage C patients treated by surgery or radiation-based therapy with concomitant hormonal therapy obtained 93 percent and 100 percent cause-specific survival rates, respectively, and those treated by hormonal therapy alone showed a 79 percent rate. The number of patients with localized prostate cancer was increasing in this decade. While long-term hormonal therapy alone was highly efficient in controlling localized prostate cancer, radical therapies in conjunction with neo-adjuvant hormonal therapy produced better survival rates in cases of locally advanced disease.

  20. Predictive Accuracy of the PanCan Lung Cancer Risk Prediction Model -External Validation based on CT from the Danish Lung Cancer Screening Trial

    DEFF Research Database (Denmark)

    Winkler Wille, Mathilde M.; van Riel, Sarah J.; Saghir, Zaigham; Dirksen, Asger; Pedersen, Jesper Holst; Jacobs, Colin; Thomsen, Laura Hohwü; Scholten, Ernst Th; Skovgaard, Lene T.; van Ginneken, Bram; Skovgaard, Lene Theil

    2015-01-01

    Objectives: Lung cancer risk models should be externally validated to test generalizability and clinical usefulness. The Danish Lung Cancer Screening Trial (DLCST) is a population-based prospective cohort study, used to assess the discriminative performances of the PanCan models. Methods: From th...

  1. Randomized controlled trial of a collaborative care intervention to manage cancer-related symptoms: lessons learned

    Science.gov (United States)

    Steel, Jennifer; Geller, David A; Tsung, Allan; Marsh, J Wallis; Dew, Mary Amanda; Spring, Michael; Grady, Jonathan; Likumahuwa, Sonja; Dunlavy, Andrea; Youssef, Michael; Antoni, Michael; Butterfield, Lisa H; Schulz, Richard; Day, Richard; Helgeson, Vicki; Kim, Kevin H; Gamblin, T Clark

    2012-01-01

    Background Collaborative care interventions to treat depression have begun to be tested in settings outside of primary care. However, few studies have expanded the collaborative care model to other settings and targeted comorbid physical symptoms of depression. Purpose The aims of this report were to: (1) describe the design and methods of a trial testing the efficacy of a stepped collaborative care intervention designed to manage cancer-related symptoms and improve overall quality of life in patients diagnosed with hepatobiliary carcinoma; and (2) share the lessons learned during the design, implementation, and evaluation of the trial. Methods The trial was a phase III randomized controlled trial testing the efficacy of a stepped collaborative care intervention to reduce depression, pain, and fatigue in patients diagnosed with advanced cancer. The intervention was compared to an enhanced usual care arm. The primary outcomes included the Center for Epidemiological Studies-Depression scale, Brief Pain Inventory, and Functional Assessment of Cancer Therapy (FACT)-Fatigue, and the FACT-Hepatobiliary. Sociodemographic and disease-specific characteristics were recorded from the medical record; Natural Killer cells and cytokines that are associated with these symptoms and with disease progression were assayed from serum. Results and Discussion The issues addressed include: (1) development of collaborative care in the context of oncology (e.g., timing of the intervention, tailoring of the intervention, ethical issues regarding randomization of patients, and changes in medical treatment over the course of the study); (2) use of a website by chronically ill populations (e.g., design and access to the website, development of the website and intervention, ethical issues associated with website development, website usage, and unanticipated costs associated with website development); (3) evaluation of the efficacy of intervention (e.g., patient preferences, proxy raters

  2. Intravenous chemotherapy for resected gastric cancer: meta-analysis of randomized controlled trials

    Institute of Scientific and Technical Information of China (English)

    Jian-Kun Hu; You-Ping Li; Zhi-Xin Chen; Zong-Guang Zhou; Bo Zhang; Jing Tian; Jia-Ping Chen; Li Wang; Chao-Hua Wang; Hong-Yan Chen

    2002-01-01

    gastrectomy was better than surgery alone (odds ratio 0.56, 95 %CI 0.40-0.79). There was a significant difference between the two groups by u-test (P=0.0008). Sensitivity analysis revealed the same difference (odds ratio 0.81, 95 % CI 0.70-0.94). Of fourteen trials, only three studies were of high quality according to the Jadad-scale (with three score). There was one meta-analysis trial and the others, about ten trials, were of low quality. There was no trial which mentioned samplesize calculation, allocation concealment, intention-to-treat analysis. Most of the thals didn't describe the blind-procedure. There were five trials which detailed the side-effects according to the toxicity grade by WHO standard. The sideeffects halting treatment were haematologic and biochemical toxicity, debilitating nausea and vomiting. There were two patients died of chemotherapy toxicity.CONCLUSION: Based on the review, intravenous chemotherapy after gastrectomy may have positive treatment effect on gastric cancer. However, the evidence is not strong because of the general low methodologic quality of the RCTs.Therefore, we can't make the conclusion that intravenous chemotherapy after gastrectomy may have better treatment effect on gastric cancer than that of surgery alone. Rigorously designed, randomised, double-blind, placebo-controlled trials are required.

  3. Sipjeondaebo-tang in patients with cancer with anorexia: a protocol for a pilot, randomised, controlled trial

    OpenAIRE

    Cheon, ChunHoo; Park, Sunju; Park, Yu Lee; Huang, Ching-Wen; Ko, Youme; Jang, Bo-Hyoung; Shin, Yong-Cheol; Ko, Seong-Gyu

    2016-01-01

    Introduction Cancer-related anorexia is the loss of appetite or desire to eat in patients with cancer. Although treatments for cancer-related anorexia do exist, patients have sought complementary and alternative medicine including herbal remedies, due to safety concerns. Sipjeondaebo-tang is one among other popular herbal medicines that are beneficial to management of anorexia in Korea. The purpose of this study is to examine the feasibility for a full randomised clinical trial of Sipjeondaeb...

  4. Effects of an 18-week exercise programme started early during breast cancer treatment: a randomised controlled trial

    OpenAIRE

    Travier, Noémie; Velthuis, Miranda J; Steins Bisschop, Charlotte N.; van den Buijs, Bram; Monninkhof, Evelyn M; Backx, Frank; Los, Maartje; Erdkamp, Frans; Bloemendal, Haiko J.; Rodenhuis, Carla; de Roos, Marnix A.J.; Verhaar, Marlies; ten Bokkel Huinink, Daan; van der Wall, Elsken; Peeters, Petra H. M.

    2015-01-01

    Background Exercise started shortly after breast cancer diagnosis might prevent or diminish fatigue complaints. The Physical Activity during Cancer Treatment (PACT) study was designed to primarily examine the effects of an 18-week exercise intervention, offered in the daily clinical practice setting and starting within 6 weeks after diagnosis, on preventing an increase in fatigue. Methods This multi-centre controlled trial randomly assigned 204 breast cancer patients to usual care (n = 102) o...

  5. KRAS oncogene in lung cancer: focus on molecularly driven clinical trials

    Directory of Open Access Journals (Sweden)

    Emmanuelle Kempf

    2016-03-01

    Full Text Available KRAS mutations are the most frequent molecular abnormalities found in one out of four nonsmall cell lung cancers (NSCLC. Their incidence increases in cases of adenocarcinoma, smokers and Caucasian patients. Their negative value in terms of prognosis and responsiveness to both standard chemotherapy and targeted therapies remains under debate. Many drugs have been developed specifically for KRAS-mutated NSCLC patients. Direct inhibition of RAS activation failed to show any clinical efficacy. Inhibition of downstream targets of the mitogen-activated protein kinase (MEK pathway is a promising strategy: phase II combinations of MEK 1/2 kinase inhibitors with chemotherapy doubled patients’ clinical outcomes. One phase III trial in such a setting is ongoing. Double inhibition of MEK and epidermal growth factor receptor proteins is currently being assessed in early-phase trials. The association with mammalian target of rapamycin pathway inhibition leads to non-manageable toxicity. Other strategies, such as inhibition of molecular heat-shock proteins 90 or focal adhesion kinase are currently assessed. Abemaciclib, a cyclin-dependent kinase 4/6 inhibitor, showed promising results in a phase I trial, with a 54% disease control rate. Results of an ongoing phase III trial are warranted. Immunotherapy might be the next relevant step in KRAS-mutated NSCLC management due to the high burden of associated mutations and neo-antigens.

  6. Statistical evaluation of surrogate endpoints with examples from cancer clinical trials.

    Science.gov (United States)

    Buyse, Marc; Molenberghs, Geert; Paoletti, Xavier; Oba, Koji; Alonso, Ariel; Van der Elst, Wim; Burzykowski, Tomasz

    2016-01-01

    A surrogate endpoint is intended to replace a clinical endpoint for the evaluation of new treatments when it can be measured more cheaply, more conveniently, more frequently, or earlier than that clinical endpoint. A surrogate endpoint is expected to predict clinical benefit, harm, or lack of these. Besides the biological plausibility of a surrogate, a quantitative assessment of the strength of evidence for surrogacy requires the demonstration of the prognostic value of the surrogate for the clinical outcome, and evidence that treatment effects on the surrogate reliably predict treatment effects on the clinical outcome. We focus on these two conditions, and outline the statistical approaches that have been proposed to assess the extent to which these conditions are fulfilled. When data are available from a single trial, one can assess the "individual level association" between the surrogate and the true endpoint. When data are available from several trials, one can additionally assess the "trial level association" between the treatment effect on the surrogate and the treatment effect on the true endpoint. In the latter case, the "surrogate threshold effect" can be estimated as the minimum effect on the surrogate endpoint that predicts a statistically significant effect on the clinical endpoint. All these concepts are discussed in the context of randomized clinical trials in oncology, and illustrated with two meta-analyses in gastric cancer. PMID:25682941

  7. The impact of radiologists' expertise on screen results decisions in a CT lung cancer screening trial

    International Nuclear Information System (INIS)

    To evaluate the impact of radiological expertise on screen result decisions in a CT lung cancer screening trial. In the NELSON lung cancer screening trial, the baseline CT result was based on the largest lung nodule's volume. The protocol allowed radiologists to manually adjust screen results in cases of high suspicion of benign or malignant nodule nature. Participants whose baseline CT result was based on a solid or part-solid nodule were included in this study. Adjustments by radiologists at baseline were evaluated. Histology was the reference for diagnosis or to confirm benignity and stability on subsequent CT examinations. A total of 3,318 participants (2,796 male, median age 58.0 years) were included. In 195 participants (5.9 %) the initial baseline screen result was adjusted by the radiologist. Adjustment was downwards from positive or indeterminate to negative in two and 119 participants, respectively, and from positive to indeterminate in 65 participants. None of these nodules turned out to be malignant. In 9/195 participants (4.6 %) the screen result was adjusted upwards from negative to indeterminate or indeterminate to positive; two nodules were malignant. In one in 20 cases of baseline lung cancer screening, nodules were reclassified by the radiologist, leading to a reduction of false-positive screen results. (orig.)

  8. Preparation of human ovarian cancer ascites-derived exosomes for a clinical trial.

    Science.gov (United States)

    Navabi, H; Croston, D; Hobot, J; Clayton, A; Zitvogel, L; Jasani, B; Bailey-Wood, R; Wilson, K; Tabi, Z; Mason, M D; Adams, M

    2005-01-01

    Despite initial response to chemotherapy, at least 50% of ovarian cancer patients will relapse within 18 months. Progression-free survival is related to tumour infiltration with cytotoxic T lymphocytes (CTL). We recently demonstrated that CD8+ T cell responses to recall antigens improve following tumour response to chemotherapy. Vaccination designed to expand CTL, specific for tumour-associated antigens, may be a means of improving outcome. We are planning a clinical trial in advanced ovarian cancer patients undergoing chemotherapy using a combination of a Toll-like receptor 3 (TLR3) agonist and tumour-associated ascites-derived exosomes. Tumour-derived exosomes are a potential source of tumour antigens able to induce CD8+ T cell responses when loaded on mature dendritic cells (DC). DC maturation can be achieved with Toll-like receptor (TLR) agonists, such as the GMP-grade synthetic double stranded RNA, poly[I]:poly[C12U] (Ampligen) which is a TLR-3 agonist. Here, we describe the development of a method suitable for the preparation of GMP-grade exosomes from the ascites fluid of ovarian cancer patients, and the methods used for the molecular and immunological characterisation of these exosomes preceding their use in a clinical trial. PMID:16061407

  9. IGF-1R as an anti-cancer target-trials and tribulations

    Institute of Scientific and Technical Information of China (English)

    Helen X.Chen; Elad Sharon

    2013-01-01

    Type Ⅰ insulin-like growth factor receptor (IGF-1R) has long been recognized for its role in tumorigenesis and growth,but only recently have the tools for targeting the IGF pathway become available.More than 10 IGF/IGF-1R inhibitors have entered clinical trials,and these belong to three main classes:(1)monoclonal antibodies against IGF-1R,(2) monoclonal antibodies against IGF-1R ligands (IGF-1 and IGF-2),and (3) IGF-1R tyrosine kinase inhibitors.These IGF-1R-targeting agents share common effects on IGF-1R signaling but differ in mechanisms of action,spectrum of target inhibition,and pharmacological features.Clinical activity of IGF-1R inhibitors has been demonstrated with sustained responses in a small number of patients with select tumor types,such as Ewing sarcoma and thymoma.However,many large clinical trials involving patients with adult tumors,including non-small cell lung cancer,breast cancer,and pancreatic cancer,failed to show clinical benefit in the overall patient population.Possible reasons for failure include the complexity of the IGF-1R/insulin receptor system and parallel growth and survival pathways,as well as a lack of patient selection markers.While IGF-1R remains a valid target for selected tumor types,identification of predictive markers and rational combinations will be critical to success in future development.

  10. Resection of the primary tumour versus no resection prior to systemic therapy in patients with colon cancer and synchronous unresectable metastases (UICC stage IV): SYNCHRONOUS - a randomised controlled multicentre trial (ISRCTN30964555)

    International Nuclear Information System (INIS)

    Currently, it remains unclear, if patients with colon cancer and synchronous unresectable metastases who present without severe symptoms should undergo resection of the primary tumour prior to systemic chemotherapy. Resection of the primary tumour may be associated with significant morbidity and delays the beginning of chemotherapy. However, it may prevent local symptoms and may, moreover, prolong survival as has been demonstrated in patients with metastatic renal cell carcinoma. It is the aim of the present randomised controlled trial to evaluate the efficacy of primary tumour resection prior to systemic chemotherapy to prolong survival in patients with newly diagnosed colon cancer who are not amenable to curative therapy. The SYNCHRONOUS trial is a multicentre, randomised, controlled, superiority trial with a two-group parallel design. Colon cancer patients with synchronous unresectable metastases are eligible for inclusion. Exclusion criteria are primary tumour-related symptoms, inability to tolerate surgery and/or systemic chemotherapy and history of another primary cancer. Resection of the primary tumour as well as systemic chemotherapy is provided according to the standards of the participating institution. The primary endpoint is overall survival that is assessed with a minimum follow-up of 36 months. Furthermore, it is the objective of the trial to assess the safety of both treatment strategies as well as quality of life. The SYNCHRONOUS trial is a multicentre, randomised, controlled trial to assess the efficacy and safety of primary tumour resection before beginning of systemic chemotherapy in patients with metastatic colon cancer not amenable to curative therapy. http://www.controlled-trials.com/ISRCTN30964555

  11. Chemoprevention of Lung Cancer: Prospects and Disappointments in Human Clinical Trials

    Directory of Open Access Journals (Sweden)

    William N. Rom

    2013-01-01

    Full Text Available Decreasing the risk of lung cancer, or preventing its development in high-risk individuals, would have a huge impact on public health. The most effective means to decrease lung cancer incidence is to eliminate exposure to carcinogens. However, with recent advances in the understanding of pulmonary carcinogenesis and the identification of intermediate biomarkers, the prospects for the field of chemoprevention research have improved dramatically. Here we review the most recent research in lung cancer chemoprevention—focusing on those agents that have been investigated in human clinical trials. These agents fall into three major categories. First, oxidative stress plays an important role in pulmonary carcinogenesis; and therefore, antioxidants (including vitamins, selenium, green tea extracts, and isothiocyanates may be particularly effective in preventing the development of lung cancer. Second, inflammation is increasingly accepted as a crucial factor in carcinogenesis, and many investigators have focused on anti-inflammatory agents, such as glucocorticoids, NSAIDs, statins, and PPARγ agonists. Finally, the PI3K/AKT/mTOR pathway is recognized to play a central role in tobacco-induced carcinogenesis, and inhibitors of this pathway, including myoinositol and metformin, are promising agents for lung cancer prevention. Successful chemoprevention will likely require targeting of multiple pathways to carcinogenesis—both to minimize toxicity and maximize efficacy.

  12. Vocational rehabilitation services for patients with cancer: design of a feasibility study incorporating a pilot randomised controlled trial among women with breast cancer following surgery

    Directory of Open Access Journals (Sweden)

    Ayansina Dolapo

    2011-03-01

    Full Text Available Abstract Background Due to improvements in cancer survival the number of people of working age living with cancer across Europe is likely to increase. UK governments have made commitments to reduce the number of working days lost to ill-health and to improve access to vocational rehabilitation (VR services. Return to work for people with cancer has been identified as a priority. However, there are few services to support people to remain in or return to work after cancer and no associated trials to assess their impact. A pilot randomised controlled trial among women with breast cancer has been designed to assess the feasibility of a larger definitive trial of VR services for people with cancer. Methods Patients are being recruited from three clinical sites in two Scottish National Health Service (NHS Boards for 6 months. Eligible patients are all women who are: (1 aged between 18 and 65 years; (2 in paid employment or self-employed; (3 living or working in Lothian or Tayside, Scotland, UK; (4 diagnosed with an invasive breast cancer tumour; (5 treated first with surgery. Patients are randomly allocated to receive referral to a VR service or usual care, which involves no formal employment support. The primary outcome measure is self-reported sickness absence in the first 6 months following surgery. Secondary outcome measures include changes in quality of life (FACT-B, fatigue (FACIT-Fatigue and employment status between baseline and 6- and 12-months post-surgery. A post-trial evaluation will be conducted to assess the acceptability of the intervention among participants and the feasibility of a larger, more definitive, trial with patients with lung and prostate cancer. Discussion To our knowledge this is the first study to determine the feasibility of a randomised controlled trial of the effectiveness of VR services to enable people with cancer to remain in or return to employment. The study will provide evidence to assess the relevance and

  13. The Brustkrebs-Studien.de website for breast cancer patients: User acceptance of a German internet portal offering information on the disease and treatment options, and a clinical trials matching service

    Directory of Open Access Journals (Sweden)

    Hartkopf Andreas D

    2010-12-01

    Full Text Available Abstract Background The internet portal http://www.brustkrebs-studien.de (BKS was launched in 2000 by the German Society of Senology (DGS and the Baden-Württemberg Institute for Women's Health (IFG to provide expert-written information on breast cancer online and to encourage and facilitate the participation of breast cancer patients in clinical trials. We describe the development of BKS and its applications, and report on website statistics and user acceptance. Methods Existing registries, including ClinicalTrials.gov, were analysed before we designed BKS, which combines a trial registry, a knowledge portal, and an online second opinion service. An advisory board guided the process. Log files and patient enquiries for trial participation and second opinions were analysed. A two-week user satisfaction survey was conducted online. Results During 10/2005-06/2010, the portal attracted 702,655 visitors, generating 15,507,454 page views. By 06/2010, the website's active scientific community consisted of 189 investigators and physicians, and the registry covered 163 clinical trial protocols. In 2009, 143 patients requested trial enrolment and 119 sought second opinions or individual treatment advice from the expert panel. During the two-week survey in 2008, 5,702 BKS visitors submitted 507 evaluable questionnaires. Portal acceptance was high. Respondents trusted information correctness (80%, welcomed self-matching to clinical trials (79% and planned to use the portal in the future (76% and recommend it to others (81%. Conclusions BKS is an established and trusted breast cancer information platform offering up-to-date resources and protocols to the growing physician and patient community to encourage participation in clinical trials. Further studies are needed to assess potential increases in trial enrolment by eligibility matching services.

  14. Adherence to the World Cancer Research Fund/American Institute for Cancer Research recommendations and breast cancer risk.

    Science.gov (United States)

    Harris, Holly R; Bergkvist, Leif; Wolk, Alicja

    2016-06-01

    The World Cancer Research Fund/American Association for Cancer Research (WCRF/AICR) has published eight nutrition-related recommendations for the prevention of cancer. However, few prospective studies have examined these recommendations by breast cancer hormone receptor subtype and only one case-control study has included the dietary supplements recommendation in their evaluation. We investigated whether adherence to the WCRF/AICR cancer prevention recommendations was associated with breast cancer incidence, overall and by hormone receptor subtype, in the Swedish Mammography Cohort. Among 31,514 primarily postmenopausal women diet and lifestyle factors were assessed with a self-administered food frequency questionnaire. A score was constructed based on adherence to the recommendations for body fatness, physical activity, energy density, plant foods, animal foods, alcoholic drinks and dietary supplements (score range 0-7). Cox proportional hazard models were used to calculate hazard ratios (HRs) and 95% confidence intervals (95% CIs). During 15 years of follow-up 1,388 cases of breast cancer were identified. Women who met six to seven recommendations had a 51% decreased risk of breast cancer compared to women meeting only zero to two recommendations (95% CI = 0.35-0.70). The association between each additional recommendation met and breast cancer risk was strongest for the ER-positive/PR-positive subtype (HR = 0.86; 95% CI = 0.79-0.94), while for the ER-negative/PR-negative subtype the individual recommendations regarding plant and animal foods were most strongly associated with reduced risk. Our findings support that adherence to the WCRF/AICR recommendations reduces breast cancer risk in a population of primarily postmenopausal women. Promoting these recommendations to the public could help reduce breast cancer incidence. PMID:26804371

  15. Randomized trial addressing risk features and time factors of surgery plus radiotherapy in advanced head-and-neck cancer

    International Nuclear Information System (INIS)

    Purpose: A multi-institutional, prospective, randomized trial was undertaken in patients with advanced head-and-neck squamous cell carcinoma to address (1) the validity of using pathologic risk features, established from a previous study, to determine the need for, and dose of, postoperative radiotherapy (PORT); (2) the impact of accelerating PORT using a concomitant boost schedule; and (3) the importance of the overall combined treatment duration on the treatment outcome. Methods and Materials: Of 288 consecutive patients with advanced disease registered preoperatively, 213 fulfilled the trial criteria and went on to receive therapy predicated on a set of pathologic risk features: no PORT for the low-risk group (n=31); 57.6 Gy during 6.5 weeks for the intermediate-risk group (n=31); and, by random assignment, 63 Gy during 5 weeks (n=76) or 7 weeks (n=75) for the high-risk group. Patients were irradiated with standard techniques appropriate to the site of disease and likely areas of spread. The study end points were locoregional control (LRC), survival, and morbidity. Results: Patients with low or intermediate risks had significantly higher LRC and survival rates than those with high-risk features (p=0.003 and p=0.0001, respectively), despite receiving no PORT or lower dose PORT, respectively. For high-risk patients, a trend toward higher LRC and survival rates was noted when PORT was delivered in 5 rather than 7 weeks. A prolonged interval between surgery and PORT in the 7-week schedule was associated with significantly lower LRC (p=0.03) and survival (p=0.01) rates. Consequently, the cumulative duration of combined therapy had a significant impact on the LRC (p=0.005) and survival (p=0.03) rates. A 2-week reduction in the PORT duration by using the concomitant boost technique did not increase the late treatment toxicity. Conclusions: This Phase III trial established the power of risk assessment using pathologic features in determining the need for, and dose of

  16. Epoetin alfa in platinum-treated ovarian cancer patients: results of a multinational, multicentre, randomised trial

    OpenAIRE

    Wilkinson, P. M.; Antonopoulos, M; Lahousen, M; Lind, M.; Kosmidis, P

    2006-01-01

    This multicentre, open-label, controlled clinical trial assessed the effects of epoetin alfa treatment on haematologic and quality of life (QOL) parameters in 182 anaemic (Hb⩽12 g dl−1) ovarian cancer patients receiving platinum chemotherapy. Patients were randomised 2 : 1 to receive epoetin alfa 10 000–20 000 IU three times weekly plus best standard treatment (BST) or BST only. Main study end points were changes from baseline in haemoglobin (Hb) level, transfusion requirements, and QOL. For ...

  17. Triple-Negative Breast Cancer: An Update on Neoadjuvant Clinical Trials

    International Nuclear Information System (INIS)

    Triple-negative breast cancer (TNBC) is an aggressive malignancy with a poor prognosis despite the high rates of response to chemotherapy. This scenario highlights the need to develop novel therapies and/or treatment strategies to reduce the mortality associated with TNBC. The neoadjuvant setting provides a model for rapid assessment of treatment efficacy with smaller patient accruals and over shorter periods of time compared to the traditional adjuvant setting. In addition, a clear surrogate endpoint of improved survival, known as pathologic complete response, already exists in this setting. Here, we review current data from completed and ongoing neoadjuvant clinical trials for TNBC

  18. A randomized double-blind trial on perioperative administration of probiotics in colorectal cancer patients

    Institute of Scientific and Technical Information of China (English)

    Luca; Gianotti; Lorenzo; Morelli; Francesca; Galbiati; Simona; Rocchetti; Sara; Coppola; Aldo; Beneduce; Cristina; Gilardini; Daniela; Zonenschain; Angelo; Nespoli; Marco; Braga

    2010-01-01

    AIM:To investigate whether probiotic bacteria,given perioperatively,might adhere to the colonic mucosa, reduce concentration of pathogens in stools,and modulate the local immune function. METHODS:A randomized,double-blind clinical trial was carried out in 31 subjects undergoing elective colorectal resection for cancer.Patients were allocated to receive either a placebo(group A,n=10),or a dose of 10 7 of a mixture of Bifidobacterium longum(BB536) and Lactobacillus johnsonii(La1)(group B,n=11),or the same mix...

  19. Plant collecting program in Southeast Asia under the sponsorship of the United States National Cancer Institute (NCI) (1986-1991)

    OpenAIRE

    Soejarto, D. D.

    1992-01-01

    Under the funding from the United States National Cancer Institute (NCI)¹, a program was undertaken to collect plant samples in Southeast Asia to be tested for their cancer- and AIDS-arresting properties, for the period of September 1, 1986 through August 31, 1991. The program was implemented with the collaboration of the Arnold Arboretum and the Bishop Museum. Botanists from these and other institutions collaborated in the field work operation for the program, among others: J.S. BURLEY (A), ...

  20. A randomised clinical trial to contrast radiotherapy and methotrexate given synchronously in head and neck cancer

    International Nuclear Information System (INIS)

    Three hundred and thirteen patients with squamous cell cancer of the head and neck were entered in a randomised clinical trial to determine whether the addition of methotrexate during the course of irradiation improved the rate of primary control and subsequent survival. The overall primary control (P=0.016) and survival (P=0.075) for the patients receiving methotrexate was better than the patients treated by radiotherapy alone. The improvement in primary control (P=0.0019) and survival (P=0.0089) in patients with oropharyngeal cancers who had methotrexate in addition to radiotherapy is statistically significant. The treatment was well tolerated and there has been no increase of late morbidity. (author)

  1. Effect of a multimodal high intensity exercise intervention in cancer patients undergoing chemotherapy: randomised controlled trial

    DEFF Research Database (Denmark)

    Adamsen, Lis; Quist, Morten; Andersen, Christina;

    2009-01-01

    OBJECTIVE: To assess the effect of a multimodal group exercise intervention, as an adjunct to conventional care, on fatigue, physical capacity, general wellbeing, physical activity, and quality of life in patients with cancer who were undergoing adjuvant chemotherapy or treatment for advanced...... disease. DESIGN: Randomised controlled trial. SETTING: Two university hospitals in Copenhagen, Denmark. PARTICIPANTS: 269 patients with cancer; 73 men, 196 women, mean age 47 years (range 20-65) representing 21 diagnoses. Main exclusion criteria were brain or bone metastases. 235 patients completed follow......-up. INTERVENTION: Supervised exercise comprising high intensity cardiovascular and resistance training, relaxation and body awareness training, massage, nine hours weekly for six weeks in addition to conventional care, compared with conventional care. MAIN OUTCOME MEASURES: European Organization for Research...

  2. Lumboaortic radiotherapy in patients with cervical cancer. Experience of the National Cancer Institute

    International Nuclear Information System (INIS)

    Background: Uterine cancer is still a prevalent disease in Chile. Is common to treat patients with tumors in stages IIB and IIIB where the risk of pelvic and paraortic limph node involvement is very high. Its treatment is radio-chemotherapy. Objective: To present a retrospective analysis of patients that suffered cervix-uterine cancer who were treated with radiotherapy including the aortic-lumbar area. Methods: From the revision of patients who were treated of cervix-uterine cancer between the years 1995 and 2007, 39 were treated including aortic-lumbar chains. Evolution and toxicity were analyzed. Two radiotherapy techniques were used. The first one, during the nineties, included two parallel previous and later and opposed fields, and a second technique, currently used, where pelvis and paraortic are radiated at the same time through four lateral (AP-PA) fields. Results: The dosimeter analysis of both techniques shows that there is a higher volume of radiated normal tissue with the two fields techniques, mainly in the small bowel. On the other hand, the toxicity was significantly different being today's technique less toxic and showing low gastrointestinal

  3. Cancer pain assessment in clinical trials. A review of the literature (1999-2002).

    Science.gov (United States)

    Caraceni, Augusto; Brunelli, Cinzia; Martini, Cinzia; Zecca, Ernesto; De Conno, Franco

    2005-05-01

    The aim of this review was to evaluate the methods of pain measurement in controlled clinical trials in oncology published between 1999 and 2002. An electronic literature search strategy was used according to established criteria applied to the Medline database and PubMed search engine. Articles were selected to include only studies that had chronic cancer pain as the primary or secondary objective of a controlled clinical trial. A specific evaluation scheme was used to examine how pain measurement methods were chosen and implemented in the study procedures. The search strategy identified 613 articles, and 68 were selected for evaluation. Most articles (69%) chose unidimensional pain measurement tools, such as visual analogue scales, numerical rating scales and verbal rating scales, whereas others used questionnaires. The implementation of the pain assessment method was problematic in many studies, especially as far as time frame of pain assessment (70%), administration modalities (46%), and use of non-validated measurement methods (10%). Design of study and data analysis were often unclear about the definition of pain outcome measure (40%), patient compliance with pain assessment (98%), and impact of missing data (56%). Statistical techniques were seldom appropriate to the type of data collected and often inadequate to describe the pain variable under study. It is clear from this review that most authors were aware of the need of valid pain measurement tools to be used in clinical trials. However, too often these tools were not appropriately used in the trial, or at least their use was not described with sufficient accuracy in the trial methods. PMID:15904753

  4. From Planning to Implementation: An Examination of Changes in the Research Design, Sample Size, and Precision of Group Randomized Trials Launched by the Institute of Education Sciences

    Science.gov (United States)

    Spybrook, Jessaca; Puente, Anne Cullen; Lininger, Monica

    2013-01-01

    This article examines changes in the research design, sample size, and precision between the planning phase and implementation phase of group randomized trials (GRTs) funded by the Institute of Education Sciences. Thirty-eight GRTs funded between 2002 and 2006 were examined. Three studies revealed changes in the experimental design. Ten studies…

  5. Progress in the Past Decade: An Examination of the Precision of Cluster Randomized Trials Funded by the U.S. Institute of Education Sciences

    Science.gov (United States)

    Spybrook, Jessaca; Shi, Ran; Kelcey, Benjamin

    2016-01-01

    This article examines the statistical precision of cluster randomized trials (CRTs) funded by the Institute of Education Sciences (IES). Specifically, it compares the total number of clusters randomized and the minimum detectable effect size (MDES) of two sets of studies, those funded in the early years of IES (2002-2004) and those funded in the…

  6. Protocol for a pilot randomised controlled trial of an online intervention for post-treatment cancer survivors with persistent fatigue

    Science.gov (United States)

    Corbett, Teresa; Walsh, Jane C; Groarke, AnnMarie; Moss-Morris, Rona; McGuire, Brian E

    2016-01-01

    Introduction Many post-treatment cancer survivors experience persistent fatigue that can disrupt attempts to resume normal everyday activities after treatment. Theoretical models that aim to explain contributory factors that initiate and sustain fatigue symptoms, or that influence the efficacy of interventions for cancer-related fatigue (CrF) require testing. Adjustment to fatigue is likely to be influenced by coping behaviours that are guided by the representations of the symptom. Objectives This paper describes the protocol for a pilot trial of a systematically and theoretically designed online intervention to enable self-management of CrF after cancer treatment. Methods and analysis This 2-armed randomised controlled pilot trial will study the feasibility and potential effectiveness of an online intervention. Participants will be allocated to either the online intervention (REFRESH (Recovery from Cancer-Related Fatigue)), or a leaflet comparator. Participants 80 post-treatment cancer survivors will be recruited for the study. Interventions An 8-week online intervention based on cognitive–behavioural therapy. Primary and secondary outcome measures The primary outcome is a change in fatigue as measured by the Piper Fatigue Scale (revised). Quality of life will be measured using the Quality of Life in Adult Survivors of Cancer Scale. Outcome measures will be collected at baseline, and at completion of intervention. Results The feasibility of trial procedures will be tested, as well as the effect of the intervention on the outcomes. Conclusions This study may lead to the development of a supportive resource to target representations and coping strategies of cancer survivors with CrF post-treatment. Setting Recruitment from general public in Ireland. Ethics and dissemination This trial was approved by the Research Ethics Committee at National University of Ireland Galway in January 2013. Trial results will be communicated in a peer-reviewed journal. Trial

  7. Participating in Clinical Trials

    Medline Plus

    Full Text Available Home > Health topics A-Z > Participating in Clinical Trials: About Clinical Trials In This Topic About Clinical Trials Risks ... centers across the country. The National Institutes of Health funds much of this basic research. Screening Trials ...

  8. Pilot crossover trial of Reiki versus rest for treating cancer-related fatigue.

    Science.gov (United States)

    Tsang, Kathy L; Carlson, Linda E; Olson, Karin

    2007-03-01

    Fatigue is an extremely common side effect experienced during cancer treatment and recovery. Limited research has investigated strategies stemming from complementary and alternative medicine to reduce cancer-related fatigue. This research examined the effects of Reiki, a type of energy touch therapy, on fatigue, pain, anxiety, and overall quality of life. This study was a counterbalanced crossover trial of 2 conditions: (1) in the Reiki condition, participants received Reiki for 5 consecutive daily sessions, followed by a 1-week washout monitoring period of no treatments, then 2 additional Reiki sessions, and finally 2 weeks of no treatments, and (2) in the rest condition, participants rested for approximately 1 hour each day for 5 consecutive days, followed by a 1-week washout monitoring period of no scheduled resting and an additional week of no treatments. In both conditions, participants completed questionnaires investigating cancer-related fatigue (Functional Assessment of Cancer Therapy Fatigue subscale [FACT-F]) and overall quality of life (Functional Assessment of Cancer Therapy, General Version [FACT-G]) before and after all Reiki or resting sessions. They also completed a visual analog scale (Edmonton Symptom Assessment System [ESAS]) assessing daily tiredness, pain, and anxiety before and after each session of Reiki or rest. Sixteen patients (13 women) participated in the trial: 8 were randomized to each order of conditions (Reiki then rest; rest then Reiki). They were screened for fatigue on the ESAS tiredness item, and those scoring greater than 3 on the 0 to 10 scale were eligible for the study. They were diagnosed with a variety of cancers, most commonly colorectal (62.5%) cancer, and had a median age of 59 years. Fatigue on the FACT-F decreased within the Reiki condition (P=.05) over the course of all 7 treatments. In addition, participants in the Reiki condition experienced significant improvements in quality of life (FACT-G) compared to those in

  9. Plant collecting program in Southeast Asia under the sponsorship of the United States National Cancer Institute (NCI) (1986-1991)

    NARCIS (Netherlands)

    Soejarto, D.D.

    1992-01-01

    Under the funding from the United States National Cancer Institute (NCI)¹, a program was undertaken to collect plant samples in Southeast Asia to be tested for their cancer- and AIDS-arresting properties, for the period of September 1, 1986 through August 31, 1991. The program was implemented with t

  10. PI3K inhibitors as new cancer therapeutics: implications for clinical trial design.

    Science.gov (United States)

    Massacesi, Cristian; Di Tomaso, Emmanuelle; Urban, Patrick; Germa, Caroline; Quadt, Cornelia; Trandafir, Lucia; Aimone, Paola; Fretault, Nathalie; Dharan, Bharani; Tavorath, Ranjana; Hirawat, Samit

    2016-01-01

    The PI3K-AKT-mTOR pathway is frequently activated in cancer. PI3K inhibitors, including the pan-PI3K inhibitor buparlisib (BKM120) and the PI3Kα-selective inhibitor alpelisib (BYL719), currently in clinical development by Novartis Oncology, may therefore be effective as anticancer agents. Early clinical studies with PI3K inhibitors have demonstrated preliminary antitumor activity and acceptable safety profiles. However, a number of unanswered questions regarding PI3K inhibition in cancer remain, including: what is the best approach for different tumor types, and which biomarkers will accurately identify the patient populations most likely to benefit from specific PI3K inhibitors? This review summarizes the strategies being employed by Novartis Oncology to help maximize the benefits of clinical studies with buparlisib and alpelisib, including stratification according to PI3K pathway activation status, selective enrollment/target enrichment (where patients with PI3K pathway-activated tumors are specifically recruited), nonselective enrollment with mandatory tissue collection, and enrollment of patients who have progressed on previous targeted agents, such as mTOR inhibitors or endocrine therapy. An overview of Novartis-sponsored and Novartis-supported trials that are utilizing these approaches in a range of cancer types, including breast cancer, head and neck squamous cell carcinoma, non-small cell lung carcinoma, lymphoma, and glioblastoma multiforme, is also described. PMID:26793003

  11. L-Carnitine-supplementation in advanced pancreatic cancer (CARPAN - a randomized multicentre trial

    Directory of Open Access Journals (Sweden)

    Kraft Matthias

    2012-07-01

    Full Text Available Abstract Background Cachexia, a >10% loss of body-weight, is one factor determining the poor prognosis of pancreatic cancer. Deficiency of L-Carnitine has been proposed to cause cancer cachexia. Findings We screened 152 and enrolled 72 patients suffering from advanced pancreatic cancer in a prospective, multi-centre, placebo-controlled, randomized and double-blinded trial to receive oral L-Carnitine (4 g or placebo for 12 weeks. At entry patients reported a mean weight loss of 12 ± 2,5 (SEM kg. During treatment body-mass-index increased by 3,4 ± 1,4% under L-Carnitine and decreased (−1,5 ± 1,4% in controls (p  Conclusion While these data are preliminary and need confirmation they indicate that patients with pancreatic cancer may have a clinically relevant benefit from the inexpensive and well tolerated oral supplementation of L-Carnitine.

  12. Targeting FAK in human cancer: from finding to first clinical trials.

    Science.gov (United States)

    Golubovskaya, Vita M

    2014-01-01

    It is twenty years since Focal Adhesion Kinase (FAK) was found to be overexpressed in many types of human cancer. FAK plays an important role in adhesion, spreading, motility, invasion, metastasis, survival, angiogenesis, and recently has been found to play an important role as well in epithelial to mesenchymal transition (EMT), cancer stem cells and tumor microenvironment. FAK has kinase-dependent and kinase independent scaffolding, cytoplasmic and nuclear functions. Several years ago FAK was proposed as a potential therapeutic target; the first clinical trials were just reported, and they supported further studies of FAK as a promising therapeutic target. This review discusses the main functions of FAK in cancer, and specifically focuses on recent novel findings on the role of FAK in cancer stem cells, microenvironment, epithelial-to-mesenchymal transition, invasion, metastasis, and also highlight new approaches of targeting FAK and critically discuss challenges that lie ahead for its targeted therapeutics. The review provides a summary of translational approaches of FAK-targeted and combination therapies and outline perspectives and future directions of FAK research. PMID:24389213

  13. European organization for research on treatment of cancer trials using radiotherapy with multiple fractions per day

    International Nuclear Information System (INIS)

    During the past decade (1976-1986), radiotherapy with altered fractionation schemes using multiple fractions per day (MFD) was the major field of the clinical research undertaken in the EORTC Cooperative Group of Radiotherapy. Some of its participating institutions (Portsmouth, Dijon, Leuven, Amsterdam, Rome) performed pilot studies in the midseventies in more than 400 patients. Then largely based upon the previous institutional experiences, EORTC-labelled phase II and III were activated: 1,678 patients have been entered in 8 trials during the period 1978-1987. In order to summarize these clinical experiments covering various fields of tumor pathology, radiotherapy schemes are divided according to the type of altered fractionation: pure hyperfractionation, accelerated fractionation and mixed hyprfractionated and accelerated schemes

  14. Tailored information increases patient/physician discussion of colon cancer risk and testing: The Cancer Risk Intake System trial.

    Science.gov (United States)

    Skinner, Celette Sugg; Gupta, Samir; Bishop, Wendy Pechero; Ahn, Chul; Tiro, Jasmin A; Halm, Ethan A; Farrell, David; Marks, Emily; Morrow, Jay; Julka, Manjula; McCallister, Katharine; Sanders, Joanne M; Rawl, Susan M

    2016-12-01

    Assess whether receipt of tailored printouts generated by the Cancer Risk Intake System (CRIS) - a touch-screen computer program that collects data from patients and generates printouts for patients and physicians - results in more reported patient-provider discussions about colorectal cancer (CRC) risk and screening than receipt of non-tailored information. Cluster-randomized trial, randomized by physician, with data collected via CRIS prior to visit and 2-week follow-up telephone survey among 623 patients. Patients aged 25-75 with upcoming primary-care visits and eligible for, but currently non-adherent to CRC screening guidelines. Patient-reported discussions with providers about CRC risk and testing. Tailored recipients were more likely to report patient-physician discussions about personal and familial risk, stool testing, and colonoscopy (all p cancer (+ 10%); family history (+ 15%); stool testing (+ 9%); and colonoscopy (+ 8%) (all p < 0.05). CRIS is a promising strategy for facilitating discussions about testing in primary-care settings. PMID:27413654

  15. Patterns of care for ovarian cancer patients at Institute of Nuclear Medicine and Oncology (INMOL) Lahore

    International Nuclear Information System (INIS)

    The study was carried out to analyze the incidence of ovarian cancer and changing patterns of therapy during the last six years at INMOL (Institute of Nuclear Medicine and Oncology, Lahore Pakistan). Main objective was to review the results of treatment given and find out the causes of failure. Treatment and its outcome was also recorded to correlate the results with histological subtype and stage of diseases. It has been studied various factors like age of presentation, parity, social class, family history, method of surgery, stage of disease along with histologic type of the tumor. Epithelial ovarian cancer is not curable at advanced stages. Efforts should be made to find out some effective screening procedures for early detection. (Orig./A.B.)

  16. Male breast cancer: a report of 127 cases at a Moroccan institution

    Directory of Open Access Journals (Sweden)

    Tijami Fouad

    2011-06-01

    Full Text Available Abstract Background Male breast cancer (MBC is a rare disease representing less than 1% of all malignancies in men and only 1% of all incident breast cancers. Our study details clinico-pathological features, treatments and prognostic factors in a large Moroccan cohort. Findings One hundred and twenty-seven patients were collected from 1985 to 2007 at the National Institute of Oncology in Rabat, Morocco. Median age was 62 years and median time for consultation 28 months. The main clinical complaint was a mass beneath the areola in 93, 5% of the cases. Most patients have an advanced disease. Ninety-one percent of tumors were ductal carcinomas. Management consisted especially of radical mastectomy; followed by adjuvant radiotherapy and hormonal therapy with or without chemotherapy. The median of follow-up was 30 months. The evolution has been characterized by local recurrence; in twenty two cases (17% of all patients. Metastasis occurred in 41 cases (32% of all patients. The site of metastasis was the bone in twenty cases; lung in twelve cases; liver in seven case; liver and skin in one case and pleura and skin in one case. Conclusion Male breast cancer has many similarities to breast cancer in women, but there are distinct features that should be appreciated. Future research for better understanding of this disease at national or international level are needed to improve the management and prognosis of male patients.

  17. [The (German) Center for Cancer Registry Data (ZfKD) at the Robert Koch Institute (RKI) in Berlin].

    Science.gov (United States)

    Wolf, U; Barnes, B; Bertz, J; Haberland, J; Laudi, A; Stöcker, M; Schönfeld, I; Kraywinkel, K; Kurth, B-M

    2011-11-01

    Cancer represents the second most common cause of death in Germany. The country's federal states operate regional population-based cancer registries that collect and analyze data on cancer patients. This provides an essential basis for describing the cancer burden in the German population. In order to obtain valid and reliable information on cancer incidence at the national level, the Robert Koch Institute (RKI) set up the Federal Cancer Surveillance Unit in 1983 as a central institution for evaluating this cancer registry data. In August 2009, when the Federal Cancer Registry Data Act (BKRG) came into force, the Center for Cancer Registry Data (ZfKD) at the RKI took over the work of the Cancer Surveillance Unit with a broader remit. In the future, it will also regularly publish findings on survival, prevalence, and tumor stage distribution. A newly established record linkage process will help identify multiple submissions from the federal states. Further innovations and new tasks of the ZfKD include expanding an interactive Internet platform and encouraging a more intensive use of cancer registry data for epidemiological research by providing datasets to external scientists. The range of information available to the interested public is also to be expanded. PMID:22015795

  18. Biorepository for Prostate Cancer Prevention Trial (PCPT) | Division of Cancer Prevention

    Science.gov (United States)

    The PCPT biorepository and extended data was used to further explore the initial suggestion that some men taking finasteride were at risk of developing high-grade prostate cancers, and to look at the value of prostate-specific antigen (PSA) for early detection. Researchers showed that: |

  19. Towards optimised information about clinical trials; identification and validation of key issues in collaboration with cancer patient advocates

    DEFF Research Database (Denmark)

    Dellson, P; Nilbert, M; Bendahl, P-O;

    2011-01-01

    for improvements, 21 key issues were defined and validated through a questionnaire in an independent group of breast cancer patient advocates. Clear messages, emotionally neutral expressions, careful descriptions of side effects, clear comparisons between different treatment alternatives and information about......Clinical trials are crucial to improve cancer treatment but recruitment is difficult. Optimised patient information has been recognised as a key issue. In line with the increasing focus on patients' perspectives in health care, we aimed to study patients' opinions about the written information used...... the possibility to discontinue treatment were perceived as the most important issues. Patients' views of the information in clinical trials provide new insights and identify key issues to consider in optimising future written information and may improve recruitment to clinical cancer trials....

  20. Patient-reported genitourinary dysfunction after laparoscopic and open rectal cancer surgery in a randomized trial (COLOR II)

    DEFF Research Database (Denmark)

    Andersson, J; Abis, G; Gellerstedt, M; Angenete, E; Angerås, U; Cuesta, M A; Jess, P; Rosenberg, J; Bonjer, H J; Haglind, E

    2014-01-01

    BACKGROUND: This article reports on patient-reported sexual dysfunction and micturition symptoms following a randomized trial of laparoscopic and open surgery for rectal cancer. METHODS: Patients in the COLOR II randomized trial, comparing laparoscopic and open surgery for rectal cancer, completed...... the European Organization for Research and Treatment of Cancer (EORTC) QLQ-CR38 questionnaire before surgery, and after 4 weeks, 6, 12 and 24 months. Adjusted mean differences on a 100-point scale were calculated using changes from baseline value at the various time points in the domains of sexual...... functioning, sexual enjoyment, male and female sexual problems, and micturition symptoms. RESULTS: Of 617 randomized patients, 385 completed this phase of the trial. Their mean age was 67·1 years. Surgery caused an anticipated reduction in genitourinary function after 4 weeks, with no significant differences...

  1. Lessons for Successful Study Enrollment from the Veterans Affairs/National Institutes of Health Acute Renal Failure Trial Network Study

    OpenAIRE

    Crowley, Susan T.; Chertow, Glenn M.; Vitale, Joseph; O'Connor, Theresa; Zhang, Jane; Schein, Roland M.H.; Choudhury, Devasmita; Finkel, Kevin; Vijayan, Anitha; Paganini, Emil; Palevsky, Paul M

    2008-01-01

    Background and objectives: Design elements of clinical trials can introduce recruitment bias and reduce study efficiency. Trials involving the critically ill may be particularly prone to design-related inefficiencies.

  2. Recombinant leukocyte A interferon in advanced breast cancer. Results of a phase II efficacy trial.

    Science.gov (United States)

    Sherwin, S A; Mayer, D; Ochs, J J; Abrams, P G; Knost, J A; Foon, K A; Fein, S; Oldham, R K

    1983-05-01

    Nineteen patients with advanced refractory metastatic breast cancer no longer responsive to chemotherapy were treated in the first phase II efficacy trial of recombinant leukocyte A interferon (IFL-rA), a highly purified single molecular species of alpha interferon prepared by recombinant DNA methods. Patients received a previously determined maximum tolerated dose for this agent (50 X 10(6) U/m2 body surface area) by intramuscular injection three times weekly for up to 3 months. The symptoms of toxicity observed in this trial resemble those previously reported for alpha interferons and include fever, chills, fatigue, anorexia, and leukopenia. All patients required dose reductions, most often for reasons of severe fatigue. Of the 17 patients evaluable for tumor response, one patient had stable disease and 16 had evidence of tumor progression. We conclude that IFL-rA is not an active agent in the treatment of advanced, refractory breast cancer when used at a maximum tolerated dose on this treatment schedule. PMID:6342490

  3. Immune Monitoring in Cancer Vaccine Clinical Trials: Critical Issues of Functional Flow Cytometry-Based Assays

    Directory of Open Access Journals (Sweden)

    Iole Macchia

    2013-01-01

    Full Text Available The development of immune monitoring assays is essential to determine the immune responses against tumor-specific antigens (TSAs and tumor-associated antigens (TAAs and their possible correlation with clinical outcome in cancer patients receiving immunotherapies. Despite the wide range of techniques used, to date these assays have not shown consistent results among clinical trials and failed to define surrogate markers of clinical efficacy to antitumor vaccines. Multiparameter flow cytometry- (FCM- based assays combining different phenotypic and functional markers have been developed in the past decade for informative and longitudinal analysis of polyfunctional T-cells. These technologies were designed to address the complexity and functional heterogeneity of cancer biology and cellular immunity and to define biomarkers predicting clinical response to anticancer treatment. So far, there is still a lack of standardization of some of these immunological tests. The aim of this review is to overview the latest technologies for immune monitoring and to highlight critical steps involved in some of the FCM-based cellular immune assays. In particular, our laboratory is focused on melanoma vaccine research and thus our main goal was the validation of a functional multiparameter test (FMT combining different functional and lineage markers to be applied in clinical trials involving patients with melanoma.

  4. Novel histone deacetylase inhibitors in clinical trials as anti-cancer agents

    Directory of Open Access Journals (Sweden)

    Petrillo Richard L

    2010-02-01

    Full Text Available Abstract Histone deacetylases (HDACs can regulate expression of tumor suppressor genes and activities of transcriptional factors involved in both cancer initiation and progression through alteration of either DNA or the structural components of chromatin. Recently, the role of gene repression through modulation such as acetylation in cancer patients has been clinically validated with several inhibitors of HDACs. One of the HDAC inhibitors, vorinostat, has been approved by FDA for treating cutaneous T-cell lymphoma (CTCL for patients with progressive, persistent, or recurrent disease on or following two systemic therapies. Other inhibitors, for example, FK228, PXD101, PCI-24781, ITF2357, MGCD0103, MS-275, valproic acid and LBH589 have also demonstrated therapeutic potential as monotherapy or combination with other anti-tumor drugs in CTCL and other malignancies. At least 80 clinical trials are underway, testing more than eleven different HDAC inhibitory agents including both hematological and solid malignancies. This review focuses on recent development in clinical trials testing HDAC inhibitors as anti-tumor agents.

  5. Preliminary Analysis of Difficulty of Importing Pattern-Based Concepts into the National Cancer Institute Thesaurus.

    Science.gov (United States)

    He, Zhe; Geller, James

    2016-01-01

    Maintenance of biomedical ontologies is difficult. We have developed a pattern-based method for dealing with the problem of identifying missing concepts in the National Cancer Institute thesaurus (NCIt). Specifically, we are mining patterns connecting NCIt concepts with concepts in other ontologies to identify candidate missing concepts. However, the final decision about a concept insertion is always up to a human ontology curator. In this paper, we are estimating the difficulty of this task for a domain expert by counting possible choices for a pattern-based insertion. We conclude that even with support of our mining algorithm, the insertion task is challenging. PMID:27577410

  6. Cardiac troponin I elevation and overall survival among cancer patients receiving investigational compounds during phase I trials

    OpenAIRE

    Hollebecque, Antoine; Lanoy, Emilie; Troallen, Frederic; Soulat-Dufour, Laurie; Massard, Christophe; Bahleda, Rastislav; VARGA, Andrea; Gazzah, Anas; Postel-Vinay, Sophie; Ribrag, Vincent; Deutsch, Eric; Angevin, Eric; Boccara, Franck; Cohen, Ariel; Soria, Jean-Charles

    2016-01-01

    Objective : To identify factors associated with troponin elevation and to measure the effect of elevated troponin on survival in cancer patients participating in phase I trials.Methods : Clinical characteristics, cardiovascular risk factors, and biological data from consecutive patients treated in phase I trials (January 2010–November 2012) were reviewed. Troponin value was measured for each patient before study-drug administration and then weekly. Cardiac troponin I was considered elevated i...

  7. The GRAIDS Trial: a cluster randomised controlled trial of computer decision support for the management of familial cancer risk in primary care

    OpenAIRE

    Emery, J.; Morris, H.; R. Goodchild; Fanshawe, T.; Prevost, A.T.; Bobrow, M.; Kinmonth, A L

    2007-01-01

    The objective was to evaluate the effect of an assessment strategy using the computer decision support system (the GRAIDS software), on the management of familial cancer risk in British general practice in comparison with best current practice. The design included cluster randomised controlled trial, and involved forty-five general practice teams in East Anglia, UK. Randomised to GRAIDS (Genetic Risk Assessment on the Internet with Decision Support) support (intervention n=23) or comparison (...

  8. Serum IgE and risk of pancreatic cancer in the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial (PLCO)

    Science.gov (United States)

    Olson, Sara H.; Hsu, Meier; Wiemels, Joseph L.; Bracci, Paige M.; Zhou, Mi; Patoka, Joseph; Reisacher, William I.; Wang, Julie; Kurtz, Robert C.; Silverman, Debra T.; Stolzenberg-Solomon, Rachael Z.

    2014-01-01

    Epidemiologic studies have consistently found that self-reported allergies are associated with reduced risk of pancreatic cancer. Our aim was to prospectively assess the relationship between serum IgE, a marker of allergy, and risk. This nested case-control study within the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial (PLCO) included subjects enrolled in 1994-2001 and followed through 2010. There were 283 cases of pancreatic cancer and 544 controls matched on age, gender, race, and calendar date of blood draw. Using the ImmunoCAP system, we measured total IgE (normal, borderline, elevated), IgE to respiratory allergens, and IgE to food allergens (negative or positive) in serum collected at baseline. Odds ratios (OR) and 95% confidence intervals (CI) were estimated using conditional logistic regression. We assessed interactions with age, gender, smoking, body mass index, and time between randomization and case diagnosis. Overall, there was no association between the IgE measures and risk. We found a statistically significant interaction by baseline age: in those aged >65, elevated risks were observed for borderline total IgE (OR=1.43; 95% CI, 0.88-2.32) and elevated total IgE (OR=1.98; 95% CI, 1.16-3.37) and positive IgE to food allergens (OR=2.83; 95% CI, 1.29-6.20); among participants <65, ORs were <1. Other interactions were not statistically significant. The reduced risk of pancreatic cancer associated with self-reported allergies is not reflected in serum IgE. PMID:24718282

  9. Serum immunoglobulin e and risk of pancreatic cancer in the prostate, lung, colorectal, and ovarian cancer screening trial.

    Science.gov (United States)

    Olson, Sara H; Hsu, Meier; Wiemels, Joseph L; Bracci, Paige M; Zhou, Mi; Patoka, Joseph; Reisacher, William R; Wang, Julie; Kurtz, Robert C; Silverman, Debra T; Stolzenberg-Solomon, Rachael Z

    2014-07-01

    Epidemiologic studies have consistently found that self-reported allergies are associated with reduced risk of pancreatic cancer. Our aim was to prospectively assess the relationship between serum immunoglobulin E (IgE), a marker of allergy, and risk. This nested case-control study within the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial (PLCO) included subjects enrolled in 1994 to 2001 and followed through 2010. There were 283 cases of pancreatic cancer and 544 controls matched on age, gender, race, and calendar date of blood draw. Using the ImmunoCAP system, we measured total IgE (normal, borderline, elevated), IgE to respiratory allergens, and IgE to food allergens (negative or positive) in serum collected at baseline. Odds ratios (OR) and 95% confidence intervals (CI) were estimated using conditional logistic regression. We assessed interactions with age, gender, smoking, body mass index, and time between randomization and case diagnosis. Overall, there was no association between the IgE measures and risk. We found a statistically significant interaction by baseline age: in those aged ≥65 years, elevated risks were observed for borderline total IgE (OR, 1.43; 95% CI, 0.88-2.32) and elevated total IgE (OR, 1.98; 95% CI, 1.16-3.37) and positive IgE to food allergens (OR, 2.83; 95% CI, 1.29-6.20); among participants cancer associated with self-reported allergies is not reflected in serum IgE. PMID:24718282

  10. Phase 1 Clinical Trial of Stereotactic Body Radiation Therapy Concomitant With Neoadjuvant Chemotherapy for Breast Cancer

    International Nuclear Information System (INIS)

    Purpose: Stereotactic body radiation therapy (SBRT) allows stereotactic irradiation of thoracic tumors. It may have a real impact on patients who may not otherwise qualify for breast-conserving surgery. We conducted a phase 1 trial that tested 5 dose levels of SBRT concomitant with neoadjuvant chemotherapy (NACT) before to surgery. The purpose of the current dose escalation study was to determine the maximum tolerable dose of SBRT in the treatment of breast cancer. Methods and Materials: To define toxicity, we performed dermatologic examinations that included clinical examinations by 2 separate physicians and technical evaluations using colorimetry, dermoscopy, and skin ultrasonography. Dermatologic examinations were performed before NACT, 36 and 56 days after the beginning of NACT, and before surgery. Surgery was performed 4 to 8 weeks after the last chemotherapy session. Efficacy, the primary endpoint, was determined by the pathologic complete response (pCR) rate. Results: Maximum tolerable dose was not reached. Only 1 case of dose-limiting toxicity was reported (grade 3 dermatologic toxicity), and SBRT was overall well tolerated. The pCR rate was 36%, with none being observed at the first 2 dose levels, and the highest rate being obtained at dose level 3 (25.5 Gy delivered in 3 fractions). Furthermore, the breast-conserving surgery rate was up to 92% compared with an 8% total mastectomy rate. No surgical complications were reported. Conclusions: This study demonstrates that SBRT can be safely combined with NACT. Regarding the efficacy endpoints, this trial showed promising results in terms of pCR rate (36%) and breast-conserving rate (92%). The findings provide a strong rationale for extending the study into a phase 2 trial. In view of the absence of correlation between dose and pCR, and given that the data from dose level 3 met the statistical requirements, a dose of 25.5 Gy in 3 fractions should be used for the phase 2 trial

  11. Phase 1 Clinical Trial of Stereotactic Body Radiation Therapy Concomitant With Neoadjuvant Chemotherapy for Breast Cancer

    Energy Technology Data Exchange (ETDEWEB)

    Bondiau, Pierre-Yves, E-mail: pierre-yves.bondiau@nice.unicancer.fr [Department of Radiotherapy, Centre Antoine Lacassagne, Nice (France); Courdi, Adel [Department of Radiotherapy, Centre Antoine Lacassagne, Nice (France); Bahadoran, Phillipe [Department of Dermatology, University Hospital of Nice, Nice (France); Chamorey, Emmanuel [Department of Radiotherapy, Centre Antoine Lacassagne, Nice (France); Queille-Roussel, Catherine [Centre de Pharmacologie Clinique Appliquée à la Dermatologie, Nice (France); Lallement, Michel; Birtwisle-Peyrottes, Isabelle; Chapellier, Claire; Pacquelet-Cheli, Sandrine; Ferrero, Jean-Marc [Department of Radiotherapy, Centre Antoine Lacassagne, Nice (France)

    2013-04-01

    Purpose: Stereotactic body radiation therapy (SBRT) allows stereotactic irradiation of thoracic tumors. It may have a real impact on patients who may not otherwise qualify for breast-conserving surgery. We conducted a phase 1 trial that tested 5 dose levels of SBRT concomitant with neoadjuvant chemotherapy (NACT) before to surgery. The purpose of the current dose escalation study was to determine the maximum tolerable dose of SBRT in the treatment of breast cancer. Methods and Materials: To define toxicity, we performed dermatologic examinations that included clinical examinations by 2 separate physicians and technical evaluations using colorimetry, dermoscopy, and skin ultrasonography. Dermatologic examinations were performed before NACT, 36 and 56 days after the beginning of NACT, and before surgery. Surgery was performed 4 to 8 weeks after the last chemotherapy session. Efficacy, the primary endpoint, was determined by the pathologic complete response (pCR) rate. Results: Maximum tolerable dose was not reached. Only 1 case of dose-limiting toxicity was reported (grade 3 dermatologic toxicity), and SBRT was overall well tolerated. The pCR rate was 36%, with none being observed at the first 2 dose levels, and the highest rate being obtained at dose level 3 (25.5 Gy delivered in 3 fractions). Furthermore, the breast-conserving surgery rate was up to 92% compared with an 8% total mastectomy rate. No surgical complications were reported. Conclusions: This study demonstrates that SBRT can be safely combined with NACT. Regarding the efficacy endpoints, this trial showed promising results in terms of pCR rate (36%) and breast-conserving rate (92%). The findings provide a strong rationale for extending the study into a phase 2 trial. In view of the absence of correlation between dose and pCR, and given that the data from dose level 3 met the statistical requirements, a dose of 25.5 Gy in 3 fractions should be used for the phase 2 trial.

  12. Quality of Life in Hematologic Cancer Patients: A Randomized Clinical Trial of Low Dose Naltrexone Versus Placebo

    Directory of Open Access Journals (Sweden)

    Mohammad A. Seifrabiei

    2008-01-01

    Full Text Available This study aimed to investigate its effect on hematologic cancer patients. This was a randomized controlled trial assessing quality of life in patients with hematologic malignancies from a single institute in Hamedan. Patients were allocated into two study arms and in addition to their routine treatment received either daily naltrexone 3 mg capsules (treatment group or 3 mg starch (placebo group and were followed up for 5 months. Quality of life was measured using the EORTC QLQ-C30 in four points in time (at admission, 1, 3 and 5 months follow-up. Data were analyzed to compare quality of life in two groups. Totally, 89 patients were studied (45 in treatment group and 44 in placebo group. There were no significant differences between two groups either in demographic and clinical characteristics or in baseline quality of life scores. However, at 1 month, 3 and 5-month follow-up assessments significant differences were observed. In one month follow-up two groups were significantly different in social functioning (p<0.05 indicating a better condition in the treatment group. In the 3-month follow-up, social functioning, role functioning, nausea and vomiting and appetite loss were better in the treatment group (all p-values <0.05. In the 5-month follow-up, physical functioning, social functioning, role functioning, global quality of life, nausea and vomiting and appetite loss were significantly better in the nalterxone group. Low dose naltrexone is an effective drug in improving quality of life in patients with hematologic cancers.

  13. Electrons for intraoperative radiotherapy in selected breast-cancer patients: late results of the Montpellier phase II trial

    International Nuclear Information System (INIS)

    The Montpellier cancer institute phase II trial started in 2004 and evaluated the feasibility of intraoperative radiotherapy (IORT) technique given as a sole radiation treatment for patients with an excellent prognostic and very low recurrence risk. Forty-two patients were included between 2004 and 2007. Inclusion criteria were patients ≥ 65 years old, T0-T1, N0, ductal invasive unifocal carcinoma, free-margin > 2 mm. IORT was delivered using dedicated linear accelerator. One fraction of 21 Gy was prescribed and specified at the 90% isodose using electrons. In vivo dosimetry was performed for all patients. Primary end-point was the quality index. Secondary endpoints were quality of life, local recurrences, cosmetic results, specific and overall survival. At inclusion, median age was 72 years (range, 66–80). Median tumor diameter was 10 mm. All patients received the total prescribed dose. No acute grade 3 toxicities were observed. Late cosmetic results were good at 5 years despite the poor agreement of accuracy assessment between patients and physicians. Four patients (9.5%) experienced a local failure and underwent salvage mastectomy. The 5 year-disease free survival is 92.7% (range 79.1−97.6). All patients are still alive with a median follow-up of 72 months (range 66–74). Our results confirm with a long-term follow-up that exclusive partial breast IORT is feasible for early-breast cancer in selected patients. IORT provides good late cosmetics results and should be considered as a safe and very comfortable “one-step” treatment procedure. Nevertheless, patient assessments are essential for long-term quality results

  14. Phase I trial of thymidylate synthase poly-epitope peptide (TSPP) vaccine in advanced cancer patients.

    Science.gov (United States)

    Cusi, Maria Grazia; Botta, Cirino; Pastina, Pierpaolo; Rossetti, Maria Grazia; Dreassi, Elena; Guidelli, Giacomo Maria; Fioravanti, Antonella; Martino, Elodia Claudia; Gandolfo, Claudia; Pagliuchi, Marco; Basile, Assunta; Carbone, Salvatore Francesco; Ricci, Veronica; Micheli, Lucia; Tassone, Pierfrancesco; Tagliaferri, Pierosandro; Pirtoli, Luigi; Correale, Pierpaolo

    2015-09-01

    Thymidylate synthase (TS) poly-epitope peptide (TSPP) is a 27-mer peptide vaccine containing the amino acidic sequences of three epitopes with HLA-A2.1-binding motifs of TS, an enzyme overexpressed in cancer cells, which plays a crucial role in DNA repair and replication. Based on the results of preclinical studies, we designed a phase Ib trial (TSPP/VAC1) to investigate, in a dose escalation setting, the safety and the biological activity of TSPP vaccination alone (arm A) or in combination with GM-CSF and IL-2 (arm B) in cancer patients. Twenty-one pretreated metastatic cancer patients, with a good performance status (ECOG ≤ 1) and no severe organ failure or immunological disease, were enrolled in the study (12 in arm A, nine in arm B) between April 2011 and January 2012, with a median follow-up of 28 months. TSPP resulted safe, and its maximal tolerated dose was not achieved. No grade 4 toxicity was observed. The most common adverse events were grade 2 dermatological reactions to the vaccine injection, cough, rhinitis, fever, poly-arthralgia, gastro-enteric symptoms and, to a lesser extent, moderate hypertension and hypothyroidism. We detected a significant rise in auto-antibodies and TS-epitope-specific CTL precursors. Furthermore, TSPP showed antitumor activity in this group of pretreated patients; indeed, we recorded one partial response and seven disease stabilizations (SD) in arm A, and three SD in arm B. Taken together, our findings provide the framework for the evaluation of the TSPP anti-tumor activity in further disease-oriented clinical trials. PMID:26031574

  15. The effectiveness of group positive psychotherapy on depression and happiness in breast cancer patients: A randomized controlled trial

    Science.gov (United States)

    Dowlatabadi, Mohammad Mehdi; Ahmadi, Seyed Mojtaba; Sorbi, Mohammad Hossein; Beiki, Omid; Razavi, Tayebeh Khademeh; Bidaki, Reza

    2016-01-01

    Background Breast cancer is one of the most prevalent cancers in women in the world. It causes fear, despair, and takes a tremendous toll on psychological status. Objective To determine the effectiveness of group positive psychotherapy on the depression and happiness of breast cancer patients. Methods This randomized controlled trial was conducted with 42 breast cancer patients in The Oncology Center at Kermanshah, Iran in 2015. The Data were gathered before intervention and ten weeks afterwards. The data were collected using Beck’s Depression Inventory (BDI-II) and Oxford’s happiness Inventory (OHI). The data were analyzed by SPSS-16, Kolmogorov-Smirnov (K-S), chi-squared, and multivariate analysis of covariance (MANCOVA). Results The results showed a significant reduction in the depression of the group on positive psychotherapy compared with the control group. Also the positive psychotherapy group experienced a significant increase in the patients’ happiness, while there was no significant increase in the control group. Conclusion The results of this research showed the effectiveness of positive psychotherapy on the reduction of mental pressure and the improvement of the mental status of breast cancer patients. This economical therapy can be used to increase patients’ psychological health. Clinical Trial Registration The trial was registered at the Iranian Registry of Clinical Trials (IRST) with the identification number IRCT2013101410063N4. Funding The authors received financial support for the research from Kermanshah University of Medical Sciences. PMID:27123227

  16. Hypofractionated Volumetric Modulated Arc Radiotherapy with simultaneous Elective Nodal Irradiation is feasible in prostate cancer patients: A single institution experience

    Directory of Open Access Journals (Sweden)

    Mohamed W. Hegazy

    2016-06-01

    Conclusions: Hypo-fractionation dose escalation VMAT–SIB–ENI–WPRT using 2 arcs is a feasible technique for intermediate/high risk OC prostate cancer patients, with acceptable rates of acute/late toxicities, much favorable planning target volume (PTV coverage, and shorter overall treatment time. Prospective randomized controlled trials are encouraged to confirm its equivalence to other fractionation schemes.

  17. Quality of life among young women with breast cancer: Study from a tertiary cancer institute in south India

    Directory of Open Access Journals (Sweden)

    B Dubashi

    2010-01-01

    Full Text Available Background : The incidence of breast cancer in young patients less than 35 years is less than 1%. The physical and psychosocial morbidity may affect their ability to successfully function in their social roles. Hence we studied the quality of life (QOL issues in this subset. Materials and Methods :Younger women with age less than 35 years, diagnosed with non-metastatic breast cancer at our Institute, from 1995 to 2005, were included in the study. Quality of life issues were studied during the follow-up using EORTC QOL C30 and BR23. Descriptive and inferential statistics were used in order to analyze the data. Results : A total of 51 patients were included for the study. The mean age at diagnosis was 30 years. The effect of breast cancer on the occupation and marital status was minimal. The global health status and the functional scores were high, while the overall sexual function was lower. The global health status was higher in the mastectomy group. The arm symptoms (P = 0.027 and pain were higher in the Breast conservation surgery (BCS group. The sexual symptoms appeared to be higher in the ovary ablated group when compared to the ovary preserved group. The sexual functional scores (P = 0.02 and sexual enjoyment scores (P = 0.003 were better in the mastectomy group. Conclusion : The overall QOL in younger patients with breast cancer appeared to be good. The QOL and sexual function were marginally worse in the breast conservation group when compared to mastectomy group.

  18. Endobronchial Ultrasound Changed the World of Lung Cancer Patients: A 11-Year Institutional Experience.

    Directory of Open Access Journals (Sweden)

    Chia-Hung Chen

    Full Text Available The role of advanced bronchoscopic diagnostic techniques in the detection and staging of lung cancer has increased sharply in recent years. The development of endobronchial ultrasound (EBUS improved minimally invasive mediastinal staging and diagnosis of peripheral lung lesions (PLLs. We investigated the impact of using EBUS as a diagnostic method for tissue acquisition in lung cancer patients.In a single center observational retrospective study, 3712 subjects were diagnosed with lung cancer from 2003 to 2013 (EBUS was introduced in 2008. Thus, we divided the data into two periods: the conventional bronchoscopy period (2003 to 2007 and the EBUS period (2008 to 2013.A total of 3712 patients were included in the analysis. Comparing the conventional bronchoscopy period with the EBUS period data, there has been a significant reduction in the use of diagnostic modalities: CT-guided biopsy (P < 0.0001 and pleural effusion cytology (P < 0.0001. The proportion of subjects diagnosed using bronchoscopy significantly increased from 39.4% in the conventional period to 47.4% in the EBUS period (P < 0.0001. In the EBUS period, there has also been a significant increase in the proportion of patients proceeding directly to diagnostic surgery (P < 0.0001. Compared to bronchoscopy, the incidence of complications was higher in those who underwent CT guide biopsy. The incidence of iatrogenic pneumothorax significantly decreased in the EBUS period.Advanced bronchoscopic techniques are widely used in the diagnosis of lung cancer. At our institution, the increasing use of EBUS for providing lung cancer diagnosis has led to a significant reduction in other diagnostic modalities, namely CT-guided biopsy and pleural effusion cytology. These changes in practice also led to a reduction in the incidence of complications.

  19. 78 FR 69428 - Submission for OMB Review; 30-Day Comment Request: Cancer Trials Support Unit (CTSU) (NCI)

    Science.gov (United States)

    2013-11-19

    ... on the proposed project contact: Michael Montello, Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, 9609 Medical Center Drive, Rockville, MD 20850 or call non-toll-free... HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-Day Comment Request:...

  20. A Phase I study of olaparib and irinotecan in patients with colorectal cancer: Canadian Cancer Trials Group IND 187.

    Science.gov (United States)

    Chen, Eric X; Jonker, Derek J; Siu, Lillian L; McKeever, Karyn; Keller, Deborah; Wells, Julie; Hagerman, Linda; Seymour, Lesley

    2016-08-01

    Background Olaparib is an orally available inhibitor of PARP-1. In pre-clinical studies, olaparib was shown to potentiate anti-tumor effects of irinotecan in colon cancer cell lines. This phase I study was conducted to evaluate the safety and tolerability of olaparib in combination with irinotecan. Patients and Methods Patients with advanced colorectal cancer whose disease progressed after at least one systemic therapy regimen were enrolled. Dose escalation and de-escalation were based on toxicity assessment. Pharmacokinetic samples were collected in Cycle 1 for olaparib, irinotecan and SN-38. Results Twenty-five patients were enrolled, 11 patients on a schedule of continuous olaparib and irinotecan every 3 weeks (Part A) and 14 patients on a schedule of intermittent olaparib and irinotecan every 2 weeks (Part B). Continuous olaparib administration was associated with higher than expected toxicities and was not considered to be tolerable. Intermittent olaparib administration was better tolerated, and the recommended phase 2 doses were olaparib 50 mg p.o twice daily days 1-5 and irinotecan 125 mg/m(2) i.v. every 2 weeks. Common toxicities included fatigue, anorexia, diarrhea, nausea, vomiting, neutropenia, thrombocytopenia and abdominal pain. Nine patients had stable disease as the best response, 2 from Part A (3 and 9 months respectively), and 7 from Part B (median duration: 7.4 months; range: 4 to 13 months). There was no pharmacokinetic interaction between olaparib and irinotecan. Conclusions Olaparib can be combined with irinotecan if administered intermittently. Both olaparib and irinotecan required significant dose reductions. The lack of anti-tumor efficacy observed in this trial makes this combination of little interest for further clinical development. Trial Registration ID NCT00535353. PMID:27075016

  1. A randomized controlled Phase III trial comparing 2-weekly docetaxel combined with cisplatin plus fluorouracil (2-weekly DCF) with cisplatin plus fluorouracil (CF) in patients with metastatic or recurrent esophageal cancer: rationale, design and methods of Japan Clinical Oncology Group study JCOG1314 (MIRACLE study).

    Science.gov (United States)

    Kataoka, Kozo; Tsushima, Takahiro; Mizusawa, Junki; Hironaka, Shuichi; Tsubosa, Yasuhiro; Kii, Takayuki; Shibuya, Yuichi; Chin, Keisho; Katayama, Hiroshi; Kato, Ken; Fukuda, Haruhiko; Kitagawa, Yuko

    2015-05-01

    Chemotherapy with cisplatin plus fluorouracil is the current standard treatment for metastatic or recurrent esophageal cancer. We have developed a 2-weekly docetaxel combined with CF regimen and conducted a Phase I/II trial for metastatic or recurrent esophageal cancer (JCOG0807). Promising efficacy and safety were shown in JCOG0807, and we have commenced a Phase III trial in September 2014 to confirm the superiority of 2-weekly DCF to CF for patients with metastatic or recurrent esophageal cancer. A total of 240 patients will be accrued from 41 Japanese institutions over a period of 4 years. The primary end point is overall survival. The secondary end points are progression-free survival, response rate and proportion of adverse events. This trial has been registered in the UMIN Clinical Trials Registry as UMIN000015107 (http://www.umin.ac.jp/ctr/index.htm). PMID:25646357

  2. Environmental dose in the Nuclear Medicine Department of the National Institute of Cancer

    International Nuclear Information System (INIS)

    The dosimeters TLD-100 and TLD-900 were used to know the levels of environmental dose in areas of the Nuclear Medicine Department of the National Institute of Cancer. The dosimeters calibration was carried out in the Metrology Department of the National Institute of Nuclear Research. The radioisotopes used in the studied areas are 131I, 18F, 67Ga, 99mTc, 111In, 201Tl and 137Cs with gamma energies between 93 and 662 KeV. Dosimeters were placed during five months in the diagnostic, injection, waiting and PET rooms as well as hot room, waste room, enclosed corridors to patient rooms treated with 131I and 137Cs and witness dosimeters to know the bottom. The values found vary between 0.3 and 70 major times that those of bottom. The maximum doses were measured in the waste room and in the enclosed corridor to the patient rooms with cervical uterine cancer treated with 137Cs. (Author)

  3. A meta-analysis of clinical trials assessing the effect of radiofrequency ablation for breast cancer

    Directory of Open Access Journals (Sweden)

    Chen J

    2016-03-01

    Full Text Available Jiayan Chen,1,* Chi Zhang,1,* Fei Li,1,* Liping Xu,1 Hongcheng Zhu,1 Shui Wang,2 Xiaoan Liu,2 Xiaoming Zha,2 Qiang Ding,2 Lijun Ling,2 Wenbin Zhou,2 Xinchen Sun1 1Department of Radiation Oncology, 2Department of Breast Surgery, The First Affiliated Hospital, Nanjing Medical University, Nanjing, People’s Republic of China *These authors contributed equally to this work Background: Radiofrequency ablation (RFA is a minimally invasive thermal ablation technique. We conducted a meta-analysis based on eligible studies to assess the efficacy and safety of RFA for treating patients with breast cancer.Methods: A literature search was conducted in PubMed, Embase, and Web of Science databases. Eligible studies were clinical trials that assessed RFA in patients with breast cancer. The outcomes included complete ablation rate, recurrence rate, excellent or good cosmetic rates, and complication rate. A random-effects or fixed-effects model was used to pool the estimate, according to the heterogeneity among the included studies.Results: Fifteen studies, with a total of 404 patients, were included in this meta-analysis. Pooled results showed that 89% (95% confidence interval: 85%–93% of patients achieved a complete ablation after RFA treatment and 96% of patients reported a good-to-excellent cosmetic result. Although the pooled result for recurrence rate was 0, several cases of relapse were observed at different follow-up times. No RFA-related complications were recorded, except for skin burn with an incidence of 4% (95% confidence interval: 1%–6%.Conclusion: This meta-analysis showed that RFA can be a promising alternative option for treating breast cancer since it produces a higher complete ablation rate with a low complication rate. Further well-designed randomized controlled trials are needed to confirm the efficacy and safety of RFA for breast cancer. Keywords: radiofrequency ablation, breast cancer, meta-analysis

  4. A Phase II/III Randomized, Placebo-Controlled, Double-Blind Clinical Trial of Ginger (Zingiber officinale) for Nausea Caused by Chemotherapy for Cancer: A Currently Accruing URCC CCOP Cancer Control Study.

    Science.gov (United States)

    Hickok, Jane T; Roscoe, Joseph A; Morrow, Gary R; Ryan, Julie L

    2007-09-01

    Despite the widespread use of 5-HT3 receptor antagonist antiemetics such as ondansetron and granistron, up to 70% of patients with cancer receiving highly emetogenic chemotherapy agents experience postchemotherapy nausea and vomiting. Delayed postchemotherapy nausea (nausea that occurs >/= 24 hours after chemotherapy administration) and anticipatory nausea (nausea that develops before chemotherapy administration, in anticipation of it) are poorly controlled by currently available antiemetic agents. Scientific studies suggest that ginger (Zingiber officinale) might have beneficial effects on nausea and vomiting associated with motion sickness, surgery, and pregnancy. In 2 small studies of patients with cancer receiving chemotherapy, addition of ginger to standard antiemetic medication further reduced the severity of postchemotherapy nausea. This article describes a phase II/III randomized, dose-finding, placebo-controlled, double-blind clinical trial to assess the efficacy of ginger for nausea associated with chemotherapy for cancer. The study is currently being conducted by private practice oncology groups that are funded by the National Cancer Institute's Community Clinical Oncology Program and affiliated with the University of Rochester Cancer Center Community Clinical Oncology Program Research Base. PMID:18632524

  5. Can the referring surgeon enhance accrual of breast cancer patients to medical and radiation oncology trials? The ENHANCE study

    Science.gov (United States)

    Arnaout, A.; Kuchuk, I.; Bouganim, N.; Pond, G.; Verma, S.; Segal, R.; Dent, S.; Gertler, S.; Song, X.; Kanji, F.; Clemons, M.

    2016-01-01

    Introduction The accrual rate to clinical trials in oncology remains low. In this exploratory pilot study, we prospectively assessed the role that engaging a referring surgeon plays in enhancing nonsurgical oncologic clinical trial accrual. Methods Newly diagnosed breast cancer patients were seen by a surgeon who actively introduced specific patient-and physician-centred strategies to increase clinical trial accrual. Patient-centred strategies included providing patients, before their oncology appointment, with information about specific clinical trials for which they might be eligible, as evaluated by the surgeon. The attitudes of the patients about clinical trials and the interventions used to improve accrual were assessed at the end of the study. The primary outcome was the clinical trial accrual rate during the study period. Results Overall clinical trial enrolment during the study period among the 34 participating patients was 15% (5 of 34), which is greater than the institution’s historical average of 7%. All patients found the information delivered by the surgeon before the oncology appointment to be very helpful. Almost three quarters of the patients (73%) were informed about clinical trials by their oncologist. The top reasons for nonparticipation reported by the patients who did not participate in clinical trials included lack of interest (35%), failure of the oncologist to mention clinical trials (33%), and inconvenience (19%). Conclusions Accrual of patients to clinical trials is a complex multistep process with multiple potential barriers. The findings of this exploratory pilot study demonstrate a potential role for the referring surgeon in enhancing nonsurgical clinical trial accrual.

  6. A randomized trial of amifostine as a cytoprotective agent in patients receiving chemotherapy for small cell lung cancer

    OpenAIRE

    Johnson, P. W. M.; Muers, M. F.; Peake, M D; Poulter, K M; Gurney, E M; Napp, V; Hepburn, P M; Brown, J. M.

    2001-01-01

    A randomized trial was conducted to determine whether administration of Amifostine with chemotherapy for small cell lung cancer could decrease the toxicity. 84 patients with small cell lung cancer of favourable prognosis (limited disease, performance status 0–1; limited disease with performance status 2 but normal sodium and alkaline phosphatase, or extensive diseas with performance status 0–1, normal sodium and alkaline phosphatase) received treatment with Ifosfamide 3 g/m2intravenously, Car...

  7. Conjugated Equine Estrogens and Breast Cancer Risk in the Women’s Health Initiative Clinical Trial and Observational Study

    OpenAIRE

    Prentice, Ross L.; Chlebowski, Rowan T.; Stefanick, Marcia L.; Joann E Manson; Langer, Robert D; Pettinger, Mary; Hendrix, Susan L.; Hubbell, F Allan; Kooperberg, Charles; Lewis H Kuller; Lane, Dorothy S.; McTiernan, Anne; O’Sullivan, Mary Jo; Rossouw, Jacques E; Anderson, Garnet L.

    2008-01-01

    The Women’s Health Initiative randomized controlled trial found a trend (p = 0.09) toward a lower breast cancer risk among women assigned to daily 0.625-mg conjugated equine estrogens (CEEs) compared with placebo, in contrast to an observational literature that mostly reports a moderate increase in risk with estrogenalone preparations. In 1993–2004 at 40 US clinical centers, breast cancer hazard ratio estimates for this CEE regimen were compared between the Women’s Health Initiative clinical ...

  8. Description of the Protocols for Randomized Controlled Trials on Cancer Drugs Conducted in Spain (1999–2003)

    OpenAIRE

    Bonfill, Xavier; Ballesteros, Mónica; Gich, Ignasi; Serrano, María Antonia; García López, Fernando; Urrútia, Gerard

    2013-01-01

    Objective To describe the characteristics of randomized controlled clinical trials (RCT) on cancer drugs conducted in Spain between 1999 and 2003 based on their protocols. Methods We conducted an observational retrospective cohort study to identify the protocols of RCTs on cancer drugs authorized by the Agencia Española del Medicamento y Productos Sanitarios (AEMPS) (Spanish Agency for Medicines and Medical Devices) during 1999-2003. A descriptive analysis was completed and the association be...

  9. Dietary components and risk of total, cancer and cardiovascular disease mortality in the Linxian Nutrition Intervention Trials cohort in China

    OpenAIRE

    Jian-Bing Wang; Jin-Hu Fan; Dawsey, Sanford M.; Rashmi Sinha; Freedman, Neal D.; Taylor, Philip R.; You-Lin Qiao; Abnet, Christian C.

    2016-01-01

    Although previous studies have shown that dietary consumption of certain food groups is associated with a lower risk of cancer, heart disease and stroke mortality in western populations, limited prospective data are available from China. We prospectively examined the association between dietary intake of different food groups at baseline and risk of total, cancer, heart disease and stroke mortality outcomes in the Linxian Nutrition Intervention Trials(NIT) cohort. In 1984–1991, 2445 subjects ...

  10. The Clinical Effects of Aromatherapy Massage on Reducing Pain for the Cancer Patients: Meta-Analysis of Randomized Controlled Trials

    OpenAIRE

    Ting-Hao Chen; Tao-Hsin Tung; Pei-Shih Chen; Shu-Hui Wang; Chuang-Min Chao; Nan-Hsing Hsiung; Ching-Chi Chi

    2016-01-01

    Purpose. Aromatherapy massage is an alternative treatment in reducing the pain of the cancer patients. This study was to investigate whether aromatherapy massage could improve the pain of the cancer patients. Methods. We searched PubMed and Cochrane Library for relevant randomized controlled trials without language limitations between 1 January 1990 and 31 July 2015 with a priori defined inclusion and exclusion criteria. The search terms included aromatherapy, essential oil, pain, ache, cance...

  11. Efficacy of psychodynamic short-term psychotherapy for depressed breast cancer patients: study protocol for a randomized controlled trial

    OpenAIRE

    Zwerenz Rüdiger; Beutel Manfred E; Imruck Barbara H; Wiltink Jörg; Haselbacher Antje; Ruckes Christian; Schmidberger Heinz; Hoffmann Gerald; Schmidt Marcus; Köhler Uwe; Langanke Dagmar; Kortmann Rolf-Dieter; Kuhnt Susanne; Weißflog Gregor; Barthel Yvette

    2012-01-01

    Abstract Background There is a lack of psychotherapeutic trials of treatments of comorbid depression in cancer patients. Our study determines the efficacy of a manualized short-term psychodynamic psychotherapy and predictors of outcome by personality and quality of the therapeutic relationship. Methods/design Eligible breast cancer patients with comorbid depression are assigned to short-term psychodynamic psychotherapy (up to 20 + 5 sessions) or to treatment as usual (augmented by recommendat...

  12. Conquer fear: protocol of a randomised controlled trial of a psychological intervention to reduce fear of cancer recurrence

    OpenAIRE

    Butow, Phyllis N.; Bell, Melanie L; Smith, Allan B; Fardell, Joanna E.; Thewes, Belinda; Turner, Jane; Gilchrist, Jemma; Beith, Jane; Girgis, Afaf; Sharpe, Louise; Shih, Sophy; Mihalopoulos, Cathrine

    2013-01-01

    Background Up to 70% of cancer survivors report clinically significant levels of fear of cancer recurrence (FCR). Despite the known negative impact of FCR on psychological wellbeing and quality of life, little research has investigated interventions for high FCR. Our team has developed and piloted a novel intervention (Conquer Fear) based on the Self-Regulatory Executive Function Model and Relational Frame Theory and is evaluating Conquer Fear in a randomised controlled trial (RCT). We aim to...

  13. Neoadjuvant radiochemotherapy for locally advanced gastric cancer: Long-term results of a phase I trial

    International Nuclear Information System (INIS)

    Purpose: To assess the long-term results of radiation therapy (RT) when added preoperatively to systemic chemotherapy in patients with locally advanced gastric cancer. Methods and Materials: Patients presenting with T3-4 or N+ gastric cancer received two cycles of cisplatin 100 mg/m2 d1, 5FU 800 mg/m2 d1-4, and Leucovorin 60 mg twice daily d1-4; one cycle before and one concomitantly with hyperfractionated RT (median dose, 38.4; range, 31.2-45.6 Gy). All patients underwent a total or subtotal gastrectomy with D2 lymph node resection. Results: Nineteen patients were accrued and 18 completed the neoadjuvant therapeutic program. All patients were subsequently operated and no fatality occurred. At a mean follow-up of 8 years for the surviving patients, no severe late toxicity was observed. The 5-year locoregional control, disease-free, and overall survival were of 85%, 41%, and 35%, respectively. The peritoneum was the most frequent site of relapse. Among long terms survivors, no severe (Radiation Therapy Oncology Group Grade 3-4) late complication was reported. Conclusions: The present neoadjuvant treatment does not seem to increase the operative risk, nor the late side effects. The encouraging locoregional control rate suggests that the neoadjuvant approach should be considered for future trials in locally advanced gastric cancer. Also, the frequency of peritoneal recurrence stresses the need for a more efficient systemic or intraperitoneal treatment

  14. Folic acid supplements and colorectal cancer risk: meta-analysis of randomized controlled trials

    Science.gov (United States)

    Qin, Tingting; Du, Mulong; Du, Haina; Shu, Yongqian; Wang, Meilin; Zhu, Lingjun

    2015-07-01

    Numerous studies have investigated the effects of folic acid supplementation on colorectal cancer risk, but conflicting results were reported. We herein performed a meta-analysis based on relevant studies to reach a more definitive conclusion. The PubMed and Embase databases were searched for quality randomized controlled trials (RCTs) published before October 2014. Eight articles met the inclusion criteria and were subsequently analyzed. The results suggested that folic acid treatment was not associated with colorectal cancer risk in the total population (relative risk [RR] = 1.00, 95% confidence interval [CI] = 0.82-1.22, P = 0.974). Moreover, no statistical effect was identified in further subgroup analyses stratified by ethnicity, gender, body mass index (BMI) and potential confounding factors. No significant heterogeneity or publication bias was observed. In conclusion, our meta-analysis demonstrated that folic acid supplementation had no effect on colorectal cancer risk. However, this finding must be validated by further large studies.

  15. A multicentric observational trial of pegylated liposomal doxorubicin for metastatic breast cancer

    International Nuclear Information System (INIS)

    Pegylated liposomal doxorubicin (PLD) is active in metastatic breast cancer. This observational study evaluated the efficacy and safety of PLD in patients treated during routine clinical practice. Eligible patients had metastatic breast cancer and were treated with PLD according to the dose and schedule determined by their physician as part of routine practice. The primary objectives were to analyze the efficacy and toxicity of PLD therapy. 125 patients were assessable. Median age was 62 years, 78% had performance status 0-1, and 60% had estrogen-receptor-positive disease. PLD treatment was second- or third-line in 69% of patients. Prior anthracyclines (adjuvant or metastatic) had been used in 56% of patients. The majority of patients (79%) received PLD every 4 weeks at a median dose of 40 mg/m2. Overall response rate was 43% in all patients and 34% in those previously treated with anthracyclines. The most common grade 3/4 adverse events were skin toxicity/hand-foot syndrome (6%), and leukopenia (3%). This observational study supports the activity and tolerability of PLD in metastatic breast cancer as demonstrated in PLD clinical trials

  16. No effect of meat, meat cooking preferences, meat mutagens or heme iron on lung cancer risk in the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial

    OpenAIRE

    Tasevska, Nataša; Cross, Amanda J.; Dodd, Kevin W.; Ziegler, Regina G.; Caporaso, Neil E; Sinha, Rashmi

    2010-01-01

    Recent epidemiological studies have suggested that red and processed meat may increase the risk of lung cancer. Possible underlying mechanisms include mutagens produced during high temperature cooking or preservation, or formed endogenously from heme iron in meat. We used data from 99,579 participants of both screened and non-screened arms of the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial (PLCO), aged 55–74 years, to investigate whether meat type, cooking method, doneness ...

  17. A randomised controlled trial of a cognitive behavioural intervention for women who have menopausal symptoms following breast cancer treatment (MENOS 1: Trial protocol

    Directory of Open Access Journals (Sweden)

    Hellier Jennifer

    2011-01-01

    Full Text Available Abstract Background This trial aims to evaluate the effectiveness of a group cognitive behavioural intervention to alleviate menopausal symptoms (hot flushes and night sweats in women who have had breast cancer treatment. Hot flushes and night sweats are highly prevalent but challenging to treat in this population. Cognitive behaviour therapy has been found to reduce these symptoms in well women and results of an exploratory trial suggest that it might be effective for breast cancer patients. Two hypotheses are tested: Compared to usual care, group cognitive behavioural therapy will: 1. Significantly reduce the problem rating and frequency of hot flushes and nights sweats after six weeks of treatment and at six months post-randomisation. 2. Improve mood and quality of life after six weeks of treatment and at six months post-randomisation. Methods/Design Ninety-six women who have completed their main treatment for breast cancer and who have been experiencing problematic hot flushes and night sweats for over two months are recruited into the trial from oncology and breast clinics in South East London. They are randomised to either six weekly group cognitive behavioural therapy (Group CBT sessions or to usual care. Group CBT includes information and discussion about hot flushes and night sweats in the context of breast cancer, monitoring and modifying precipitants, relaxation and paced respiration, stress management, cognitive therapy for unhelpful thoughts and beliefs, managing sleep and night sweats and maintaining changes. Prior to randomisation women attend a clinical interview, undergo 24-hour sternal skin conductance monitoring, and complete questionnaire measures of hot flushes and night sweats, mood, quality of life, hot flush beliefs and behaviours, optimism and somatic amplification. Post-treatment measures (sternal skin conductance and questionnaires are collected six to eight weeks later and follow-up measures (questionnaires and a use

  18. Radiation therapy with or without primary limited surgery for operable breast cancer: A 20-year experience at the Marseilles Cancer Institute

    International Nuclear Information System (INIS)

    At the Marseilles Cancer Institute, the authors' first source of radioactive cesium was promptly applied to the treatment of breast cancer, to which it seemed ideally suited because of good superficial and intermediate penetration. Their favorable early experience led them to embark on a program of conservative treatment of operable breast cancer, which has supplanted the routine use of radical mastectomy at our institution. Since June 1960, more than 3000 consecutive operable breast cancers were treated primarily with radiation therapy with or without initial limited surgery. This paper presents the treatment results in 1440 cases eligible for five-year analysis, including 320 ten-year cases, thus representing the largest series of breast cancer patients treated with modern radiation therapy techniques thus far reported in the literature

  19. Nano medicine in Action: An Overview of Cancer Nano medicine on the Market and in Clinical Trials

    International Nuclear Information System (INIS)

    Nano medicine, defined as the application of nano technology in the medical field, has the potential to significantly change the course of diagnostics and treatment of life-threatening diseases, such as cancer. In comparison with traditional cancer diagnostics and therapy, cancer nano medicine provides sensitive cancer detection and/or enhances treatment efficacy with significantly minimized adverse effects associated with standard therapeutics. Cancer nano medicine has been increasingly applied in areas including nano drug delivery systems, nano pharmaceuticals, and nano analytical contrast reagents in laboratory and animal model research. In recent years, the successful introduction of several novel nano medicine products into clinical trials and even onto the commercial market has shown successful outcomes of fundamental research into clinics. This paper is intended to examine several nano medicines for cancer therapeutics and/or diagnostics-related applications, to analyze the trend of nano medicine development, future opportunities, and challenges of this fast-growing area.

  20. Robot-assisted minimally invasive thoraco-laparoscopic esophagectomy versus open transthoracic esophagectomy for resectable esophageal cancer, a randomized controlled trial (ROBOT trial

    Directory of Open Access Journals (Sweden)

    van der Sluis Pieter C

    2012-11-01

    Full Text Available Abstract Background For esophageal cancer patients, radical esophagolymphadenectomy is the cornerstone of multimodality treatment with curative intent. Transthoracic esophagectomy is the preferred surgical approach worldwide allowing for en-bloc resection of the tumor with the surrounding lymph nodes. However, the percentage of cardiopulmonary complications associated with the transthoracic approach is high (50 to 70%. Recent studies have shown that robot-assisted minimally invasive thoraco-laparoscopic esophagectomy (RATE is at least equivalent to the open transthoracic approach for esophageal cancer in terms of short-term oncological outcomes. RATE was accompanied with reduced blood loss, shorter ICU stay and improved lymph node retrieval compared with open esophagectomy, and the pulmonary complication rate, hospital stay and perioperative mortality were comparable. The objective is to evaluate the efficacy, risks, quality of life and cost-effectiveness of RATE as an alternative to open transthoracic esophagectomy for treatment of esophageal cancer. Methods/design This is an investigator-initiated and investigator-driven monocenter randomized controlled parallel-group, superiority trial. All adult patients (age ≥18 and ≤80 years with histologically proven, surgically resectable (cT1-4a, N0-3, M0 esophageal carcinoma of the intrathoracic esophagus and with European Clinical Oncology Group performance status 0, 1 or 2 will be assessed for eligibility and included after obtaining informed consent. Patients (n = 112 with resectable esophageal cancer are randomized in the outpatient department to either RATE (n = 56 or open three-stage transthoracic esophageal resection (n = 56. The primary outcome of this study is the percentage of overall complications (grade 2 and higher as stated by the modified Clavien–Dindo classification of surgical complications. Discussion This is the first randomized controlled trial designed to compare RATE with

  1. Cost comparison of curative therapies for localized prostate cancer in Japan. A single-institution experience

    International Nuclear Information System (INIS)

    In addition to open surgery, curative therapies for prostate cancer now include endoscopic surgery and radiation therapies. Because of the expansion and subdivision of treatment methods for prostate cancer, the medical fee point schedule in Japan was revised in fiscal year 2006. We examined changes in medical income and expenditure after this revision of the medical fee system. We studied income and expenditure, after institution of the new medical fee schedule, for the five types of therapies for prostate cancer performed at our hospital: two surgical therapies (radical retropubic prostatectomy and laparoscopic prostatectomy) and three radiation therapies (three-dimensional conformal radiation therapy, 192Ir high-dose-rate brachytherapy, and 125I low-dose-rate brachytherapy). Low-dose-rate brachytherapy was found to be associated with a profit of 199 yen per patient. Laparoscopic prostatectomy, a highly advanced medical treatment that the fee revision changed from a partially insured to an insured procedure, yielded a profit of 75672 yen per patient. However, high-dose-rate brachytherapy was associated with a loss of 654016 yen per patient. Given the loss in hospital income per patient undergoing high-dose-rate brachytherapy, the medical fee point system for this procedure should be reassessed. (author)

  2. Altered plasma apolipoprotein modifications in patients with pancreatic cancer: protein characterization and multi-institutional validation.

    Directory of Open Access Journals (Sweden)

    Kazufumi Honda

    Full Text Available BACKGROUND: Among the more common human malignancies, invasive ductal carcinoma of the pancreas has the worst prognosis. The poor outcome seems to be attributable to difficulty in early detection. METHODS: We compared the plasma protein profiles of 112 pancreatic cancer patients with those of 103 sex- and age-matched healthy controls (Cohort 1 using a newly developed matrix-assisted laser desorption/ionization (oMALDI QqTOF (quadrupole time-of-flight mass spectrometry (MS system. RESULTS: We found that hemi-truncated apolipoprotein AII dimer (ApoAII-2; 17252 m/z, unglycosylated apolipoprotein CIII (ApoCIII-0; 8766 m/z, and their summed value were significantly decreased in the pancreatic cancer patients [P = 1.36×10(-21, P = 4.35×10(-14, and P = 1.83×10(-24 (Mann-Whitney U-test; area-under-curve values of 0.877, 0.798, and 0.903, respectively]. The significance was further validated in a total of 1099 plasma/serum samples, consisting of 2 retrospective cohorts [Cohort 2 (n = 103 and Cohort 3 (n = 163] and a prospective cohort [Cohort 4 (n = 833] collected from 8 medical institutions in Japan and Germany. CONCLUSIONS: We have constructed a robust quantitative MS profiling system and used it to validate alterations of modified apolipoproteins in multiple cohorts of patients with pancreatic cancer.

  3. Pelvic exenteration for colorectal cancer: oncologic outcome in 59 patients at a single institution

    International Nuclear Information System (INIS)

    Pelvic exenteration (PE) continues to be the only curative option in selected patients with advanced or recurrent pelvic neoplasms. A current debate exists concerning the appropriate selection of patients for PE, with the most important factor being the absence of extrapelvic disease. To evaluate the outcome of patients submitted to exenterative surgery. A review of the clinical charts of patients with colorectal cancer who underwent PE between January 1994 and June 2010 at the Institute National of Cancerología in Mexico City was performed. We selected 59 patients, 53 of whom were females (90%), and six of whom were males (10%). Mean age at the time of diagnosis was 50 years (range, 21–77 years). A total of 51 patients underwent posterior PE (86%), and eight patients underwent total PE (14%). Operative mortality occurred in two cases (3%), and 29 patients developed complications (49%). Overall, 11 patients (19%) experienced local failure with mean disease-free survival time of 10.2 months. After a mean follow-up of 28.3 months, nine patients are still alive without evidence of the disease (15%). PE should be considered in advanced colorectal cancer without extrapelvic metastatic disease. PE is accompanied by considerable morbidity (49%) and mortality (3%), but local control is desirable. Overall survival justifies the use of this procedure in patients with primary or recurrent locally advanced rectal cancer

  4. Adjuvant radiation therapy of regional lymph nodes in breast cancer - a meta-analysis of randomized trials- an update

    International Nuclear Information System (INIS)

    Adjuvant radiotherapy (RT) of regional lymph nodes (LN) in early breast cancer is still a matter of debate. RT increases the Overall survival (OS) rate of breast cancer patients after breast conserving surgery and after mastectomy in patients with involved LN. The contribution of RT to regional LN to this improvement was poorly identified. Recently, the results of three large randomized trials addressing this question were published as full papers. Published data of the MA.20 (n = 1832), the EORTC22922–10925 (EORTC) (n = 4004) trial and the French trial (n = 1334) were the foundation of this meta-analysis. Major eligibility criteria were positive i) axillary LN (all trials), ii) LN negative disease with high risk for recurrence (MA.20), and iii) medial/central tumor location (French, EORTC). The MA.20 and the EORTC trial analyzed the effect of additional regional RT to the internal mammary (IM) LN and medial supraclavicular (MS) LN, whereas in the French trial all patients received RT to the MS-LN and solely RT to the IM-LN was randomized. Primary endpoint was OS. Secondary endpoints were disease-free survival (DFS) and distant metastasis free survival (DMFS). Regional RT of MS-LN and IM-LN (MA.20 and EORTC) resulted in a significant improvement of OS [Hazard Ratio (HR) 0.88 (95 % CL 0.78 - 0.99)]. Adding results of the French trial and using a random effects model to respect the different design of the French trial, the effect on OS of regional RT remained significant [HR 0.90 (95 % CL 0.82 - 0.99)]. The absolute benefits in OS were 1 % in the MA.20 trial at 10 years, 1.6 % in the EORTC trial at 10 years, and 3.3 % in the French trial at 10 years (not significant in single trials). Regional RT of MS-LN and IM-LN (MA.20 and EORTC) yielded to a significant improvement of DFS [HR 0.86 (95 % CL 0.78 - 0.95)] and DMFS [HR 0.84 (95 % CL 0.75 - 0.94)]. Additional regional RT to the internal mammary and medial supraclavicular LN statistically significantly improved DFS

  5. Alcohol consumption and colon cancer prognosis among participants in north central cancer treatment group phase III trial N0147.

    Science.gov (United States)

    Phipps, Amanda I; Shi, Qian; Limburg, Paul J; Nelson, Garth D; Sargent, Daniel J; Sinicrope, Frank A; Chan, Emily; Gill, Sharlene; Goldberg, Richard M; Kahlenberg, Morton; Nair, Suresh; Shields, Anthony F; Newcomb, Polly A; Alberts, Steven R

    2016-09-01

    Alcohol consumption is associated with a modest increased risk of colon cancer, but its relationship with colon cancer survival has not been elucidated. Using data from a phase III randomized adjuvant trial, we assessed the association of alcohol consumption with colon cancer outcomes. Patients completed a risk factor questionnaire before randomization to FOLFOX or FOLFOX + cetuximab (N = 1984). Information was collected on lifestyle factors, including smoking, physical activity and consumption of different types of alcohol. Cox models assessed the association between alcohol consumption and outcomes of disease-free survival (DFS), time-to-recurrence (TTR) and overall survival (OS), adjusting for age, sex, study arm, body mass, smoking, physical activity and performance status. No statistically significant difference in outcomes between ever and never drinkers were noted [hazard ratio (HR)DFS  = 0.86, HRTTR  = 0.87, HROS  = 0.86, p-values = 0.11-0.17]. However, when considering alcohol type, ever consumers of red wine (n = 628) had significantly better outcomes than never consumers (HRDFS  = 0.80, HRTTR  = 0.81, HROS  = 0.78, p-values = 0.01-0.02). Favorable outcomes were confirmed in patients who consumed 1-30 glasses/month of red wine (n = 601, HR = 0.80-0.83, p-values = 0.03-0.049); there was a suggestion of more favorable outcomes in patients who consumed >30 glasses/month of red wine (n = 27, HR = 0.33-0.38, p-values = 0.05-0.06). Beer and liquor consumption were not associated with outcomes. Although alcohol consumption was not associated with colon cancer outcomes overall, mild to moderate red wine consumption was suggestively associated with longer OS, DFS and TTR in stage III colon cancer patients. PMID:27060850

  6. Meeting the information needs of lower income cancer survivors: results of a randomized control trial evaluating the american cancer society's "I can cope".

    Science.gov (United States)

    Martin, Michelle Y; Evans, Mary B; Kratt, Polly; Pollack, Lori A; Smith, Judith Lee; Oster, Robert; Dignan, Mark; Prayor-Patterson, Heather; Watson, Christopher; Houston, Peter; Andrews, Shiquina; Liwo, Amandiy; Tseng, Tung Sung; Hullett, Sandral; Oliver, Joann; Pisu, Maria

    2014-04-01

    The American Cancer Society is a leader in the development of cancer survivorship resources. One resource of the American Cancer Society is the I Can Cope program, an educational program for cancer survivors and their families. Evaluations of this program indicate that cancer patients highly rate its objectives. Yet, there are gaps in the understanding of the full impact of the program on diverse cancer survivors. In this study, the authors used a randomized trial to evaluate the program. Participants included 140 low-income survivors (79% Black; 38% breast cancer) from community hospitals who were randomized to 4 sessions of I Can Cope (learning about cancer; understanding cancer treatments; relieving cancer pain; and keeping well in mind and body) or 4 sessions of a wellness intervention (humor, meditation, relaxation, and music therapy). The authors' primary outcome was "met information needs." After controlling for covariates, their analysis indicated that I Can Cope was no more effective than the wellness intervention in addressing survivor information needs relative to the learning objectives. Participants provided high overall ratings for both interventions. Self-efficacy for obtaining advice about cancer, age, education, and income were associated with information needs. Educational programs tailored to levels of self-efficacy and patient demographics may be needed. PMID:24433231

  7. Nimotuzumab combined with radiotherapy for esophageal cancer: preliminary study of a Phase II clinical trial

    Directory of Open Access Journals (Sweden)

    Liang J

    2013-11-01

    Full Text Available Jun Liang,1 Mingyan E,2 Gang Wu,3 Lujun Zhao,4 Xia Li,5 Xia Xiu,6 Ning Li,1 Bo Chen,1 Zhouguang Hui,1 Jima Lv,1 Hui Fang,1 Yu Tang,1 Nan Bi,1 Wenqing Wang,1 Yirui Zhai,1 Tao Li,1 Dongfu Chen,1 Shuangmei Zou,7 Ning Lu,7 Rolando Perez-Rodríguez,8 Junqi Zheng,9 Luhua Wang11Department of Radiotherapy, Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, People's Republic of China; 2Department of Radiotherapy, Cancer Hospital of Harbin Medical University, Harbin, People's Republic of China; 3Department of Radiotherapy, Tongji Cancer Center Hospital, Wuhan, People's Republic of China; 4Department of Radiotherapy, Cancer Hospital of Tianjin Medical University, Tianjin, People's Republic of China; 5Department of Radiotherapy, LiaoNing Province Cancer Hospital, Shenyang, People's Republic of China; 6Department of Radiotherapy, Beijing Hospital, Beijing, People's Republic of China; 7Department of Pathology, Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, People's Republic of China; 8Center of Molecular Immunology, Havana, Cuba; 9School of Medicine, Tongji University, Shanghai, People's Republic of ChinaObjective: To determine the safety and therapeutic effects of nimotuzumab (h-R3 combined with radiotherapy in esophageal cancer.Methods: This Phase II clinical trial involved 42 patients with stage II (inoperable or refused surgery to stage IV (supraclavicular lymph node metastasis only esophageal cancers treated between November 2008 and July 2010. All patients had squamous cell carcinomas, and all received three-dimensional conformal radiotherapy and 200 mg nimotuzumab per week during radiotherapy.Results: There were 9, 25, and 8 patients with stage II, III and IV disease, respectively. All except two patients received 50–70 Gy radiation; 37 patients (88.1% received more than five nimotuzumab doses. Grade III toxicities (21.4% of all adverse events included esophagitis and gastrointestinal, dermatological and hematological

  8. A phase I trial of intravenous bromodeoxyuridine and radiation therapy for pancreatic cancer

    International Nuclear Information System (INIS)

    Purpose: Improved radiosensitization may lead to improved results of treatment for pancreatic cancer. This Phase I trial was designed to determine the maximum tolerable dose of intravenous bromodeoxyuridine (BrdUrd) when given in an alternating weekly fashion with radiation therapy for patients with pancreatic cancer. Methods and Materials: Patients with resected or locally unresectable pancreatic cancer were eligible if distant metastases were not present. A continuous intravenous infusion of BrdUrd was given on weeks 1, 3, 5, and 7. Twice a day radiation therapy (1.5 Gy per fraction) was given on weeks 2, 4, 6, and 8 to the pancreas/pancreatic bed (total dose 60 Gy) and draining regional lymph nodes (total dose 45 Gy). The starting dose of BrdUrd was 800 mg/m2/day with a planned escalation to 1000 mg/m2/day if at least six out of eight patients were without Grade ≥ 3 toxicity. Patients were assessed weekly for toxicity, and were followed every 3 months after treatment for complications and survival. Results: Fifteen patients with resected (six) or unresectable (nine) pancreatic cancer were enrolled. One patient failed to complete therapy due to tumor progression. One of 11 patients treated with 800 mg/m2/day had a Grade 3 toxicity, while Grade 3 or 4 toxicity was found in all 3 patients receiving 1000 mg/m2/day. The dose-limiting toxicities were hematologic. The acute gastrointestinal toxicity was minimal. Two patients, including one with unresectable disease, were without evidence of disease during exploration for complications (ulcer, small bowel obstruction). Conclusions: The recommended dose of BrdUrd for Phase II study is 800 mg/m2/day. The gastrointestinal mucosa did not appear to be sensitized by this method of BrdUrd administration. The presence of a pathologic complete response is encouraging. Further improvements in radiosensitization are possible and may lead to improved local control

  9. The mTOR pathway in obesity driven gastrointestinal cancers: Potential targets and clinical trials.

    Science.gov (United States)

    Malley, Cian O; Pidgeon, Graham P

    2016-06-01

    The mechanistic target of rapamycin (mTOR) is a crucial point of convergence between growth factor signalling, metabolism, nutrient status and cellular proliferation. The mTOR pathway is heavily implicated in the progression of many cancers and is emerging as an important driver of gastrointestinal (GI) malignancies. Due to its central role in adapting metabolism to environmental conditions, mTOR signalling is also believed to be critical in the development of obesity. Recent research has delineated that excessive nutrient intake can promote signalling through the mTOR pathway and possibly evoke changes to cellular metabolism that could accelerate obesity related cancers. Acting through its two effector complexes mTORC1 and mTORC2, mTOR dictates the transcription of genes important in glycolysis, lipogenesis, protein translation and synthesis and has recently been defined as a central mediator of the Warburg effect in cancer cells. Activation of the mTOR pathway is involved in both the pathogenesis of GI malignancies and development of resistance to conventional chemotherapy and radiotherapy. The use of mTOR inhibitors is a promising therapeutic option in many GI malignancies, with greatest clinical efficacy seen in combination regimens. Recent research has also provided insight into crosstalk between mTOR and other pathways which could potentially expand the list of therapeutic targets in the mTOR pathway. Here we review the available strategies for targeting the mTOR pathway in GI cancers. We discuss current clinical trials of both established and novel mTOR inhibitors, with particular focus on combinations of these drugs with conventional chemotherapy, radiotherapy and targeted therapies. PMID:27051587

  10. A 20 years evaluation of cancer of the tongue at cancer institute Imam Khomeini Hospital, 1978-98

    Directory of Open Access Journals (Sweden)

    Mir M

    2001-08-01

    Full Text Available Informations regarding 152 patients of cancer of tongue in cancer institute from 1978 to 1998 was collected and analyzed. From these cases, 53.3 percent were male with a mean age of 54.49 years (SD=16.23 and the mean age of female was 2.5 years more than of male. Positive lymphadenopathy in men was positive and significantly more than that of female (P<0.05. The physical appearance of the tumor was ulcerative (66.7 percent. Most of the referrals were in the range of T1 (62.8 percent and were operated. Information from 88 patients was evaluated and it was found that 23.9 percent of the patients has died. One year survival was 92.05 percent and 3 years survival 83.3 percent and it was confirmed that advanced stage of the illness decreases the survival rate (P<0.001.      

  11. Open comparative trial of formestane versus megestrol acetate in postmenopausal patients with advanced breast cancer previously treated with tamoxifen

    NARCIS (Netherlands)

    Freue, M; Kjaer, M; Boni, C; Joliver, J; Janicke, F; Willemse, PHB; Coombes, RC; Van Belle, S; Perez-Carrion, R; Zieschang, J; de Palacios, PI; Rose, C

    2000-01-01

    The aim of the trial was to compare efficacy and safety of the aromatase inhibitor formestane (250 mg i.m. given every 2 weeks) with the progestin megestrol acetate (160 mg administered orally once daily), as second-line therapy in postmenopausal patients with advanced breast cancer previously treat

  12. Non-participants and reasons for non-participation in a pragmatic trial of energy healing as cancer rehabilitation

    DEFF Research Database (Denmark)

    Techau, Marzcia; Lunde, Anita; Pedersen, Christina Gundgaard;

    2014-01-01

    pragmatic trial of energy healing for rehabilitation for colorectal cancer. Methods: Three to seven days after postal recruitment, all eligible participants (n=783) were contacted by telephone. Reasons given for non-participation were recorded in 5 categories. Data were analyzed using Chi2. Results: More...

  13. Why do patients choose (not) to participate in an exercise trial during adjuvant chemotherapy for breast cancer?

    NARCIS (Netherlands)

    Waart, van Hanna; Harten, van Wim H.; Buffart, Laurien M.; Sonke, Gabe S.; Stuiver, Martijn M.; Aaronson, Neil K.

    2015-01-01

    Objective Only between 25% and 50% of patients invited to participate in clinical trial-based physical exercise programs during cancer treatment agree to do so. The purpose of this study was to identify factors associated significantly with the decision (not) to participate in a randomized controlle

  14. Physical exercise in cancer patients during and after medical treatment: a systematic review of randomized and controlled clinical trials.

    NARCIS (Netherlands)

    Knols, R.H.; Aaronson, N.K.; Uebelhart, D.; Fransen, J.; Aufdemkampe, G.

    2005-01-01

    PURPOSE: To systematically review the methodologic quality of, and summarize the evidence from trials examining the effectiveness of physical exercise in improving the level of physical functioning and psychological well-being of cancer patients during and after medical treatment. METHODS: Thirty-fo

  15. Adaptation of a Cancer Clinical Trials Education Program for African American and Latina/o Community Members

    Science.gov (United States)

    Pelto, Debra J.; Sadler, Georgia Robins; Njoku, Ogo; Rodriguez, Maria Carina; Villagra, Cristina; Malcarne, Vanessa L.; Riley, Natasha E.; Behar, Alma I.; Jandorf, Lina

    2016-01-01

    The pilot study reported in this article culturally and linguistically adapted an educational intervention to promote cancer clinical trials (CCTs) participation among Latinas/os and African Americans. The single-session slide presentation with embedded videos, originally developed through a campus-community partnership in Southern California, was…

  16. Developing Outcomes Assessments as Endpoints for Registrational Clinical Trials of Antibacterial Drugs: 2015 Update From the Biomarkers Consortium of the Foundation for the National Institutes of Health.

    Science.gov (United States)

    Talbot, George H; Powers, John H; Hoffmann, Steven C

    2016-03-01

    One important component in determining the benefits and harms of medical interventions is the use of well-defined and reliable outcome assessments as endpoints in clinical trials. Improving endpoints can better define patient benefits, allowing more accurate assessment of drug efficacy and more informed benefit-vs-risk decisions; another potential plus is facilitating efficient trial design. Since our first report in 2012, 2 Foundation for the National Institutes of Health Biomarkers Consortium Project Teams have continued to develop outcome assessments for potential uses as endpoints in registrational clinical trials of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. In addition, the teams have initiated similar work in the indications of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. This report provides an update on progress to date in these 4 diseases. PMID:26668337

  17. Retaining Low-Income Minority Cancer Patients in a Depression Treatment Intervention Trial: Lessons Learned.

    Science.gov (United States)

    Wells, Anjanette A; Palinkas, Lawrence A; Williams, Sha-Lai L; Ell, Kathleen

    2015-08-01

    Previously published work finds significant benefit from medical and behavioral health team care among safety-net patients with major depression. This qualitative study assessed clinical social worker, psychiatrist and patient navigator strategies to increase depression treatment among low-income minority cancer patients participating in the ADAPt-C clinical depression trial. Patient care retention strategies were elicited through in-depth, semi-structured interviews with nine behavioral health providers. Using grounded theory, concepts from the literature and dropout barriers identified by patients, guided interview prompts. Retention strategies clustered around five dropout barriers: (1) informational, (2) instrumental, (3) provider-patient therapeutic alliance, (4) clinic setting, and (5) depression treatment. All strategies emphasized the importance of communication between providers and patients. Findings suggest that strong therapeutic alliance and telephone facilitates collaborative team provider communication and depression treatment retention among patients in safety-net oncology care systems. PMID:25544505

  18. The Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial Etiologic and Early Marker Studies (EEMS), 2016 Winter Review Cycle Has New Website | Division of Cancer Prevention

    Science.gov (United States)

    The Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial Etiologic and Early Marker Studies (EEMS) has a new application process for specimen requests. Researchers planning to submit a grant application in response to the Funding Opportunity Announcement PAR-15-297 must use a new website to submit applications. |

  19. Understanding the molecular mechanisms of cancer prevention by dietary phytochemicals: From experimental models to clinical trials.

    Science.gov (United States)

    Maru, Girish B; Hudlikar, Rasika R; Kumar, Gaurav; Gandhi, Khushboo; Mahimkar, Manoj B

    2016-02-26

    Chemoprevention is one of the cancer prevention approaches wherein natural/synthetic agent(s) are prescribed with the aim to delay or disrupt multiple pathways and processes involved at multiple steps, i.e., initiation, promotion, and progression of cancer. Amongst environmental chemopreventive compounds, diet/beverage-derived components are under evaluation, because of their long history of exposure to humans, high tolerability, low toxicity, and reported biological activities. This compilation briefly covers and compares the available evidence on chemopreventive efficacy and probable mechanism of chemoprevention by selected dietary phytochemicals (capsaicin, curcumin, diallyl sulphide, genistein, green/black tea polyphenols, indoles, lycopene, phenethyl isocyanate, resveratrol, retinoids and tocopherols) in experimental systems and clinical trials. All the dietary phytochemicals covered in this review have demonstrated chemopreventive efficacy against spontaneous or carcinogen-induced experimental tumors and/or associated biomarkers and processes in rodents at several organ sites. The observed anti-initiating, anti-promoting and anti-progression activity of dietary phytochemicals in carcinogen-induced experimental models involve phytochemical-mediated redox changes, modulation of enzymes and signaling kinases resulting to effects on multiple genes and cell signaling pathways. Results from clinical trials using these compounds have not shown them to be chemopreventive. This may be due to our: (1) inability to reproduce the exposure conditions, i.e., levels, complexity, other host and lifestyle factors; and (2) lack of understanding about the mechanisms of action and agent-mediated toxicity in several organs and physiological processes in the host. Current research efforts in addressing the issues of exposure conditions, bioavailability, toxicity and the mode of action of dietary phytochemicals may help address the reason for observed mismatch that may ultimately

  20. Off-trial evaluation of bisphosphonates in patients with metastatic breast cancer

    Directory of Open Access Journals (Sweden)

    Lih Anna

    2005-07-01

    Full Text Available Abstract Background Bisphosphonate therapy has been readily accepted as standard of care for individuals with bone metastases from breast cancer. In this study we determined whether the proportion of patients experiencing a skeletal related event (SRE in a clinical practice population was similar to that observed in phase III randomized controlled studies. Methods A retrospective chart review was conducted of 110 patients receiving intravenous bisphosphonates for advanced breast cancer. The proportion of patients experiencing at least one SRE after 12 months of therapy was determined. SRE included vertebral or non-vertebral fracture, cord compression, surgery and/or radiotherapy to bone. Results The proportion of patients who had an SRE was 30% (28 individuals and the median time to first event was greater than 350 days. Non-vertebral events and radiotherapy were the most frequent type of SRE, while cord compression and hypercalcaemia were rare (1%. Most patients in the study had bone-only disease (58.2% and most had multiple bone lesions. In the first 12 months the mean duration of exposure to intravenous bisphosphonates was 261 days and most patients remained on treatment until just before death (median 27 days. Conclusion This study suggests that the rate of clinically relevant SREs is substantially lower than the event rate observed in phase III clinical trials. We attribute this lower rate to observational bias. In the clinical trial setting it is possible that over-detection of skeletal events occurs due to the utilisation of regular skeletal survey or radionucleotide bone scan, whereas these procedures are not routine in clinical practice. Phase IV observational studies need to be conducted to determine the true benefits of bisphosphonate therapy in order to implement rationale use of bisphosphonates.

  1. Treatment outcome of advanced pancreatic cancer patients who are ineligible for a clinical trial

    Directory of Open Access Journals (Sweden)

    Ueda A

    2013-05-01

    Full Text Available Akira Ueda, Ayumu Hosokawa, Kohei Ogawa, Hiroki Yoshita, Takayuki Ando, Shinya Kajiura, Haruka Fujinami, Kengo Kawai, Jun Nishikawa, Kazuto Tajiri, Masami Minemura, Toshiro SugiyamaDepartment of Gastroenterology and Hematology, Faculty of Medicine, University of Toyama, Toyama, JapanObjective: The aim of this study was to evaluate the outcome of patients with advanced pancreatic cancer in clinical practice, and assess whether chemotherapy provided a clinical benefit for patients who did not meet the eligibility criteria of the clinical trial.Methods: We retrospectively analyzed the medical records of 75 patients who received first-line chemotherapy for pancreatic cancer between April 2006 and September 2011. Patients were treated with gemcitabine (GEM alone, S-1 (tegafur, gimeracil, and oteracil potassium alone, or GEM plus S-1. Patients were divided into the clinical trial eligible group (arm eligible or the ineligible group (arm ineligible. We evaluated the efficacy and the safety of the chemotherapy.Results: A total of 23 patients out of 75 (31% belonged to the ineligible group, for the following reasons: 20 patients had poor performance status, eight had massive ascites, one had synchronous malignancy, and one had icterus. The median progression-free survival (PFS was 3.5 months, and the median overall survival (OS was 6.7 months in all patients. In arm eligible, median PFS was 4.5 months, and median OS was 10.5 months. In arm ineligible, median PFS was 1.1 months, and median OS was 2.9 months.Conclusion: The outcome of the patients who did not meet the eligibility criteria was very poor. It is important to select the patients that could benefit from either chemotherapy or optimal supportive care.Keywords: gemcitabine, S-1, clinical practice

  2. Off-trial evaluation of bisphosphonates in patients with metastatic breast cancer

    International Nuclear Information System (INIS)

    Bisphosphonate therapy has been readily accepted as standard of care for individuals with bone metastases from breast cancer. In this study we determined whether the proportion of patients experiencing a skeletal related event (SRE) in a clinical practice population was similar to that observed in phase III randomized controlled studies. A retrospective chart review was conducted of 110 patients receiving intravenous bisphosphonates for advanced breast cancer. The proportion of patients experiencing at least one SRE after 12 months of therapy was determined. SRE included vertebral or non-vertebral fracture, cord compression, surgery and/or radiotherapy to bone. The proportion of patients who had an SRE was 30% (28 individuals) and the median time to first event was greater than 350 days. Non-vertebral events and radiotherapy were the most frequent type of SRE, while cord compression and hypercalcaemia were rare (1%). Most patients in the study had bone-only disease (58.2%) and most had multiple bone lesions. In the first 12 months the mean duration of exposure to intravenous bisphosphonates was 261 days and most patients remained on treatment until just before death (median 27 days). This study suggests that the rate of clinically relevant SREs is substantially lower than the event rate observed in phase III clinical trials. We attribute this lower rate to observational bias. In the clinical trial setting it is possible that over-detection of skeletal events occurs due to the utilisation of regular skeletal survey or radionucleotide bone scan, whereas these procedures are not routine in clinical practice. Phase IV observational studies need to be conducted to determine the true benefits of bisphosphonate therapy in order to implement rationale use of bisphosphonates

  3. Awareness and behavior of oncologists and support measures in medical institutions related to ongoing employment of cancer patients in Japan

    International Nuclear Information System (INIS)

    Improved outcomes of cancer treatment allow patients to undergo treatment while working. However, support from oncologists and medical institutions is essential for patients to continue working. This study aimed to clarify oncologists' awareness and behavior regarding patients who work during treatment, support in medical institutions and their association. A questionnaire was mailed to all 453 diplomates and faculty of the subspecialty board of medical oncology in the Japanese Society of Medical Oncology and all 1016 surgeons certified by the Japanese Board of Cancer Therapy living in the Kanto area. The questionnaire assessed demographics, oncologist awareness and behavior regarding patient employment and support measures at their medical institutions. Logistic regression analysis was used to examine the association of awareness and behavior of oncologists with support measures at their institutions. A total of 668 individuals participated. The overall response rate was 45.5%. Only 53.6% of respondents advised patients to tell their supervisors about prospects for treatment and ask for understanding. For medical institutions, 28.8% had a nurse-involved counseling program and adjustments in radiation therapy (28.0%) and chemotherapy (41.9%) schedules to accommodate patients' work. There was a significant correlation between awareness and behavior of oncologists and medical institutions' measures to support employed cancer patients. There is room for improvement in awareness and behavior of oncologists and support in medical institutions for cancer patients continuing to work. Oncologists could support working patients by exerting influence on their medical institutions. Conversely, proactive development of support measures by medical institutions could alter the awareness and behavior of oncologists. (author)

  4. Characteristics and outcomes of patients with advanced non-small-cell lung cancer who declined to participate in randomised clinical chemotherapy trials

    OpenAIRE

    Tanai, C; Nokihara, H; Yamamoto, S.; Kunitoh, H; Yamamoto, N.; Sekine, I.; Ohe, Y; Tamura, T.

    2009-01-01

    There are inadequate data on the outcomes of patients who declined to participate in randomised clinical trials as compared with those of participants. We retrospectively reviewed the patient characteristics and treatment outcomes of both participants and non-participants in the two randomised trials for chemotherapy-naive advanced non-small-cell lung cancer. Trial 1 compared four platinum-based combination regimens. Trial 2 compared two sequences of carboplatin plus paclitaxel and gefitinib ...

  5. Cancer-Related Fatigue and Rehabilitation: A Randomized Controlled Multicenter Trial Comparing Physical Training Combined With Cognitive-Behavioral Therapy With Physical Training Only and With No Intervention

    OpenAIRE

    van Weert, E; May, A M; Korstjens, I.; Post, W.J.; van der Schans, C P; van den Borne, B; Mesters, I.; Ros, W J G; Hoekstra-Weebers, J.E.H.M.

    2010-01-01

    textabstractBackground. Research suggests that cancer rehabilitation reduces fatigue in survivors of cancer. To date, it is unclear what type of rehabilitation is most beneficial. Objective. This randomized controlled trial compared the effect on cancerrelated fatigue of physical training combined with cognitive behavioral therapy with physical training alone and with no intervention. Design. In this multicenter randomized controlled trial, 147 survivors of cancer were randomly assigned to a ...

  6. Daily Pomegranate intake has no impact on PSA levels in patients with advanced prostate cancer - Results of a phase IIb randomized controlled trial

    OpenAIRE

    Stenner-Liewen, Frank; Liewen, Heike; Cathomas, Richard; Renner, Christoph; Petrausch, Ulf; Sulser, Tullio; Spanaus, Katharina; Seifert, Hans Helge; Strebel, Räto Thomas; Knuth, Alexander; Samaras, Panagiotis; Müntener, Michael

    2013-01-01

    Pomegranate has been shown to prolong PSA doubling time in early prostate cancer, but no data from a placebo controlled trial has been published yet. The objective of this study was to prospectively evaluate the impact of pomegranate juice in patients with prostate cancer. We conducted a phase IIb, double blinded, randomized placebo controlled trial in patients with histologically confirmed prostate cancer. Only patients with a PSA value ≥ 5ng/ml were included. The subjects consumed 500 ml of...

  7. Daily Pomegranate Intake Has No Impact on PSA Levels in Patients with Advanced Prostate Cancer - Results of a Phase IIb Randomized Controlled Trial

    OpenAIRE

    Stenner-Liewen, Frank; Liewen, Heike; Cathomas, Richard; Renner, Christoph; Petrausch, Ulf; Sulser, Tullio; Spanaus, Katharina; Seifert, Hans Helge; Strebel, Räto Thomas; Knuth, Alexander; Samaras, Panagiotis; Müntener, Michael

    2013-01-01

    Pomegranate has been shown to prolong PSA doubling time in early prostate cancer, but no data from a placebo controlled trial has been published yet. The objective of this study was to prospectively evaluate the impact of pomegranate juice in patients with prostate cancer. We conducted a phase IIb, double blinded, randomized placebo controlled trial in patients with histologically confirmed prostate cancer. Only patients with a PSA value ≥ 5ng/ml were included. The subjects consumed 500 ml of...

  8. Panitumumab and irinotecan versus irinotecan alone for patients with KRAS wild-type, fluorouracil-resistant advanced colorectal cancer (PICCOLO): a prospectively stratified randomised trial

    OpenAIRE

    Seymour, Matthew T; Brown, Sarah R; Middleton, Gary; Maughan, Timothy; Richman, Susan; Gwyther, Stephen; Lowe, Catherine; Seligmann, Jennifer F; Wadsley, Jonathan; Maisey, Nick; Chau, Ian; Hill, Mark; Dawson, Lesley; Falk, Stephen; O'Callaghan, Ann

    2013-01-01

    Summary Background Therapeutic antibodies targeting EGFR have activity in advanced colorectal cancer, but results from clinical trials are inconsistent and the population in which most benefit is derived is uncertain. Our aim was to assess the addition of panitumumab to irinotecan in pretreated advanced colorectal cancer. Methods In this open-label, randomised trial, we enrolled patients who had advanced colorectal cancer progressing after fluoropyrimidine treatment with or without oxaliplati...

  9. Accrediting radiation technique in a multicentre trial of chemoradiation for pancreatic cancer

    International Nuclear Information System (INIS)

    Full text: Before a multicentre trial of 3-D conformal radiotherapy to treat cancer of the pancreas, participating clinicians were asked to complete an accreditation exercise. This involved planning two test cases according to the study protocol, then returning hard copies of the plans and dosimetric data for review. Any radiation technique that achieved the specified constraints was allowed. Eighteen treatment plans were assessed. Seven plans were prescribed incorrect doses and two of the planning target volumes did not comply with protocol guidelines. All plans met predefined normal tissue dose constraints. The identified errors were attributable to unforeseen ambiguities in protocol documentation. They were addressed by feedback and corresponding amendments to protocol documentation. Summary radiobiological measures including total weighted normal tissue equivalent uniform dose varied significantly between centres. This accreditation exercise successfully identified significant potential sources of protocol violations, which were then easily corrected. We believe that this process should be applied to all clinical trials involving radiotherapy. Due to the limitations of data analysis with hard-copy information only, it is recommended that complete planning datasets from treatment-planning systems be collected through a digital submission process

  10. From Molecular Biology to Clinical Trials: Toward Personalized Colorectal Cancer Therapy.

    Science.gov (United States)

    Palma, Sabina; Zwenger, Ariel O; Croce, María V; Abba, Martín C; Lacunza, Ezequiel

    2016-06-01

    During the past years, molecular studies through high-throughput technologies have led to the confirmation of critical alterations in colorectal cancer (CRC) and the discovery of some new ones, including mutations, DNA methylations, and structural chromosomal changes. These genomic alterations might act in concert to dysregulate specific signaling pathways that normally exert their functions on critical cell phenotypes, including the regulation of cellular metabolism, proliferation, differentiation, and survival. Targeted therapy against key components of altered signaling pathways has allowed an improvement in CRC treatment. However, a significant percentage of patients with CRC and metastatic CRC will not benefit from these targeted therapies and will be restricted to systemic chemotherapy. Mechanisms of resistance have been associated with specific gene alterations. To fully understand the nature and significance of the genetic and epigenetic defects in CRC that might favor a tumor evading a given therapy, much work remains. Therefore, a dynamic link between basic molecular research and preclinical studies, which ultimately constitute the prelude to standardized therapies, is very important to provide better and more effective treatments against CRC. We present an updated revision of the main molecular features of CRC and their associated therapies currently under study in clinical trials. Moreover, we performed an unsupervised classification of CRC clinical trials with the aim of obtaining an overview of the future perspectives of preclinical studies. PMID:26777471

  11. Use of heparins in patients with cancer: individual participant data meta-analysis of randomised trials study protocol

    Science.gov (United States)

    Schünemann, Holger J; Ventresca, Matthew; Crowther, Mark; Briel, Matthias; Zhou, Qi; Garcia, David; Lyman, Gary; Noble, Simon; Macbeth, Fergus; Griffiths, Gareth; DiNisio, Marcello; Beyene, Joseph; Mbuagbaw, Lawrance; Neumann, Ignacio; Van Es, Nick; Brouwers, Melissa; Brozek, Jan; Guyatt, Gordon; Levine, Mark; Moll, Stephan; Santesso, Nancy; Streiff, Michael; Baldeh, Tejan; Florez, Ivan; Gurunlu Alma, Ozlem; Solh, Ziad; Ageno, Walter; Marcucci, Maura; Bozas, George; Zulian, Gilbert; Maraveyas, Anthony; Lebeau, Bernard; Buller, Harry; Evans, Jessica; McBane, Robert; Bleker, Suzanne; Pelzer, Uwe; Akl, Elie A

    2016-01-01

    Introduction Parenteral anticoagulants may improve outcomes in patients with cancer by reducing risk of venous thromboembolic disease and through a direct antitumour effect. Study-level systematic reviews indicate a reduction in venous thromboembolism and provide moderate confidence that a small survival benefit exists. It remains unclear if any patient subgroups experience potential benefits. Methods and analysis First, we will perform a comprehensive systematic search of MEDLINE, EMBASE and The Cochrane Library, hand search scientific conference abstracts and check clinical trials registries for randomised control trials of participants with solid cancers who are administered parenteral anticoagulants. We anticipate identifying at least 15 trials, exceeding 9000 participants. Second, we will perform an individual participant data meta-analysis to explore the magnitude of survival benefit and address whether subgroups of patients are more likely to benefit from parenteral anticoagulants. All analyses will follow the intention-to-treat principle. For our primary outcome, mortality, we will use multivariable hierarchical models with patient-level variables as fixed effects and a categorical trial variable as a random effect. We will adjust analysis for important prognostic characteristics. To investigate whether intervention effects vary by predefined subgroups of patients, we will test interaction terms in the statistical model. Furthermore, we will develop a risk-prediction model for venous thromboembolism, with a focus on control patients of randomised trials. Ethics and dissemination Aside from maintaining participant anonymity, there are no major ethical concerns. This will be the first individual participant data meta-analysis addressing heparin use among patients with cancer and will directly influence recommendations in clinical practice guidelines. Major cancer guideline development organisations will use eventual results to inform their guideline

  12. Commentary on "Reproductive factors and kidney cancer risk in 2 US cohort studies, 1993-2010." Karami S, Daugherty SE, Schonfeld SJ, Park Y, Hollenbeck AR, Grubb RL 3rd, Hofmann JN, Chow WH, Purdue MP, Occupational and Environmental Epidemiology Branch, Division of Cancer Epidemiology and Genetics, Department of Health and Human Services, National Cancer Institute, National Institutes of Health, Bethesda, MD. Am J Epidemiol 2013; 177(12):1368-77. [Epub 2013 Apr 26]. doi: 10.1093/aje/kws406.

    Science.gov (United States)

    Boorjian, Stephen

    2014-08-01

    Clinical and experimental findings suggest that female hormonal and reproductive factors could influence kidney cancer development. To evaluate this association, we conducted analyses in 2 large prospective cohorts (the National Institutes of Health-AARP Diet and Health Study (NIH-AARP), 1995-2006, and the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial (PLCO), 1993-2010). Cohort-specific and aggregated hazard ratios and 95% confidence intervals relating reproductive factors and kidney cancer risk were computed by Cox regression. The analysis included 792 incident kidney cancer cases among 283,952 postmenopausal women. Women who had undergone a hysterectomy were at a significantly elevated kidney cancer risk in both NIH-AARP (hazard ratio = 1.28, 95% confidence interval: 1.09, 1.50) and PLCO (hazard ratio = 1.41, 95% confidence interval: 1.06, 1.88). Similar results were observed for both cohorts after analyses were restricted to women who had undergone a hysterectomy with or without an oophorectomy. For the NIH-AARP cohort, an inverse association was observed with increasing age at menarche (P for trend= 0.02) and increasing years of oral contraceptive use (P for trend = 0.02). No clear evidence of an association with parity or other reproductive factors was found. Our results suggest that hysterectomy is associated with increased risk of kidney cancer. The observed associations with age at menarche and oral contraceptive use warrant further investigation. PMID:25087669

  13. Belonging to a peer support group enhance the quality of life and adherence rate in patients affected by breast cancer: A non-randomized controlled clinical trial*

    OpenAIRE

    Tehrani, Afsaneh Malekpour; Farajzadegan, Ziba; Rajabi, Fariborz Mokarian; Zamani, Ahmad Reza

    2011-01-01

    BACKGROUND: Breast cancer is the most common cancer in women. It seems that breast cancer patients benefit from meeting someone who had a similar experience. This study evaluated the effect of two kinds of interventions (peer support and educational program) on quality of life in breast cancer patients. METHODS: This study was a controlled clinical trial on women with non-metastatic breast cancer. The patients studied in two experimental and control groups. Experimental group took part in pee...

  14. Time to second prostate specific antigen (PSA) failure is a surrogate endpoint for prostate cancer death in prospective trials of therapy for localized disease

    International Nuclear Information System (INIS)

    Purpose In assessing the efficacy of the competing curative therapies for prostate cancer the most relevant endpoint is cancer specific death. Due to the long natural history of the disease and the use of salvage androgen suppression prospective trials need to mature for at least a decade to provide meaningful results. An endpoint that predicted for cancer death with high probability would allow more rapid completion of prospective studies, hopefully before the tested therapies become outdated. Materials and methods 202 patients entered into a single institution prospective randomized study for T3-4 prostate cancer between 1982 and 1992 were evaluated. All received radical irradiation to either a standard dose of 67.2Gy or a higher dose of 75.6Gy (the latter employing a proton beam boost). 76 men have received androgen suppression or orchiectomy for salvage following relapse (median follow-up 6.9 years). Of this group 35 experienced a second relapse heralded by a rise in the serum PSA. Second failure was scored on the date that the serum PSA rose to greater than 10% above the post-androgen suppression nadir. Kaplan-Meier analysis was made of survival from the time of second PSA failure and the cause of death established in all patients who subsequently died. Results The median duration of response to hormone therapy following first failure was 27.2 months. The actuarial survival from the time of second biochemical relapse was 93%, 66%, 35%, and 0% at 1, 2, 3, and 4 years respectively (50% at 32 months). 16 patients have so far died after second failure all from causes related to their prostate cancer. Conclusion Second PSA failure appears to be a secure surrogate for impending prostate cancer death. Its use as an endpoint in prospective studies should allow earlier reporting by 2 - 3 years

  15. Recruitment strategies, design, and participant characteristics in a trial of weight-loss and metformin in breast cancer survivors.

    Science.gov (United States)

    Patterson, Ruth E; Marinac, Catherine R; Natarajan, Loki; Hartman, Sheri J; Cadmus-Bertram, Lisa; Flatt, Shirley W; Li, Hongying; Parker, Barbara; Oratowski-Coleman, Jesica; Villaseñor, Adriana; Godbole, Suneeta; Kerr, Jacqueline

    2016-03-01

    Weight loss and metformin are hypothesized to improve breast cancer outcomes; however the joint impacts of these treatments have not been investigated. Reach for Health is a randomized trial using a 2 × 2 factorial design to investigate the effects of weight loss and metformin on biomarkers associated with breast cancer prognosis among overweight/obese postmenopausal breast cancer survivors. This paper describes the trial recruitment strategies, design, and baseline sample characteristics. Participants were randomized in equal numbers to (1) placebo, (2) metformin, (3) weight loss intervention and placebo, or (4) weight-loss intervention and metformin. The lifestyle intervention was a personalized, telephone-based program targeting a 7% weight-loss in the intervention arm. The metformin dose was 1500 mg/day. The duration of the intervention was 6 months. Main outcomes were biomarkers representing 3 metabolic systems putatively related to breast cancer mortality: glucoregulation, inflammation, and sex hormones. Between August 2011 and May 2015, we randomized 333 breast cancer survivors. Mass mailings from the California Cancer Registry were the most successful recruitment strategy with over 25,000 letters sent at a cost of $191 per randomized participant. At baseline, higher levels of obesity were significantly associated with worse sleep disturbance and impairment scores, lower levels of physical activity and higher levels of sedentary behavior, hypertension, hypercholesterolemia, and lower quality of life (pbreast cancer prognosis. PMID:26706665

  16. Recruitment and Early Retention of Women with Advanced Breast Cancer in a Complementary and Alternative Medicine Trial

    Directory of Open Access Journals (Sweden)

    Alla Sikorskii

    2011-01-01

    Full Text Available More than 80% of women with breast cancer are now reported to be using complementary and alternative medicine (CAM therapies during conventional treatment. A randomized clinical trial (RCT of reflexology with late stage breast cancer patients serves as the data source for this article. The purposes were to investigate: (i reasons for refusal to participate in a RCT of reflexology; (ii the differences between those who completed the baseline interview and those who dropped out before baseline; and (iii the utility of the Palliative Prognostic Score (PPS as a prognostic screening tool in minimizing early attrition (before baseline from the trial. Eligible women (N = 400 approached at 12 cancer centers in the Midwest had advanced breast cancer, were on chemotherapy or hormonal therapy, and had a PPS of 11 or less. Comparisons of those who dropped out early (N = 33 to those who stayed in the trial (N = 240 were carried out using Wilcoxon rank, t-, chi-squared and Fisher's exact tests. The reasons of being “too sick” or “overwhelmed” were given by less than 12% of the women who refused to participate. There was a higher early dropout rate among black women compared to other (primarily white women (P = .01. Cancer recurrence and metastasis, age, and the PPS were not predictive of early retention of women. Specialized techniques may be needed to ensure black women remain in the trial once consented. Women with advanced disease were likely to enter and remain in the trial despite deterioration in health.

  17. Relationship of Internet health information use with patient behavior and self-efficacy: experiences of newly diagnosed cancer patients who contact the National Cancer Institute's Cancer Information Service.

    Science.gov (United States)

    Bass, Sarah Bauerle; Ruzek, Sheryl Burt; Gordon, Thomas F; Fleisher, Linda; McKeown-Conn, Nancy; Moore, Dirk

    2006-03-01

    This study examines the relationship of Internet health information use with patient behavior and self-efficacy among 498 newly diagnosed cancer patients. Subjects were classified by types of Internet use: direct use (used Internet health information themselves), indirect use (used information accessed by friends or family), and non-use (never accessing Internet information). Subjects were recruited from callers of the National Cancer Institute's (NCI's) Cancer Information Service, Atlantic Region. They were classified by type of Internet use at enrollment and interviewed by telephone after 8 weeks. There were significant relationships among Internet use and key study variables: subject characteristics, patient task behavior, and self-efficacy. Subjects' Internet use changed significantly from enrollment to 8 week follow-up; 19% of nonusers and indirect users moved to a higher level of Internet use. Significant relationships also were found among Internet use and perceived patient-provider relationship, question asking, and treatment compliance. Finally, Internet use was also significantly associated with self-efficacy variables (confidence in actively participating in treatment decisions, asking physicians questions, and sharing feelings of concern). The results of this study show that patients who are newly diagnosed with cancer perceive the Internet as a powerful tool, both for acquiring information and for enhancing confidence to make informed decisions. PMID:16537289

  18. Intraoperative radiation therapy at the National Cancer Institute: technical innovations and dosimetry

    International Nuclear Information System (INIS)

    The technical complexity of intraoperative radiotherapy (IORT) requires modification of the standard physical and dosimetric methods used in external electron beam therapy. At the National Cancer Institute, a number of technical innovations have been integrated into ongoing clinical studies of IORT. These include: (1) an electron beam applicator system that is significantly different from other IORT systems and includes customized squircle applicators; (2) peripheral dose shields; (3) a modified surgical table replacing the standard radiation treatment couch; and (4) routine use of multiple IORT fields that necessitates field matching. The IORT applicator system and related devices and techniques are dosimetrically characterized in detail both for use in the IORT program and in order to illustrate many useful facets of electron dosimetry

  19. The Bone Marrow Transplantation Center of the National Cancer Institute - its resources to assist patients with bone marrow failure

    International Nuclear Information System (INIS)

    This paper describes the bone marrow transplantation center of the brazilian National Cancer Institute, which is responsible for the cancer control in Brazil. The document also describes the resources available in the Institute for assisting patients presenting bone marrow failures. The Center provides for allogeneic and autologous bone marrow transplants, peripheral stem cell transplants, umbilical cord collections and transplants, and a small experience with unrelated bone marrow transplants. The Center receives patient from all over the country and provides very sophisticated medical care at no direct cost to the patients

  20. A multiple-dose phase I trial of recombinant leukocyte A interferon in cancer patients.

    Science.gov (United States)

    Sherwin, S A; Knost, J A; Fein, S; Abrams, P G; Foon, K A; Ochs, J J; Schoenberger, C; Maluish, A E; Oldham, R K

    1982-11-19

    Eighty-one patients with a variety of refractory disseminated malignant neoplasms have been treated in the first multiple fixed-dose phase I trial of recombinant leukocyte A interferon (IFL-rA). Each patient received IFL-rA by intramuscular injection, three times weekly for 28 days. Dosages were escalated in different patients from 1 to 136 x 10(6) units per injection. The toxic reactions seen with IFL-rA resembled those of nonrecombinant leukocyte interferon and included fever, chills, fatigue, anorexia, myalgia, headache, occasional nausea and vomiting, and dose-dependent reversible leukopenia and hepatic transaminase elevations. The pharmacokinetics of IFL-rA were also comparable with nonrecombinant leukocyte interferon. Objective evidence of antitumor activity was seen in non-Hodgkin's lymphoma, chronic lymphocytic leukemia, Hodgkin's disease, breast cancer, and melanoma, indicating that IFL-rA, the first genetically engineered biological response modifier available for testing in cancer patients, is biologically active in vivo. PMID:6752447

  1. Epoetin alfa in platinum-treated ovarian cancer patients: results of a multinational, multicentre, randomised trial

    Science.gov (United States)

    Wilkinson, P M; Antonopoulos, M; Lahousen, M; Lind, M; Kosmidis, P

    2006-01-01

    This multicentre, open-label, controlled clinical trial assessed the effects of epoetin alfa treatment on haematologic and quality of life (QOL) parameters in 182 anaemic (Hb⩽12 g dl−1) ovarian cancer patients receiving platinum chemotherapy. Patients were randomised 2 : 1 to receive epoetin alfa 10 000–20 000 IU three times weekly plus best standard treatment (BST) or BST only. Main study end points were changes from baseline in haemoglobin (Hb) level, transfusion requirements, and QOL. For the epoetin alfa group, mean Hb increased by 1.8 g dl−1 by weeks 4–6 and was significantly increased from baseline through study end (P<0.001). The mean change in Hb from baseline was significantly (P<0.001) greater for epoetin alfa than BST patients at all postbaseline evaluations. Significantly fewer epoetin alfa than BST patients required transfusion(s) after the first 4 weeks of treatment (7.9 vs 30.5%; P<0.001). Also, significant (P⩽0.04) differences favouring the epoetin alfa group over the BST group were found for all three median CLAS scores (Energy Level, Ability to Do Daily Activities, Overall QOL) and the median average CLAS score during chemotherapy. These findings support use of epoetin alfa to increase Hb levels, reduce transfusion use, and improve QOL in anaemic ovarian cancer patients receiving platinum chemotherapy. PMID:16570051

  2. Systems medicine in colorectal cancer: from a mathematical model toward a new type of clinical trial.

    Science.gov (United States)

    Castagnino, Nicoletta; Maffei, Massimo; Tortolina, Lorenzo; Zoppoli, Gabriele; Piras, Daniela; Nencioni, Alessio; Moran, Eva; Ballestrero, Alberto; Patrone, Franco; Parodi, Silvio

    2016-07-01

    Current colorectal cancer (CRC) treatment guidelines are primarily based on clinical features, such as cancer stage and grade. However, outcomes may be improved using molecular treatment guidelines. Potentially useful biomarkers include driver mutations and somatically inherited alterations, signaling proteins (their expression levels and (post) translational modifications), mRNAs, micro-RNAs and long noncoding RNAs. Moving to an integrated system is potentially very relevant. To implement such an integrated system: we focus on an important region of the signaling network, immediately above the G1-S restriction point, and discuss the reconstruction of a Molecular Interaction Map and interrogating it with a dynamic mathematical model. Extensive model pretraining achieved satisfactory, validated, performance. The model helps to propose future target combination priorities, and restricts drastically the number of drugs to be finally tested at a cellular, in vivo, and clinical-trial level. Our model allows for the inclusion of the unique molecular profiles of each individual patient's tumor. While existing clinical guidelines are well established, dynamic modeling may be used for future targeted combination therapies, which may progressively become part of clinical practice within the near future. WIREs Syst Biol Med 2016, 8:314-336. doi: 10.1002/wsbm.1342 For further resources related to this article, please visit the WIREs website. PMID:27240214

  3. Routine assessment of psychosocial problems after cancer genetic counseling: results from a randomized controlled trial.

    Science.gov (United States)

    Eijzenga, W; Bleiker, E M A; Ausems, M G E M; Sidharta, G N; Van der Kolk, L E; Velthuizen, M E; Hahn, D E E; Aaronson, N K

    2015-05-01

    Approximately 70% of counselees undergoing cancer genetic counseling and testing (CGCT) experience some degree of CGCT-related psychosocial problems. We evaluated the efficacy of an intervention designed to increase detection and management of problems 4 weeks after completion of CGCT. In this randomized, controlled trial, 118 participants completed a CGCT-related problem questionnaire prior to an - audiotaped - telephone session with their counselor 1 month after DNA-test disclosure. For those randomized to the intervention group (n = 63), a summary of the questionnaire results was provided to the counselor prior to the telephone session. Primary outcomes were discussion of the problems, counselors' awareness of problems, and problem management. Secondary outcomes included self-reported distress, cancer worries, CGCT-related problems, and satisfaction. Counselors who received a summary of the questionnaire were more aware of counselees' problems in only one psychosocial domain (practical issues). No significant differences in the number of problems discussed, in problem management, or on any of the secondary outcomes were observed. The prevalence of problems was generally low. The telephone session, combined with feedback on psychosocial problems, has minimal impact. The low prevalence of psychosocial problems 1 month post-CGCT recommends against its use as a routine extension of the CGCT procedure. PMID:25130962

  4. Prophylactic cranial irradiation in patients with small-cell lung cancer: the experience at the Institute of Oncology Ljubljana:

    OpenAIRE

    Stanic, Karmen; Kovac, Viljem

    2010-01-01

    Background Prophylactic cranial irradiation (PCI) has been used in patients with small-cell lung cancer (SCLC) to reduce the incidence of brain metastases (BM) and thus increase overall survival. The aim of this retrospective study was to analyze the characteristics of patients with SCLC referred to the Institute of Oncology Ljubljana, their eligibility for PCI, patterns of dissemination, and survival. Patients and methods Medical charts of 357 patients with SCLC, referred to the Institute of...

  5. Adoption of Hypofractionated Radiation Therapy for Breast Cancer After Publication of Randomized Trials

    International Nuclear Information System (INIS)

    Purpose: Large randomized trials have established the noninferiority of shorter courses of “hypofractionated” radiation therapy (RT) to the whole breast compared to conventional courses using smaller daily doses in the adjuvant treatment of selected breast cancer patients undergoing lumpectomy. Hypofractionation is more convenient and less costly. Therefore, we sought to determine uptake of hypofractionated breast RT over time. Methods and Materials: In the Surveillance, Epidemiology, and End Results (SEER)-Medicare-linked database, we identified 16,096 women with node-negative breast cancer and 4269 with ductal carcinoma in situ (DCIS) who received lumpectomy followed by more than 12 fractions of RT between 2004 and 2010. Based on Medicare claims, we determined the number of RT treatments given and grouped patients into those receiving hypofractionation (13-24) or those receiving conventional fractionation (≥25). We also determined RT technique (intensity modulated RT or not) using Medicare claims. We evaluated patterns and correlates of hypofractionation receipt using bivariate and multivariable analyses. Results: Hypofractionation use was similar in patients with DCIS and those with invasive disease. Overall, the use of hypofractionation increased from 3.8% in 2006 to 5.4% in 2007, to 9.4% in 2008, and to 13.6% in 2009 and 2010. Multivariable analysis showed increased use of hypofractionation in recent years and in patients with older age, smaller tumors, increased comorbidity, higher regional education, and Western SEER regions. However, even in patients over the age of 80, the hypofractionation rate in 2009 to 2010 was only 25%. Use of intensity modulated RT (IMRT) also increased over time (from 9.4% in 2004 to 22.7% in 2009-2010) and did not vary significantly between patients receiving hypofractionation and those receiving traditional fractionation. Conclusions: Hypofractionation use increased among low-risk older US breast cancer patients with

  6. Adoption of Hypofractionated Radiation Therapy for Breast Cancer After Publication of Randomized Trials

    Energy Technology Data Exchange (ETDEWEB)

    Jagsi, Reshma, E-mail: rjagsi@med.umich.edu [Department of Radiation Oncology, University of Michigan Medical School, Ann Arbor, Michigan (United States); Falchook, Aaron D.; Hendrix, Laura H. [Department of Radiation Oncology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina (United States); Curry, Heather [Radiation Oncology, Eviti, Inc, Philadelphia, Pennsylvania (United States); Chen, Ronald C. [Department of Radiation Oncology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina (United States)

    2014-12-01

    Purpose: Large randomized trials have established the noninferiority of shorter courses of “hypofractionated” radiation therapy (RT) to the whole breast compared to conventional courses using smaller daily doses in the adjuvant treatment of selected breast cancer patients undergoing lumpectomy. Hypofractionation is more convenient and less costly. Therefore, we sought to determine uptake of hypofractionated breast RT over time. Methods and Materials: In the Surveillance, Epidemiology, and End Results (SEER)-Medicare-linked database, we identified 16,096 women with node-negative breast cancer and 4269 with ductal carcinoma in situ (DCIS) who received lumpectomy followed by more than 12 fractions of RT between 2004 and 2010. Based on Medicare claims, we determined the number of RT treatments given and grouped patients into those receiving hypofractionation (13-24) or those receiving conventional fractionation (≥25). We also determined RT technique (intensity modulated RT or not) using Medicare claims. We evaluated patterns and correlates of hypofractionation receipt using bivariate and multivariable analyses. Results: Hypofractionation use was similar in patients with DCIS and those with invasive disease. Overall, the use of hypofractionation increased from 3.8% in 2006 to 5.4% in 2007, to 9.4% in 2008, and to 13.6% in 2009 and 2010. Multivariable analysis showed increased use of hypofractionation in recent years and in patients with older age, smaller tumors, increased comorbidity, higher regional education, and Western SEER regions. However, even in patients over the age of 80, the hypofractionation rate in 2009 to 2010 was only 25%. Use of intensity modulated RT (IMRT) also increased over time (from 9.4% in 2004 to 22.7% in 2009-2010) and did not vary significantly between patients receiving hypofractionation and those receiving traditional fractionation. Conclusions: Hypofractionation use increased among low-risk older US breast cancer patients with

  7. Medical care costs incurred by patients with smoking-related non-small cell lung cancer treated at the National Cancer Institute of Mexico

    OpenAIRE

    Arrieta, Oscar; Quintana-Carrillo, Roger Humberto; Ahumada-Curiel, Gabriel; Corona-Cruz, Jose Francisco; Correa-Acevedo, Elma; Zinser-Sierra, Juan; de la Mata-Moya, Dolores; Mohar-Betancourt, Alejandro; Morales-Oyarvide, Vicente; Reynales-Shigematsu, Luz Myriam

    2015-01-01

    Background Smoking is a public health problem in Mexico and worldwide; its economic impact on developing countries has not been well documented. The aim of this study was to assess the direct medical costs attributable to smoking incurred by lung cancer patients treated at the National Cancer Institute of Mexico (INCan). Methods The study was conducted at INCan in 2009. We carried out a cost of illness (COI) methodology, using data derived from an expert panel consensus and from medical chart...

  8. Cancer-Related Fatigue and Rehabilitation : A Randomized Controlled Multicenter Trial Comparing Physical Training Combined With Cognitive-Behavioral Therapy With Physical Training Only and With No Intervention

    NARCIS (Netherlands)

    van Weert, E.; May, A.M.; Korstjens, I.; Post, W.J.; van der Schans, C.P.; van den Borne, B.; Mesters, I.; Ros, W.J.G.; Hoekstra-Weebers, J.E.H.M.

    2010-01-01

    Background. Research suggests that cancer rehabilitation reduces fatigue in survivors of cancer. To date, it is unclear what type of rehabilitation is most beneficial. Objective. This randomized controlled trial compared the effect on cancer-related fatigue of physical training combined with cogniti

  9. Phase II trial of proton beam accelerated partial breast irradiation in breast cancer

    International Nuclear Information System (INIS)

    Background and purpose: Here, we report the results of our phase II, prospective study of proton beam accelerated partial breast irradiation (PB-APBI) in patients with breast cancer after breast conserving surgery (BCS). Materials and methods: Thirty patients diagnosed with breast cancer were treated with PB-APBI using a single-field proton beam or two fields after BCS. The treatment dose was 30 cobalt gray equivalent (CGE) in six CGE fractions delivered once daily over five consecutive working days. Results: All patients completed PB-APBI. The median follow-up time was 59 months (range: 43–70 months). Of the 30 patients, none had ipsilateral breast recurrence or regional or distant metastasis, and all were alive at the last follow-up. Physician-evaluated toxicities were mild to moderate, except in one patient who had severe wet desquamation at 2 months that was not observed beyond 6 months. Qualitative physician cosmetic assessments of good or excellent were noted in 83% and 80% of the patients at the end of PB-APBI and at 2 months, respectively, and decreased to 69% at 3 years. A good or excellent cosmetic outcome was noted in all patients treated with a two-field proton beam at any follow-up time point except for one. For all patients, the mean percentage breast retraction assessment (pBRA) value increased significantly during the follow-up period (p = 0.02); however, it did not increase in patients treated with two-field PB-APBI (p = 0.3). Conclusions: PB-APBI consisting of 30 CGE in six CGE fractions once daily for five consecutive days can be delivered with excellent disease control and tolerable skin toxicity to properly selected patients with early-stage breast cancer. Multiple-field PB-APBI may achieve a high rate of good-to-excellent cosmetic outcomes. Additional clinical trials with larger patient groups are needed

  10. Iodine-125 seed brachytherapy for early stage prostate cancer: a single-institution review

    International Nuclear Information System (INIS)

    We are reporting the five-year biochemical control, toxicity profile and dosimetric parameters using iodine-125 low dose rate brachytherapy (BT) as monotherapy for early stage prostate cancer at a single institution. Between April 2006 and December 2010, 169 men with early stage prostate cancer were treated with BT. Biochemical failure was defined using the Phoenix definition (nadir + 2 ng/mL). Treatment-related morbidities, including urinary, rectal and sexual function, were measured, applying the International Prostate Symptom Score (IPSS), the 7-grade Quality of Life Scale (QoL) and medical status, the International Consultation on Incontinence Modular Questionnaire (ICIQ), the International Index of Erectile Function (IIEF-5) and the Common Terminology Criteria for Adverse Events (CTCAE v4.03). Seed migration and loss, dosimetric parameters and learning effects were also analyzed. Medium follow-up time was 50 months (range, 1–85 months). The five-year biochemical failure rate was 7%. Acute proctitis rates were 19% (grade 1) and 1% (grade 2), respectively. The overall incidence of incontinence was 19% (mild), 16% (moderate) and < 1% (severe). An increase in IPSS ≥ 5 points was detected in 59% of patients, with 38% regaining their baseline. Seed dislocation was found in 24% of patients and correlated with D90 and V100. A learning curve was found for seed migration, D90 and V100. QoL correlated with the general health condition of patient, incontinence symptoms and IPSS. BT for early stage prostate cancer offers excellent five-year biochemical control with low toxicities. QoL aspects are favorable. A learning curve was detected for procedural aspects but its impact on patient relevant endpoints remains inconclusive

  11. 78 FR 69426 - Submission for OMB Review; 30-Day Comment Request: NIH NCI Central Institutional Review Board...

    Science.gov (United States)

    2013-11-19

    ... review. The benefits to the National Clinical Trials Network and Experimental Therapy-Clinical Trials... for Participants 25 1 2 50 Treatment Studies. NCI Adult/Pediatric CIRB Application for Participants 10... National Cancer Institute (NCI), National Institutes of Health, may not conduct or sponsor, and...

  12. Current Molecular Targeted Therapy in Advanced Gastric Cancer: A Comprehensive Review of Therapeutic Mechanism, Clinical Trials, and Practical Application

    Directory of Open Access Journals (Sweden)

    Kaichun Li

    2016-01-01

    Full Text Available Despite the great progress in the treatment of gastric cancer, it is still the third leading cause of cancer death worldwide. Patients often miss the opportunity for a surgical cure, because the cancer has already developed into advanced cancer when identified. Compared to best supportive care, chemotherapy can improve quality of life and prolong survival time, but the overall survival is often short. Due to the molecular study of gastric cancer, new molecular targeted drugs have entered the clinical use. Trastuzumab, an antibody targeting human epidermal growth factor receptor 2 (HER2, can significantly improve survival in advanced gastric cancer patients with HER2 overexpression. Second-line treatment of advanced gastric cancer with ramucirumab, an antibody targeting VEGFR-2, alone or in combination with paclitaxel, has been proved to provide a beneficial effect. The VEGFR-2 tyrosine kinase inhibitor, apatinib, can improve the survival of advanced gastric cancer patients after second-line chemotherapy failure. Unfortunately, none of the EGFR targeting antibodies (cetuximab or panitumumab, VEGF targeting monoclonal antibodies (bevacizumab, mTOR inhibitor (everolimus, or HGF/MET pathway targeting drugs has a significant survival benefit. Many other clinical trials based on molecular markers are underway. This review will summarize targeted therapies for advanced gastric cancer.

  13. Effectiveness of pranayama on cancer-related fatigue in breast cancer patients undergoing radiation therapy: A randomized controlled trial

    OpenAIRE

    Jyothi Chakrabarty; M S Vidyasagar; Donald Fernandes; Ganapathi Joisa; Prabha Varghese; Sreemathi Mayya

    2015-01-01

    Context: Incidence of breast cancer is very high among women around the world. Breast cancer patients experience cancer-related fatigue at some points during the treatment for breast cancer. Since cancer-related fatigue is of multifactorial origin, there are no evidence-based treatment strategies for fatigue. This study tested the effectiveness of certain pranayama techniques in reducing cancer-related fatigue among breast cancer patients undergoing radiation therapy. Aims: The objective of t...

  14. Liquid biopsy-based clinical research in early breast cancer: The EORTC 90091-10093 Treat CTC trial.

    Science.gov (United States)

    Ignatiadis, Michail; Rack, Brigitte; Rothé, Francoise; Riethdorf, Sabine; Decraene, Charles; Bonnefoi, Hervé; Dittrich, Christian; Messina, Carlo; Beauvois, Melanie; Trapp, Elisabeth; Goulioti, Theodora; Tryfonidis, Konstantinos; Pantel, Klaus; Repollet, Madeline; Janni, Wolfgang; Piccart, Martine; Sotiriou, Christos; Litiere, Saskia; Pierga, Jean-Yves

    2016-08-01

    There is increasing evidence that breast cancer evolves over time under the selection pressure of systemic treatment. Today, treatment decisions in early breast cancer are based on primary tumour characteristics without considering the disease evolution. Chemoresistant micrometastatic disease is poorly characterised and thus it is not used in current clinical practice as a tool to personalise treatment approaches. The detection of chemoresistant circulating tumour cells (CTCs) has been shown to be associated with worse prognosis in early breast cancer. The ongoing Treat CTC trial is the first international, liquid biopsy-based trial evaluating the concept of targeting chemoresistant minimal residual disease: detection of CTCs following adjuvant chemotherapy (adjuvant cohort) or neoadjuvant chemotherapy in patients who did not achieve pathological complete response (neoadjuvant cohort). This article presents the rational and design of this trial and the results of the pilot phase after 350 patients have been screened and provides insights that might provide information for future trials using the liquid biopsy approach as a tool towards precision medicine (NCT01548677). PMID:27289552

  15. Understanding breast cancer patients' preference for two types of exercise training during chemotherapy in an unblinded randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Vallance Jeffrey K

    2008-10-01

    Full Text Available Abstract Background Patient preference for group assignment may affect outcomes in unblinded trials but few studies have attempted to understand such preferences. The purpose of the present study was to examine factors associated with breast cancer patients' preference for two types of exercise training during chemotherapy. Methods Breast cancer patients (N = 242 completed a battery of tests including a questionnaire that assessed patient preference and the theory of planned behavior (TPB prior to being randomized to usual care, resistance exercise training (RET, or aerobic exercise training (AET. Results 99 (40.9% participants preferred RET, 88 (36.4% preferred AET, and 55 (22.7% reported no preference. Past exercisers (p = 0.023, smokers (p = 0.004, and aerobically fitter participants (p = 0.005 were more likely to prefer RET. As hypothesized, participants that preferred AET had more favorable TPB beliefs about AET whereas participants that preferred RET had more favorable TPB beliefs about RET. In multivariate modeling, patient preference for RET versus AET was explained (R2 = .46; p 2 = .48; p Conclusion Breast cancer patients' preference for RET versus AET during chemotherapy was predicted largely by a difference in motivation for each type of exercise which, in turn, was based on differences in their beliefs about the anticipated benefits, enjoyment, and difficulty of performing each type of exercise during chemotherapy. These findings may help explain patient preference effects in unblinded behavioral trials. Trial Registration ClinicalTrials.gov Identifier NCT00115713.

  16. Designing exercise clinical trials for older adults with cancer: Recommendations from 2015 Cancer and Aging Research Group NCI U13 Meeting

    Science.gov (United States)

    Kilari, Deepak; Soto-Perez-de-Celis, Enrique; Mohile, Supriya Gupta; Alibhai, Shabbir M.H.; Presley, Carolyn J.; Wildes, Tanya M.; Klepin, Heidi D.; Demark-Wahnefried, Wendy; Jatoi, Amina; Harrison, Robert; Won, Elizabeth; Mustian, Karen M.

    2016-01-01

    Cancer and its treatment can lead to a myriad of adverse events and negatively impact quality of life of older cancer patients and survivors. Unmet physical activity needs vary across the cancer continuum and remain an important yet understudied area of research in this population. Exercise interventions have been shown to be effective in treating both the physical and psychological declines associated with cancer and its treatment, with a potential to improve cancer-related outcomes. Despite the current evidence, exercise is clearly underutilized due to several barriers and knowledge gaps in existing trials that include appropriate population identification, design, and outcome measures selection. The benefits of regular exercise in both the primary and secondary prevention of chronic conditions are well established in the non-cancer population. In older cancer patients and survivors, further research is needed before exercise gains widespread acceptance. The Cancer and Aging Research Group convened experts in exercise, aging and cancer to evaluate current scientific evidence and knowledge gaps in geriatric exercise oncology. This report summarizes these findings and provides future research directions. PMID:27197916

  17. Quality Improvement in the National Cancer Institute Community Cancer Centers Program: The Quality Oncology Practice Initiative Experience

    Science.gov (United States)

    Siegel, Robert D.; Castro, Kathleen M.; Eisenstein, Jana; Stallings, Holley; Hegedus, Patricia D.; Bryant, Donna M.; Kadlubek, Pam J.; Clauser, Steven B.

    2015-01-01

    Purpose: The National Cancer Institute (NCI) Community Cancer Centers Program (NCCCP) began in 2007; it is a network of community-based hospitals funded by the NCI. Quality of care is an NCCCP priority, with participation in the American Society of Clinical Oncology Quality Oncology Practice Initiative (QOPI) playing a fundamental role in quality assessment and quality improvement (QI) projects. Using QOPI methodology, performance on quality measures was analyzed two times per year over a 3-year period to enhance our implementation of quality standards at NCCCP hospitals. Methods: A data-sharing agreement allowed individual-practice QOPI data to be electronically sent to the NCI. Aggregated data with the other NCCCP QOPI participants were presented to the network via Webinars. The NCCCP Quality of Care Subcommittee selected areas in which to focus subsequent QI efforts, and high-performing practices shared voluntarily their QI best practices with the network. Results: QOPI results were compiled semiannually between fall 2010 and fall 2013. The network concentrated on measures with a quality score of ≤ 0.75 and planned voluntary group-wide QI interventions. We identified 13 measures in which the NCCCP fell at or below the designated quality score in fall 2010. After implementing a variety of QI initiatives, the network registered improvements in all parameters except one (use of treatment summaries). Conclusion: Using the NCCCP as a paradigm, QOPI metrics provide a useful platform for group-wide measurement of quality performance. In addition, these measurements can be used to assess the effectiveness of QI initiatives. PMID:25538082

  18. A randomised controlled trial of forward-planned radiotherapy (IMRT) for early breast cancer: Baseline characteristics and dosimetry results

    International Nuclear Information System (INIS)

    Background and purpose: This large trial was designed to investigate whether correction of dose inhomogeneities using intensity-modulated radiotherapy (IMRT) reduces late toxicity and improves quality of life in patients with early breast cancer. This paper reports baseline characteristics of trial participants and dosimetry results. Materials and methods: Standard tangential plans of 1145 trials were analysed. Patients with inhomogeneous plans, defined by ICRU recommendations, were randomised to forward-planned IMRT or standard radiotherapy. Results: Twenty-nine percentage of patients had adequate dosimetry with standard 2D radiotherapy. In the randomised patients, the decreases in mean volumes receiving greater than 107% (Vol > 107) and less than 95% (Vol 3 (95% CI 26.4-41.6; P 3 (95% CI 34.4-61.9; P 107 > 2 cm3 on standard radiotherapy plans. Conclusion: This large trial, in which patients with all breast sizes were eligible, confirmed that breast dosimetry can be significantly improved with a simple method of forward-planned IMRT and has little impact on radiotherapy resources. It is shown that patients with larger breasts are more likely to have dose inhomogeneities and breast separation gives some indication of this likelihood. Photographic assessment of patients at 2 years after radiotherapy, as the next part of this randomised controlled trial, will show whether these results for IMRT translate into improved cosmetic outcome in patients with early breast cancer. This would provide impetus for the widespread adoption of 3D planning and IMRT.

  19. The Evolving Biology of Castration-Resistant Prostate Cancer: Review of Recommendations From the Prostate Cancer Clinical Trials Working Group 3.

    Science.gov (United States)

    Geethakumari, Praveen Ramakrishnan; Cookson, Michael S; Kelly, William Kevin

    2016-02-01

    In 2008, the Prostate Cancer Clinical Trials Working Group 2 (PCWG2) developed consensus guidelines for clinical trial design and conduct that redefined trial endpoints, with a dual-objective paradigm: to (1) controlling, relieving, or eliminating disease manifestations at the start of treatment; and (2) preventing or delaying further disease manifestations. Clinical and translational research in prostate cancer has expanded our current-day understanding of the mechanisms of its pathogenesis, as well as the different clinicopathologic and molecular subtypes of the disease, and has improved the therapeutic armamentarium for the management of metastatic castration-resistant prostate cancer (CRPC). These new advances led to the development of the updated PCWG3 guidelines in 2015. In this review, we analyze our evolving understanding of the biology of CRPC, acquired resistance mechanisms, and emerging therapeutic targets in light of the updated PCWG3 guidelines. We present a joint perspective from the medical oncology and urologic disciplines on the ongoing efforts to advance clinical trial performance in order to discover new therapies for this fatal disease. PMID:26888794

  20. A feasibility dosimetric study on prostate cancer. Are we ready for a multicenter clinical trial on SBRT?

    International Nuclear Information System (INIS)

    The Italian Association of Medical Physics (AIFM) started a working group dedicated to stereotactic body radiotherapy (SBRT) treatment. In this work, we performed a multicenter planning study on patients who were candidates for SBRT in the treatment of prostate cancer with the aim of evaluating the dosimetric consistency among the different hospitals. Fourteen centers were provided the contours of 5 patients. Plans were performed following the dose prescription and constraints for organs at risk (OARs) of a reference paper. The dose prescription was 35 Gy in five fractions for the planning target volume (PTV). Different techniques were used (3D-CRT, fixed-Field IMRT, VMAT, CyberKnife). Plans were compared in terms of dose-volume histogram (DVH) parameters. Furthermore, the median DVH was calculated and one patient was re-planned. A total of 70 plans were compared. The maximum dose to the body was 107.9 ± 4.5 % (range 101.5-116.3 %). Dose at 98 % (D98 %) and mean dose to the clinical target volume (CTV) were 102.0 ± 0.9 % (global range 101.1-102.9 %) and 105.1 ± 0.6 % (range 98.6-124.6 %). Similar trends were found for D95 % and mean dose to the PTV. Important differences were found in terms of the homogeneity index. Doses to OARs were heterogeneous. The subgroups with the same treatment planning system showed differences comparable to the differences of the whole group. In the re-optimized plans, DVH differences among institutes were reduced and OAR sparing improved. Important dosimetric differences with possible clinical implications, in particular related to OARs, were found. Replanning allowed a reduction in the OAR dose and decreased standard deviations. Multicenter clinical trials on SBRT should require a preplanning study to standardize the optimization procedure. (orig.)