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Sample records for radiotherapy start trials

  1. Late normal tissue effects in the arm and shoulder following lymphatic radiotherapy: Results from the UK START (Standardisation of Breast Radiotherapy) trials.

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    Haviland, Joanne S; Mannino, Mariella; Griffin, Clare; Porta, Nuria; Sydenham, Mark; Bliss, Judith M; Yarnold, John R

    2018-01-01

    Adjuvant lymphatic radiotherapy (LNRT) is recommended for selected axillary node positive women with early breast cancer. We investigated whether hypofractionated LNRT is safe combined with similarly-hypofractionated breast/chest wall radiotherapy (RT). The Standardisation of Breast Radiotherapy (START) pilot, A and B trials randomised women with early breast cancer to schedules of 2.67-3.3 Gy versus 2.0 Gy fractions (control). RT adverse effects were assessed by patients using the EORTC QLQ-BR23 and protocol-specific questions, and by physicians. Rates of arm/shoulder effects were compared between schedules for patients given LNRT. 864/5861 (14.7%) patients received LNRT (385 START-pilot, 318 START-A, 161 START-B). Prevalences of moderate/marked arm/shoulder effects were low up to 10 years. There were no significant differences between the hypofractionated and control groups for patient- and physician-assessed symptoms in START-A or START-B. In START-pilot, adverse effect rates were higher after 13 fractions of 3.3 Gy, consistent with effects reported in the breast/chest wall (significant for shoulder stiffness, HR 3.07, 95%CI 1.62-5.83, p = 0.001). The START trial results suggest that appropriately-dosed hypofractionated LNRT is safe in the long-term, according to patient and physician-assessed arm and shoulder symptoms. These findings are consistent with those reported after the same schedules delivered to the breast/chest wall. Copyright © 2017 The Author(s). Published by Elsevier B.V. All rights reserved.

  2. A survey of radiotherapy quality control practice in the United Kingdom for the START trial

    International Nuclear Information System (INIS)

    Venables, Karen; Winfield, Elizabeth; Deighton, Amanda; Aird, Edwin; Hoskin, Peter

    2001-01-01

    Background and purpose: This paper compares the quality control checks performed in departments in the United Kingdom with those recommended by the Institute of Physics and Engineering in Medicine (IPEM) in Report 81. Method: The data were gathered by the quality assurance team for the START trial, during visits to individual departments. Data are compared with the frequencies suggested in IPEM report 81. Where applicable, data are also analyzed with respect to machine manufacturer. Results: All departments with linear accelerators check the output at least weekly for both photons and electrons, however 11% of departments do not perform a constancy check of the output on a daily basis. The majority of departments check flatness at gantry zero on a monthly basis. However 27% of departments never check at non-zero gantry angles. In 51% of departments no fluoroscopy checks are performed on simulators on a daily basis. Conclusion: The majority of departments are following the frequencies suggested in IPEM report 81 although there are a number of discrepancies particularly for simulators. Accelerator type needs to be considered when designing quality assurance checks. In many departments more time than is currently allocated is needed on equipment, particularly simulators, to complete all of the checks suggested in Report 81

  3. Quality assurance in radiotherapy: analysis of the causes of not starting or early radiotherapy withdrawal

    International Nuclear Information System (INIS)

    Arenas, Meritxell; Sabater, Sebastià; Gascón, Marina; Henríquez, Ivan; Bueno, M José; Rius, Àngels; Rovirosa, Àngels; Gómez, David; Lafuerza, Anna; Biete, Albert; Colomer, Jordi

    2014-01-01

    The aim of this study was to analyse the reasons for not starting or for early of radiotherapy at the Radiation Oncology Department. All radiotherapy treatments from March 2010 to February 2012 were included. Early withdrawals from treatment those that never started recorded. Clinical, demographic and dosimetric variables were also noted. From a total of 3250 patients treated and reviewed, 121 (4%) did not start or complete the planned treatment. Of those, 63 (52%) did not receive any radiotherapy fraction and 58 (48%) did not complete the course, 74% were male and 26% were female. The mean age was 67 ± 13 years. The most common primary tumour was lung (28%), followed by rectum (16%). The aim of treatment was 62% radical and 38% palliative, 44% of patients had metastases; the most common metastatic site was bone, followed by brain. In 38% of cases (46 patients) radiotherapy was administered concomitantly with chemotherapy (10 cases (22%) were rectal cancers). The most common reason for not beginning or for early withdrawal of treatment was clinical progression (58/121, 48%). Of those, 43% died (52/121), 35 of them because of the progression of the disease and 17 from other causes. Incomplete treatment regimens were due to toxicity (12/121 (10%), of which 10 patients underwent concomitant chemotherapy for rectal cancer). The number of patients who did not complete their course of treatment is low, which shows good judgement in indications and patient selection. The most common reason for incomplete treatments was clinical progression. Rectal cancer treated with concomitant chemotherapy was the most frequent reason of the interruption of radiotherapy for toxicity

  4. Use of 'sham' radiotherapy in randomized clinical trials

    International Nuclear Information System (INIS)

    Schwarz, F.; Christie, D.

    2008-01-01

    The objective of this systematic review was to identify quality trials that use sham radiotherapy in their design and review them to determine its potential value. The Cochrane Library, Pubmed and a Reference Search served as data sources. Trials were included if they met a minimum quality score of 3 on a validated assessment instrument (which assesses randomization, control and blinding) and if they compared sham radiotherapy to active treatment. External beam therapy and brachytherapy trials were considered. Twenty-six trials were identified, collectively including 2663 participants in the period of 1970-2004. All the trials studied the value of radiotherapy for treatment or prevention of benign diseases, including multiple sclerosis, coronary artery restenosis, age-related macular degeneration and Graves' ophthalmopathy. There were no trials relating to the use of radiotherapy in the treatment of malignancy. This review showed that it is possible to carry out sham radiotherapy with due regard for ethical concerns, with effective blinding and high levels of patient acceptance. Large sample sizes with multicentre trial designs were achievable. Although the statistical philosophy for using sham radiotherapy in trials is legitimate, it is no longer routinely used.

  5. Systemic Inflammation, Coagulation, and Clinical Risk in the START Trial

    DEFF Research Database (Denmark)

    Baker, Jason V; Sharma, Shweta; Grund, Birgit

    2017-01-01

    Background: The Strategic Timing of AntiRetroviral Treatment (START) trial demonstrated that immediate (at CD4+ >500 cells/µL) vs deferred (to CD4+ ... available for 4299 START participants (92%). Mean follow-up was 3.2 years. Higher levels of IL-6 and D-dimer were the only biomarkers associated with risk for AIDS, SNA or death, as well as the individual components of SNA and AIDS events (HRs ranged 1.37-1.41 per 2-fold higher level), even after adjustment...

  6. Quality assurance of the SCOPE 1 trial in oesophageal radiotherapy.

    Science.gov (United States)

    Wills, Lucy; Maggs, Rhydian; Lewis, Geraint; Jones, Gareth; Nixon, Lisette; Staffurth, John; Crosby, Tom

    2017-11-15

    SCOPE 1 was the first UK based multi-centre trial involving radiotherapy of the oesophagus. A comprehensive radiotherapy trials quality assurance programme was launched with two main aims: 1. To assist centres, where needed, to adapt their radiotherapy techniques in order to achieve protocol compliance and thereby enable their participation in the trial. 2. To support the trial's clinical outcomes by ensuring the consistent planning and delivery of radiotherapy across all participating centres. A detailed information package was provided and centres were required to complete a benchmark case in which the delineated target volumes and organs at risk, dose distribution and completion of a plan assessment form were assessed prior to recruiting patients into the trial. Upon recruiting, the quality assurance (QA) programme continued to monitor the outlining and planning of radiotherapy treatments. Completion of a questionnaire was requested in order to gather information about each centre's equipment and techniques relating to their trial participation and to assess the impact of the trial nationally on standard practice for radiotherapy of the oesophagus. During the trial, advice was available for individual planning issues, and was circulated amongst the SCOPE 1 community in response to common areas of concern using bulletins. 36 centres were supported through QA processes to enable their participation in SCOPE1. We discuss the issues which have arisen throughout this process and present details of the benchmark case solutions, centre questionnaires and on-trial protocol compliance. The range of submitted benchmark case GTV volumes was 29.8-67.8cm 3 ; and PTV volumes 221.9-513.3 cm 3 . For the dose distributions associated with these volumes, the percentage volume of the lungs receiving 20Gy (V20Gy) ranged from 20.4 to 33.5%. Similarly, heart V40Gy ranged from 16.1 to 33.0%. Incidence of incorrect outlining of OAR volumes increased from 50% of centres at benchmark

  7. Hypnotherapy in radiotherapy patients: A randomized trial

    NARCIS (Netherlands)

    Stalpers, Lukas J. A.; da Costa, Hanna C.; Merbis, Merijn A. E.; Fortuin, Andries A.; Muller, Martin J.; van Dam, Frits S. A. M.

    2005-01-01

    Purpose: To determine whether hypnotherapy reduces anxiety and improves the quality of life in cancer patients undergoing curative radiotherapy (RT). Methods and Materials: After providing written informed consent, 69 patients were randomized between standard curative RT alone (36 controls) and RT

  8. Hypnotherapy in radiotherapy patients: A randomized trial

    International Nuclear Information System (INIS)

    Stalpers, Lukas J.A.; Costa, Hanna C. da; Merbis, Merijn A.E.; Fortuin, Andries A.; Muller, Martin J.; Dam, Frits van

    2005-01-01

    Purpose: To determine whether hypnotherapy reduces anxiety and improves the quality of life in cancer patients undergoing curative radiotherapy (RT). Methods and materials: After providing written informed consent, 69 patients were randomized between standard curative RT alone (36 controls) and RT plus hypnotherapy (33 patients). Patients in the hypnotherapy group received hypnotherapy at the intake, before RT simulation, before the first RT session, and halfway between the RT course. Anxiety was evaluated by the State-Trait Anxiety Inventory DY-1 form at six points. Quality of life was measured by the Rand Medical Outcomes Study 36-item Health Survey (SF-36) at five points. Additionally, patients answered a questionnaire to evaluate their experience and the possible benefits of this research project. Results: No statistically significant difference was found in anxiety or quality of life between the hypnotherapy and control groups. However, significantly more patients in the hypnotherapy group indicated an improvement in mental (p < 0.05) and overall (p < 0.05) well-being. Conclusion: Hypnotherapy did not reduce anxiety or improve the quality of life in cancer patients undergoing curative RT. The absence of statistically significant differences between the two groups contrasts with the hypnotherapy patients' own sense of mental and overall well-being, which was significantly greater after hypnotherapy. It cannot be excluded that the extra attention by the hypnotherapist was responsible for this beneficial effect in the hypnotherapy group. An attention-only control group would be necessary to control for this effect

  9. Preventive Effect of Glycyrrhiza Glabra Extract on Oral Mucositis in Patients under Head and Neck Radiotherapy: A Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Shamsolmolok Najafi

    2017-12-01

    Full Text Available Objectives: About two-thirds of cancer patients undergo radiotherapy. Oral mucositis represents a major complication of radiotherapy, causing morbidity and mortality and decreasing the quality of life of patients. This study aimed to assess the preventive effect of Glycyrrhiza aqueous extract on oral mucositis in cancer patients under head and neck radiotherapy.Materials and Methods: In this double-blind clinical trial, 37 head and neck cancer patients were divided into intervention (n=19 group receiving Glycyrrhiza aqueous extract and control (n=18 group receiving placebo. Patients in the test group used Glycyrrhiza aqueous extract topically twice a day from the first day of starting radiotherapy until the end of the second week. Patients were examined in the first day of radiotherapy for any type of wound before treatment and those with oral ulcers before radiotherapy were excluded from the study. The grade of mucositis was determined using the classification by the World Health Organization. ANCOVA was performed to assess any difference between the two groups with regard to oral mucosal irritation and wound size after the intervention while controlling for the covariates such as sex and age.Results: Significant differences were found in the maximum grade of mucositis and oral mucosal irritation between the intervention and control groups (P<0.001.Conclusions: This study showed that aqueous extract of Glycyrrhiza can be effective for decreasing the severity of oral mucositis in head and neck cancer patients undergoing radiotherapy.

  10. Quality of radiotherapy reporting in randomized controlled trials of prostate cancer.

    Science.gov (United States)

    Soon, Yu Yang; Chen, Desiree; Tan, Teng Hwee; Tey, Jeremy

    2018-06-07

    Good radiotherapy reporting in clinical trials of prostate radiotherapy is important because it will allow accurate reproducibility of radiotherapy treatment and minimize treatment variations that can affect patient outcomes. The aim of our study is to assess the quality of prostate radiotherapy (RT) treatment reporting in randomized controlled trials in prostate cancer. We searched MEDLINE for randomized trials of prostate cancer, published from 1996 to 2016 and included prostate RT as one of the intervention arms. We assessed if the investigators reported the ten criteria adequately in the trial reports: RT dose prescription method; RT dose-planning procedures; organs at risk (OAR) dose constraints; target volume definition, simulation procedures; treatment verification procedures; total RT dose; fractionation schedule; conduct of quality assurance (QA) as well as presence or absence of deviations in RT treatment planning and delivery. We performed multivariate logistic regression to determine the factors that may influence the quality of reporting. We found 59 eligible trials. There was significant variability in the quality of reporting. Target volume definition, total RT dose and fractionation schedule were reported adequately in 97% of included trials. OAR constraints, simulation procedures and presence or absence of deviations in RT treatment planning and delivery were reported adequately in 30% of included trials. Twenty-four trials (40%) reported seven criteria or more adequately. Multivariable logistic analysis showed that trials that published their quality assurance results and cooperative group trials were more likely to have adequate quality in reporting in at least seven criteria. There is significant variability in the quality of reporting on prostate radiotherapy treatment in randomized trials of prostate cancer. We need to have consensus guidelines to standardize the reporting of radiotherapy treatment in randomized trials.

  11. Radiotherapy

    International Nuclear Information System (INIS)

    Prosnitz, L.R.; Kapp, D.S.; Weissberg, J.B.

    1983-01-01

    This review highlights developments over the past decade in radiotherapy and attempts to summarize the state of the art in the management of the major diseases in which radiotherapy has a meaningful role. The equipment, radiobiology of radiotherapy and carcinoma of the lung, breast and intestines are highlighted

  12. Toxicity, physical function and everyday activity reported by patients with inoperable non-small cell lung cancer in a randomized trial (chemotherapy versus radiotherapy)

    International Nuclear Information System (INIS)

    Kaasa, S.; Mastekaasa, A.; Thorud, E.

    1988-01-01

    In a randomized trial, patients with inoperable non-small cell lung cancer with limited disease were randomly given either radiotherapy (42 Gy) or combination chemotherapy with cisplatin, 70 mg/m 2 , and etoposide, 100 mg/m 2 , given every third week with a maximum of 4 cycles. The patients were asked to fill in a questionnaire concerning psychosocial well-being, medical and treatment related symptoms, physical function and everyday activity. Of the chemotherapy patients 61% reported nausea 5 weeks after their last chemotherapy session and 44% had spells of vomiting. Only 14% of the radiotherapy patients had nausea and 5% vomited 14 weeks after start of treatment. Of the radiotherapy patients 64% experienced dysphagia compared to 8% of the chemotherapy patients 6 weeks after the start of treatment. (orig.)

  13. A randomized trial of combined multidrug chemotherapy and radiotherapy in advanced squamous cell carcinoma of the head and neck

    International Nuclear Information System (INIS)

    1986-01-01

    This report concerns the design and results of a randomized prospective trial (SECOG I) in the treatment of advanced Stage III and IV head and neck cancer with radical radiotherapy combined with polychemotherapy. Synchronous administration of chemotherapy and radiotherapy was compared with sequential chemotherapy and radiotherapy and VBM (vincristine, bleomycin and methotrexate) compared with VBM plus 5-fluorouracil in a 2 x 2 standard factorial design. Two-hundred-and-seventy patients were entered and 267 were included in the analysis. Treatment did not present serious problems of toxicity. The addition of 5-fluorouracil to VBM produced a significant improvement in disease-free survival (P=0.04) though not in overall survival. Synchronous chemotherapy was similarly better than sequential chemotherapy, though not significantly so (P=0.1). A new study (SECOG II), based on this was started in February 1984, and one-third of the patients are now being allocated to treatment by radiotherapy as the sole method of treatment. (author)

  14. Radiotherapy with or without hyperthermia in the treatment of superficial localized breast cancer: results from five randomized controlled trials

    International Nuclear Information System (INIS)

    Vernon, Clare C.; Hand, Jeffrey W.; Field, Stanley B.; Machin, David; Whaley, Jill B.; Zee, Jacoba van der; Putten, Wim L.J. van; Rhoon, Gerard C. van; Dijk, Jan D.P. van; Gonzalez, Dionisio Gonzalez; Liu, F.-F.; Goodman, Phyllis; Sherar, Michael

    1996-01-01

    Purpose: Claims for the value of hyperthermia as an adjunct to radiotherapy in the treatment of cancer have mostly been based on small Phase I or II trials. To test the benefit of this form of treatment, randomized Phase III trials were needed. Methods and Materials: Five randomized trials addressing this question were started between 1988 and 1991. In these trials, patients were eligible if they had advanced primary or recurrent breast cancer, and local radiotherapy was indicated in preference to surgery. In addition, heating of the lesions and treatment with a prescribed (re)irradiation schedule had to be feasible and informed consent was obtained. The primary endpoint of all trials was local complete response. Slow recruitment led to a decision to collaborate and combine the trial results in one analysis, and report them simultaneously in one publication. Interim analyses were carried out and the trials were closed to recruitment when a previously agreed statistically significant difference in complete response rate was observed in the two larger trials. Results: We report on pretreatment characteristics, the treatments received, the local response observed, duration of response, time to local failure, distant progression and survival, and treatment toxicity of the 306 patients randomized. The overall CR rate for RT alone was 41% and for the combined treatment arm was 59%, giving, after stratification by trial, an odds ratio of 2.3. Not all trials demonstrated an advantage for the combined treatment, although the 95% confidence intervals of the different trials all contain the pooled odds ratio. The greatest effect was observed in patients with recurrent lesions in previously irradiated areas, where further irradiation was limited to low doses. Conclusion: The combined result of the five trials has demonstrated the efficacy of hyperthermia as an adjunct to radiotherapy for treatment of recurrent breast cancer. The implication of these encouraging results is that

  15. Physical and psychosocial support requirements of 1,500 patients starting radiotherapy

    Energy Technology Data Exchange (ETDEWEB)

    Kirchheiner, K.; Czajka, A.; Luetgendorf-Cacig, C.; Schmid, M.P.; Komarek, E.; Poetter, R. [Medical Univ. of Vienna, Comprehensive Cancer Center, Vienna (Austria). Dept. of Radiation Oncology; Ponocny-Seliger, E. [Sigmund Freud Private Univ. Vienna (Austria). Dept. of Psychology; Doerr, W. [Medical Univ. of Vienna, Comprehensive Cancer Center, Vienna (Austria). Dept. of Radiation Oncology; Medical Univ. of Vienna (Austria). Christian Doppler Lab. for Medical Radiation Research for Radiation Oncology

    2013-05-15

    Background. The need for psychosocial support in cancer patients is estimated in the literature at 14-50%. At the Department of Radiation Oncology, Medical University of Vienna, approximately 3,000 patients are seen annually. Due to limited staff resources, highly distressed patients need to be selected for focused support. A multidisciplinary screening questionnaire covering physical, social and psychological problems and needs was successfully implemented in clinical routine. We present the results of a representative sample of 1,500 heterogeneous cancer patients before beginning radiotherapy. Patients and methods. The prevalence rates of physical, social and psychological problems and needs were evaluated. Independent risk factors for critical psychological distress were analyzed in a multivariate logistic regression model, in order to identify vulnerable subgroups for focused psychosocial support. Results. Critical psychological distress was found in 22% of the overall cohort, of whom only 26% reported a need for psychological information. Clinically relevant pain was suffered by 31%. Patients' most frequent complaints were weakness, sleeping difficulties and exhaustion. Consequently, 40% were impaired in activities and 35% reported a requirement for support in daily life. A need for further information was expressed by 37% of patients. Significant risk factors for critical psychological distress included pain, functional status, support requirements and patient-reported symptoms. Differences in tumor type, metastases and sociodemographic variables had no impact on critical psychological distress. Conclusion. Approximately one third of all patients beginning radiotherapy have physical, social and psychological problems and should receive focused psychosocial support. Multivariate analysis reveals that patients with impaired ''physical integrity'' are at a significantly higher risk of experiencing critical psychological distress. (orig.)

  16. Physical and psychosocial support requirements of 1,500 patients starting radiotherapy

    International Nuclear Information System (INIS)

    Kirchheiner, K.; Czajka, A.; Luetgendorf-Cacig, C.; Schmid, M.P.; Komarek, E.; Poetter, R.; Ponocny-Seliger, E.; Doerr, W.; Medical Univ. of Vienna

    2013-01-01

    Background. The need for psychosocial support in cancer patients is estimated in the literature at 14-50%. At the Department of Radiation Oncology, Medical University of Vienna, approximately 3,000 patients are seen annually. Due to limited staff resources, highly distressed patients need to be selected for focused support. A multidisciplinary screening questionnaire covering physical, social and psychological problems and needs was successfully implemented in clinical routine. We present the results of a representative sample of 1,500 heterogeneous cancer patients before beginning radiotherapy. Patients and methods. The prevalence rates of physical, social and psychological problems and needs were evaluated. Independent risk factors for critical psychological distress were analyzed in a multivariate logistic regression model, in order to identify vulnerable subgroups for focused psychosocial support. Results. Critical psychological distress was found in 22% of the overall cohort, of whom only 26% reported a need for psychological information. Clinically relevant pain was suffered by 31%. Patients' most frequent complaints were weakness, sleeping difficulties and exhaustion. Consequently, 40% were impaired in activities and 35% reported a requirement for support in daily life. A need for further information was expressed by 37% of patients. Significant risk factors for critical psychological distress included pain, functional status, support requirements and patient-reported symptoms. Differences in tumor type, metastases and sociodemographic variables had no impact on critical psychological distress. Conclusion. Approximately one third of all patients beginning radiotherapy have physical, social and psychological problems and should receive focused psychosocial support. Multivariate analysis reveals that patients with impaired ''physical integrity'' are at a significantly higher risk of experiencing critical psychological distress. (orig.)

  17. A single center analysis of factors influencing study start-up timeline in clinical trials.

    Science.gov (United States)

    Krafcik, Brianna M; Doros, Gheorghe; Malikova, Marina A

    2017-11-01

    Efficient start-up phase in clinical trials is crucial to execution. The goal was to determine factors contributing to delays. The start-up milestones were assessed for 38 studies and analyzed. Total start-up time was shorter for following studies: device trials, no outsourcing, fewer ancillary services used and in interventional versus observational designs. The use of a centralized Institutional Review Board (IRB) versus a local IRB reduced time to approval. Studies that never enrolled took longer on average to finalize their budget/contract, and obtain IRB than ones that did enroll. Different features of clinical trials can affect timeline of start-up process. An understanding of the impact of each feature allows for optimization.

  18. Radiotherapy

    Directory of Open Access Journals (Sweden)

    Rema Jyothirmayi

    1999-01-01

    Full Text Available Purpose. Conservative treatment in the form of limited surgery and post-operative radiotherapy is controversial in hand and foot sarcomas, both due to poor radiation tolerance of the palm and sole, and due to technical difficulties in achieving adequate margins.This paper describes the local control and survival of 41 patients with soft tissue sarcoma of the hand or foot treated with conservative surgery and radiotherapy. The acute and late toxicity of megavoltage radiotherapy to the hand and foot are described. The technical issues and details of treatment delivery are discussed. The factors influencing local control after radiotherapy are analysed.

  19. Redesigning Radiotherapy Quality Assurance: Opportunities to Develop an Efficient, Evidence-Based System to Support Clinical Trials

    Science.gov (United States)

    Bekelman, Justin E.; Deye, James A.; Vikram, Bhadrasain; Bentzen, Soren M.; Bruner, Deborah; Curran, Walter J.; Dignam, James; Efstathiou, Jason A.; FitzGerald, T. J.; Hurkmans, Coen; Ibbott, Geoffrey S.; Lee, J. Jack; Merchant, Timothy E.; Michalski, Jeff; Palta, Jatinder R.; Simon, Richard; Ten Haken, Randal K.; Timmerman, Robert; Tunis, Sean; Coleman, C. Norman; Purdy, James

    2012-01-01

    Background In the context of national calls for reorganizing cancer clinical trials, the National Cancer Institute (NCI) sponsored a two day workshop to examine the challenges and opportunities for optimizing radiotherapy quality assurance (QA) in clinical trial design. Methods Participants reviewed the current processes of clinical trial QA and noted the QA challenges presented by advanced technologies. 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 like proton beam therapy, and the international harmonization of clinical trial QA. Results Four recommendations were made: 1) Develop a tiered (and more efficient) system for radiotherapy QA and tailor intensity of QA to clinical trial objectives. Tiers include (i) general credentialing, (ii) trial specific credentialing, and (iii) individual case review; 2) Establish a case QA repository; 3) Develop an evidence base for clinical trial QA and introduce innovative prospective trial designs to evaluate radiotherapy QA in clinical trials; and 4) Explore the feasibility of consolidating clinical trial QA in the United States. Conclusion Radiotherapy QA may impact clinical trial accrual, cost, outcomes and generalizability. To achieve maximum benefit, QA programs must become more efficient and evidence-based. PMID:22425219

  20. Does the StartReact Effect Apply to First-Trial Reactive Movements?

    Directory of Open Access Journals (Sweden)

    Katrin Sutter

    Full Text Available StartReact is the acceleration of reaction time by a startling acoustic stimulus (SAS. The SAS is thought to release a pre-prepared motor program. Here, we investigated whether the StartReact effect is applicable to the very first trial in a series of repeated unpractised single-joint movements.Twenty healthy young subjects were instructed to perform a rapid ankle dorsiflexion movement in response to an imperative stimulus. Participants were divided in two groups of ten. Both groups performed 17 trials. In one group a SAS (116 dB was given in the first trial, whereas the other group received a non-startling sound (70 dB as the first imperative stimulus. In the remaining 16 trials, the SAS was given as the imperative stimulus in 25% of the trials in both groups. The same measurement was repeated one week later, but with the first-trial stimuli counterbalanced between groups.When a SAS was given in the very first trial, participants had significantly shorter onset latencies compared to first-trial responses to a non-startling stimulus. Succeeding trials were significantly faster compared to the first trial, both for trials with and without a SAS. However, the difference between the first and succeeding trials was significantly larger for responses to a non-startling stimulus compared to responses triggered by a SAS. SAS-induced acceleration in the first trial of the second session was similar to that in succeeding trials of session 1.The present results confirm that the StartReact phenomenon also applies to movements that have not yet been practiced in the experimental context. The excessive SAS-induced acceleration in the very first trial may be due to the absence of integration of novel context-specific information with the existing motor memory for movement execution. Our findings demonstrate that StartReact enables a rapid release of motor programs in the very first trial also without previous practice, which might provide a behavioural

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

    International Nuclear Information System (INIS)

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

    2012-01-01

    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.

  2. A prospective observational trial on emesis in radiotherapy: Analysis of 1020 patients recruited in 45 Italian radiation oncology centres

    International Nuclear Information System (INIS)

    Maranzano, Ernesto; De Angelis, Verena; Pergolizzi, Stefano; Lupattelli, Marco; Frata, Paolo; Spagnesi, Stefano; Frisio, Maria Luisa; Mandoliti, Giovanni; Malinverni, Giuseppe; Trippa, Fabio; Fabbietti, Letizia; Parisi, Salvatore; Di Palma, Annamaria; De Vecchi, Pietro; De Renzis, Costantino; Giorgetti, Celestino; Bergami, Tiziano; Orecchia, Roberto; Portaluri, Maurizio; Signor, Marco

    2010-01-01

    Purpose: A prospective observational multicentre trial was carried out to assess the incidence, pattern, and prognostic factors of radiation-induced emesis (RIE), and to evaluate the use of antiemetic drugs in patients treated with radiotherapy or concomitant radio-chemotherapy. The application in clinical practice of the Multinational Association of Supportive Care in Cancer guidelines was also studied. Materials and methods: Forty-five Italian radiation oncology centres took part in this trial. The accrual lasted for 3 consecutive weeks and only patients starting radiotherapy or concomitant radio-chemotherapy in this period were enrolled. Evaluation was based on diary card filled in daily by patients during treatment and one week after stopping it. Diary card recorded the intensity of nausea/vomiting and prophylactic/symptomatic antiemetic drug prescriptions. Results: A total of 1020 patients entered into the trial, and 1004 were evaluable. Vomiting and nausea occurred in 11.0% and 27.1% of patients, respectively, and 27.9% patients had both vomiting and nausea. In multifactorial analysis, the only statistically significant patient-related risk factors were concomitant chemotherapy and previous experience of vomiting induced by chemotherapy. Moreover, two radiotherapy-related factors were significant risk factors for RIE, the irradiated site (upper abdomen) and field size (>400 cm 2 ). An antiemetic drug was given only to a minority (17%) of patients receiving RT, and the prescriptions were prophylactic in 12.4% and symptomatic in 4.6%. Different compounds and a wide range of doses and schedules were used. Conclusions: These data were similar to those registered in our previous observational trial, and the radiation oncologists' attitude in underestimating RIE and under prescribing antiemetics was confirmed.

  3. Randomised clinical trial of Levonantradol and Chlorpromazine in the prevention of radiotherapy-induced vomiting

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    Lucraft, H H; Palmer, M K [Christie Hospital and Holt Radium Inst., Manchester (UK)

    1982-11-01

    Levonantradol is a cannabis derivative. Cannabinoid anti-emetics are being assessed in cancer chemotherapy but have been little used in radiotherapy to date. A pilot study and randomised trial compared the anti-emetic effect of a standard drug (Chlorpromazine 25 mg) with Levonantradol at two doses (0.5 and 0.75 mg) in patients receiving palliative single fraction radiotherapy to sites likely to cause nausea and vomiting. Most patients were out-patients. Both drugs were well tolerated. The frequency of vomiting was similar in all three groups in both the pilot study and randomised trial.

  4. Randomised clinical trial of Levonantradol and Chlorpromazine in the prevention of radiotherapy-induced vomiting

    International Nuclear Information System (INIS)

    Lucraft, H.H.; Palmer, M.K.

    1982-01-01

    Levonantradol is a cannabis derivative. Cannabinoid anti-emetics are being assessed in cancer chemotherapy but have been little used in radiotherapy to date. A pilot study and randomised trial compared the anti-emetic effect of a standard drug (Chlorpromazine 25 mg) with Levonantradol at two doses (0.5 and 0.75 mg) in patients receiving palliative single fraction radiotherapy to sites likely to cause nausea and vomiting. Most patients were out-patients. Both drugs were well tolerated. The frequency of vomiting was similar in all three groups in both the pilot study and randomised trial. (author)

  5. Radiotherapy

    International Nuclear Information System (INIS)

    Zedgenidze, G.A.; Kulikov, V.A.; Mardynskij, Yu.S.

    1984-01-01

    The technique for roentgenotopometric and medicamentous preparation of patients for radiotherapy has been reported in detail. The features of planning and performing of remote, intracavitary and combined therapy in urinary bladder cancer are considered. The more effective methods of radiotherapy have been proposed taking into account own experience as well as literature data. The comparative evaluation of treatment results and prognosis are given. Radiation pathomorphism of tumors and tissues of urinary bladder is considered in detail. The problems of diagnosis, prophylaxis and treatment of complications following radiodiagnosis and radiotherapy in patients with urinary bladder cancer are illustrated widely

  6. Evaluating quality of life and cost implications of prophylactic radiotherapy in mesothelioma: Health economic analysis of the SMART trial.

    Science.gov (United States)

    Stewart, Samuel Alan; Clive, Amelia O; Maskell, Nick A; Penz, Erika

    2018-01-01

    The SMART trial is a UK-based, multicentre RCT comparing prophylactic radiotherapy and symptom-based (deferred) radiotherapy in 203 patients with Malignant Pleural Mesothelioma who had undergone large bore pleural interventions. Using costs and quality of life data collected alongside the clinical trial, we will estimate the cost-effectiveness of prophylactic radiotherapy compared to deferred radiotherapy over a 1-year period. Healthcare utilization and costs were captured during the trial. Utility weights produced by the EQ-5D questionnaire were used to determine quality-adjusted life-years (QALY) gained. The incremental cost-effectiveness ratio was calculated over the one-year trial period. Costs were similar in the immediate and deferred radiotherapy groups: £5480.40 (SD = £7040; n = 102) and £5461.40 (SD = £7770; n = 101) respectively. There was also no difference in QALY: 0.498 (95% CI: [0.45, 0.547]) in the prophylactic radiotherapy group versus 0.525 (95% CI: [0.471, 0.580]) in the deferred group. At a willingness to pay threshold of £30,000/QALY there was only a 24% chance that prophylactic radiotherapy was cost-effective compared to deferred radiotherapy. There was no significant effect of prophylactic radiotherapy on quality of life in the intervention group, nor was there any discernable decrease in healthcare costs. There is little evidence to suggest that prophylactic radiotherapy is a cost-effective intervention in this population. ISRCTN72767336 with ISRCTN.

  7. Training Head Start Teachers to Conduct Trial-Based Functional Analysis of Challenging Behavior

    Science.gov (United States)

    Rispoli, Mandy; Burke, Mack D.; Hatton, Heather; Ninci, Jennifer; Zaini, Samar; Sanchez, Lisa

    2015-01-01

    Trial-based functional analysis (TBFA) is a procedure for experimentally identifying the function of challenging behavior within applied settings. The purpose of this study was to examine the effects of a TBFA teacher-training package in the context of two Head Start centers implementing programwide positive behavior support (PWPBS). Four Head…

  8. Design of FRESH START: A Randomized Trial of Exercise and Diet among Cancer Survivors.

    Science.gov (United States)

    Demark-Wahnefried, Wendy; Clipp, Elizabeth C.; McBride, Colleen; Lobach, David F.; Lipkus, Isaac; Peterson, Bercedis; Snyder, Denise Clutter; Sloane, Richard; Arbanas, Jennifer; Kraus, William E.

    2003-01-01

    Fresh Start is a randomized, controlled trial that will test whether personally tailored, distance-medicine-based programs will increase exercise and fruit and vegetable consumption and decrease fat intake among individuals recently diagnosed with breast or prostate cancer. People from hospital cancer registries and oncologic practices will…

  9. A phase I trial of pre-operative radiotherapy for prostate cancer: Clinical and translational studies

    International Nuclear Information System (INIS)

    Supiot, Stephane; Shubbar, Shubber; Fleshner, Neil; Warde, Padraig; Hersey, Karen; Wallace, Kris; Cole, Heather; Sweet, Joan; Tsihlias, John; Jewett, Michael A.S.; Klotz, Laurence; Bristow, Robert G.

    2008-01-01

    Background and purpose: Selected patients undergoing radical prostatectomy for localized prostate cancer can be at high-risk for pT3 disease and require subsequent radiotherapy. In a phase I trial, we investigated the feasibility of pre-operative radiotherapy for this patient subset. Materials and methods: Eligibility criteria were: T1/T2N0M0 tumors plus (i) Gleason ≥ 7, PSA > 10 ng/ml and 15 ng/ml and less WAF associated with reduced cell proliferation. Conclusion: Intra-operative morbidity is low following short-course, pre-operative radiotherapy. A phase II trial is planned to fully document biochemical response with this combined-modality approach

  10. Radiotherapy

    International Nuclear Information System (INIS)

    Wannenmacher, M.; Debus, J.; Wenz, F.

    2006-01-01

    The book is focussed on the actual knowledge on the clinical radiotherapy and radio-oncology. Besides fundamental and general contributions specific organ systems are treated in detail. The book contains the following contributions: Basic principles, radiobiological fundamentals, physical background, radiation pathology, basics and technique of brachytherapy, methodology and technique of the stereotactic radiosurgery, whole-body irradiation, operative radiotherapy, hadron therapy, hpyerthermia, combined radio-chemo-therapy, biometric clinical studies, intensity modulated radiotherapy, side effects, oncological diagnostics; central nervous system and sense organs, head-neck carcinomas, breast cancer, thorax organs, esophagus carcinoma, stomach carcinoma, pancreas carcinoma, heptabiliary cancer and liver metastases, rectal carcinomas, kidney and urinary tract, prostate carcinoma, testicular carcinoma, female pelvis, lymphatic system carcinomas, soft tissue carcinoma, skin cancer, bone metastases, pediatric tumors, nonmalignant diseases, emergency in radio-oncology, supporting therapy, palliative therapy

  11. Persistent pain after targeted intraoperative radiotherapy (TARGIT) or external breast radiotherapy for breast cancer: A randomized trial

    DEFF Research Database (Denmark)

    Andersen, Kenneth Geving; Gärtner, Rune; Kroman, Niels

    2012-01-01

    for participation, and a total of 244 patients were included and received a detailed questionnaire. The response rate was 98%, leaving 238 patients for the final analysis. Pain prevalence were 33.9% in the EBRT group and 24.6% in the IORT group (p = 0.11). Treatment with IORT may not alter the risk of PPBCT.......Persistent pain after breast cancer treatment (PPBCT) affects between 25 and 60% of patients depending on surgical and adjuvant treatment. External breast radiotherapy (EBRT) has been shown to be a riskfactor for PPBCT, raising the question whether intraoperative radiation therapy (IORT), with its...... smaller radiation field may reduce the development of PPBCT. Using data from the TARGIT-A trial, the aim of this study was to compare these two treatments with regard to development of PPBCT. A total of 281 patients enrolled in the TARGIT-A trial from the Copenhagen University Hospitals was screened...

  12. Radiotherapy.

    Science.gov (United States)

    Krause, Sonja; Debus, Jürgen; Neuhof, Dirk

    2011-01-01

    Solitary plasmocytoma occurring in bone (solitary plasmocytoma of the bone, SBP) or in soft tissue (extramedullary plasmocytoma, EP) can be treated effectively and with little toxicity by local radiotherapy. Ten-year local control rates of up to 90% can be achieved. Patients with multiple myeloma often suffer from symptoms such as pain or neurological impairments that are amenable to palliative radiotherapy. In a palliative setting, short treatment schedules and lower radiation doses are used to reduce toxicity and duration of hospitalization. In future, low-dose total body irradiation (TBI) may play a role in a potentially curative regimen with nonmyeloablative conditioning followed by allogenic peripheral blood stem cell transplantation.

  13. Radiotherapy for calcaneodynia. Results of a single center prospective randomized dose optimization trial

    Energy Technology Data Exchange (ETDEWEB)

    Ott, O.J.; Jeremias, C.; Gaipl, U.S.; Frey, B.; Schmidt, M.; Fietkau, R. [University Hospital Erlangen (Germany). Dept. of Radiation Oncology

    2013-04-15

    The aim of this work was to compare the efficacy of two different dose fractionation schedules for radiotherapy of patients with calcaneodynia. Between February 2006 and April 2010, 457 consecutive evaluable patients were recruited for this prospective randomized trial. All patients received radiotherapy using the orthovoltage technique. One radiotherapy series consisted of 6 single fractions/3 weeks. In case of insufficient remission of pain after 6 weeks a second radiation series was performed. Patients were randomly assigned to receive either single doses of 0.5 or 1.0 Gy. Endpoint was pain reduction. Pain was measured before, immediately after, and 6 weeks after radiotherapy using a visual analogue scale (VAS) and a comprehensive pain score (CPS). The overall response rate for all patients was 87 % directly after and 88 % 6 weeks after radiotherapy. The mean VAS values before, immediately after, and 6 weeks after treatment for the 0.5 and 1.0 Gy groups were 65.5 {+-} 22.1 and 64.0 {+-} 20.5 (p = 0.188), 34.8 {+-} 24.7 and 39.0 {+-} 26.3 (p = 0.122), and 25.1 {+-} 26.8 and 28.9 {+-} 26.8 (p = 0.156), respectively. The mean CPS before, immediately after, and 6 weeks after treatment was 10.1 {+-} 2.7 and 10.0 {+-} 3.0 (p = 0.783), 5.6 {+-} 3.7 and 6.0 {+-} 3.9 (p = 0.336), 4.0 {+-} 4.1 and 4.3 {+-} 3.6 (p = 0.257), respectively. No statistically significant differences between the two single dose trial arms for early (p = 0.216) and delayed response (p = 0.080) were found. Radiotherapy is an effective treatment option for the management of calcaneodynia. For radiation protection reasons, the dose for a radiotherapy series is recommended not to exceed 3-6 Gy. (orig.)

  14. Radiotherapy

    International Nuclear Information System (INIS)

    Pistenma, D.A.

    1980-01-01

    The need for radiotherapy research is exemplified by the 100,000 cancer patients who will fail treatment locally and/or regionally annually for the next several years but who would benefit from better local treatment modalities. Theoretically, all of the areas of investigation discussed in this projection paper have the potential to significantly improve local-regional treatment of cancer by radiotherapy alone or in combination with other modalities. In many of the areas of investigation discussed in this paper encouraging results have been obtained in cellular and animal tumor studies and in limited studies in humans as well. In the not too distant future the number of patients who would benefit from better local control may increase by tens of thousands if developments in chemotherapy and/or immunotherapy provide a means to eradicate disseminated microscopic foci of cancer. Thus the efforts to improve local-regional control take on even greater significance

  15. PP22. PROGRESSING RADIOTHERAPY-DRUG COMBINATIONS TOWARDS EARLY PHASE CLINICAL TRIALS

    Science.gov (United States)

    Jones, Dr Hazel; Stock, Dr Julie; Chalmers, Prof Anthony

    2017-01-01

    Abstract The Radiotherapy-Drug Combinations consortium (RaDCom) works with UK-based investigators to design and deliver high quality preclinical projects evaluating specific radiotherapy-drug combinations. We have several collaborations with industry, from in vitro projects to understand the novel agent in the context of radiobiology, through to preclinical studies that will generate data to support the development of radiotherapy combination trials. RaDCom facilitates the coordination of industry interactions, triage new proposals, monitor active projects, and engages with the radiotherapy community to promote collaboration and networking (via a capability map). The CRUK New Agents Committee Preclinical Combination Grant scheme provides one of the funding options for these studies, with the potential to feed into early phase clinical trials via the ECMC Combinations Alliance. RaDCom also supports broader radiotherapy research initiatives, by working to improve preclinical quality assurance and identifying a route to registration for radiotherapy-drug treatments. These activities will place the UK at the forefront of radiotherapy-drug preclinical research and provide a significant incentive for pharmaceutical companies to invest in this area and utilise the RaDCom network. Further information can be found on our webpage: http://ctrad.ncri.org.uk/research-support/radiation-drug-combinations-radcom Successful projects from RaDCom can then move into early phase combinations trials within the Combinations Alliance. The Combinations Alliance supports early phase combination studies in the UK via the ECMC (Experimental Cancer Medicine Centres) network. It focuses on translational research, and enables clinical project teams to work with disease experts to set up investigator led trials. The CRUK Centre of Drug Development (CDD) supports these studies with further management and coordination ensuring more robust timelines and delivery. The Combinations Alliance framework

  16. Quality control of involved field radiotherapy in the HD 13 and HD 14 trials. Report of the radiotherapy panel of the German Hodgkin Study Group (GHSG)

    International Nuclear Information System (INIS)

    Kriz, J.; Haverkamp, U.; Eich, H.T.; Baues, C.; Engenhart-Cabillic, R.; Herfarth, K.; Lukas, P.; Pluetschow, A.; Fuchs, M.; Engert, A.; Schmidberger, H.; Staar, S.

    2017-01-01

    As part of the foundation of the German Hodgkin Study Group (GHSG) in 1978, a central radiotherapy (RT) reference centre was established to evaluate and to improve the quality of treatment. During the study generations, the quality assurance programs (QAP) were continued and adapted to the demands of each study. The purpose of this article is to demonstrate the results of the fifth study generation and to compare them to the previous findings. With the start of the fourth GHSG study generation (HD10-12), a central prospective review of all diagnostic images was established to create an individual treatment plan for each early stage study patient. The quality of involved field RT was retrospectively evaluated by an expert panel of radiation oncologists. In the fifth study generation (HD13-15), the retrospective review of radiotherapy performed was refined and the results were compared with the findings of the fourth generation. The expert panel analyzed the RT planning and application of 1037 (28 %) patients (HD13 n = 465, HD14 n = 572). Simulation films were available in 85 % of cases and verification films in 87 %. RT was assessed as major violation in 46 % (HD13 = 38 %, HD14 = 52 %), minor violation in 9 % (HD13 = 9 %, HD14 = 9 %) and according to the protocol in 45 % (HD13 = 52 %, HD14 = 38 %). The value for QAP of RT within the GHSG trials is well known. Still there were several protocol violations. In the future, the QAP program has to be adapted to the requirements of ''modern RT'' in malignant lymphoma. (orig.) [de

  17. Randomized multicenter trial on the effect of radiotherapy for plantar Fasciitis (painful heel spur using very low doses – a study protocol

    Directory of Open Access Journals (Sweden)

    Micke Oliver

    2008-09-01

    Full Text Available Abstract Background A lot of retrospective data concerning the effect of radiotherapy on the painful heel spur (plantar fasciitis is available in the literature. Nevertheless, a randomized proof of this effect is still missing. Thus, the GCGBD (German cooperative group on radiotherapy for benign diseases of the DEGRO (German Society for Radiation Oncology decided to start a randomized multicenter trial in order to find out if the effect of a conventional total dose is superior compared to that of a very low dose. Methods/Design In a prospective, controlled and randomized phase III trial two radiotherapy schedules are to be compared: standard arm: total dose 6.0 Gy in single fractions of 1.0 Gy applied twice a week experimental arm: total dose 0.6 Gy in single fractions of 0.1 Gy applied twice a week (acting as a placebo Patients aged over 40 years who have been diagnosed clinically and radiologically to be suffering from a painful heel spur for at least six months can be included. Former trauma, surgery or radiotherapy to the heel are not allowed nor are patients with a severe psychiatric disease or women during pregnancy and breastfeeding. According to the statistical power calculation 100 patients have to be enrolled into each arm. After having obtaining a written informed consent a patient is randomized by the statistician to one of the arms mentioned above. After radiotherapy, the patients are seen first every six weeks, then regularly up to 48 months after therapy, they additionally receive a questionnaire every six weeks after the follow-up examinations. The effect is measured using several target variables (scores: Calcaneodynia-score according to Rowe et al., SF-12 score, and visual analogue scale of pain. The most important endpoint is the pain relief three months after therapy. Patients with an inadequate result are offered a second radiotherapy series applying the standard dose (equally in both arms. This trial protocol has been

  18. 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

    Energy Technology Data Exchange (ETDEWEB)

    Bekelman, Justin E., E-mail: bekelman@uphs.upenn.edu [University of Pennsylvania, Philadelphia, Pennsylvania (United States); Deye, James A.; Vikram, Bhadrasain [National Cancer Institute, Bethesda, Maryland (United States); Bentzen, Soren M. [University of Wisconsin, Madison, Wisconsin (United States); Bruner, Deborah [University of Pennsylvania, Philadelphia, Pennsylvania (United States); Curran, Walter J. [Emory University, Atlanta, Georgia (United States); Dignam, James [University of Chicago, Chicago, Illinois (United States); Efstathiou, Jason A. [Massachusetts General Hospital, Boston, Massachusetts (United States); FitzGerald, T.J. [University of Massachusetts, Boston, Massachusetts (United States); Hurkmans, Coen [European Organization for Research and Treatment of Cancer, Brussels (Belgium); Ibbott, Geoffrey S.; Lee, J. Jack [University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Merchant, Thomas E. [St. Jude Children' s Research Hospital, Memphis, Tennessee (United States); Michalski, Jeff [University of Washington, St. Louis, Missouri (United States); Palta, Jatinder R. [University of Florida, Miami, Florida (United States); Simon, Richard [National Institutes of Health, Bethesda, Maryland (United States); Ten Haken, Randal K. [University of Michigan, Ann Arbor, Michigan (United States); Timmerman, Robert [University of Texas Southwestern Medical Center, Dallas, Texas (United States); Tunis, Sean [Center for Medical Technology Policy, Baltimore, Maryland (United States); Coleman, C. Norman [National Cancer Institute, Bethesda, Maryland (United States); and others

    2012-07-01

    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.

  19. Evaluating quality of life and cost implications of prophylactic radiotherapy in mesothelioma: Health economic analysis of the SMART trial.

    Directory of Open Access Journals (Sweden)

    Samuel Alan Stewart

    Full Text Available The SMART trial is a UK-based, multicentre RCT comparing prophylactic radiotherapy and symptom-based (deferred radiotherapy in 203 patients with Malignant Pleural Mesothelioma who had undergone large bore pleural interventions. Using costs and quality of life data collected alongside the clinical trial, we will estimate the cost-effectiveness of prophylactic radiotherapy compared to deferred radiotherapy over a 1-year period.Healthcare utilization and costs were captured during the trial. Utility weights produced by the EQ-5D questionnaire were used to determine quality-adjusted life-years (QALY gained. The incremental cost-effectiveness ratio was calculated over the one-year trial period.Costs were similar in the immediate and deferred radiotherapy groups: £5480.40 (SD = £7040; n = 102 and £5461.40 (SD = £7770; n = 101 respectively. There was also no difference in QALY: 0.498 (95% CI: [0.45, 0.547] in the prophylactic radiotherapy group versus 0.525 (95% CI: [0.471, 0.580] in the deferred group. At a willingness to pay threshold of £30,000/QALY there was only a 24% chance that prophylactic radiotherapy was cost-effective compared to deferred radiotherapy.There was no significant effect of prophylactic radiotherapy on quality of life in the intervention group, nor was there any discernable decrease in healthcare costs. There is little evidence to suggest that prophylactic radiotherapy is a cost-effective intervention in this population.ISRCTN72767336 with ISRCTN.

  20. Phase II Trial of Erlotinib during and after Radiotherapy in Children with Newly Diagnosed High-Grade Gliomas

    Directory of Open Access Journals (Sweden)

    Ibrahim eQaddoumi

    2014-04-01

    Full Text Available Background. Epidermal growth factor receptor is overexpressed in most pediatric high-grade gliomas (HGG. Since erlotinib had shown activity in adults with HGG, we conducted a phase II trial of erlotinib and local radiotherapy in children with newly diagnosed HGG. Methods. Following maximum surgical resection, patients between 3 and 21 years with nonmetastatic HGG received local radiotherapy at 59.4 Gy (54 Gy for spinal tumors and those with ≥70% brain involvement. Erlotinib started on day 1 of radiotherapy (120 mg/m2 per day and continued for 2 years unless there was tumor progression or intolerable toxicities. The 2-year progression-free survival (PFS was estimated for patients with intracranial anaplastic astrocytoma (AA and glioblastoma.Results. Median age at diagnosis for 41 patients with intracranial tumors (21 with glioblastoma and 20 with AA was 10.9 years (range, 3.3 to 19 years. The 2-year PFS for patients with AA and glioblastoma was 15% ± 7% and 19% ± 8%, respectively. Only five patients remained alive without tumor progression. Twenty-six patients had at least one grade 3 or 4 toxicity irrespective of association with erlotinib; only four required dose modifications. The main toxicities were gastrointestinal (n=11, dermatologic (n=5, and metabolic (n=4. One patient with gliomatosis cerebri who required prolonged corticosteroids died of septic shock associated with pancreatitis. Conclusions. Although therapy with erlotinib was mostly well tolerated, it did not change the poor outcome of our patients. Our results showed that erlotinib is not a promising medication in the treatment of children with intracranial AA and glioblastoma.

  1. Identifying Treatment Effect Modifiers in the STarT Back Trial: A Secondary Analysis.

    Science.gov (United States)

    Beneciuk, Jason M; Hill, Jonathan C; Campbell, Paul; Afolabi, Ebenezer; George, Steven Z; Dunn, Kate M; Foster, Nadine E

    2017-01-01

    Identification of patient characteristics influencing treatment outcomes is a top low back pain (LBP) research priority. Results from the STarT Back trial support the effectiveness of prognostic stratified care for LBP compared with current best care, however, patient characteristics associated with treatment response have not yet been explored. The purpose of this secondary analysis was to identify treatment effect modifiers within the STarT Back trial at 4-month follow-up (n = 688). Treatment response was dichotomized using back-specific physical disability measured using the Roland-Morris Disability Questionnaire (≥7). Candidate modifiers were identified using previous literature and evaluated using logistic regression with statistical interaction terms to provide preliminary evidence of treatment effect modification. Socioeconomic status (SES) was identified as an effect modifier for disability outcomes (odds ratio [OR] = 1.71, P = .028). High SES patients receiving prognostic stratified care were 2.5 times less likely to have a poor outcome compared with low SES patients receiving best current care (OR = .40, P = .006). Education level (OR = 1.33, P = .109) and number of pain medications (OR = .64, P = .140) met our criteria for effect modification with weaker evidence (.20 > P ≥ .05). These findings provide preliminary evidence for SES, education, and number of pain medications as treatment effect modifiers of prognostic stratified care delivered in the STarT Back Trial. This analysis provides preliminary exploratory findings about the characteristics of patients who might least likely benefit from targeted treatment using prognostic stratified care for LBP. Copyright © 2016 American Pain Society. Published by Elsevier Inc. All rights reserved.

  2. 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

  3. Randomized multicenter trial on the effect of radiotherapy for plantar Fasciitis (painful heel spur) using very low doses – a study protocol

    International Nuclear Information System (INIS)

    Niewald, Marcus; Seegenschmiedt, M Heinrich; Micke, Oliver; Gräber, Stefan

    2008-01-01

    A lot of retrospective data concerning the effect of radiotherapy on the painful heel spur (plantar fasciitis) is available in the literature. Nevertheless, a randomized proof of this effect is still missing. Thus, the GCGBD (German cooperative group on radiotherapy for benign diseases) of the DEGRO (German Society for Radiation Oncology) decided to start a randomized multicenter trial in order to find out if the effect of a conventional total dose is superior compared to that of a very low dose. In a prospective, controlled and randomized phase III trial two radiotherapy schedules are to be compared: standard arm: total dose 6.0 Gy in single fractions of 1.0 Gy applied twice a week experimental arm: total dose 0.6 Gy in single fractions of 0.1 Gy applied twice a week (acting as a placebo) Patients aged over 40 years who have been diagnosed clinically and radiologically to be suffering from a painful heel spur for at least six months can be included. Former trauma, surgery or radiotherapy to the heel are not allowed nor are patients with a severe psychiatric disease or women during pregnancy and breastfeeding. According to the statistical power calculation 100 patients have to be enrolled into each arm. After having obtaining a written informed consent a patient is randomized by the statistician to one of the arms mentioned above. After radiotherapy, the patients are seen first every six weeks, then regularly up to 48 months after therapy, they additionally receive a questionnaire every six weeks after the follow-up examinations. The effect is measured using several target variables (scores): Calcaneodynia-score according to Rowe et al., SF-12 score, and visual analogue scale of pain. The most important endpoint is the pain relief three months after therapy. Patients with an inadequate result are offered a second radiotherapy series applying the standard dose (equally in both arms). This trial protocol has been approved by the expert panel of the DEGRO as well as

  4. Acute toxicity in pelvic radiotherapy; a randomised trial of conformal versus conventional treatment

    International Nuclear Information System (INIS)

    Tait, Diana M.; Nahum, Alan E.; Meyer, Lesley C.; Law, Matthew; Dearnaley, David P.; Horwich, Alan; Mayles, W. Philip; Yarnold, John R.

    1997-01-01

    Background: A prospective, randomized clinical trial to assess the effect of reducing the volume of irradiated normal tissue on acute reactions in pelvic radiotherapy accrued 266 evaluable patients between 1988 and 1993. Purpose: This is the definitive analysis to assess the differences between the conformal and conventional arms of the trial. Materials and methods: In both arms, patients were treated with 6 MV X-rays using a 3-field technique (in all but 5 cases) consisting of an anterior and two wedged lateral or posterior oblique fields; in the conventional arm, rectangular fields were employed, whereas in the conformal arm, the fields were shaped with customized blocks drawn according to the beam's-eye-view of the target volume. The most common dosage was 65 Gy in 2-Gy fractions 5 times a week, although a subgroup (of ca. bladder patients) were treated with 30-36 Gy in once-a-week 6 Gy fractions. Each patient completed a comprehensive acute toxicity scoring questionnaire concentrating on bowel and bladder problems, tiredness and nausea, before the start of treatment, weekly during and for 3 weeks after the end of treatment and then monthly for a further 2 months. Compliance was excellent. Results: There were no differences between the patients in the two arms with respect to age, gender, tumour type (52% prostate, 41% bladder, 5% rectum, 2% other) fractionation/dosage, anterior field size, weight, or baseline symptoms. Substantial differences in normal-tissue volumes (rectum, bladder, etc.) were achieved: median high-dose volume (HDV) of 689 cm 3 for the conformal technique versus 792 cm 3 for the conventional. A clear pattern of an increase in symptoms during RT, followed by a decrease after RT, was observed for the patient group as a whole. However, a very extensive analysis has not revealed any (statistically) significant differences between the two arms in level of symptoms, nor in medication prescribed. The disparity between our findings and those of other

  5. Protocol for the combined immunosuppression & radiotherapy in thyroid eye disease (CIRTED trial: A multi-centre, double-masked, factorial randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Kingston Laura

    2008-01-01

    Full Text Available Abstract Background Medical management of thyroid eye disease remains controversial due to a paucity of high quality evidence on long-term treatment outcomes. Glucocorticoids are known to be effective initially but have significant side-effects with long-term use and recrudescence can occur on cessation. Current evidence is conflicting on the efficacy of radiotherapy and non-steroid systemic immunosuppression, and the majority of previous studies have been retrospective, uncontrolled, small or poorly designed. The Combined Immunosuppression and Radiotherapy in Thyroid Eye Disease (CIRTED trial was designed to investigate the efficacy of radiotherapy and azathioprine in combination with a standard course of oral prednisolone in patients with active thyroid eye disease. Methods/design Patients with active thyroid eye disease will be randomised to receive (i azathioprine or oral placebo and (ii radiotherapy or sham-radiotherapy in this multi-centre, factorial randomised control trial. The primary outcome is improvement in disease severity (assessed using a composite binary measure at 12 months and secondary end-points include quality of life scores and health economic measures. Discussion The CIRTED trial is the first study to evaluate the role of radiotherapy and azathioprine as part of a long-term, combination immunosuppressive treatment regime for Thyroid Eye Disease. It will provide evidence for the role of radiotherapy and prolonged immunosuppression in the management of this condition, as well as pilot data on their use in combination. We have paid particular attention in the trial design to establishing (a robust placebo controls and masking protocols which are effective and safe for both radiotherapy and the systemic administration of an antiproliferative drug; (b constructing effective inclusion and exclusion criteria to select for active disease; and (c selecting pragmatic outcome measures. Trial registration Current controlled trials

  6. Randomized clinical trial of post-operative radiotherapy versus concomitant carboplatin and radiotherapy for head and neck cancers with lymph node involvement

    International Nuclear Information System (INIS)

    Racadot, Severine; Mercier, Mariette; Dussart, Sophie; Dessard-Diana, Bernadette; Bensadoun, Rene-Jean; Martin, Michel; Malaurie, Emmanuelle; Favrel, Veronique; Housset, Martin; Durdux, Catherine; Journel, Catherine; Calais, Gilles; Huet, Jocelyne; Pillet, Gerard; Hennequin, Christophe; Haddad, Elias; Diana, Christian; Blaska-Jaulerry, Brigitte; Henry-Amar, Michel; Gehanno, Pierre

    2008-01-01

    Background and purpose: Post-operative radiotherapy is indicated for the treatment of head and neck cancers. In vitro, chemotherapy potentiates the cytotoxic effects of radiation. We report the results of a randomized trial testing post-operative radiotherapy alone versus concomitant carboplatin and radiotherapy for head and neck cancers with lymph node involvement. Materials and methods: The study involved patients undergoing curative-intent surgery for head and neck cancers with histological evidence of lymph node involvement. Patients were randomly assigned to receive radiotherapy alone (54-72 Gy, 30-40 fractions, 6-8 weeks) or identical treatment plus concomitant Carboplatin (50 mg/m 2 administered by IV infusion twice weekly). Results: Between February 1994 and June 2002, 144 patients were included. With a median follow-up of 106 months (95% confidence interval (CI) [92-119]), the 2-year rate of loco-regional control was 73% (95% CI: 0.61-0.84) in the combined treatment group and 68% (95% CI: 0.57-0.80) in the radiotherapy group (p = 0.26). Overall survival did not differ significantly between groups (hazard ratio for death, 1.05; 95% CI: 0.69-1.60; p = 0.81). Conclusions: Twice-weekly administration of carboplatin concomitant to post-operative radiotherapy did not improve local control or overall survival rates in this population of patients with node-positive head and neck cancers

  7. PLANNING PHASE 2 MULTICENTER RANDOMIZED TRIAL OF NEOADJUVANT CHEMO-RADIOTHERAPY FOLLOWED BY D2 GASTRECTOMY AND ADJUVANT CHEMOTHERAPY FOR LOCALLY ADVANCED GASTRIC CANCER

    Directory of Open Access Journals (Sweden)

    V. Yu. Skoropad

    2016-01-01

    Full Text Available Introduction. The prognosis for surgical treatment of locally advanced gastric cancer remains disappointing. Neoadjuvant chemo-radiation therapy is relatively new and the least researched method of treatment, it is attracting more and more attention, mainly abroad in recent years. The aims of neoadjuvant therapy is the earliest start of systemic therapy, damage of the primary tumor and regional metastases, an increase in the percentage of radical operations, improving treatment outcome. Material and methods. The planning study is a multicenter, randomized clinical phase II trial. Patients of the first (experimental group will be treated as the followes: neoadjuvant chemo-radiotherapy (total tumor dose of 46 Gy in 23 fractions with the concurrent modified CapOX scheme followed by D2 gastrectomy and adjuvant chemotherapy. Patients of the second (control group will be treated with D2 gastrectomy and adjuvant chemotherapy. Adjuvant chemotherapy will be carried out under the following schemes (optional for the researchers: CapOX or FOLFOX. Toxicity evaluation of neoadjuvant chemo-radiotherapy and adjuvant chemotherapy will be conducted with NCI CTC Toxicity Scale Version 3.0. The main objectives of the trial are to assess the safety and immediate effectiveness of neoadjuvant chemo-radiotherapy according to the criteria of the frequency and severity of postoperative complications and mortality, and tumor response. We are planning to include 80 patients with morphologically confirmed gastric cancer сT2–4N1–3, сT3–4N0–3; М0. The proposed trial will be carried out in accordance with the principles of the Helsinki Declaration, it has been approved by local ethic committees of the participated institutions. Results. As a result of this multicenter randomized trial it is planned to show the reproducibility of obtained in MRRC and a number of foreign centers results – that is, the safety and high immediate effectiveness of neoadjuvant chemo-radiotherapy

  8. Skin treatment with bepanthen cream versus no cream during radiotherapy. A randomized controlled trial

    International Nuclear Information System (INIS)

    Loekkevik, E.; Skovlund, E.; Oslo Univ.; Reitan, J.B.; Norwegian Radiation Protection Authority, Oslo; Hannisdal, E.; Tanum, G.

    1996-01-01

    In several radiotherapy departments, dexpanthenol cream (Bepanthen 'Roche') has been used extensively to ameliorate acute radiotherapy skin reactions. The evidence base for this practice is obscure as no randomized trials have been performed. In the present clinical prospective study of 86 patients we have compared Bepanthen cream with no topical ointment at all. The cream was applied on randomly selected parts of treatment fields in laryngeal and breast cancer patients, and so each patient acted as his own control. Seven patients were widthdrawn from analysis. Scoring of skin reactions in 16 laryngeal and 63 breast cancer patients was performed without knowledge of which are that had been given cream or not. Endpoints were a modified skin reaction grading according to EORTC/RTOG, and itching/apin in treated fields. The study did not indicate any clinically important benefits of using Bepanthen cream for ameliorating radiogenic skin reactions under the conditions applied. (orig.)

  9. Evaluation of the 'healthy start to pregnancy' early antenatal health promotion workshop: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Wilkinson Shelley A

    2012-11-01

    Full Text Available Abstract Background Pregnancy is an ideal time to encourage healthy lifestyles as most women access health services and are more receptive to health messages; however few effective interventions exist. The aim of this research was to deliver a low-intensity, dietitian-led behavior change workshop at a Maternity Hospital to influence behaviors with demonstrated health outcomes. Methods Workshop effectiveness was evaluated using an RCT; ‘usual care’ women (n = 182 received a nutrition resource at their first antenatal visit and 'intervention' women also attended a one-hour ‘Healthy Start to Pregnancy’ workshop (n = 178. Dietary intake, physical activity levels, gestational weight gain knowledge, smoking cessation, and intention to breastfeed were assessed at service-entry and 12 weeks later. Intention-to-treat (ITT and per-protocol (PP analyses examined change over time between groups. Results Approximately half (48.3% the intervention women attended the workshop and overall response rate at time 2 was 67.2%. Significantly more women in the intervention met pregnancy fruit guidelines at time 2 (+4.3%, p = 0.011 and had a clinically-relevant increase in physical activity (+27 minutes/week compared with women who only received the resource (ITT. Women who attended the workshop increased their consumption of serves of fruit (+0.4 serves/day, p = 0.004, vegetables (+0.4 serves/day, p = 0.006, met fruit guidelines (+11.9%, p , had a higher diet quality score (p = 0.027 and clinically-relevant increases in physical activity (+21.3 minutes/week compared with those who only received the resource (PP. Conclusions The Healthy Start to Pregnancy workshop attendance facilitates improvements in important health behaviors. Service changes and accessibility issues are required to assist women's workshop attendance to allow more women to benefit from the workshop’s effects. Trial registration Australian New Zealand Clinical Trials Registry ACTRN

  10. A randomised trial of preoperative radiotherapy for stage T3 adenocarcinoma of rectum (TROG 01.04): a progress report

    International Nuclear Information System (INIS)

    Ngan, S.; Fisher, R.; McKay, M.J.; McClure, B.; Burmeister, B.H.; Schache, D.; Joseph, D.; Solomon, M.; Ackland, S.P.; Goldstein, D.; McLachlan, S.; Dhillon, H.; Thompson, P.

    2003-01-01

    To provide a progress report of the conduct of the randomised trial TROG 01.04. This is a randomised Australian and New Zealand multi-centre trial of preoperative radiotherapy for rectal cancer currently being conducted under the auspices of Trans-Tasman Radiation Oncology Group, Australasian Gastrointestinal Trials Group, Colorectal Surgical Society of Australasia, and Royal Australasian College of Surgeons. The trial comprises two studies, each with its own main objective. These objectives are, in patients with T3 clinically resectable carcinoma of the rectum, to demonstrate that (Study 1) the local recurrence rate in patients treated with a long course (LC) of pre-operative radiotherapy with continuous infusion 5-FU is lower than that in patients treated with a short course (SC) of pre-operative radiotherapy with early surgery; and (Study 2) the local recurrence rate in patients given pre-operative radiotherapy and chemotherapy is lower than that in patients treated with initial surgery. Over 150 patients have been accrued from 21 centres in the first 21 months. All patients were enrolled on Study 1, SC versus LC pre-operative radiotherapy. Study 2 has enrolled no patients in 15 months and has been discontinued. There was no obvious difference in rates of serious adverse events of SC and LC. An Independent Data Monitoring Committee is monitoring these and other aspects of the trial. The trial of SC versus LC is progressing well: such a trial is clearly feasible in Australia and New Zealand. It is however not feasible to compare initial surgery with preoperative radiotherapy

  11. Comparison of Self-report to Biomarkers of Recent HIV Infection: Findings from the START Trial.

    Science.gov (United States)

    Schlusser, Katherine E; Sharma, Shweta; de la Torre, Pola; Tambussi, Giuseppe; Draenert, Rika; Pinto, Angie N; Metcalf, Julia A; German, Danielle; Neaton, James D; Laeyendecker, Oliver

    2018-02-09

    Identifying individuals with recent HIV infection is critical to research related to viral reservoirs, outbreak investigations and intervention applications. A multi-assay algorithm (MAA) for recency of infection was used in conjunction with self-reported date of infection and documented date of diagnosis to estimate the number of participants recently infected in the Strategic Timing of AntiRetroviral Treatment (START) trial. We tested samples for three groups of participants from START using a MAA: (1) 167 individuals who reported being infected ≤ 6 months before randomization; (2) 771 individuals who did not know their date of infection but were diagnosed within 6 months before randomization; and (3) as controls for the MAA, 199 individuals diagnosed with HIV ≥ 2 years before randomization. Participants with low titer and avidity and a baseline viral load > 400 copies/mL were classified as recently infected. A significantly higher percentage of participants who self-reported being infected ≤ 6 months were classified as recently infected compared to participants diagnosed ≥ 2 years (65% [109/167] vs. 2.5% [5/199], p START were infected within 6 months of randomization. Compared to those not recently infected, these participants were younger, had higher HIV RNA levels and were more likely to come from high income countries and from populations such as MSM with more regular HIV testing.

  12. Nausea and vomiting in fractionated radiotherapy: a prospective on-demand trial of tropisetron rescue for non-responders to metoclopramide

    International Nuclear Information System (INIS)

    Miralbell, R.; Behrouz, F.; Coucke, P.

    1995-01-01

    A prospective trial was performed to better assess the risk of nausea and vomiting and the rescue value of tropisetron (TRO), a 5-HT 3 receptor antagonist, in 88 patients undergoing fractionated radiotherapy to the abdomen or to large supradiaphragmatic fields and failing a first anti-emetic trial with metoclopramide (MET). Nausea was graded 0 (absent), 1 (mild), 2 (moderate) and 3 (severe). Nausea requiring anti-emetics (≥ grade 2) was present in 64% of the patients. MET was able to control nausea (≤ grade 1) in 26 of 58 patients (45%) who developed ≥ grade 2 nausea during radiation treatment (2 patients vomiting without nausea included). 34 patients required TRO, and 31 experienced immediate relief. However, nausea (≥ grade 2) recurred in 7 patients from 1 to 3 weeks after starting TRO. Sex, age, field type and field size (cm 2 ) did not influence the incidence and severity of nausea and vomiting. Only 24/88 patients vomited after starting radiotherapy. MET helped to eliminate emesis in one third of these patients. TRO helped to control vomiting in 73% of the salvaged patients. Constipation was observed in 8 patients on TRO and was a reason to stop the medication in 4 cases. (author)

  13. Phase II Trial of Radiotherapy After Hyperbaric Oxygenation With Multiagent Chemotherapy (Procarbazine, Nimustine, and Vincristine) for High-Grade Gliomas: Long-Term Results

    Energy Technology Data Exchange (ETDEWEB)

    Ogawa, Kazuhiko, E-mail: kogawa@med.u-ryukyu.ac.jp [Department of Radiology, University of the Ryukyus, Okinawa (Japan); Ishiuchi, Shogo [Department of Neurosurgery, University of the Ryukyus, Okinawa (Japan); Inoue, Osamu [Department of Hyperbaric Medicine, University of the Ryukyus, Okinawa (Japan); Yoshii, Yoshihiko [Department of Neurosurgery, University of the Ryukyus, Okinawa (Japan); Department of Neurosurgery, Tsukuba Memorial Hospital, Tsukuba (Japan); Saito, Atsushi [Department of Neurosurgery, University of the Ryukyus, Okinawa (Japan); Department of Neurosurgery, Tsukuba Medical Center Hospital, Tsukuba (Japan); Watanabe, Takashi [Department of Neurosurgery, University of the Ryukyus, Okinawa (Japan); Iraha, Shiro [Department of Radiology, Okinawa South Medical Center, Okinawa (Japan); Department of Radiology, University of the Ryukyus, Okinawa (Japan); Toita, Takafumi; Kakinohana, Yasumasa; Ariga, Takuro; Kasuya, Goro; Murayama, Sadayuki [Department of Radiology, University of the Ryukyus, Okinawa (Japan)

    2012-02-01

    Purpose: To analyze the long-term results of a Phase II trial of radiotherapy given immediately after hyperbaric oxygenation (HBO) with multiagent chemotherapy in adults with high-grade gliomas. Methods and Materials: Patients with histologically confirmed high-grade gliomas were administered radiotherapy in daily 2 Gy fractions for 5 consecutive days per week up to a total dose of 60 Gy. Each fraction was administered immediately after HBO, with the time interval from completion of decompression to start of irradiation being less than 15 minutes. Chemotherapy consisting of procarbazine, nimustine, and vincristine and was administered during and after radiotherapy. Results: A total of 57 patients (39 patients with glioblastoma and 18 patients with Grade 3 gliomas) were enrolled from 2000 to 2006, and the median follow-up of 12 surviving patients was 62.0 months (range, 43.2-119.1 months). All 57 patients were able to complete a total radiotherapy dose of 60 Gy immediately after HBO with one course of concurrent chemotherapy. The median overall survival times in all 57 patients, 39 patients with glioblastoma and 18 patients with Grade 3 gliomas, were 20.2 months, 17.2 months, and 113.4 months, respectively. On multivariate analysis, histologic grade alone was a significant prognostic factor for overall survival (p < 0.001). During treatments, no patients had neutropenic fever or intracranial hemorrhage, and no serious nonhematologic or late toxicities were seen in any of the 57 patients. Conclusions: Radiotherapy delivered immediately after HBO with multiagent chemotherapy was safe, with virtually no late toxicities, and seemed to be effective in patients with high-grade gliomas.

  14. The Erlangen Dose Optimization Trial for radiotherapy of benign painful shoulder syndrome. Long-term results

    International Nuclear Information System (INIS)

    Ott, O.J.; Hertel, S.; Gaipl, U.S.; Frey, B.; Schmidt, M.; Fietkau, R.

    2014-01-01

    To evaluate the long-term efficacy of pain reduction by two dose-fractionation schedules for radiotherapy of painful shoulder syndrome. Between February 2006 and February 2010, 312 evaluable patients were recruited for this prospective trial. All patients received low-dose orthovoltage radiotherapy. One course consisted of 6 fractions in 3 weeks. In the case of insufficient pain remission after 6 weeks, a second course was administered. Patients were randomly assigned to one of two groups to receive single doses of either 0.5 or 1.0 Gy. Endpoint was pain reduction. Pain was measured before radiotherapy, as well as immediately after (early response), 6 weeks after (delayed response) and approximately 3 years after (long-term response) completion of radiotherapy using a questionnaire-based visual analogue scale (VAS) and a comprehensive pain score (CPS). Median follow-up was 35 months (range 11-57). The overall early, delayed and long-term response rates for all patients were 83, 85 and 82%, respectively. The mean VAS scores before treatment and those for early, delayed and long-term response in the 0.5- and 1.0-Gy groups were 56.8±23.7 and 53.2±21.8 (p=0.16); 38.2±36.1 and 34.0±24.5 (p=0.19); 33.0±27.2 and 23.7±22.7 (p=0.04) and 27.9±25.8 and 32.1±26.9 (p=0.25), respectively. The mean CPS values before treatment and those for early, delayed and long-term response were 9.7±3.0 and 9.5±2.7 (p=0.31); 6.1±3.6 and 5.4±3.6 (p=0.10); 5.3±3.7 and 4.1±3.7 (p=0.05) and 4.0±3.9 and 5.3±4.4 (p=0.05), respectively. No significant differences in the quality of the long-term response were found between the 0.5- and 1.0-Gy arms (p=0.28). Radiotherapy is an effective treatment for the management of benign painful shoulder syndrome. For radiation protection reasons, the dose for a radiotherapy series should not exceed 3.0 Gy. (orig.)

  15. Sexual Function After Stereotactic Body Radiotherapy for Prostate Cancer: Results of a Prospective Clinical Trial

    International Nuclear Information System (INIS)

    Wiegner, Ellen A.; King, Christopher R.

    2010-01-01

    Purpose: To study the sexual quality of life for prostate cancer patients after stereotactic body radiotherapy (SBRT). Methods and Materials: Using the Expanded Prostate Cancer Index Composite (EPIC)-validated quality-of-life questionnaire, the sexual function of 32 consecutive patients who received prostate SBRT in a prospective Phase II clinical trial were analyzed at baseline, and at median times of 4, 12, 20, and 50 months after treatment. SBRT consisted of 36.25 Gy in five fractions of 7.25 Gy using the Cyberknife. No androgen deprivation therapy was given. The use of erectile dysfunction (ED) medications was monitored. A comprehensive literature review for radiotherapy-alone modalities based on patient self-reported questionnaires served as historical comparison. Results: Median age at treatment was 67.5 years, and median follow-up was 35.5 months (minimum 12 months). The mean EPIC sexual domain summary score, sexual function score, and sexual bother score decreased by 45%, 49%, and 25% respectively at 50 months follow-up. These differences reached clinical relevance by 20 months after treatment. Baseline ED rate was 38% and increased to 71% after treatment (p = 0.024). Use of ED medications was 3% at baseline and progressed to 25%. For patients aged <70 years at follow-up, 60% maintained satisfactory erectile function after treatment compared with only 12% aged ≥70 years (p = 0.008). Penile bulb dose was not associated with ED. Conclusions: The rates of ED after treatment appear comparable to those reported for other modalities of radiotherapy. Given the modest size of this study and the uncertainties in the physiology of radiotherapy-related ED, these results merit further investigations.

  16. 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

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

    International Nuclear Information System (INIS)

    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.

    2008-01-01

    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

  18. Evaluation of time, attendance of medical staff, and resources during stereotactic radiotherapy/radiosurgery. QUIRO-DEGRO trial

    Energy Technology Data Exchange (ETDEWEB)

    Zabel-du Bois, A.; Milker-Zabel, S.; Debus, J. [Heidelberg Univ. (Germany). Dept. of Radiotherapy and Radiooncology; Henzel, M.; Engenhart-Cabillic, R. [Marburg Univ. (Germany). Dept. of Radiotherapy and Radiation Oncology; Popp, W. [Prime Networks AG, Basel (Switzerland); Sack, H. [Essen Univ. (Germany). Dept. of Radiation Oncology

    2012-09-15

    Background: The German Society of Radiation Oncology ('Deutsche Gesellschaft fuer Radioonkologie', DEGRO) initiated a multicenter trial to develop and evaluate adequate modules to assert core processes and subprocesses in radiotherapy. The aim of this prospective evaluation was to methodical assess the required resources (technical equipment and medical staff) for stereotactic radiotherapy/radiosurgery. Material and methods: At two radiotherapy centers of excellence (University Hospitals of Heidelberg and Marburg/Giessen), the manpower and time required for the implementation of intra- and extracranial stereotactic radiotherapy was prospectively collected consistently over a 3-month period. The data were collected using specifically developed process acquisition tools and standard forms and were evaluated using specific process analysis tools. Results: For intracranial (extracranial) fractionated stereotactic radiotherapy (FSRT) and radiosurgery (RS), a total of 1,925 (270) and 199 (36) records, respectively, could be evaluated. The approximate time needed to customize the immobilization device was median 37 min (89 min) for FRST and 31 min (26 min) for RS, for the contrast enhanced planning studies 22 and 27 min (25 and 28 min), for physical treatment planning 122 and 59 min (187 and 27 min), for the first and routine radiotherapy sessions for FSRT 40 and 13 min (58 and 31 min), respectively. The median time needed for the RS session was 58 min (45 min). The corresponding minimal manpower needed was 2 technicians for customization of the immobilization device, 2.5 technicians and 1 consultant for the contrast-enhanced planning studies, 1 consultant, 0.5 resident and 0.67 medical physics expert (MPE) for physical treatment planning, as well as 1 consultant, 0.5 resident, and 2.5 technicians for the first radiotherapy treatment and 2.33 technicians for routine radiotherapy sessions. Conclusion: For the first time, the resource requirements for a

  19. Clinical trials radiotherapy treatment plan review software : is this the first quantified assessment

    International Nuclear Information System (INIS)

    Hatton, J.A.; Cornes, D.A.

    2011-01-01

    Full text: Clinical trials require robust quality assurance (QA) procedures to ensure commonality of all treatments, with independent reviews to assess compliance with trial protocols. All clinical trials tools, including QA software, require testing for validity and reliability. enabling inter- and intra-trial comparison. Unlike clinical radiotherapy treatment planning (RTP) systems, review software has no published guidelines. This study describes the design and development of a test suite to quantify the performance of review software in TROG clinical trials. Test areas are image handling and reconstruction; geometric accuracy; dosimetric accuracy; dose-volume histogram (DVH) calculation; display of plan parameters. TROG have developed tests for commissioning plan review software, assessed with SWAN 2.3, and CMS Elekta FocalPro. While image handling tests were based on published guidelines for RTP systems, dosimetric tests used the TROG QA case review requirements. Treatment plans represented systems of all manufacturers (Pinnacle, Eclipse, Xio and Oncentra) used in Australasian centres. The test suite identified areas for SW A software development, including the DVH algorithm, changed to reduce calculation time. Results, in Fig. I, for known volumes of varying shapes and sizes, demonstrate differences between SWAN 2.1 and 2.3 when compared with Eclipse. Liaison with SWAN programmers enabled re-instatement of 2.1 algorithm. The test suite has quantified the RTP review software, prioritised areas for development with the programmers, and improved the user experience.

  20. Quality control of involved field radiotherapy in the HD 13 and HD 14 trials. Report of the radiotherapy panel of the German Hodgkin Study Group (GHSG)

    Energy Technology Data Exchange (ETDEWEB)

    Kriz, J.; Haverkamp, U.; Eich, H.T. [University of Muenster, Department of Radiation Oncology, Muenster (Germany); Baues, C. [University of Cologne, Department of Radiation Oncology, Cologne (Germany); Engenhart-Cabillic, R. [University of Marburg, Department of Radiation Oncology, Marburg (Germany); Herfarth, K. [University of Heidelberg, Department of Radiation Oncology, Heidelberg (Germany); Lukas, P. [University of Innsbruck, Department of Radiation Oncology, Innsbruck (Austria); Pluetschow, A.; Fuchs, M.; Engert, A. [University of Cologne, Department of Internal Medicine, Cologne (Germany); Schmidberger, H. [University of Mainz, Department of Radiation Oncology, Mainz (Germany); Staar, S. [Bremen Mitte, Department of Radiation Oncology, Bremen (Germany)

    2017-02-15

    As part of the foundation of the German Hodgkin Study Group (GHSG) in 1978, a central radiotherapy (RT) reference centre was established to evaluate and to improve the quality of treatment. During the study generations, the quality assurance programs (QAP) were continued and adapted to the demands of each study. The purpose of this article is to demonstrate the results of the fifth study generation and to compare them to the previous findings. With the start of the fourth GHSG study generation (HD10-12), a central prospective review of all diagnostic images was established to create an individual treatment plan for each early stage study patient. The quality of involved field RT was retrospectively evaluated by an expert panel of radiation oncologists. In the fifth study generation (HD13-15), the retrospective review of radiotherapy performed was refined and the results were compared with the findings of the fourth generation. The expert panel analyzed the RT planning and application of 1037 (28 %) patients (HD13 n = 465, HD14 n = 572). Simulation films were available in 85 % of cases and verification films in 87 %. RT was assessed as major violation in 46 % (HD13 = 38 %, HD14 = 52 %), minor violation in 9 % (HD13 = 9 %, HD14 = 9 %) and according to the protocol in 45 % (HD13 = 52 %, HD14 = 38 %). The value for QAP of RT within the GHSG trials is well known. Still there were several protocol violations. In the future, the QAP program has to be adapted to the requirements of ''modern RT'' in malignant lymphoma. (orig.) [German] Seit Gruendung der German Hodgkin Study Group (GHSG) im Jahr 1978 wurde ein zentrales Qualitaetssicherungsprogramm (QAP) der Radiotherapie (RT) etabliert, um die Qualitaet der RT sicherzustellen. Waehrend der fortlaufenden Studiengenerationen wurde dieses QAP kontinuierlich weiterentwickelt. In dieser Auswertung werden die Ergebnisse der fuenften Studiengeneration (HD13-15) praesentiert und mit frueheren Ergebnissen

  1. Circle of Security–Parenting: A randomized controlled trial in Head Start

    Science.gov (United States)

    CASSIDY, JUDE; BRETT, BONNIE E.; GROSS, JACQUELYN T.; STERN, JESSICA A.; MARTIN, DAVID R.; MOHR, JONATHAN J.; WOODHOUSE, SUSAN S.

    2017-01-01

    Although evidence shows that attachment insecurity and disorganization increase risk for the development of psychopathology (Fearon, Bakermans-Kranenburg, van IJzendoorn, Lapsley, & Roisman, 2010; Groh, Roisman, van IJzendoorn, Bakermans-Kranenburg, & Fearon, 2012), implementation challenges have precluded dissemination of attachment interventions on the broad scale at which they are needed. The Circle of Security–Parenting Intervention (COS-P; Cooper, Hoffman, & Powell, 2009), designed with broad implementation in mind, addresses this gap by training community service providers to use a manualized, video-based program to help caregivers provide a secure base and a safe haven for their children. The present study is a randomized controlled trial of COS-P in a low-income sample of Head Start enrolled children and their mothers. Mothers (N = 141; 75 intervention, 66 waitlist control) completed a baseline assessment and returned with their children after the 10-week intervention for the outcome assessment, which included the Strange Situation. Intent to treat analyses revealed a main effect for maternal response to child distress, with mothers assigned to COS-P reporting fewer unsupportive (but not more supportive) responses to distress than control group mothers, and a main effect for one dimension of child executive functioning (inhibitory control but not cognitive flexibility when maternal age and marital status were controlled), with intervention group children showing greater control. There were, however, no main effects of intervention for child attachment or behavior problems. Exploratory follow-up analyses suggested intervention effects were moderated by maternal attachment style or depressive symptoms, with moderated intervention effects emerging for child attachment security and disorganization, but not avoidance; for inhibitory control but not cognitive flexibility; and for child internalizing but not externalizing behavior problems. This initial

  2. Randomized, controlled trial of an intervention for toddlers with autism: the Early Start Denver Model.

    Science.gov (United States)

    Dawson, Geraldine; Rogers, Sally; Munson, Jeffrey; Smith, Milani; Winter, Jamie; Greenson, Jessica; Donaldson, Amy; Varley, Jennifer

    2010-01-01

    To conduct a randomized, controlled trial to evaluate the efficacy of the Early Start Denver Model (ESDM), a comprehensive developmental behavioral intervention, for improving outcomes of toddlers diagnosed with autism spectrum disorder (ASD). Forty-eight children diagnosed with ASD between 18 and 30 months of age were randomly assigned to 1 of 2 groups: (1) ESDM intervention, which is based on developmental and applied behavioral analytic principles and delivered by trained therapists and parents for 2 years; or (2) referral to community providers for intervention commonly available in the community. Compared with children who received community-intervention, children who received ESDM showed significant improvements in IQ, adaptive behavior, and autism diagnosis. Two years after entering intervention, the ESDM group on average improved 17.6 standard score points (1 SD: 15 points) compared with 7.0 points in the comparison group relative to baseline scores. The ESDM group maintained its rate of growth in adaptive behavior compared with a normative sample of typically developing children. In contrast, over the 2-year span, the comparison group showed greater delays in adaptive behavior. Children who received ESDM also were more likely to experience a change in diagnosis from autism to pervasive developmental disorder, not otherwise specified, than the comparison group. This is the first randomized, controlled trial to demonstrate the efficacy of a comprehensive developmental behavioral intervention for toddlers with ASD for improving cognitive and adaptive behavior and reducing severity of ASD diagnosis. Results of this study underscore the importance of early detection of and intervention in autism.

  3. Circle of Security-Parenting: A randomized controlled trial in Head Start.

    Science.gov (United States)

    Cassidy, Jude; Brett, Bonnie E; Gross, Jacquelyn T; Stern, Jessica A; Martin, David R; Mohr, Jonathan J; Woodhouse, Susan S

    2017-05-01

    Although evidence shows that attachment insecurity and disorganization increase risk for the development of psychopathology (Fearon, Bakermans-Kranenburg, van IJzendoorn, Lapsley, & Roisman, 2010; Groh, Roisman, van IJzendoorn, Bakermans-Kranenburg, & Fearon, 2012), implementation challenges have precluded dissemination of attachment interventions on the broad scale at which they are needed. The Circle of Security-Parenting Intervention (COS-P; Cooper, Hoffman, & Powell, 2009), designed with broad implementation in mind, addresses this gap by training community service providers to use a manualized, video-based program to help caregivers provide a secure base and a safe haven for their children. The present study is a randomized controlled trial of COS-P in a low-income sample of Head Start enrolled children and their mothers. Mothers (N = 141; 75 intervention, 66 waitlist control) completed a baseline assessment and returned with their children after the 10-week intervention for the outcome assessment, which included the Strange Situation. Intent to treat analyses revealed a main effect for maternal response to child distress, with mothers assigned to COS-P reporting fewer unsupportive (but not more supportive) responses to distress than control group mothers, and a main effect for one dimension of child executive functioning (inhibitory control but not cognitive flexibility when maternal age and marital status were controlled), with intervention group children showing greater control. There were, however, no main effects of intervention for child attachment or behavior problems. Exploratory follow-up analyses suggested intervention effects were moderated by maternal attachment style or depressive symptoms, with moderated intervention effects emerging for child attachment security and disorganization, but not avoidance; for inhibitory control but not cognitive flexibility; and for child internalizing but not externalizing behavior problems. This initial randomized

  4. Random-start GnRH antagonist for emergency fertility preservation: a self-controlled trial

    Directory of Open Access Journals (Sweden)

    Checa MA

    2015-02-01

    Full Text Available Miguel A Checa,1,2 Mario Brassesco,2 Margalida Sastre,1 Manuel Gómez,2 Julio Herrero,3 Laura Marque,3 Arturo Brassesco,2 Juan José Espinós3 1Department of Obstetrics and Gynecology, Parc de Salut Mar, Universitat Autònoma de Barcelona, 2Centro de Infertilidad y Reproducción Humana (CIRH, 3Centro de Reproducción Asistida Sagrada Familia, Clínica Sagrada Familia, Barcelona, Spain Abstract: The aim of this study is to evaluate the feasibility and safety of random-start controlled ovarian hyperstimulation (COH for emergency fertility preservation, regardless of the phase of the menstrual cycle. A self-controlled pilot clinical trial (NCT01385332 was performed in an acute-care teaching hospital and in two private reproductive centers in Barcelona, Spain. Eleven egg donors participated in the study. Two random-start gonadotropin-releasing hormone (GnRH antagonist protocols were assessed in which ganirelix was initiated on either day 10 (protocol B or on day 20 (protocol C of the menstrual cycle and was continued until estradiol levels were below 60 pg/dL. These protocols were compared with a standard protocol (protocol A. The main outcome of interest was the number of metaphase 2 oocytes retrieved. Results from this study show that the number of mature oocytes retrieved was comparable across the different protocols (14.3±4.6 in the standard protocol versus 13.0±9.1 and 13.2±5.2 in protocols B and C, respectively; values expressed as mean ± standard deviation. The mean number of days needed for a GnRH antagonist to lower estradiol levels, as well as the ongoing pregnancy rates, were also similar when protocols B (stimulation in follicular phase and C (stimulation on luteal phase were compared with protocol A (standard stimulation. GnRH antagonists can be effectively used for random-start controlled ovarian hyperstimulation with an ovarian response similar to that of standard protocols, and the antagonists appear suitable for emergency

  5. A randomised multicentre trial of CHART versus conventional radiotherapy in head and neck cancer

    International Nuclear Information System (INIS)

    Dische, Stanley; Saunders, Michele; Barrett, Ann; Harvey, Angela; Gibson, Della; Parmar, Mahesh

    1997-01-01

    Background and purpose: Continuous, hyperfractionated, accelerated radiotherapy (CHART) has shown promise of improved tumour control and reduced late morbidity in pilot studies and has now been tested in a multicentre randomised controlled clinical trial. Material and methods: Patients with squamous cell cancer in the main sites within the head and neck region with the general exception of early T1 N0 tumours were entered into the study by 11 centres. There was a 3:2 randomisation to either CHART, where a dose of 54 Gy was given in 36 fractions over 12 days, or to conventional therapy where 66 Gy was given in 33 fractions over 6.5 weeks. A total of 918 patients were included over a 5 year period from March 1990. Results: Acute Morbidity: Acute radiation mucositis was more severe with CHART, occurred earlier but settled sooner and was in nearly all cases healed by 8 weeks in both arms. Skin reactions were less severe and settled more quickly in the CHART treated patients. Tumour control and survival: Life table analyses of loco-regional control, primary tumour control, nodal control, disease-free interval, freedom from metastasis and survival showed no evidence of differences between the two arms. In exploratory subgroup analyses there was evidence of a greater response to CHART in younger patients (P = 0.041) and poorly differentiated tumours appeared to fare better with conventional radiotherapy (P = 0.030). In the larynx there was evidence of a trend towards increasing benefit with more advanced T stage (P = 0.002). Late treatment related morbidity: Osteoradionecrosis occurred in 0.4% of patients after CHART and 1.4% of patients after conventional radiotherapy. The incidence of chondritis or cartilage necrosis was similar in both arms. Life table analysis showed evidence of reduced severity in a number of late morbidities in favour of CHART. These were most striking for skin telangiectasia, superficial and deep ulceration of the mucosa and laryngeal oedema

  6. Update of the International Consensus on Palliative Radiotherapy Endpoints for Future Clinical Trials in Bone Metastases

    Energy Technology Data Exchange (ETDEWEB)

    Chow, Edward, E-mail: Edward.Chow@sunnybrook.ca [Department of Radiation Oncology, Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON (Canada); Hoskin, Peter [Mount Vernon Centre for Cancer Treatment, Mount Vernon Hospital, Northwood, Middlesex (United Kingdom); Mitera, Gunita; Zeng Liang [Department of Radiation Oncology, Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON (Canada); Lutz, Stephen [Department of Radiation Oncology, Blanchard Valley Regional Cancer Center, Findlay, OH (United States); Roos, Daniel [Department of Radiation Oncology, Royal Adelaide Hospital, Adelaide, South Australia (Australia); Hahn, Carol [Department of Radiation Oncology, Duke University Medical Center, Durham, NC (United States); Linden, Yvette van der [Radiotherapeutic Institute Friesland, Leeuwarden (Netherlands); Hartsell, William [Department of Radiation Oncology, Advocate Good Samaritan Cancer Center, Downers Grove, IL (United States); Kumar, Eshwar [Department of Oncology, Atlantic Health Sciences Cancer Centre, Saint John Regional Hospital, Saint John, NB (Canada)

    2012-04-01

    Purpose: To update the international consensus on palliative radiotherapy endpoints for future clinical trials in bone metastases by surveying international experts regarding previous uncertainties within the 2002 consensus, changes that may be necessary based on practice pattern changes and research findings since that time. Methods and Materials: A two-phase survey was used to determine revisions and new additions to the 2002 consensus. A total of 49 experts from the American Society for Radiation Oncology, the European Society for Therapeutic Radiology and Oncology, the Faculty of Radiation Oncology of the Royal Australian and New Zealand College of Radiologists, and the Canadian Association of Radiation Oncology who are directly involved in the care of patients with bone metastases participated in this survey. Results: Consensus was established in areas involving response definitions, eligibility criteria for future trials, reirradiation, changes in systemic therapy, radiation techniques, parameters at follow-up, and timing of assessments. Conclusion: An outline for trials in bone metastases was updated based on survey and consensus. Investigators leading trials in bone metastases are encouraged to adopt the revised guideline to promote consistent reporting. Areas for future research were identified. It is intended for the consensus to be re-examined in the future on a regular basis.

  7. Update of the International Consensus on Palliative Radiotherapy Endpoints for Future Clinical Trials in Bone Metastases

    International Nuclear Information System (INIS)

    Chow, Edward; Hoskin, Peter; Mitera, Gunita; Zeng Liang; Lutz, Stephen; Roos, Daniel; Hahn, Carol; Linden, Yvette van der; Hartsell, William; Kumar, Eshwar

    2012-01-01

    Purpose: To update the international consensus on palliative radiotherapy endpoints for future clinical trials in bone metastases by surveying international experts regarding previous uncertainties within the 2002 consensus, changes that may be necessary based on practice pattern changes and research findings since that time. Methods and Materials: A two-phase survey was used to determine revisions and new additions to the 2002 consensus. A total of 49 experts from the American Society for Radiation Oncology, the European Society for Therapeutic Radiology and Oncology, the Faculty of Radiation Oncology of the Royal Australian and New Zealand College of Radiologists, and the Canadian Association of Radiation Oncology who are directly involved in the care of patients with bone metastases participated in this survey. Results: Consensus was established in areas involving response definitions, eligibility criteria for future trials, reirradiation, changes in systemic therapy, radiation techniques, parameters at follow-up, and timing of assessments. Conclusion: An outline for trials in bone metastases was updated based on survey and consensus. Investigators leading trials in bone metastases are encouraged to adopt the revised guideline to promote consistent reporting. Areas for future research were identified. It is intended for the consensus to be re-examined in the future on a regular basis.

  8. Adjuvant external beam radiotherapy in the treatment of endometrial cancer (MRC ASTEC and NCIC CTG EN.5 randomised trials): pooled trial results, systematic review, and meta-analysis.

    Science.gov (United States)

    Blake, P; Swart, Ann Marie; Orton, J; Kitchener, H; Whelan, T; Lukka, H; Eisenhauer, E; Bacon, M; Tu, D; Parmar, M K B; Amos, C; Murray, C; Qian, W

    2009-01-10

    Early endometrial cancer with low-risk pathological features can be successfully treated by surgery alone. External beam radiotherapy added to surgery has been investigated in several small trials, which have mainly included women at intermediate risk of recurrence. In these trials, postoperative radiotherapy has been shown to reduce the risk of isolated local recurrence but there is no evidence that it improves recurrence-free or overall survival. We report the findings from the ASTEC and EN.5 trials, which investigated adjuvant external beam radiotherapy in women with early-stage disease and pathological features suggestive of intermediate or high risk of recurrence and death from endometrial cancer. Between July, 1996, and March, 2005, 905 (789 ASTEC, 116 EN.5) women with intermediate-risk or high-risk early-stage disease from 112 centres in seven countries (UK, Canada, Poland, Norway, New Zealand, Australia, USA) were randomly assigned after surgery to observation (453) or to external beam radiotherapy (452). A target dose of 40-46 Gy in 20-25 daily fractions to the pelvis, treating five times a week, was specified. Primary outcome measure was overall survival, and all analyses were by intention to treat. These trials were registered ISRCTN 16571884 (ASTEC) and NCT 00002807 (EN.5). After a median follow-up of 58 months, 135 women (68 observation, 67 external beam radiotherapy) had died. There was no evidence that overall survival with external beam radiotherapy was better than observation, hazard ratio 1.05 (95% CI 0.75-1.48; p=0.77). 5-year overall survival was 84% in both groups. Combining data from ASTEC and EN.5 in a meta-analysis of trials confirmed that there was no benefit in terms of overall survival (hazard ratio 1.04; 95% CI 0.84-1.29) and can reliably exclude an absolute benefit of external beam radiotherapy at 5 years of more than 3%. With brachytherapy used in 53% of women in ASTEC/EN.5, the local recurrence rate in the observation group at 5 years

  9. Dosimetry, clinical factors and medication intake influencing urinary symptoms after prostate radiotherapy: An analysis of data from the RADAR prostate radiotherapy trial

    International Nuclear Information System (INIS)

    Yahya, Noorazrul; Ebert, Martin A.; Bulsara, Max; Haworth, Annette; Kennedy, Angel; Joseph, David J.; Denham, Jim W.

    2015-01-01

    Purpose/objective: To identify dosimetry, clinical factors and medication intake impacting urinary symptoms after prostate radiotherapy. Material and methods: Data describing clinical factors and bladder dosimetry (reduced with principal component (PC) analysis) for 754 patients treated with external beam radiotherapy accrued by TROG 03.04 RADAR prostate radiotherapy trial were available for analysis. Urinary symptoms (frequency, incontinence, dysuria and haematuria) were prospectively assessed using LENT-SOMA to a median of 72 months. The endpoints assessed were prevalence (grade ⩾1) at the end of radiotherapy (representing acute symptoms), at 18-, 36- and 54-month follow-ups (representing late symptoms) and peak late incidence including only grade ⩾2. Impact of factors was assessed using multivariate logistic regression models with correction for over-optimism. Results: Baseline symptoms, non-insulin dependent diabetes mellitus, age and PC1 (correlated to the mean dose) impact symptoms at >1 timepoints. Associations at a single timepoint were found for cerebrovascular condition, ECOG status and non-steroidal anti-inflammatory drug intake. Peak incidence analysis shows the impact of baseline, bowel and cerebrovascular condition and smoking status. Conclusions: The prevalence and incidence analysis provide a complementary view for urinary symptom prediction. Sustained impacts across time points were found for several factors while some associations were not repeated at different time points suggesting poorer or transient impact

  10. Radiotherapy for pediatric brain tumors: Standards of care, current clinical trials, and new directions

    International Nuclear Information System (INIS)

    Goldwein, Joel W.

    1995-01-01

    The objectives of the course are to evaluate the role of radiation therapy in the treatment of pediatric brain tumors. Areas where the role is evolving will be identified, and the results of clinical trials which been mounted to clarify radiotherapy's role will be reviewed. Brain tumors are the second most common malignancy of childhood after leukemias and lymphomas. However, they remain the most common group of childhood tumors to require radiation therapy. Therefore, a thorough understanding of these tumors, and the appropriate role of surgery, radiation and chemotherapy is critical. Issues surrounding the management of sequelae are no less important. The role of radiotherapy for the treatment of these tumors is far different from that for adults. These differences relate to the profound potential for sequelae from therapy, the higher overall cure rates, and the utility of multimodality therapies. In addition, the rarity of childhood brain tumors compared with adults' makes them more difficult to study. In this session, the following issues will be reviewed; 1. Incidence of pediatric brain tumors, 2. General issues regarding symptoms, diagnosis, diagnostic tests and evaluation, 3. Importance of a team approach, 4. General issues regarding treatment sequelae, 5. Specific tumor types/entities; a. Cerebellar Astrocytomas b. Benign and malignant Gliomas including brainstem and chiasmatic lesions c. Primitive Neuroectodermal Tumors (PNET) and Medulloblastoma d. Ependymomas e. Craniopharyngiomas f. Germ cell tumors g. Miscellaneous and rare pediatric brain tumors 6. Management of sequelae 7. New and future directions a. Treatment of infants b. The expanding role of chemotherapy c. Advances in radiotherapy. The attendees will complete the course with a better understanding of the role that radiation therapy plays in the treatment of pediatric brain tumors. They will be knowledgeable in the foundation for that role, and the changes which are likely to take place in the

  11. The starting dose of levothyroxine in primary hypothyroidism treatment: a prospective, randomized, double-blind trial

    NARCIS (Netherlands)

    Roos, Annemieke; Linn-Rasker, Suzanne P.; van Domburg, Ron T.; Tijssen, Jan P.; Berghout, Arie

    2005-01-01

    BACKGROUND: The treatment of hypothyroidism with levothyroxine is effective and simple; however, recommendations for the starting dose vary considerably. To our knowledge, the levothyroxine starting dose has never been studied prospectively. METHODS: We conducted a prospective, randomized,

  12. Phase I Clinical Trial Assessing Temozolomide and Tamoxifen With Concomitant Radiotherapy for Treatment of High-Grade Glioma

    International Nuclear Information System (INIS)

    Patel, Shilpen; DiBiase, Steven; Meisenberg, Barry; Flannery, Todd; Patel, Ashish; Dhople, Anil; Cheston, Sally; Amin, Pradip

    2012-01-01

    Purpose: The new standard treatment of glioblastoma multiforme is concurrent radiotherapy (RT) and temozolomide. The proliferation of high-grade gliomas might be partly dependent on protein kinase C-mediated pathways. Tamoxifen has been shown in vitro to inhibit protein kinase C through estrogen receptor-independent antineoplastic effects. This Phase I trial was designed to determine the maximal tolerated dose (MTD) of tamoxifen when given with temozolomide and concurrent RT to patients with high-grade gliomas. Methods and Materials: A total of 17 consecutive patients in four cohorts with World Health Organization Grade 3 (n = 2) and 4 (n = 15) gliomas were given tamoxifen twice daily during 6 weeks of concurrent RT and temozolomide. Eligibility included histologic diagnosis, age >18 years old, Karnofsky performance status ≥60, and no previous brain RT or chemotherapy. The starting dose was 50 mg/m 2 divided twice daily. If no dose-limiting toxicities (DLTs) occurred in 3 patients, the dose was escalated in 25-mg/m 2 increments until the MTD was reached. When ≥2 patients within a cohort experienced a DLT, the MTD had been exceeded. Temozolomide was given with RT at 75 mg/m 2 . A dose of 60 Gy in 2 Gy/d fractions to a partial brain field was delivered. Results: A total of 6 patients in Cohort 4 had received tamoxifen at 125 mg/m 2 . One patient was excluded, and the fourth patient developed Grade 4 thrombocytopenia (DLT). Thus, 3 more patients needed to be enrolled. A deep venous thrombosis (DLT) occurred in the sixth patient. Thus, the MTD was 100 mg/m 2 . Conclusions: The MTD of tamoxifen was 100 mg/m 2 when given concurrently with temozolomide 75 mg/m 2 and RT. Tamoxifen might have a role in the initial treatment of high-grade gliomas and should be studied in future Phase II trials building on the newly established platform of concurrent chemoradiotherapy.

  13. Results of a prospective randomised trial comparing conventional radiotherapy to split course bifractionated radiation therapy in patients with nasopharyngeal carcinoma

    International Nuclear Information System (INIS)

    Daoud, Jamel; Toumi, Nabil; Siala, Wissem; Ghorbel, Abdelmonem; Drira, Mohamed Mokthar; Frikha, Mounir

    2007-01-01

    Background and purpose: Nasopharyngeal carcinoma (NPC) is generally responsive to radiation therapy. However therapeutic results after conventional radiotherapy remain relatively poor especially for patients with locoregional advanced NPC. The aim of this study was to evaluate the impact of a split course bifractionated radiotherapy regimen in a phase III randomised trial. Patients and methods: From January 1997 to September 2003, 154 patients with M0 histologically proven NPC were treated in our institution. They were staged according to the American Joint Committee on Cancer - International Union Against Cancer (AJCC-UICC) 1986 TNM classification. Patients with locally advanced nodal disease (N2-N3) received induction chemotherapy. All patients were randomised to receive either conventional radiotherapy at 2 Gy/fraction/day, 5 days/week to 70 Gy/7 weeks or split course bifractionated radiotherapy at 1.6 Gy/fraction, twice daily, 5 days/week to 70.4 Gy/6 weeks. Response and toxicity were evaluated according to the WHO and RTOG criteria. Results: Patients were well balanced between the two arms. The complete remission rate was 91% in conventional radiotherapy arm and 93% in bifractionated radiotherapy arm (p = 0.3). There was more grade II-III skin fibrosis in experimental arm with a 5 year actuarial probability of 66% vs 52% (p = 0.04). Locoregional and distant relapses occurred in 34% of cases in conventional arm and 38% in experimental arm (p = 0.28). With a median follow-up of 56 months, the 5 year overall survival and the disease free survival rates were, respectively (71% and 61%), in conventional arm and (62% and 60%) in bifractionated arm, the difference being statistically non significant. Comments: The present trial comparing conventional radiotherapy to a split course bifractionated radiation therapy failed to demonstrate significant improvement in locoregional control and survival in experimental arm which was associated with more grade II-III skin

  14. Adaptive radiotherapy for head and neck cancer—Dosimetric results from a prospective clinical trial

    International Nuclear Information System (INIS)

    Schwartz, David L.; Garden, Adam S.; Shah, Shalin J.; Chronowski, Gregory; Sejpal, Samir; Rosenthal, David I.; Chen, Yipei; Zhang, Yongbin; Zhang, Lifei; Wong, Pei-Fong; Garcia, John A.; Kian Ang, K.; Dong, Lei

    2013-01-01

    Purpose: To conduct a clinical trial evaluating adaptive head and neck radiotherapy (ART). Methods: Patients with locally advanced oropharyngeal cancer were prospectively enrolled. Daily CT-guided setup and deformable image registration permitted mapping of dose to avoidance structures and CTVs. We compared four planning scenarios: (1) original IMRT plan aligned daily to marked isocenter (BB); (2) original plan aligned daily to bone (IGRT); (3) IGRT with one adaptive replan (ART1); and (4) actual treatment received by each study patient (IGRT with one or two adaptive replans, ART2). Results: All 22 study patients underwent one replan (ART1); eight patients had two replans (ART2). ART1 reduced mean dose to contralateral parotid by 0.6 Gy or 2.8% (paired t-test; p = 0.003) and ipsilateral parotid by 1.3 Gy (3.9%) (p = 0.002) over the IGRT alone. ART2 further reduced the mean contralateral parotid dose by 0.8 Gy or 3.8% (p = 0.026) and ipsilateral parotid by 4.1 Gy or 9% (p = 0.001). ART significantly reduced integral body dose. Conclusions: This pilot trial suggests that head and neck ART dosimetrically outperforms IMRT. IGRT that leverages conventional PTV margins does not improve dosimetry. One properly timed replan delivers the majority of achievable dosimetric improvement. The clinical impact of ART must be confirmed by future trials

  15. DBCG hypo trial validation of radiotherapy parameters from a national data bank versus manual reporting.

    Science.gov (United States)

    Brink, Carsten; Lorenzen, Ebbe L; Krogh, Simon Long; Westberg, Jonas; Berg, Martin; Jensen, Ingelise; Thomsen, Mette Skovhus; Yates, Esben Svitzer; Offersen, Birgitte Vrou

    2018-01-01

    The current study evaluates the data quality achievable using a national data bank for reporting radiotherapy parameters relative to the classical manual reporting method of selected parameters. The data comparison is based on 1522 Danish patients of the DBCG hypo trial with data stored in the Danish national radiotherapy data bank. In line with standard DBCG trial practice selected parameters were also reported manually to the DBCG database. Categorical variables are compared using contingency tables, and comparison of continuous parameters is presented in scatter plots. For categorical variables 25 differences between the data bank and manual values were located. Of these 23 were related to mistakes in the manual reported value whilst the remaining two were a wrong classification in the data bank. The wrong classification in the data bank was related to lack of dose information, since the two patients had been treated with an electron boost based on a manual calculation, thus data was not exported to the data bank, and this was not detected prior to comparison with the manual data. For a few database fields in the manual data an ambiguity of the parameter definition of the specific field is seen in the data. This was not the case for the data bank, which extract all data consistently. In terms of data quality the data bank is superior to manually reported values. However, there is a need to allocate resources for checking the validity of the available data as well as ensuring that all relevant data is present. The data bank contains more detailed information, and thus facilitates research related to the actual dose distribution in the patients.

  16. Symptoms 10-17 years after breast cancer radiotherapy data from the randomised SWEBCG91-RT trial

    International Nuclear Information System (INIS)

    Lundstedt, Dan; Gustafsson, Magnus; Malmstroem, Per; Johansson, Karl-Axel; Alsadius, David; Sundberg, Agnetha; Wilderaeng, Ulrica; Holmberg, Erik; Anderson, Harald; Steineck, Gunnar; Karlsson, Per

    2010-01-01

    Background: Postoperative radiotherapy decreases the risk for local recurrence and improves overall survival in women with breast cancer. We have limited information on radiotherapy-induced symptoms 10-17 years after therapy. Material and methods: Between 1991 and 1997, women with lymph node-negative breast cancer were randomised in a Swedish multi-institutional trial to breast conserving surgery with or without postoperative radiotherapy. In 2007, 10-17 years after randomisation, the group included 422 recurrence-free women. We collected data with a study-specific questionnaire on eight pre-selected symptom groups. Results: For six symptom groups (oedema in breast or arm, erysipelas, heart symptoms, lung symptoms, rib fractures, and decreased shoulder mobility) we found similar occurrence in both groups. Excess occurrence after radiotherapy was observed for pain in the breast or in the skin, reported to occur 'occasionally' by 38.1% of survivors having undergone radiotherapy and surgery versus 24.0% of those with surgery alone (absolute difference 14.1%; p = 0.004) and at least once a week by 10.3% of the radiotherapy group versus 1.7% (absolute difference 8.6%; p = 0.001). Daily life and analgesic use did not differ between the groups. Conclusions: Ten to 17 years after postoperative radiotherapy 1 in 12 women had weekly pain that could be attributed to radiotherapy. The symptoms did not significantly affect daily life and thus the reduced risk for local recurrence seems to outweigh the risk for long-term symptoms for most women.

  17. Randomised phase I/II study to evaluate carbon ion radiotherapy versus fractionated stereotactic radiotherapy in patients with recurrent or progressive gliomas: The CINDERELLA trial

    International Nuclear Information System (INIS)

    Combs, Stephanie E; Wick, Wolfgang; Debus, Jürgen; Burkholder, Iris; Edler, Lutz; Rieken, Stefan; Habermehl, Daniel; Jäkel, Oliver; Haberer, Thomas; Haselmann, Renate; Unterberg, Andreas

    2010-01-01

    Treatment of patients with recurrent glioma includes neurosurgical resection, chemotherapy, or radiation therapy. In most cases, a full course of radiotherapy has been applied after primary diagnosis, therefore application of re-irradiation has to be applied cauteously. With modern precision photon techniques such as fractionated stereotactic radiotherapy (FSRT), a second course of radiotherapy is safe and effective and leads to survival times of 22, 16 and 8 months for recurrent WHO grade II, III and IV gliomas. Carbon ions offer physical and biological characteristics. Due to their inverted dose profile and the high local dose deposition within the Bragg peak precise dose application and sparing of normal tissue is possible. Moreover, in comparison to photons, carbon ions offer an increased relative biological effectiveness (RBE), which can be calculated between 2 and 5 depending on the GBM cell line as well as the endpoint analyzed. Protons, however, offer an RBE which is comparable to photons. First Japanese Data on the evaluation of carbon ion radiation therapy for the treatment of primary high-grade gliomas showed promising results in a small and heterogeneous patient collective. In the current Phase I/II-CINDERELLA-trial re-irradiation using carbon ions will be compared to FSRT applied to the area of contrast enhancement representing high-grade tumor areas in patients with recurrent gliomas. Within the Phase I Part of the trial, the Recommended Dose (RD) of carbon ion radiotherapy will be determined in a dose escalation scheme. In the subsequent randomized Phase II part, the RD will be evaluated in the experimental arm, compared to the standard arm, FSRT with a total dose of 36 Gy in single doses of 2 Gy. Primary endpoint of the Phase I part is toxicity. Primary endpoint of the randomized part II is survival after re-irradiation at 12 months, secondary endpoint is progression-free survival. The Cinderella trial is the first study to evaluate carbon ion

  18. The effect of planning algorithms in oesophageal radiotherapy in the context of the SCOPE 1 trial

    International Nuclear Information System (INIS)

    Wills, Lucy; Millin, Anthony; Paterson, Jennifer; Crosby, Tom; Staffurth, John

    2009-01-01

    Background and purpose: In radiotherapy clinical trials multiple centres contribute to patient recruitment. Depending on the calculation algorithm used, the reported dose distributions may differ significantly: broadly, the results for algorithms which do not model lateral electron transport (type a) give less accurate results than the more recently available algorithms that do (type b) when compared to Monte Carlo simulations and measurements. Clinical implementation studies for type b algorithms have yet to be reported for oesophageal radiotherapy. Furthermore, clinical trials must ensure an equivalent effect of the treatment regardless of calculation method. This retrospective planning study aims to define guidance for type b planning in a UK oesophageal clinical trial, to enable acceptable consistency of dose distributions regardless of algorithm, and allow for the improved calculation accuracy of type b to be incorporated into the optimization. Materials and methods: Fifteen patient data sets were planned using a single type a algorithm. Plans were recalculated using a single type b algorithm and subsequently re-optimized with the type b in accordance with optimization rules. The changes in absolute dose at the point of prescription for type a were compared to the recalculated type b. Dose-volume data for organs at risk (OARs), and target volumes were compared, and the volume of the planning target volume (PTV) receiving 95% of the prescribed dose (V95%) was compared to the percentage of PTV overlapping with lung. Results: Dose at the prescription point decreased by 0.69% on average (SD = 0.71), p = 0.0021, for type b compared to that for type a. For the re-optimized type b, the OAR doses corresponding to the trial dose-volume constraints were maintained within 1.0% of the type a levels on average. Reductions in the mean PTV V95% of 9.3% and 3.8% were observed for the recalculated and re-optimized type b plans, respectively, when compared to the mean PTV V95

  19. Detailed review and analysis of complex radiotherapy clinical trial planning data: Evaluation and initial experience with the SWAN software system

    International Nuclear Information System (INIS)

    Ebert, Martin A.; Haworth, Annette; Kearvell, Rachel; Hooton, Ben; Coleman, Rhonda; Spry, Nigel; Bydder, Sean; Joseph, David

    2008-01-01

    Aim: Contemporary radiotherapy clinical trials typically require complex three-dimensional (3D) treatment planning. This produces large amounts of data relating technique and dose delivery for correlation with patient outcomes. Assessment of the quality of this information is required to ensure protocol compliance, to quantify the variation in treatments given to patients and to enhance the power of studies to determine correlates of patient outcomes. Materials and methods: A software system ('SWAN') was developed to facilitate the objective analysis, quality-assurance and review of digital treatment planning data from multi-centre radiotherapy trials. The utility of this system was assessed on the basis of its functionality and our experience of its use in the context of multi-centre clinical trials and trials-support activities. Results: The SWAN system has been shown to have the functionality required for use in several multi-centre trials, including automated review and archive processes. Approximately 800 treatment plans from over 30 participating institutions have so far been assessed with the system for several treatment planning scenarios. To illustrate this we include a description of the use of the system for a large-recruitment prostate radiotherapy trial being undertaken in Australasia, including examples of how the review process has changed clinical practice. Conclusion: The successful implementation of SWAN has been demonstrated in a number of clinical trials. The software provides an opportunity for comprehensive review of treatment parameters that could impact on clinical outcomes and trial results. Such quality-assurance (QA) has previously been difficult or impossible to achieve, particularly for a clinical trial involving large numbers of patients. Such reviews have highlighted inconsistencies in clinical practice that have since been addressed through feedback from the review process. The process of data collection and review should be

  20. Patient reported outcomes following stereotactic ablative radiotherapy or surgery for stage IA non-small-cell lung cancer : Results from the ROSEL multicenter randomized trial

    NARCIS (Netherlands)

    Louie, Alexander V.; van Werkhoven, Erik; Chen, Hanbo; Smit, Egbert F.; Paul, Marinus A.; Widder, Joachim; Groen, Harry J. M.; van den Borne, Ben E. E. M.; De Jaeger, Katrien; Slotman, Ben J.; Senan, Suresh

    2015-01-01

    We report quality of life and indirect costs from patient reported outcomes from the ROSEL randomized control trial comparing stereotactic ablative radiotherapy (SABR, also known as stereotactic body radiotherapy or SBRT) versus surgical resection for medically operable stage IA non-small cell lung

  1. A randomized control trial evaluating fluorescent ink versus dark ink tattoos for breast radiotherapy.

    Science.gov (United States)

    Landeg, Steven J; Kirby, Anna M; Lee, Steven F; Bartlett, Freddie; Titmarsh, Kumud; Donovan, Ellen; Griffin, Clare L; Gothard, Lone; Locke, Imogen; McNair, Helen A

    2016-12-01

    The purpose of this UK study was to evaluate interfraction reproducibility and body image score when using ultraviolet (UV) tattoos (not visible in ambient lighting) for external references during breast/chest wall radiotherapy and compare with conventional dark ink. In this non-blinded, single-centre, parallel group, randomized control trial, patients were allocated to receive either conventional dark ink or UV ink tattoos using computer-generated random blocks. Participant assignment was not masked. Systematic (∑) and random (σ) setup errors were determined using electronic portal images. Body image questionnaires were completed at pre-treatment, 1 month and 6 months to determine the impact of tattoo type on body image. The primary end point was to determine that UV tattoo random error (σ setup ) was no less accurate than with conventional dark ink tattoos, i.e. tattoos. 45 patients completed treatment (UV: n = 23, dark: n = 22). σ setup for the UV tattoo group was tattoo group compared with the dark ink group at 1 month [56% (13/23) vs 14% (3/22), respectively] and 6 months [52% (11/21) vs 38% (8/21), respectively]. UV tattoos were associated with interfraction setup reproducibility comparable with conventional dark ink. Patients reported a more favourable change in body image score up to 6 months following treatment. Advances in knowledge: This study is the first to evaluate UV tattoo external references in a randomized control trial.

  2. Radiotherapy with concomitant chemotherapy superior to radiotherapy alone in the treatment of locally advanced anal cancer: results of a phase III randomized trial of the EORTC radiotherapy and gastrointestinal tract cooperative groups

    International Nuclear Information System (INIS)

    Bartelink, H.; Roelofsen, F.; Bosset, J.F.; Eschwege, F.; Rougier, Ph.; Peiffert, D.; Glabbeke, M. van; Pierart, M.

    1996-01-01

    Purpose: To investigate the potential gain of the concomitant use of radiotherapy and chemotherapy in improving local control and reducing the need for colostomy, a randomized phase-III trial was performed in patients with locally advanced anal cancer. Material and methods: In the period 1987-1994 110 patients were randomized between radiotherapy alone and a combination of radiotherapy and chemotherapy. The patients had tumors larger than 4 cm, or T 3-4 N 0-3 , or T 1-2 N 1-3 anal cancer. Radiotherapy consisted of 45 Gy given in 5 weeks, with a daily dose of 1.8 Gy. After a rest period of 6 weeks a boost of 15 Gy or 20 Gy was given in case of partial or complete response respectively. Chemotherapy was given during radiotherapy, 750 mg/m2 daily as continuous infusion on day 1-5 and 29-33, a single dose of Mitomycin C 15 mg/m 2 was administered on day 1. Results: The addition of chemotherapy to radiotherapy has resulted in an increase in the complete remission rate from 54% to 80%, and from 83% to 94% if results are considered after surgical resections. This has led to a significant improvement in loco-regional control and colostomy free survival (P=0.04, P=0.003 resp.) both in favor of the combined modality treatment. No significant difference was found when severe side effects were considered. The survival rate remained similar in both treatment arms. Skin ulceration, nodal involvement and sex were the most important prognostic factors for both local control and survival. These remained significant after multivariate analysis. The improvement seen in local control by adding chemotherapy to radiotherapy remained also significant after adjusting for prognostic factors in the multivariate analysis. Conclusions: The concomitant use of radiotherapy and chemotherapy resulted in an improved local control rate and a reduction in the need for colostomy in patients with locally advanced anal cancer

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

    International Nuclear Information System (INIS)

    Atagi, Shinji; Kawahara, Masaaki; Tamura, Tomohide

    2005-01-01

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

  4. The early toxicity of escalated versus standard dose conformal radiotherapy with neo-adjuvant androgen suppression for patients with localised prostate cancer: Results from the MRC RT01 trial (ISRCTN47772397)

    International Nuclear Information System (INIS)

    Dearnaley, David P.; Sydes, Matthew R.; Langley, Ruth E.; Graham, John D.; Huddart, Robert A.; Syndikus, Isabel; Matthews, John H.L.; Scrase, Christopher D.; Jose, Chakiath C.; Logue, John; Stephens, Richard J.

    2007-01-01

    Background: Five-year disease-free survival rates for localised prostate cancer following standard doses of conventional radical external beam radiotherapy are around 80%. Conformal radiotherapy (CFRT) raises the possibility that radiotherapy doses can be increased and long-term efficacy outcomes improved, with safety an important consideration. Methods: MRC RT01 is a randomised controlled trial of 862 men with localised prostate cancer comparing Standard CFRT (64 Gy/32 f) versus Escalated CFRT (74 Gy/37 f), both administered with neo-adjuvant androgen suppression. Early toxicity was measured using physician-reported instruments (RTOG, LENT/SOM, Royal Marsden Scales) and patient-reported questionnaires (MOS SF-36, UCLA Prostate Cancer Index, FACT-P). Results: Overall early radiotherapy toxicity was similar, apart from increased bladder, bowel and sexual toxicity, in the Escalated Group during a short immediate post-radiotherapy period. Toxicity in both groups had abated by week 12. Using RTOG Acute Toxicity scores, cumulative Grade ≥2 bladder and bowel toxicity was 38% and 30% for Standard Group and 39% and 33% in Escalated Group, respectively. Urinary frequency (Royal Marsden Scale) improved in both groups from pre-androgen suppression to 6 months post-radiotherapy (p < 0.001), but bowel and sexual functioning deteriorated. This pattern was supported by patient-completed assessments. Six months after starting radiotherapy the incidence of RTOG Grade ≥2 side-effects was low (<1%); but there were six reports of rectal ulceration (6 Escalated Group), six haematuria (5 Escalated Group) and eight urethral stricture (6 Escalated Group). Conclusions: The two CFRT schedules with neo-adjuvant androgen suppression have broadly similar early toxicity profiles except for the immediate post-RT period. At 6 months and compared to before hormone therapy, bladder symptoms improved, whereas bowel and sexual symptoms worsened. These assessments of early treatment safety will be

  5. Cost-effectiveness of preoperative radiotherapy in rectal cancer: results from the Swedish Rectal Cancer Trial

    International Nuclear Information System (INIS)

    Dahlberg, Michael; Stenborg, Anna; Paahlman, Lars; Glimelius, Bengt

    2002-01-01

    Purpose: The Swedish Rectal Cancer Trial (SRCT) demonstrated that a short-term regimen of high-dose fractionated preoperative radiotherapy (5 x 5 Gy) reduced the local recurrence rates and improved overall survival. This has had an impact on the primary treatment of rectal cancer. The current study investigated the cost-effectiveness of the new combined approach. Methods and Materials: After an 8-year follow-up, in-hospital and outpatient costs related to the treatment of rectal cancer and its complications were analyzed for 98 randomly allocated patients who participated in the SRCT from a single Swedish health care region. The costs were then related to the clinical data from the SRCT regarding complications, local and distant recurrences, and survival. Results: The total cost for a nonirradiated patient was US$30,080 compared with US$35,268 for an irradiated patient. The surgery-alone group had increased costs related to local recurrences, and the radiotherapy group had increased costs for irradiation and complications. With a survival benefit of 21 months (retrieved from the SRCT), the cost for a saved year was US$3654. Sensitivity analyses for different rates of local recurrences, the costs related to complications and less marked survival benefit showed that this figure could vary up to US$15,228. Conclusion: The cost for a life-year saved in these data was US$3654. This figure could reach US$15,228 in the most pessimistic setting of the sensitivity tests, a cost still comparable with other well-accepted medical interventions

  6. Randomized Clinical Trial to Assess the Efficacy of Radiotherapy in Primary Mediastinal Large B-Lymphoma

    Energy Technology Data Exchange (ETDEWEB)

    Aviles, Agustin, E-mail: agustin.aviles@imss.gob.mx [Oncology Research Unit, Oncology Hospital, National Medical Center, IMSS, Mexico, D. F. (Mexico); Neri, Natividad [Department of Hematology, Oncology Hospital, National Medical Center, IMSS, Mexico, D. F. (Mexico); Fernandez, Raul [Department of Radiation Therapy, Oncology Hospital, National Medical Center, IMSS, Mexico, D. F. (Mexico); Huerta-Guzman, Judith; Nambo, Maria J. [Department of Hematology, Oncology Hospital, National Medical Center, IMSS, Mexico, D. F. (Mexico)

    2012-07-15

    Purpose: We developed a controlled clinical trial to assess the efficacy and toxicity of adjuvant-involved field radiotherapy (IFRT) in patients with primary mediastinal B-cell lymphoma that achieved complete response after the patients were treated with cyclophosphamide, doxorubicin, vincristine, prednisone, and rituximab (R-CHOP-14). Methods and Materials: Between January 2001 and June 2004, 124 consecutive patients who were in complete remission after dose dense chemotherapy and rituximab administration (R-CHOP14) were randomly assigned to received IFRT (30 Gy). Sixty-three patients received IFR, and 61 patients did not (control group). Results: The study aimed to include 182 patients in each arm but was closed prematurely because in a security analysis (June 2004), progression and early relapse were more frequent in patients that did not received IFRT. Patients were followed until March 2009, at which point actuarial curves at 10 years showed that progression free-survival was 72% in patients who received IFR and 20% in the control group (p < 0.001), overall survival was 72% and 31%, respectively (p < 0.001). Acute toxicity was mild and well tolerated. Discussion: Adjuvant radiotherapy to sites of bulky disease was the only difference to have an improvement in outcome in our patients; the use of rituximab during induction did not improve complete response rates and did affect overall survival; patients who received rituximab but not IFRT had a worse prognosis. Conclusions: The use of IFRT in patients with primary mediastinal B-cell lymphoma who achieved complete response remain as the best treatment available, even in patients that received rituximab during induction.

  7. Randomized Clinical Trial to Assess the Efficacy of Radiotherapy in Primary Mediastinal Large B-Lymphoma

    International Nuclear Information System (INIS)

    Avilés, Agustin; Neri, Natividad; Fernández, Raúl; Huerta-Guzmán, Judith; Nambo, María J.

    2012-01-01

    Purpose: We developed a controlled clinical trial to assess the efficacy and toxicity of adjuvant-involved field radiotherapy (IFRT) in patients with primary mediastinal B-cell lymphoma that achieved complete response after the patients were treated with cyclophosphamide, doxorubicin, vincristine, prednisone, and rituximab (R-CHOP-14). Methods and Materials: Between January 2001 and June 2004, 124 consecutive patients who were in complete remission after dose dense chemotherapy and rituximab administration (R-CHOP14) were randomly assigned to received IFRT (30 Gy). Sixty-three patients received IFR, and 61 patients did not (control group). Results: The study aimed to include 182 patients in each arm but was closed prematurely because in a security analysis (June 2004), progression and early relapse were more frequent in patients that did not received IFRT. Patients were followed until March 2009, at which point actuarial curves at 10 years showed that progression free-survival was 72% in patients who received IFR and 20% in the control group (p < 0.001), overall survival was 72% and 31%, respectively (p < 0.001). Acute toxicity was mild and well tolerated. Discussion: Adjuvant radiotherapy to sites of bulky disease was the only difference to have an improvement in outcome in our patients; the use of rituximab during induction did not improve complete response rates and did affect overall survival; patients who received rituximab but not IFRT had a worse prognosis. Conclusions: The use of IFRT in patients with primary mediastinal B-cell lymphoma who achieved complete response remain as the best treatment available, even in patients that received rituximab during induction.

  8. Concomitant chemo-radiotherapy for locally advanced bronchial cancer: impact of radiotherapy quality on global survival: results of a trial by the Thoracic Cancerology French-speaking Inter-group (IFCT) and Pneumo-Cancerology French Group (GFPC) 02.01

    International Nuclear Information System (INIS)

    Martel-Lafay, I.; Montella, A.; Pommier, P.; Clavere, P.; Labat, J.P.; Benchalal, M.; Teissier, E.; Talabard, J.N.; Fournel, P.; D'Hombres, A.

    2010-01-01

    The author report the assessment of the influence of radiotherapy quality and of its consequences on the future of 113 patients during a phase-II randomized trial of concomitant chemo-radiotherapy of bronchial cancers without stage-II non-resectable small cells. The patients have been submitted to a conformational radiotherapy and a concomitant induction of consolidation chemotherapy. Ten items are analysed: immobilisation, dose per fraction, total dose, ganglion radiotherapy, number of beams, images before and after radiotherapy, radiotherapy duration, duration without radiotherapy, dose-lung volume histogram. The study notably shows the deleterious effects of an interruption of the concomitant chemotherapy on the global survival. Short communication

  9. Study Protocol: Screening and Treatment of Alcohol-Related Trauma (START – a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Jayaraj Rama

    2012-10-01

    Full Text Available Abstract Background The incidence of mandibular fractures in the Northern Territory of Australia is very high, especially among Indigenous people. Alcohol intoxication is implicated in the majority of facial injuries, and substance use is therefore an important target for secondary prevention. The current study tests the efficacy of a brief therapy, Motivational Care Planning, in improving wellbeing and substance misuse in youth and adults hospitalised with alcohol-related facial trauma. Methods and design The study is a randomised controlled trial with 6 months of follow-up, to examine the effectiveness of a brief and culturally adapted intervention in improving outcomes for trauma patients with at-risk drinking admitted to the Royal Darwin Hospital maxillofacial surgery unit. Potential participants are identified using AUDIT-C questionnaire. Eligible participants are randomised to either Motivational Care Planning (MCP or Treatment as Usual (TAU. The outcome measures will include quantity and frequency of alcohol and other substance use by Timeline Followback. The recruitment target is 154 participants, which with 20% dropout, is hoped to provide 124 people receiving treatment and follow-up. Discussion This project introduces screening and brief interventions for high-risk drinkers admitted to the hospital with facial trauma. It introduces a practical approach to integrating brief interventions in the hospital setting, and has potential to demonstrate significant benefits for at-risk drinkers with facial trauma. Trial Registration The trial has been registered in Australian New Zealand Clinical Trials Registry (ANZCTR and Trial Registration: ACTRN12611000135910.

  10. Music Therapy Reduces Radiotherapy-Induced Fatigue in Patients With Breast or Gynecological Cancer: A Randomized Trial.

    Science.gov (United States)

    Alcântara-Silva, Tereza Raquel; de Freitas-Junior, Ruffo; Freitas, Nilceana Maya Aires; de Paula Junior, Wanderley; da Silva, Delson José; Machado, Graziela Dias Pinheiro; Ribeiro, Mayara Kelly Alves; Carneiro, Jonathas Paiva; Soares, Leonardo Ribeiro

    2018-04-01

    To investigate the influence of music therapy on the reduction of fatigue in women with breast or gynecological malignant neoplasia during radiotherapy, since it is one of the most frequent side effects of this type of treatment, and may interfere with self-esteem, social activities, and quality of life. Randomized controlled trial (control group [CG] and music therapy group [MTG]) to assess fatigue, quality of life, and symptoms of depression in women undergoing radiotherapy using the Functional Assessment of Cancer Therapy: Fatigue (FACT-F) version 4, Functional Assessment of Cancer Therapy-General (FACT-G) version 4, and Beck Depression Inventory in 3 separate times, namely, during the first week of radiotherapy, on the week of the intermediary phase, and during the last week of radiotherapy. Individual 30- to 40-minute sessions of music therapy with the presence of a trained music therapist were offered to participants. In this study, 164 women were randomized and 116 (63 CG and 53 MTG) were included in the analyses, with mean age of 52.90 years (CG) and 51.85 years (MTG). Participants in the MTG had an average of 10 music therapy sessions, totaling 509 sessions throughout the study. FACT-F results were significant regarding Trial Outcome Index ( P = .011), FACT-G ( P = .005), and FACT-F ( P = .001) for the MTG compared with the CG. Individual music therapy sessions may be effective to reduce fatigue related to cancer and symptoms of depression, as well as to improve quality of life for women with breast or gynecological cancer undergoing radiotherapy. Further well-designed research studies are needed to adequately determine the effects of music therapy on fatigue.

  11. The Effectiveness of Healthy Start Home Visit Program: Cluster Randomized Controlled Trial

    Science.gov (United States)

    Leung, Cynthia; Tsang, Sandra; Heung, Kitty

    2015-01-01

    Purpose: The study reported the effectiveness of a home visit program for disadvantaged Chinese parents with preschool children, using cluster randomized controlled trial design. Method: Participants included 191 parents and their children from 24 preschools, with 84 dyads (12 preschools) in the intervention group and 107 dyads (12 preschools) in…

  12. Low or High Fractionation Dose {beta}-Radiotherapy for Pterygium? A Randomized Clinical Trial

    Energy Technology Data Exchange (ETDEWEB)

    Viani, Gustavo Arruda, E-mail: gusviani@gmail.com [Department of Radiation Oncology, Marilia Medicine School, Sao Paulo, SP (Brazil); De Fendi, Ligia Issa; Fonseca, Ellen Carrara [Department of Ophthalmology, Marilia Medicine School, Sao Paulo, SP (Brazil); Stefano, Eduardo Jose [Department of Radiation Oncology, Marilia Medicine School, Sao Paulo, SP (Brazil)

    2012-02-01

    Purpose: Postoperative adjuvant treatment using {beta}-radiotherapy (RT) is a proven technique for reducing the recurrence of pterygium. A randomized trial was conducted to determine whether a low fractionation dose of 2 Gy within 10 fractions would provide local control similar to that after a high fractionation dose of 5 Gy within 7 fractions for surgically resected pterygium. Methods: A randomized trial was conducted in 200 patients (216 pterygia) between February 2006 and July 2007. Only patients with fresh pterygium resected using a bare sclera method and given RT within 3 days were included. Postoperative RT was delivered using a strontium-90 eye applicator. The pterygia were randomly treated using either 5 Gy within 7 fractions (Group 1) or 2 Gy within 10 fractions (Group 2). The local control rate was calculated from the date of surgery. Results: Of the 216 pterygia included, 112 were allocated to Group 1 and 104 to Group 2. The 3-year local control rate for Groups 1 and 2 was 93.8% and 92.3%, respectively (p = .616). A statistically significant difference for cosmetic effect (p = .034), photophobia (p = .02), irritation (p = .001), and scleromalacia (p = .017) was noted in favor of Group 2. Conclusions: No better local control rate for postoperative pterygium was obtained using high-dose fractionation vs. low-dose fractionation. However, a low-dose fractionation schedule produced better cosmetic effects and resulted in fewer symptoms than high-dose fractionation. Moreover, pterygia can be safely treated in terms of local recurrence using RT schedules with a biologic effective dose of 24-52.5 Gy{sub 10.}.

  13. Benign painful shoulder syndrome. Initial results of a single-center prospective randomized radiotherapy dose-optimization trial

    International Nuclear Information System (INIS)

    Ott, O.J.; Hertel, S.; Gaipl, U.S.; Frey, B.; Schmidt, M.; Fietkau, R.

    2012-01-01

    Background and purpose: To compare the efficacy of two different dose-fractionation schedules for radiotherapy of patients with benign painful shoulder syndrome. Patients and methods: Between February 2006 and February 2010, 312 consecutive evaluable patients were recruited for this prospective randomized trial. All patients received radiotherapy with an orthovoltage technique. One radiotherapy course consisted of 6 single fractions in 3 weeks. In case of insufficient remission of pain after 6 weeks, a second radiation series was performed. Patients were randomly assigned to receive either single doses of 0.5 or 1.0 Gy. The endpoint was pain reduction. Pain was measured before, right after, and 6 weeks after radiotherapy using a visual analogue scale (VAS) and a comprehensive pain score (CPS). Results: The overall response rate for all patients was 83% directly after and 85% 6 weeks after radiotherapy. The mean VAS values before, directly after, and 6 weeks after treatment for the 0.5 and 1.0 Gy groups were 56.8 ± 23.7 and 53.2 ± 21.8 (p = 0.158), 38.2 ± 26.1 and 34.0 ± 24.5 (p = 0.189), and 33.0 ± 27.2 and 23.7 ± 22.7 (p = 0.044), respectively. The mean CPS before, directly after, and 6 weeks after treatment was 9.7 ± 3.0 and 9.5 ± 2.7 (p = 0.309), 6.1 ± 3.6 and 5.4 ± 3.6 (p = 0.096), 5.3 ± 3.7 and 4.1 ± 3.7 (p = 0.052), respectively. Despite a slight advantage in the VAS analysis for the 1.0 Gy group for delayed response, the CPS analysis revealed no statistically significant differences between the two single-dose trial arms for early (p = 0.652) and delayed response quality (p = 0.380). Conclusion: Radiotherapy is an effective treatment option for the management of benign painful shoulder syndrome. Concerning radiation protection, the dose for a radiotherapy series is recommended not to exceed 3-6 Gy. (orig.)

  14. Toward Semi-automated Assessment of Target Volume Delineation in Radiotherapy Trials: The SCOPE 1 Pretrial Test Case

    Energy Technology Data Exchange (ETDEWEB)

    Gwynne, Sarah, E-mail: Sarah.Gwynne2@wales.nhs.uk [Department of Clinical Oncology, Velindre Cancer Centre, Cardiff, Wales (United Kingdom); Spezi, Emiliano; Wills, Lucy [Department of Medical Physics, Velindre Cancer Centre, Cardiff, Wales (United Kingdom); Nixon, Lisette; Hurt, Chris [Wales Cancer Trials Unit, School of Medicine, Cardiff University, Cardiff, Wales (United Kingdom); Joseph, George [Department of Diagnostic Radiology, Velindre Cancer Centre, Cardiff, Wales (United Kingdom); Evans, Mererid [Department of Clinical Oncology, Velindre Cancer Centre, Cardiff, Wales (United Kingdom); Griffiths, Gareth [Wales Cancer Trials Unit, School of Medicine, Cardiff University, Cardiff, Wales (United Kingdom); Crosby, Tom [Department of Clinical Oncology, Velindre Cancer Centre, Cardiff, Wales (United Kingdom); Staffurth, John [Division of Cancer, School of Medicine, Cardiff University, Cardiff, Wales (United Kingdom)

    2012-11-15

    Purpose: To evaluate different conformity indices (CIs) for use in the analysis of outlining consistency within the pretrial quality assurance (Radiotherapy Trials Quality Assurance [RTTQA]) program of a multicenter chemoradiation trial of esophageal cancer and to make recommendations for their use in future trials. Methods and Materials: The National Cancer Research Institute SCOPE 1 trial is an ongoing Cancer Research UK-funded phase II/III randomized controlled trial of chemoradiation with capecitabine and cisplatin with or without cetuximab for esophageal cancer. The pretrial RTTQA program included a detailed radiotherapy protocol, an educational package, and a single mid-esophageal tumor test case that were sent to each investigator to outline. Investigator gross tumor volumes (GTVs) were received from 50 investigators in 34 UK centers, and CERR (Computational Environment for Radiotherapy Research) was used to perform an assessment of each investigator GTV against a predefined gold-standard GTV using different CIs. A new metric, the local conformity index (l-CI), that can localize areas of maximal discordance was developed. Results: The median Jaccard conformity index (JCI) was 0.69 (interquartile range, 0.62-0.70), with 14 of 50 investigators (28%) achieving a JCI of 0.7 or greater. The median geographical miss index was 0.09 (interquartile range, 0.06-0.16), and the mean discordance index was 0.27 (95% confidence interval, 0.25-0.30). The l-CI was highest in the middle section of the volume, where the tumor was bulky and more easily definable, and identified 4 slices where fewer than 20% of investigators achieved an l-CI of 0.7 or greater. Conclusions: The available CIs analyze different aspects of a gold standard-observer variation, with JCI being the most useful as a single metric. Additional information is provided by the l-CI and can focus the efforts of the RTTQA team in these areas, possibly leading to semi-automated outlining assessment.

  15. Toward Semi-automated Assessment of Target Volume Delineation in Radiotherapy Trials: The SCOPE 1 Pretrial Test Case

    International Nuclear Information System (INIS)

    Gwynne, Sarah; Spezi, Emiliano; Wills, Lucy; Nixon, Lisette; Hurt, Chris; Joseph, George; Evans, Mererid; Griffiths, Gareth; Crosby, Tom; Staffurth, John

    2012-01-01

    Purpose: To evaluate different conformity indices (CIs) for use in the analysis of outlining consistency within the pretrial quality assurance (Radiotherapy Trials Quality Assurance [RTTQA]) program of a multicenter chemoradiation trial of esophageal cancer and to make recommendations for their use in future trials. Methods and Materials: The National Cancer Research Institute SCOPE 1 trial is an ongoing Cancer Research UK-funded phase II/III randomized controlled trial of chemoradiation with capecitabine and cisplatin with or without cetuximab for esophageal cancer. The pretrial RTTQA program included a detailed radiotherapy protocol, an educational package, and a single mid-esophageal tumor test case that were sent to each investigator to outline. Investigator gross tumor volumes (GTVs) were received from 50 investigators in 34 UK centers, and CERR (Computational Environment for Radiotherapy Research) was used to perform an assessment of each investigator GTV against a predefined gold-standard GTV using different CIs. A new metric, the local conformity index (l-CI), that can localize areas of maximal discordance was developed. Results: The median Jaccard conformity index (JCI) was 0.69 (interquartile range, 0.62-0.70), with 14 of 50 investigators (28%) achieving a JCI of 0.7 or greater. The median geographical miss index was 0.09 (interquartile range, 0.06-0.16), and the mean discordance index was 0.27 (95% confidence interval, 0.25-0.30). The l-CI was highest in the middle section of the volume, where the tumor was bulky and more easily definable, and identified 4 slices where fewer than 20% of investigators achieved an l-CI of 0.7 or greater. Conclusions: The available CIs analyze different aspects of a gold standard–observer variation, with JCI being the most useful as a single metric. Additional information is provided by the l-CI and can focus the efforts of the RTTQA team in these areas, possibly leading to semi-automated outlining assessment.

  16. A randomised comparison of radical radiotherapy with or without chemotherapy for patients with non-small cell lung cancer: Results from the Big Lung Trial

    International Nuclear Information System (INIS)

    Fairlamb, David; Milroy, Robert; Gower, Nicole; Parmar, Mahesh; Peake, Michael; Rudd, Robin; Souhami, Robert; Spiro, Stephen; Stephens, Richard; Waller, David

    2005-01-01

    Background: A meta-analysis of trials comparing primary treatment with or without chemotherapy for patients with non-small cell lung cancer published in 1995 suggested a survival benefit for cisplatin-based chemotherapy in each of the primary treatment settings studied, but it included many small trials, and trials with differing eligibility criteria and chemotherapy regimens. Methods: The Big Lung Trial was a large pragmatic trial designed to confirm the survival benefits seen in the meta-analysis, and this paper reports the findings in the radical radiotherapy setting. The trial closed before the required sample size was achieved due to slow accrual, with a total of 288 patients randomised to receive radical radiotherapy alone (146 patients) or sequential radical radiotherapy and cisplatin-based chemotherapy (142 patients). Results: There was no evidence that patients allocated sequential chemotherapy and radical radiotherapy had a better survival than those allocated radical radiotherapy alone, HR 1.07 (95% CI 0.84-1.38, P=0.57), median survival 13.0 months for the sequential group and 13.2 for the radical radiotherapy alone group. In addition, exploratory analyses could not identify any subgroup that might benefit more or less from chemotherapy. Conclusions: Despite not suggesting a survival benefit for the sequential addition of chemotherapy to radical radiotherapy, possibly because of the relatively small sample size and consequently wide confidence intervals, the results can still be regarded as consistent with the meta-analysis, and other similarly designed recently published large trials. Combining all these results suggests there may be a small median survival benefit with chemotherapy of between 2 and 8 weeks

  17. Radiotherapy for benign achillodynia. Long-term results of the Erlangen Dose Optimization Trial

    Energy Technology Data Exchange (ETDEWEB)

    Ott, Oliver J.; Jeremias, Carolin; Gaipl, Udo S.; Frey, Benjamin; Schmidt, Manfred; Fietkau, Rainer [University Hospital Erlangen, Department of Radiation Oncology, Erlangen (Germany)

    2015-12-15

    The aim of this study was to evaluate the long-term efficacy of two dose-fractionation schedules for radiotherapy of achillodynia. Between February 2006 and February 2010, 112 evaluable patients were recruited for this prospective trial. All patients received orthovoltage radiotherapy. One course consisted of 6 fractions/3 weeks. In the case of insufficient remission of pain after 6 weeks, a second series was performed. Patients were randomly assigned to receive either single doses of 0.5 or 1.0 Gy. The endpoint was pain reduction. Pain was measured before, right after (early response), 6 weeks after (delayed response), and approximately 2 years after radiotherapy (long-term response) with a questionnaire-based visual analogue scale (VAS) and a comprehensive pain score (CPS). The median follow-up was 24 months (range, 11-56). The overall early, delayed, and long-term response rates for all patients were 84 %, 88 %, and 95 %, respectively. The mean VAS values before treatment for early, delayed, and long-term responses for the 0.5-Gy and 1.0-Gy groups were 55.7 ± 21.0 and 58.2 ± 23.5 (p = 0.53), 38.0 ± 23.2 and 30.4 ± 22.6 (p = 0.08), 35.5 ± 25.9 and 30.9 ± 25.4 (p = 0.52), and 11.2 ± 16.4 and 15.3 ± 18.9 (p = 0.16), respectively. The mean CPS values before treatment for early, delayed, and long-term responses were 8.2 ± 3.0 and 8.9 ± 3.3 (p = 0.24), 5.6 ± 3.1 and 5.4 ± 3.3 (p = 0.76), 4.4 ± 2.6 and 5.3 ± 3.8 (p = 0.58), and 2.2 ± 2.9 and 2.8 ± 3.3 (p = 0.51), respectively. No significant differences in long-term response quality between the two arms was found (p = 0.73). Radiotherapy is a very effective treatment for the management of benign achillodynia. For radiation protection, the dose for a radiotherapy series should not exceed 3.0 Gy. (orig.) [German] Ziel war die Untersuchung der Langzeiteffektivitaet zweier Dosisfraktionierungskonzepte bei der Strahlentherapie von Patienten mit Achillodynie. Zwischen 2006 und 2010 wurden 112 auswertbare

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

    International Nuclear Information System (INIS)

    Barnes, M.; Duray, P.; DeLuca, A.; Anderson, W.; Sindelar, W.; Kinsella, T.

    1990-01-01

    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

  19. 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.

  20. Randomized trial of single dose versus fractionated palliative radiotherapy of bone metastases

    International Nuclear Information System (INIS)

    Nielsen, O.S.; Bentzen, S.M.; Sandberg, E.; Gadeberg, C.C.; Timothy, A.R.

    1998-01-01

    Purpose: Data in the literature suggest that for painful bone metastases a single dose is as effective as fractionated radiotherapy. In the present multicentre prospective trial, the effects of 8 Gy x1 and 5 Gy x4 were compared. Patients and methods: A total of 241 patients were randomized to 8 Gy (122 patients) or 20 Gy (119 patients). The primary tumour was in the breast in 39% of patients, in the prostate in 34% of patients, in the lung in 13% of patients and in other locations in 14% of patients. Outcome measures were pain relief as measured by VAS and in half of the patients also by a five-point categorical pain scale, global quality of life (QoL) and analgesic consumption. Evaluation was performed before and 4, 8, 12 and 20 weeks after treatment. Results: A total of 239 patients were evaluable for response. The two groups did not differ with respect to age, sex, primary tumour, metastasis localization, analgesic consumption (type and dose), performance status, prior systemic treatment, degree of pain and QoL. The treatment was completed as planned in 98% of patients. The degree of pain relief did not differ between the two treatment groups. At 4 weeks the difference in pain relief was 6% (95% CI 7, 20%) and at 8 weeks the difference was 13% (95% CI 3, 28%). Neither was there any significant difference in the duration of pain relief, the number of new painful sites and the need for reirradiation and toxicity was minor. Conclusion: The present randomized study showed that a single fraction of 8 Gy was as effective as 5 Gy x4 in relieving pain from bone metastasis. (Copyright (c) 1998 Elsevier Science B.V., Amsterdam. All rights reserved.)

  1. Cognitive-Behavioral Therapy Plus Hypnosis for Distress During Breast Radiotherapy: A Randomized Trial.

    Science.gov (United States)

    Montgomery, Guy H; Sucala, Madalina; Dillon, Matthew J; Schnur, Julie B

    2017-10-01

    Radiotherapy is a common and effective treatment for women with breast cancer. However, radiotherapy has also been shown to adversely affect patients' emotional well-being. Currently, few mind-body interventions are designed to improve patients' quality of life during radiotherapy. One intervention which has demonstrated clinical efficacy in the breast cancer radiotherapy setting is Cognitive-Behavioral Therapy plus Hypnosis. The goal of this study was to investigate the impact of Cognitive-Behavioral Therapy plus Hypnosis on emotional distress in women with breast cancer undergoing radiotherapy. One hundred patients were randomly assigned to either the Cognitive-Behavioral Therapy plus Hypnosis (n = 50) or Attention Control (n = 50) group. Results revealed significant benefits of Cognitive-Behavioral Therapy plus Hypnosis on emotional distress at the mid-point (d = 0.54), the conclusion (d = 0.64), and 4 weeks following the conclusion (d = 0.65) of radiotherapy (all ps Cognitive-Behavioral Therapy plus Hypnosis as an evidence-based intervention to reduce emotional distress in women with breast cancer. Cognitive-Behavioral Therapy plus Hypnosis has the benefits of being brief, noninvasive, lacking side-effects, and producing beneficial effects which last beyond the conclusion of radiotherapy. Given these strengths, we propose that Cognitive-Behavioral Therapy plus Hypnosis is a strong candidate for greater dissemination and implementation in cancer populations.

  2. Fifteen-Year Radiotherapy Outcomes of the Randomized PORTEC-1 Trial for Endometrial Carcinoma

    Energy Technology Data Exchange (ETDEWEB)

    Creutzberg, Carien L., E-mail: c.l.creutzberg@lumc.nl [Department of Clinical Oncology, Leiden University Medical Center (Netherlands); Nout, Remi A. [Department of Clinical Oncology, Leiden University Medical Center (Netherlands); Lybeert, Marnix L.M. [Department of Radiotherapy, Catharina Hospital Eindhoven (Netherlands); Warlam-Rodenhuis, Carla C. [Department of Radiation Oncology, University Medical Center Utrecht (Netherlands); Jobsen, Jan J. [Department of Radiotherapy, Medisch Spectrum Twente, Enschede (Netherlands); Mens, Jan-Willem M. [Department of Radiation Oncology, ErasmusMC-Daniel den Hoed Cancer Center, Rotterdam (Netherlands); Lutgens, Ludy C.H.W. [MAASTRO clinic, Maastricht (Netherlands); Pras, Elisabeth [Department of Radiotherapy, University Medical Center Groningen (Netherlands); Poll-Franse, Lonneke V. van de [Comprehensive Cancer Centre South, Eindhoven and Center of Research on Psychology in Somatic Diseases, Tilburg University (Netherlands); Putten, Wim L.J. van [Department of Biostatistics, ErasmusMC-Daniel den Hoed Cancer Center, Rotterdam (Netherlands)

    2011-11-15

    Purpose: To evaluate the very long-term results of the randomized Post Operative Radiation Therapy in Endometrial Carcinoma (PORTEC)-1 trial for patients with Stage I endometrial carcinoma (EC), focusing on the role of prognostic factors for treatment selection and the long-term risk of second cancers. Patients and Methods: The PORTEC trial (1990-1997) included 714 patients with Stage IC Grade 1-2 or Stage IB Grade 2-3 EC. After surgery, patients were randomly allocated to external-beam pelvic radiotherapy (EBRT) or no additional treatment (NAT). Analysis was by intention to treat. Results: 426 patients were alive at the date of analysis. The median follow-up time was 13.3 years. The 15-year actuarial locoregional recurrence (LRR) rates were 6% for EBRT vs. 15.5% for NAT (p < 0.0001). The 15-year overall survival was 52% vs. 60% (p = 0.14), and the failure-free survival was 50% vs. 54% (p = 0.94). For patients with high-intermediate risk criteria, the 15-year overall survival was 41% vs. 48% (p = 0.51), and the 15-year EC-related death was 14% vs. 13%. Most LRR in the NAT group were vaginal recurrences (11.0% of 15.5%). The 15-year rates of distant metastases were 9% vs. 7% (p = 0.25). Second primary cancers had been diagnosed over 15 years in 19% of all patients, 22% vs. 16% for EBRT vs. NAT (p = 0.10), with observed vs. expected ratios of 1.6 (EBRT) and 1.2 (NAT) compared with a matched population (p = NS). Multivariate analysis confirmed the prognostic significance of Grade 3 for LRR (hazard ratio [HR] 3.4, p = 0.0003) and for EC death (HR 7.3, p < 0.0001), of age >60 (HR 3.9, p = 0.002 for LRR and 2.7, p = 0.01 for EC death) and myometrial invasion >50% (HR 1.9, p = 0.03 and HR 1.9, p = 0.02). Conclusions: The 15-year outcomes of PORTEC-1 confirm the relevance of HIR criteria for treatment selection, and a trend for long-term risk of second cancers. EBRT should be avoided in patients with low- and intermediate-risk EC.

  3. Results of the Tremplin trial proposing an induction chemotherapy followed by concomitant radiotherapy with cisplatin ou cetuximab in order to protect the larynx

    International Nuclear Information System (INIS)

    Pointreau, Y.; Calais, G.; Pointreau, Y.; Calais, G.; Pointreau, Y.; Rolland, F.; Bardet, E.; Alfonsi, M.; Baudoux, A.; Sire, G.; De Raucourt, D.; Tuchais, C.; Lefebvre, J.L.

    2010-01-01

    The authors report a randomized phase II trial which aimed at comparing over three months the laryngeal protection after a TPF-based induction chemotherapy followed by radiotherapy in combination with cisplatin or cetuximab. Over two years, 153 patients have been concerned. The TPF-based induction chemotherapy followed by radiotherapy with cetuximab seems to be the less toxic. A longer monitoring is needed to get better information in terms of laryngeal protection rate, life quality, and laryngeal functionality. Short communication

  4. Predictors of severe late radiotherapy-related toxicity after hyperfractionated radiotherapy with or without concomitant cisplatin in locally advanced head and neck cancer. Secondary retrospective analysis of a randomized phase III trial (SAKK 10/94)

    International Nuclear Information System (INIS)

    Ghadjar, Pirus; Simcock, Mathew; Zimmermann, Frank; Betz, Michael; Bodis, Stephan; Bernier, Jacques; Studer, Gabriela; Aebersold, Daniel M.

    2012-01-01

    Background and purpose: This secondary analysis was performed to identify predictive factors for severe late radiotherapy (RT)-related toxicity after treatment with hyperfractionated RT +/− concomitant cisplatin in locally advanced head and neck cancer. Materials and methods: Patients were retrospectively analyzed from the previously reported randomized phase III trial: SAKK 10/94. Severe late RT-related toxicity was defined as late RTOG ⩾ grade 3 toxicity starting 3 months after end of RT and/or potential treatment-related death within 3 years of randomization. Results: Two hundred and thirteen randomized patients were analyzed; 84 (39%) experienced severe late RT-related toxicity. With median follow-up of 9.7 years (range, 0.4–15.4 years), median time to severe late RT-related toxicity was 9.6 years. In the univariate Cox proportional hazards model the following variables were associated with severe late RT-related toxicity: advanced N-classification (p < 0.001); technically unresectable disease (p = 0.04); weight loss ratio (p = 0.003); supportive measures (p = 0.009) and severe acute dysphagia (p = 0.001). In the subsequent multivariate analysis all variables except use of supportive measures remained statistically significant. Conclusions: Chemotherapy did not appear to affect severe late RT-related toxicity, but advanced N-classification, technically unresectable disease, weight loss ratio, and severe acute dysphagia were independent predictive factors for severe late RT-related toxicity.

  5. Comparing conVEntional RadioTherapy with stereotactIC body radiotherapy in patients with spinAL metastases: study protocol for an randomized controlled trial following the cohort multiple randomized controlled trial design

    International Nuclear Information System (INIS)

    Velden, Joanne M. van der; Verkooijen, Helena M.; Seravalli, Enrica; Hes, Jochem; Gerlich, A. Sophie; Kasperts, Nicolien; Eppinga, Wietse S. C.; Verlaan, Jorrit-Jan; Vulpen, Marco van

    2016-01-01

    Standard radiotherapy is the treatment of first choice in patients with symptomatic spinal metastases, but is only moderately effective. Stereotactic body radiation therapy is increasingly used to treat spinal metastases, without randomized evidence of superiority over standard radiotherapy. The VERTICAL study aims to quantify the effect of stereotactic radiation therapy in patients with metastatic spinal disease. This study follows the ‘cohort multiple Randomized Controlled Trial’ design. The VERTICAL study is conducted within the PRESENT cohort. In PRESENT, all patients with bone metastases referred for radiation therapy are enrolled. For each patient, clinical and patient-reported outcomes are captured at baseline and at regular intervals during follow-up. In addition, patients give informed consent to be offered experimental interventions. Within PRESENT, 110 patients are identified as a sub cohort of eligible patients (i.e. patients with unirradiated painful, mechanically stable spinal metastases who are able to undergo stereotactic radiation therapy). After a protocol amendment, also patients with non-spinal bony metastases are eligible. From the sub cohort, a random selection of patients is offered stereotactic radiation therapy (n = 55), which patients may accept or refuse. Only patients accepting stereotactic radiation therapy sign informed consent for the VERTICAL trial. Non-selected patients (n = 55) receive standard radiotherapy, and are not aware of them serving as controls. Primary endpoint is pain response after three months. Data will be analyzed by intention to treat, complemented by instrumental variable analysis in case of substantial refusal of the stereotactic radiation therapy in the intervention arm. This study is designed to quantify the treatment response after (stereotactic) radiation therapy in patients with symptomatic spinal metastases. This is the first randomized study in palliative care following the cohort multiple Randomized

  6. Prevention of heterotopic ossification about the hip using perioperative radiotherapy: Results of two randomized trials in 410 patients

    International Nuclear Information System (INIS)

    Seegenschmiedt, M. Heinrich; Keiholz, Ludwig; Martus, Peter; Woelfel, Rainer; Henning, Friedrich; Sauer, Rolf

    1996-01-01

    BACKGROUND: In-vivo data (Kantorowitz et al., 1991) indicate the efficacy of pre- and postoperative radiotherapy (RT) in suppressing development of heterotopic ossification (HO) after hip surgery. Since 1987 two prospective randomized trials were initiated at our institution to assess the comparative efficacy of 'high-dose RT' versus 'low-dose RT' (HOP study 1) and 'preoperative RT' versus 'postoperative RT' (HOP study 2). A control arm without radiotherapy (RT) was avoided, as only those patients (pts) were entered, who had a very high risk to develop HO after hip arthroplasty. PATIENTS and METHODS: In HOP study 1 (accrual: June 1987 - June 1992), 249 pts were randomized between the following postoperative RT schedules: 'low-dose RT' with 5 x 2 Gy, 10 Gy total RT dose (N = 129) versus 'high dose RT' with 5 x 3.5 Gy, 17.5 Gy total RT dose (N = 121); RT was applied with daily fractionation starting at postoperative day 1 - 4. In HOP study 2 (accrual : July 1992 - July 1995), 161 pts were randomized between 'preoperative RT' using a single dose of 7 Gy (N = 80 pts) and postoperative RT with 5 x 3.5 Gy (N = 51 pts). In both studies only patients were includes with one or multiple of the following risk factors for HO: ipsi- (55%) or contralateral HO (33%), hypertrophic osteoarthritis (48%), repeated hip surgery, acetabular fracture or severe hip trauma (43%); 62% of all pts had at least two risk factors. The structure of the relevant and possibly confounding patient and disease parameters and risk factors was similar in each of the treatment arms within the two randomized studies. - The assessment of 'treatment failures' was based upon the comparison of the amount of HO seen on the immediately postoperative radiograph as compared to radiographs obtained at least 6 months after surgery (Brooker Score). Any progression of HO by Brooker score was regarded as treatment failure. RESULTS: At last FU, in January 1996 both studies 369 of 410 pts (90%) had received an effective

  7. Short course radiotherapy with simultaneous integrated boost for stage I-II breast cancer, early toxicities of a randomized clinical trial

    Science.gov (United States)

    2012-01-01

    Background TomoBreast is a unicenter, non-blinded randomized trial comparing conventional radiotherapy (CR) vs. hypofractionated Tomotherapy (TT) for post-operative treatment of breast cancer. The purpose of the trial is to compare whether TT can reduce heart and pulmonary toxicity. We evaluate early toxicities. Methods The trial started inclusion in May 2007 and reached its recruitment in August 2011. Women with stage T1-3N0M0 or T1-2N1M0 breast cancer completely resected by tumorectomy (BCS) or by mastectomy (MA) who consented to participate were randomized, according to a prescribed computer-generated randomization schedule, between control arm of CR 25x2 Gy/5 weeks by tangential fields on breast/chest wall, plus supraclavicular-axillary field if node-positive, and sequential boost 8x2 Gy/2 weeks if BCS (cumulative dose 66 Gy/7 weeks), versus experimental TT arm of 15x2.8 Gy/3 weeks, including nodal areas if node-positive and simultaneous integrated boost of 0.6 Gy if BCS (cumulative dose 51 Gy/3 weeks). Outcomes evaluated were the pulmonary and heart function. Comparison of proportions used one-sided Fisher's exact test. Results By May 2010, 70 patients were randomized and had more than 1 year of follow-up. Out of 69 evaluable cases, 32 were assigned to CR (21 BCS, 11 MA), 37 to TT (20 BCS, 17 MA). Skin toxicity of grade ≥1 at 2 years was 60% in CR, vs. 30% in TT arm. Heart function showed no significant difference for left ventricular ejection fraction at 2 years, CR 4.8% vs. TT 4.6%. Pulmonary function tests at 2 years showed grade ≥1 decline of FEV1 in 21% of CR, vs. 15% of TT and decline of DLco in 29% of CR, vs. 7% of TT (P = 0.05). Conclusions There were no unexpected severe toxicities. Short course radiotherapy of the breast with simultaneous integrated boost over 3 weeks proved feasible without excess toxicities. Pulmonary tests showed a slight trend in favor of Tomotherapy, which will need confirmation with longer

  8. Dosimetric explanations of fatigue in head and neck radiotherapy: An analysis from the PARSPORT Phase III trial

    International Nuclear Information System (INIS)

    Gulliford, Sarah L.; Miah, Aisha B.; Brennan, Sinead; McQuaid, Dualta; Clark, Catharine H.; Partridge, Mike; Harrington, Kevin J.; Morden, James P.; Hall, Emma; Nutting, Christopher M.

    2012-01-01

    Background: An unexpected finding from the phase III parotid sparing radiotherapy trial, PARSPORT (ISRCTN48243537, CRUK/03/005), was a statistically significant increase in acute fatigue for those patients who were treated with intensity-modulated radiotherapy (IMRT) compared to standard conventional radiotherapy (CRT). One possible explanation was the difference in dose to central nervous system (CNS) structures due to differing beam portals. Using data from the trial, a dosimetric analysis of individual CNS structures was performed. Method: Dosimetric and toxicity data were available for 67 patients (27 CRT, 40 IMRT). Retrospective delineation of the posterior fossa, brainstem, cerebellum, pituitary gland, pineal gland, hypothalamus, hippocampus and basal ganglia was performed. Dosimetry was reviewed using summary statistics and dose–volume atlases. Results: A statistically significant increase in maximum and mean doses to each structure was observed for patients who received IMRT compared to those who received CRT. Both maximum and mean doses were significantly higher for the posterior fossa, brainstem and cerebellum for the 42 patients who reported acute fatigue of Grade 2 or higher (p ⩽ 0.01) compared to the 25 who did not. Dose–volume atlases of the same structures indicated that regions representing larger volumes and higher doses to each structure were consistent with a higher incidence of acute fatigue. There was no association between the dose distribution and acute fatigue for the other structures tested. Conclusions: The excess fatigue reported in the IMRT arm of the trial may, at least in part, be attributed to the dose distribution to the posterior fossa, cerebellum and brainstem. Future studies that modify dose delivery to these structures may allow us to test the hypothesis that radiation-induced fatigue is avoidable.

  9. Palliative radiotherapy in locally advanced head and neck cancer-A prospective trial

    Directory of Open Access Journals (Sweden)

    Ghoshal Sushmita

    2004-01-01

    Full Text Available AIM: To evaluate the role of palliative radiotherapy for symptom control in patients with locally advanced head and neck cancer. MATERIALS AND METHODS: 25 patients with stage 3 and stage 4 head and neck cancer were treated with a short course of palliative radiotherapy (30 Gray (Gy in 10 fractions over 2 weeks. Baseline symptoms were assessed using a 11 point numerical scale for pain, dysphagia, cough, insomnia and dyspnoea. The primary end point was relief of symptoms in the fourth week after radiotherapy. Percentage symptom relief was quantified by the patient using a rupee scale. RESULTS: All 22 patients with pain and 90% of patients with dysphagia, dyspnoea and disturbed sleep had greater than 50% relief in symptoms after radiotherapy. Cough was relieved in sixty percent of cases. CONCLUSION: A short course of radiation can be an effective method of symptom palliation in head and neck cancers.

  10. Accelerated partial breast irradiation with external beam radiotherapy. First results of the German phase 2 trial

    Energy Technology Data Exchange (ETDEWEB)

    Ott, Oliver J.; Strnad, Vratislav; Stillkrieg, Wilhelm; Fietkau, Rainer [University Hospital Erlangen, Department of Radiation Oncology, Erlangen (Germany); Uter, Wolfgang [University Erlangen-Nuremberg, Dept. of Medical Informatics, Biometry and Epidemiology, Erlangen (Germany); Beckmann, Matthias W. [University Hospital Erlangen, Dept. of Gynecology, Erlangen (Germany)

    2017-01-15

    To evaluate the feasibility and efficacy of external beam three-dimensional (3D) conformal accelerated partial breast irradiation (APBI) for selected patients with early breast cancer. Between 2011 and 2016, 72 patients were recruited for this prospective phase 2 trial. Patients were eligible for APBI if they had histologically confirmed breast cancer or pure ductal carcinoma in situ (DCIS), a tumor diameter ≤3 cm, clear resection margins ≥2 mm, no axillary lymph node involvement, no distant metastases, tumor bed clips, and were aged ≥50 years. Patients were excluded if mammography showed a multicentric invasive growth pattern, or if they had residual diffuse microcalcifications postoperatively, an extensive intraductal component, or vessel invasion. Patients received 3D conformal external beam APBI with a total dose of 38 Gy in 10 fractions in 1-2 weeks. The trial had been registered at the German Clinical Trials Register, DRKS-ID: DRKS00004417. Median follow-up was 25.5 months (range 1-61 months). Local control was maintained in 71 of 72 patients. The 3-year local recurrence rate was 2.1% (95% confidence interval, CI: 0-6.1%). Early toxicity (grade 1 radiodermatitis) was seen in 34.7% (25/72). Late side effects ≥ grade 3 did not occur. Cosmetic results were rated as excellent/good in 96.7% (59/61). APBI with external beam radiotherapy techniques is feasible with low toxicity and, according to the results of the present and other studies, on the way to becoming a standard treatment option for a selected subgroup of patients. (orig.) [German] Untersuchung der Vertraeglichkeit und Sicherheit der externen, 3-D-konformalen akzelerierten Teilbrustbestrahlung (APBI) fuer ausgewaehlte Patientinnen mit einem fruehen Mammakarzinom. Von 2011 bis 2016 wurden 72 Patientinnen in diese prospektive Phase-2-Studie eingebracht. Einschlusskriterien waren ein histologisch gesichertes Mammakarzinom oder DCIS, ein Tumordurchmesser ≤ 3 cm, tumorfreie Resektionsraender ≥ 2

  11. The effect of oral sucralfate on the acute proctitis associated with prostate radiotherapy: a double-blind, randomized trial

    International Nuclear Information System (INIS)

    Kneebone, Andrew; Mameghan, Hedy; Bolin, Terry; Berry, Martin; Turner, Sandra; Kearsley, John; Graham, Peter; Fisher, Richard; Delaney, Geoff

    2001-01-01

    Purpose: Acute rectal complications occur in the majority of patients receiving external-beam radiotherapy for carcinoma of the prostate. Sucralfate has been proposed to reduce radiation-induced mucosal injury by forming a protective barrier on ulcer bases, binding local growth factors, and stimulating angiogenesis. However, there is conflicting clinical evidence as to whether sucralfate, taken prophylactically during radiotherapy, can ameliorate the symptoms of acute radiation proctitis. Methods and Materials: A double-blind randomized trial was conducted at four Radiation Oncology Departments in Sydney, Australia, between February 1995 and June 1997. A total of 338 patients with clinically localized prostate cancer receiving small volume radiotherapy, of whom 335 were evaluable, were randomized to receive either 3 g of oral sucralfate suspension or placebo twice a day during radiotherapy. Patients kept a daily record of their bowel symptoms and were graded according to the RTOG/EORTC acute toxicity criteria. Results: One hundred sixty-four patients received sucralfate and 171 received placebo. Both groups were well balanced with regard to patient, tumor, treatment factors, and baseline symptoms, except that the placebo group had a significantly more liquid baseline stool consistency score (p=0.004). Patients kept a daily diary of symptoms during radiotherapy. After adjusting for baseline values, there was no significant difference between the two groups with regard to stool frequency (p=0.41), consistency (p=0.20), flatus (p=0.25), mucus (p=0.54), and pain (p=0.73). However, there was more bleeding in the sucralfate group, with 64% of patients noticing rectal bleeding, compared with 47% in the placebo group (p=0.001). There was no significant difference between the two groups with respect to RTOG/EORTC acute toxicity (p=0.88; sucralfate 13%, 44%, 43% and placebo 15%, 44%, 40% for grade 0, 1, and 2, respectively). Conclusion: This study suggests that oral

  12. Phase I Trial Using Proteasome Inhibitor Bortezomib and Concurrent Temozolomide and Radiotherapy for Central Nervous System Malignancies

    International Nuclear Information System (INIS)

    Kubicek, Gregory J.; Werner-Wasik, Maria; Machtay, Mitchell; Mallon, Gayle; Myers, Thomas; Ramirez, Michael; Andrews, David; Curran, Walter J.; Dicker, Adam P.

    2009-01-01

    Purpose: To evaluate the toxicity and response rate of bortezomib with concurrent radiotherapy and temozolomide in the treatment of patients with central nervous system malignancies. Patients and Methods: This open-label, dose-escalation, Phase I clinical study evaluated the safety of three dose levels of intravenously administered bortezomib (0.7, 1.0, and 1.3 mg/m 2 /dose) on Days 1, 4, 8, and 11 of a 21-day cycle, in addition to concurrent radiotherapy and temozolomide at a daily dose of 75 mg/m 2 starting on Day 1. The primary endpoint was dose-limiting toxicity, defined as any Grade 4-5 toxicity or Grade 3 toxicity directly attributable to protocol treatment, requiring hospitalization and/or radiotherapy interruption. The secondary endpoints included feasibility, non-dose-limiting toxicity, and treatment response. Results: A total of 27 patients were enrolled, 23 of whom had high-grade glioma (10 recurrent and 13 newly diagnosed). No dose-limiting toxicities were noted in any dose group, including the highest (1.3 mg/m 2 /dose). The most frequent toxicities were Grade 1 and 2 stomatitis, erythema, and alopecia. All 27 patients were evaluable for response. At a median follow-up of 15.0 months, 9 patients were still alive, with a median survival of 17.4 months for all patients and 15.0 months for patients with high-grade glioma. Conclusion: Bortezomib administered at its typical 'systemic' dose (1.3 mg/m 2 ) is well tolerated and safe combined with temozolomide and radiotherapy when used in the treatment of central nervous system malignancies. A Phase II study to characterize efficacy is warranted.

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

    International Nuclear Information System (INIS)

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

    2013-01-01

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

  14. 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.

  15. Phase I Trial Using Induction Ciplatin, Docetaxel, 5-FU and Erlotinib Followed by Cisplatin, Bevacizumab and Erlotinib With Concurrent Radiotherapy for Advanced Head and Neck Cancer.

    Science.gov (United States)

    Ahn, Peter H; Machtay, Mitchell; Anne, Pramila R; Cognetti, David; Keane, William M; Wuthrick, Evan; Dicker, Adam P; Axelrod, Rita S

    2018-05-01

    Bevacizumab (avastin) and erlotinib (tarceva) had shown early clinical activity against head and neck cancer (HNC). We initiated a phase I trial of induction cisplatin, docetaxel, 5-fluorouracil and erlotinib (TPF-E) followed by cisplatin, bevacizumab and erlotinib (PA-E) with radiotherapy (XRT) for advanced HNC. The goal was to determine maximum tolerated erlotinib dose. Eligible patients had stage IVA or higher HNC with good performance status, hematologic, and renal reserve. Two cycles of induction TPF-E were administered. XRT was administered with concurrent weekly cisplatin and bevacizumab every 2 weeks. Initial erlotinib dose was 50 mg daily from start of induction chemotherapy until radiotherapy completion. Erlotinib dose escalations to 100 and 150 mg were planned. Thirteen patients with previously untreated locoregional disease (11 patients) or oligometastatic (2 patients) HNC were enrolled. Totally, 11 of 13 patients completed XRT as planned. Four of 8 patients in cohort 1 (erlotinib 50 mg), 3 of 4 patients in cohort 2 (100 mg), and 0 of 1 patients in cohort 3 (150 mg) completed the regimen. Two patients had significant gastrointestinal complications (bleeding and perforation), and 1 had dose-limiting diarrhea. Maximum tolerated dose was reached at 50 mg erlotinib. At median 23.4 months follow-up, 5 patients (38%) have no evidence of disease, and 2 (15%) have stable but measurable disease. Erlotinib in combination with induction TPF followed by erlotinib, cisplatin, and bevacizumab with XRT is active but toxic. Gastrointestinal toxicities partly caused high rates of study withdrawal. All doses studied in this protocol caused unexpected toxicities and we do not recommend advancement to phase II.

  16. Preoperative hyperfractionated radiotherapy for locally advanced rectal cancers: a phase I-II trial

    International Nuclear Information System (INIS)

    Allal, Abdelkarim S.; Bieri, Sabine; Bruendler, Marie-Anne; Soravia, Claudio; Gertsch, Philippe; Bernier, Jacques; Morel, Philippe; Roth, Arnaud D.

    2002-01-01

    Purpose: To assess the toxicity, pathologic response rates, type of surgery, and oncologic results in a prospective Phase I-II trial using pure hyperfractionated radiotherapy (RT) preoperatively in locally advanced rectal cancer. Methods and Materials: Between September 1997 and April 2000, 50 patients with T3-T4 or N1 rectal cancers were treated preoperatively with 50 Gy (45 Gy to the pelvis and a 5-Gy tumor boost) in 40 fractions of 1.25 Gy during 4 weeks. The pretreatment tumor stage as determined by CT and endorectal ultrasonography (80% of patients) included 1 Stage T2 (2%), 45 T3 (90%), and 4 T4 (8%). Nodal involvement (N1) was documented in 26 patients (52%). Surgery was performed at a median interval of 45 days (range 26-114 days) after RT completion. Seventeen patients who presented with pT4 or pN1 and/or pM1 received 5-fluorouracil-based chemotherapy postoperatively. Results: All patients completed the RT schedule as planned. Severe acute toxicities included two Grade 3 skin reactions (4%) that did not require a break. The other acute toxicities were Grade 2 or less (skin, diarrhea, urinary, rectal tenesmus, and fatigue). A complete pathologic response was observed in 7 patients (14%), and microscopic residual cancer was found in 10 (20%). Of the 20 patients presenting with tumor located ≤6 cm from the anal verge, sphincter-saving surgery was performed in 14 (70%). At 3 years, the actuarial locoregional control rate was 90.5%, and the disease-free survival rate was 74.6%. At a median follow-up of 32 months, 4 patients (8%) presented with severe late complications (Grade 3-4) that might have been RT related (one rectovaginal fistula, two chronic perineal fistulas, and one bilateral ureteral stenosis). Conclusion: In locally advanced rectal cancer, preoperative hyperfractionated RT to a total dose of 50 Gy is feasible, with acceptable acute and late toxicity and an objective downstaging effect. In view of these results, this schedule might be used as a

  17. Phase I trial of Orzel (UFT plus leucovorin), cisplatin, and radiotherapy in the treatment of potentially resectable esophageal cancer

    International Nuclear Information System (INIS)

    Tedesco, Karen L.; Berlin, Jordan; Blanke, Charles D.; Teng Ming; Choy, Hak; Roberts, John; Beauchamp, R. Daniel; Leach, Steve; Wyman, Ken; Tarpley, John; Shyr, Yu; Caillouette, Carol; Chakravarthy, Bapsi

    2005-01-01

    Purpose: Fluorinated pyrimidines have been established as radiosensitizers in the combined modality therapy of esophageal cancer. UFT, an oral combination of a 5-fluorouracil pro-drug (uracil) and a dihydropyrimidine dehydrogenase inhibitor (ftorafur), may provide improvement in the ease of administration with equal efficacy. This Phase I study was designed to determine the maximal tolerated dose and dose-limiting toxicity of UFT, leucovorin, and cisplatin when given with radiotherapy in the neoadjuvant treatment of resectable esophageal cancer. Methods: Chemotherapy consisted of i.v. cisplatin 80 mg/m 2 (Days 1 and 22) and UFT with leucovorin orally on Days 1-35. UFT was escalated in 50-mg/m 2 increments, starting at 200 mg/m 2 /d. Radiotherapy consisted of 4500 cGy in 25 fractions. Patients underwent resection 4-6 weeks after chemoradiotherapy. Results: Ten patients with resectable esophageal cancer were enrolled. Of the 7 patients entered at dose level 1, 1 developed a dose-limiting toxicity of nausea. All 3 patients entered at dose level 2 developed dose-limiting toxicity. The maximal tolerated dose for UFT was the starting level, 200 mg/m 2 /d. Of the 10 patients enrolled, 8 underwent esophagectomy and 2 developed progressive disease and did not undergo surgery. The disease of 6 of the 8 patients was downstaged at surgery. Conclusion: The recommended UFT dose for Phase II studies is 200 mg/m 2 /d given orally in two divided doses when given with leucovorin, cisplatin, and radiotherapy

  18. Severe complications of 5-fluorouracil and cisplatin with concomitant radiotherapy in inoperable non-metastatic squamous cell oesophageal cancer after intubation - early termination of a prospective randomised trial

    Energy Technology Data Exchange (ETDEWEB)

    Alberts, A.S.; Friediger, D.; Nel, J. (Pretoria Univ. (South Africa). Dept. of Radiotherapy); Burger, W.; Schoeman, L.; Falkson, G. (Pretoria Univ. (South Africa). Dept. of Medical Oncology); Greeff, F.; Steyn, E.; Schmid, E.U. (Pretoria Univ. (South Africa). Dept. of Surgery)

    This brief letter describes a randomized trial in which radiotherapy is added to concomitant 5- fluorouracil and cisplatin therapy in patients with inoperable non-mestastatic squamous cell oesophageal cancer after palliative intubation. An interim analysis showed that patients randomized to observation had a median survival of 19 weeks while patients treated with radiotherapy, 5- fluorouracil and cisplatin had a median survival of 11 weeks. This difference in survival was due to the toxicity of the combined chemoradiotherapy and tube which resulted in early termination of the trial. (UK).

  19. Radiotherapy dosimetry audit: three decades of improving standards and accuracy in UK clinical practice and trials.

    Science.gov (United States)

    Clark, Catharine H; Aird, Edwin G A; Bolton, Steve; Miles, Elizabeth A; Nisbet, Andrew; Snaith, Julia A D; Thomas, Russell A S; Venables, Karen; Thwaites, David I

    2015-01-01

    Dosimetry audit plays an important role in the development and safety of radiotherapy. National and large scale audits are able to set, maintain and improve standards, as well as having the potential to identify issues which may cause harm to patients. They can support implementation of complex techniques and can facilitate awareness and understanding of any issues which may exist by benchmarking centres with similar equipment. This review examines the development of dosimetry audit in the UK over the past 30 years, including the involvement of the UK in international audits. A summary of audit results is given, with an overview of methodologies employed and lessons learnt. Recent and forthcoming more complex audits are considered, with a focus on future needs including the arrival of proton therapy in the UK and other advanced techniques such as four-dimensional radiotherapy delivery and verification, stereotactic radiotherapy and MR linear accelerators. The work of the main quality assurance and auditing bodies is discussed, including how they are working together to streamline audit and to ensure that all radiotherapy centres are involved. Undertaking regular external audit motivates centres to modernize and develop techniques and provides assurance, not only that radiotherapy is planned and delivered accurately but also that the patient dose delivered is as prescribed.

  20. Radiotherapy dosimetry audit: three decades of improving standards and accuracy in UK clinical practice and trials

    Science.gov (United States)

    Aird, Edwin GA; Bolton, Steve; Miles, Elizabeth A; Nisbet, Andrew; Snaith, Julia AD; Thomas, Russell AS; Venables, Karen; Thwaites, David I

    2015-01-01

    Dosimetry audit plays an important role in the development and safety of radiotherapy. National and large scale audits are able to set, maintain and improve standards, as well as having the potential to identify issues which may cause harm to patients. They can support implementation of complex techniques and can facilitate awareness and understanding of any issues which may exist by benchmarking centres with similar equipment. This review examines the development of dosimetry audit in the UK over the past 30 years, including the involvement of the UK in international audits. A summary of audit results is given, with an overview of methodologies employed and lessons learnt. Recent and forthcoming more complex audits are considered, with a focus on future needs including the arrival of proton therapy in the UK and other advanced techniques such as four-dimensional radiotherapy delivery and verification, stereotactic radiotherapy and MR linear accelerators. The work of the main quality assurance and auditing bodies is discussed, including how they are working together to streamline audit and to ensure that all radiotherapy centres are involved. Undertaking regular external audit motivates centres to modernize and develop techniques and provides assurance, not only that radiotherapy is planned and delivered accurately but also that the patient dose delivered is as prescribed. PMID:26329469

  1. Hypofractionated radiotherapy for the palliation of advanced head and neck cancer in patients unsuitable for curative treatment - 'Hypo Trial'

    International Nuclear Information System (INIS)

    Porceddu, Sandro V.; Rosser, Brenda; Burmeister, Bryan H.; Jones, Mark; Hickey, Brigid; Baumann, Kacy; Gogna, Kumar; Pullar, Andrew; Poulsen, Michael; Holt, Tanya

    2007-01-01

    Background and purpose: The primary purpose of the trial was to assess rate of tumour response to a hypofractionated course of radiotherapy in patients with incurable squamous cell carcinoma of the head and neck (HNSCC). Secondary objectives included radiation toxicity, symptom control, quality of life (QoL) and progression-free and overall survival. Patients and methods: Patients were planned to receive 30 Gy in 5 fractions at 2/week, at least 3 days apart, with an additional boost of 6 Gy for small volume disease (≤3 cm) in suitable patients. Thirty-seven patients were enrolled between August 2004 and March 2006. Median age was 68 (43-87) years, 81% were male and the predominant primary site was oropharynx (32%). The majority (73%) presented with Stage III-IV disease. Results: Thirty-five patients received radiotherapy, 1 died prior to treatment and one refused treatment. Of the 35 patients receiving radiotherapy, 31 (88%) received ≥30 Gy. Of the 35 patients who received treatment the overall objective response was 80%. Grade 3 mucositis and dysphagia were experienced in 9/35 (26%) and 4/35 (11%), respectively. QoL and symptom control were assessable in 21 patients. Thirteen (62%) reported an overall improvement in QoL and 14 (67%) experienced an improvement in pain. The median time to progression and death was 3.9 and 6.1 months, respectively. Conclusion: The 'Hypo Trial' regimen provided effective palliative treatment in HNSCC unsuitable for curative treatment. Compliance was excellent and resulted in high response rates, symptom control and improvement in QoL with acceptable toxicity. However, progression free and overall survival was short

  2. Jump starting shared medical appointments for diabetes with weight management: Rationale and design of a randomized controlled trial.

    Science.gov (United States)

    Crowley, Matthew J; Edelman, David; Voils, Corrine I; Maciejewski, Matthew L; Coffman, Cynthia J; Jeffreys, Amy S; Turner, Marsha J; Gaillard, Leslie A; Hinton, Teresa A; Strawbridge, Elizabeth; Zervakis, Jennifer; Barton, Anna Beth; Yancy, William S

    2017-07-01

    Rates of glycemic control remain suboptimal nationwide. Medication intensification for diabetes can have undesirable side effects (weight gain, hypoglycemia), which offset the benefits of glycemic control. A Shared Medical Appointment (SMA) intervention for diabetes that emphasizes weight management could improve glycemic outcomes and reduce weight while simultaneously lowering diabetes medication needs, resulting in less hypoglycemia and better quality of life. We describe the rationale and design for a study evaluating a novel SMA intervention for diabetes that primarily emphasizes low-carbohydrate diet-focused weight management. Jump Starting Shared Medical Appointments for Diabetes with Weight Management (Jump Start) is a randomized, controlled trial that is allocating overweight Veterans (body mass index≥27kg/m 2 ) with type 2 diabetes into two arms: 1) a traditional SMA group focusing on medication management and self-management counseling; or 2) an SMA group that combines low-carbohydrate diet-focused weight management (WM/SMA) with medication management. Hemoglobin A1c reduction at 48weeks is the primary outcome. Secondary outcomes include hypoglycemic events, diabetes medication use, weight, medication adherence, diabetes-related quality of life, and cost-effectiveness. We hypothesize that WM/SMA will be non-inferior to standard SMA for glycemic control, and will reduce hypoglycemia, diabetes medication use, and weight relative to standard SMA, while also improving quality of life and costs. Jump Start targets two common problems that are closely related but infrequently managed together: diabetes and obesity. By focusing on diet and weight loss as the primary means to control diabetes, this intervention may improve several meaningful patient-centered outcomes related to diabetes. Copyright © 2017. Published by Elsevier Inc.

  3. Questionnaire based quality assurance for the RT01 trial of dose escalation in conformal radiotherapy for prostate cancer (ISRCTN 47772397)

    International Nuclear Information System (INIS)

    Mayles, W.; Moore, A.Rollo; Aird, Edwin G.A.; Bidmead, A. Margaret; Dearnaley, David P.; Griffiths, Sue E.; Stephens, Richard J.; Warrington, A.P. Jim

    2004-01-01

    Background and purpose: In order to ensure the validity of the outcome of the Medical Research Council's 'RT01 trial' of dose escalation in conformal radiotherapy for prostate cancer it was considered important that the quality of treatment delivery should meet an adequate standard across all contributing centres. A questionnaire was therefore devised to ensure that all aspects of the planning and delivery process were adequately covered. Patients and methods: The questionnaire considered each step in the planning and delivery process and drew the attention of the participants to the specific requirements of the trial. Before entering patients into the trial each participating centre had to complete the questionnaire and an outlining exercise (reported elsewhere). Results: It was not practicable to define a detailed universally acceptable protocol for the whole process of delivery of conformal radiotherapy, not least because of the different equipment available for planning and treatment in different centres. The questionnaire identified some areas of difference in practice between centres where there may be a need for the development of a consensus as to best practice, particularly in the area of patient set-up. Occasionally it was necessary to follow up responses to questions that had been misunderstood or inadequately answered, but in most cases these issues proved to be easily resolved. Conclusions: The questionnaire proved to be a useful self-assessment tool as well as enabling the quality assurance group to ensure that the standards of the trial were being met. Subsequent follow-up visits confirmed the usefulness and validity of this self assessment process

  4. Calibration and start-up of the system of radiotherapy extract image-guided; Calibracion y puesta en marcha del sistema de radioterpia guiada por la imagen exactrac

    Energy Technology Data Exchange (ETDEWEB)

    Clemente Gutierrez, I.; Perez Vara, C.; Prieto Villacorta, M.

    2013-07-01

    The accuracy in the administration of external radiotherapy treatments may be increased through the use of guidance systems by image. Constitute a particular case x-rays teams independent of the treatment unit. Among them is the ExacTrac (Brainlab) system. The objective of this work is to briefly introduce the procedure followed in the calibration and implementation of such a system. (Author)

  5. Evaluation of time, attendance of medical staff and resources for radiotherapy in pediatric and adolescent patients. The DEGRO-QUIRO trial

    International Nuclear Information System (INIS)

    Zabel-du Bois, Angelika; Milker-Zabel, Stefanie; Debus, Juergen; Bruns, Frank; Christiansen, Hans; Ernst, Iris; Willich, Normann; Popp, Wolfgang; Sack, Horst

    2014-01-01

    The German Society of Radiation Oncology (DEGRO) initiated a multicenter trial to develop and evaluate adequate modules to assert core procedures in radiotherapy. The aim of this prospective evaluation was to methodical assess the required resources for radiotherapy in pediatric and adolescent patients. At three radiotherapy centers of excellence (University Hospitals of Heidelberg and Muenster, the Medical School of Hannover), the manpower and time required for radiotherapy in pediatric and adolescent patients was prospectively documented consistently over a 2-year period. The data were collected using specifically developed standard forms and were evaluated using specific process analysis tools. A total number of 1914 data sets were documented and carefully analyzed. The personnel time requirements for all occupational groups were calculated as total time needed for a specific procedure and mean time per person. Regarding radiotherapy in general anesthesia, the required manpower was higher. The personnel time requirements in these cases were also longer, mainly due to longer room occupancy. Overall, the required resources were remarkably similar between the three different departments and may, therefore, be considered as representative. For the first time, the personnel time requirements of a radiotherapy department for the maintenance, protection, and optimization of operational readiness for radiotherapy in pediatric and adolescent patients with and without general anesthesia were determined methodically. (orig.) [de

  6. WRAP53 is an independent prognostic factor in rectal cancer- a study of Swedish clinical trial of preoperative radiotherapy in rectal cancer patients

    International Nuclear Information System (INIS)

    Zhang, Hong; Wang, Da-Wei; Adell, Gunnar; Sun, Xiao-Feng

    2012-01-01

    Expression of WRAP53 protein has oncogenic properties and it is up regulated in several types of tumors. We examined expression of WRAP53 protein in rectal cancers and analyzed its relationship to the response to preoperative radiotherapy and patient survival. The WRAP53 protein was examined by immunohistochemistry in normal mucosa, primary tumors and lymph node metastases from 143 rectal cancer patients participated in a Swedish clinical trial of preoperative radiotherapy. Frequency of WRAP53 protein expression was increased in primary rectal cancer compared to the normal mucosa (p < 0.05). In non-radiotherapy group positive WRAP53 in primary tumors (p = 0.03, RR, 3.73, 95% CI, 1.13-11.89) or metastases (p = 0.01, RR, 4.11, 95% CI, 1.25-13.14), was associated with poor prognosis independently of stages and differentiations. In radiotherapy group, positive WRAP53 in the metastasis correlated with better survival (p = 0.04). An interaction analysis showed that the correlations of WRAP53 with the prognostic significance with and without radiotherapy in the metastasis differed (p = 0.01). In the radiotherapy group, expression of WRAP53 in metastases gave a better outcome (p = 0.02, RR, 0.32, 95% CI, 0.13-0.84), and an interaction analysis showed significance between the two groups (p = 0.01). WRAP53 may be a new biomarker used to predict prognosis and to select suitable patients for preoperative radiotherapy

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

    International Nuclear Information System (INIS)

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

    1980-01-01

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

  8. Whole brain radiotherapy after local treatment of brain metastases in melanoma patients - a randomised phase III trial

    International Nuclear Information System (INIS)

    Fogarty, Gerald; Shivalingam, Brindha; Dhillon, Haryana; Thompson, John F; Morton, Rachael L; Vardy, Janette; Nowak, Anna K; Mandel, Catherine; Forder, Peta M; Hong, Angela; Hruby, George; Burmeister, Bryan

    2011-01-01

    Cerebral metastases are a common cause of death in patients with melanoma. Systemic drug treatment of these metastases is rarely effective, and where possible surgical resection and/or stereotactic radiosurgery (SRS) are the preferred treatment options. Treatment with adjuvant whole brain radiotherapy (WBRT) following neurosurgery and/or SRS is controversial. Proponents of WBRT report prolongation of intracranial control with reduced neurological events and better palliation. Opponents state melanoma is radioresistant; that WBRT yields no survival benefit and may impair neurocognitive function. These opinions are based largely on studies in other tumour types in which assessment of neurocognitive function has been incomplete. This trial is an international, prospective multi-centre, open-label, phase III randomised controlled trial comparing WBRT to observation following local treatment of intracranial melanoma metastases with surgery and/or SRS. Patients aged 18 years or older with 1-3 brain metastases excised and/or stereotactically irradiated and an ECOG status of 0-2 are eligible. Patients with leptomeningeal disease, or who have had previous WBRT or localised treatment for brain metastases are ineligible. WBRT prescription is at least 30 Gy in 10 fractions commenced within 8 weeks of surgery and/or SRS. Randomisation is stratified by the number of cerebral metastases, presence or absence of extracranial disease, treatment centre, sex, radiotherapy dose and patient age. The primary endpoint is the proportion of patients with distant intracranial failure as determined by MRI assessment at 12 months. Secondary end points include: survival, quality of life, performance status and neurocognitive function. Accrual to previous trials for patients with brain metastases has been difficult, mainly due to referral bias for or against WBRT. This trial should provide the evidence that is currently lacking in treatment decision-making for patients with melanoma brain

  9. Pre-trial quality assurance processes for an intensity-modulated radiation therapy (IMRT) trial: PARSPORT, a UK multicentre Phase III trial comparing conventional radiotherapy and parotid-sparing IMRT for locally advanced head and neck cancer.

    Science.gov (United States)

    Clark, C H; Miles, E A; Urbano, M T Guerrero; Bhide, S A; Bidmead, A M; Harrington, K J; Nutting, C M

    2009-07-01

    The purpose of this study was to compare conventional radiotherapy with parotid gland-sparing intensity-modulated radiation therapy (IMRT) using the PARSPORT trial. The validity of such a trial depends on the radiotherapy planning and delivery meeting a defined standard across all centres. At the outset, many of the centres had little or no experience of delivering IMRT; therefore, quality assurance processes were devised to ensure consistency and standardisation of all processes for comparison within the trial. The pre-trial quality assurance (QA) programme and results are described. Each centre undertook exercises in target volume definition and treatment planning, completed a resource questionnaire and produced a process document. Additionally, the QA team visited each participating centre. Each exercise had to be accepted before patients could be recruited into the trial. 10 centres successfully completed the quality assurance exercises. A range of treatment planning systems, linear accelerators and delivery methods were used for the planning exercises, and all the plans created reached the standard required for participation in this multicentre trial. All 10 participating centres achieved implementation of a comprehensive and robust IMRT programme for treatment of head and neck cancer.

  10. A randomised controlled trial of intervention site radiotherapy in malignant pleural mesothelioma

    International Nuclear Information System (INIS)

    O'Rourke, Noelle; Garcia, Jose Curto; Paul, Jim; Lawless, Claire; McMenemin, Rhona; Hill, Jennifer

    2007-01-01

    Background and purpose: To assess the effectiveness of radiotherapy in preventing tumour seeding after chest drain or pleural biopsy in patients with malignant mesothelioma and to determine, if tract metastases appear, whether they are tender or troublesome to patients. Patients and methods: Patients with a histological diagnosis of pleural mesothelioma and an invasive procedure within the preceding 21 days were stratified by age, performance status and treatment centre. Randomisation was performed between immediate drain site radiotherapy 21 Gy in three fractions (XRT arm) or best supportive care (BSC) with follow-up to 12 months. Patients were asked to complete questionnaires on treatment toxicity and on symptoms from any tract metastases detected. Results: Sixty-one patients were recruited from two centres between 1998 and 2004; 56 men, 5 women, median age 70. 31 were allocated to drain site radiotherapy. Seven patients developed tract metastases associated with the drain site (four XRT arm, three BSC) and four developed metastases associated with subsequent procedures at other sites (three XRT, one BSC). Two patients each developed two tract metastases. Of the 12 metastases, nine overlay the previous drain site but three were adjacent to the site. No statistically significant difference was found in the risk of tract metastasis associated with the drain site between the arms (p = 0.748). Conclusions: Prophylactic drain site radiotherapy in malignant pleural mesothelioma does not reduce the incidence of tumour seeding by the margin indicated by previous studies

  11. Effect of oral sucralfate on late rectal injury associated with radiotherapy for prostate cancer: A double-blind, randomized trial.

    Science.gov (United States)

    Kneebone, Andrew; Mameghan, Hedy; Bolin, Terry; Berry, Martin; Turner, Sandra; Kearsley, John; Graham, Peter; Fisher, Richard; Delaney, Geoff

    2004-11-15

    To assess whether oral sucralfate is effective in preventing late rectal injury in prostate cancer patients treated with radiotherapy. A double-blind, placebo-controlled, randomized trial was conducted across four institutions in Australia. Patients receiving definitive radiotherapy for prostate cancer were randomized to receive either 3 g of oral sucralfate suspension or placebo twice daily. Data on patients' symptoms were collected for 2 years, and flexible sigmoidoscopy was scheduled at 12 months after treatment. A total of 338 patients were randomized, of whom 298 had adequate follow-up data available for an analysis of late symptoms. Of the 298 patients, 143 were randomized to receive sucralfate and 155 placebo. The cumulative incidence of Radiation Therapy Oncology Group Grade 2 or worse late rectal toxicity at 2 years was 28% for placebo and 22% for the sucralfate arm (p = 0.23; 95% confidence interval for the difference -3% to 16%). Seventeen percent of patients in the sucralfate group had significant bleeding (Grade 2 or worse) compared with 23% in the placebo group (p = 0.18, 95% confidence interval -15% to 3%). No statistically significant difference was found between the two groups with respect to bowel frequency (p = 0.99), mucus discharge (p = 0.64), or fecal incontinence (p = 0.90). Sigmoidoscopy findings showed a nonstatistically significant reduction in Grade 2 or worse rectal changes from 32% with placebo to 27% in the sucralfate group (p = 0.25). This trial demonstrated no statistically significant reduction in the incidence of late rectal toxicity in patients randomized to receive sucralfate. However, this result was considered inconclusive, because the trial was unable to exclude clinically important differences in the late toxicity rates.

  12. Locoregionally advanced carcinoma of the oropharynx: conventional radiotherapy vs. accelerated hyperfractionated radiotherapy vs. concomitant radiotherapy and chemotherapy - a multicenter randomized trial

    International Nuclear Information System (INIS)

    Olmi, Patrizia; Crispino, Sergio; Fallai, Carlo; Torri, Valter; Rossi, Francesca; Bolner, Andrea; Amichetti, Maurizio; Signor, Marco; Taino, Raffaella; Squadrelli, Massimo; Colombo, Alessandro; Ardizzoia, Alessandro; Ponticelli, Pietro; Franchin, Giovanni; Minatel, Emilio; Gobitti, Carlo; Atzeni, Guido; Gava, Alessandro; Flann, Monica; Marsoni, Silvia

    2003-01-01

    Purpose: To compare conventional fractionation radiation therapy (RT), Arm A, vs. split-course accelerated hyperfractionated RT (S-AHF), Arm B, vs. conventional fractionation RT plus concomitant chemotherapy (CT), Arm C, in terms of survival and toxicity for advanced, unresectable epidermoid tumors of oropharynx. Methods and Materials: Between January 1993 and June 1998, 192 previously untreated patients affected with Stage III and IV oropharyngeal carcinoma (excluding T1N1 and T2N1) were accrued in a multicenter, randomized Phase III trial (ORO 93-01). For Arms A and C, 66-70 Gy in 33-35 fractions, 5 days a week, were administered in 6.5-7 weeks to tumor and positive nodes. In Arm B, the dose delivered to tumor and involved nodes was 64-67.2 Gy, giving 2 fractions of 1.6 Gy every day with an interfraction interval of at least 4 h and preferably 6 h, 5 days a week. At 38.4 Gy, a 2-week split was planned; after the split, RT was resumed with the same modality. In Arm C, CT regimen consisted of carboplatin and 5-fluorouracil (CBDCA 75 mg/m 2 , Days 1-4; 5-FU 1,000 mg/m 2 i.v. over 96 h, Days 1-4, recycling every 28 days (at 1st, 5th, and 9th week). Results: No statistically significant difference was detected in overall survival (p=0.129): 40% Arm A vs. 37% Arm B vs. 51% Arm C were alive at 24 months. Similarly, there was no statistically significant difference in terms of event-free survival (p=0.196): 20% for Arm A, 19% for Arm B, and 37% for Arm C were event free at 24 months. On the contrary, the 2-year disease-free survival was significantly different among the three arms (p = 0.022), with a superiority for Arm C. At 24 months, the proportion of patients without relapse was 42% for Arm C vs. 23% for Arm A and 20% for Arm B. Patients in Arm A less frequently developed G3+ acute mucositis than their counterparts in Arm B or C (14.7% vs. 40.3% vs. 44%). Regarding the CT-related acute toxicity, apart from 1 case of fatal nephrotoxicity, only hematologic G3+ (Grade 3

  13. A pilot randomized trial to prevent sexual dysfunction in postmenopausal breast cancer survivors starting adjuvant aromatase inhibitor therapy.

    Science.gov (United States)

    Advani, Pragati; Brewster, Abenaa M; Baum, George P; Schover, Leslie R

    2017-08-01

    A randomized pilot trial evaluated the hypothesis that early intervention lessens sexual dysfunction in the first year on aromatase inhibitors. A secondary aim was comparing the efficacy of two vaginal moisturizers. Fifty-seven postmenopausal women with early stage breast cancer starting aromatase inhibitors were randomized to three treatment groups. All received a handout on managing sexual and other side effects. The Usual Care group received no additional therapy. The Active Treatment groups received a 6-month supply of a vaginal moisturizer (hyaluronic acid-based in Active Group-H and prebiotic in Active Group-P) and a vaginal lubricant and dilator, plus access to an educational website and phone coaching. Questionnaires completed at baseline, 6, and 12 months included the Female Sexual Function Index (FSFI), Menopausal Sexual Interest Questionnaire (MSIQ), Female Sexual Distress Scale-Revised (FSDS-R), and a menopausal symptom scale. Forty-nine women (86%) provided follow-up data. Mean age was 59 and 77% were non-Hispanic Caucasian. Sexual function was impaired at baseline, but remained stable over 12 months for all groups. The combined active treatment group had less dyspareunia (P = 0.07) and sexual distress (P = 0.02) at 6 months than the Usual Care group. At 6 months, the Active-H group improved significantly more than the Active-P group on FSFI total score (P = 0.04). Sexual counseling helped women maintain stable sexual function on aromatase inhibitors. Active intervention resulted in better outcomes at 6 months. This promising pilot trial suggests a need for more research on preventive counseling to maintain sexual function during aromatase inhibitor treatment.

  14. Adjuvant chemoradiotherapy versus radiotherapy alone for women with high-risk endometrial cancer (PORTEC-3) : final results of an international, open-label, multicentre, randomised, phase 3 trial

    NARCIS (Netherlands)

    de Boer, Stephanie M.; Powell, Melanie E.; Mileshkin, Linda; Katsaros, Dionyssios; Bessette, Paul; Haie-Meder, Christine; Ottevanger, Petronella B.; Ledermann, Jonathan A.; Khaw, Pearly; Colombo, Alessandro; Fyles, Anthony; Baron, Marie-Helene; Jurgenliemk-Schulz, Ina M.; Kitchener, Henry C.; Nijman, Hans W.; Wilson, Godfrey; Brooks, Susan; Carinelli, Silvestro; Provencher, Diane; Hanzen, Chantal; Lutgens, Ludy C. H. W.; Smit, Vincent T. H. B. M.; Singh, Naveena; Do, Viet; D'Amico, Romerai; Nout, Remi A.; Feeney, Amanda; Verhoeven-Adema, Karen W.; Putter, Hein; Creutzberg, Carien L.

    Background Although women with endometrial cancer generally have a favourable prognosis, those with high-risk disease features are at increased risk of recurrence. The PORTEC-3 trial was initiated to investigate the benefit of adjuvant chemotherapy during and after radiotherapy (chemoradiotherapy)

  15. Adjuvant chemoradiotherapy versus radiotherapy alone for women with high-risk endometrial cancer (PORTEC-3) : final results of an international, open-label, multicentre, randomised, phase 3 trial

    NARCIS (Netherlands)

    de Boer, Stephanie M.; Powell, Melanie E.; Mileshkin, Linda; Katsaros, Dionyssios; Bessette, Paul; Haie-Meder, Christine; Ottevanger, Petronella B.; Ledermann, Jonathan A.; Khaw, Pearly; Colombo, Alessandro; Fyles, Anthony; Baron, Marie Helene; Jürgenliemk-Schulz, Ina M.; Kitchener, Henry C.; Nijman, Hans W.; Wilson, Godfrey; Brooks, Susan; Carinelli, Silvestro; Provencher, Diane; Hanzen, Chantal; Lutgens, Ludy C.H.W.; Smit, Vincent T.H.B.M.; Singh, Naveena; Do, Viet; D'Amico, Romerai; Nout, Remi A.; Feeney, Amanda; Verhoeven-Adema, Karen W.; Putter, Hein; Creutzberg, Carien L.; McCormack, Mary; Whitmarsh, Karen; Allerton, Rozenn; Gregory, Deborah; Symonds, Paul; Hoskin, Peter J.; Adusumalli, Madhavi; Anand, Anjana; Wade, Robert; Stewart, Alexandra; Taylor, Wendy; Kruitwagen, Roy F.P.M.; Hollema, Harry; Pras, Elizabeth; Snyers, An; Stalpers, Lukas; Jobsen, Jan J.; Slot, Annerie; Mens, Jan Willem M.; Stam, Tanja C.; Van Triest, Baukelien; Van der Steen - Banasik, Elzbieta M.; De Winter, Karin A.J.; Quinn, Michael A.; Kolodziej, Ilka; Pyman, Jan; Johnson, Carol; Capp, Anne; Fossati, Roldano; Gribaudo, Sergio; Lissoni, Andrea A.; Ferrero, Annamaria; Artioli, Grazia; Davidson, Cathy; McLachlin, C. Meg; Ghatage, Prafull; Rittenberg, Paula V.C.; Souhami, Luis; Thomas, Gillian; Duvillard, Pierre; Berton-Rigaud, Dominique; Tubiana-Mathieu, Nicole

    2018-01-01

    Background: Although women with endometrial cancer generally have a favourable prognosis, those with high-risk disease features are at increased risk of recurrence. The PORTEC-3 trial was initiated to investigate the benefit of adjuvant chemotherapy during and after radiotherapy (chemoradiotherapy)

  16. Immune biomarkers of treatment failure for a patient on a phase I clinical trial of pembrolizumab plus radiotherapy

    Directory of Open Access Journals (Sweden)

    Gregory S. Alexander

    2016-09-01

    Full Text Available Abstract Background Pembrolizumab is a monoclonal antibody that is designed against programmed cell death protein 1 (PD-1. Pembrolizumab and other immunocheckpoint-blocking monoclonal antibodies work by modulating a patient’s own immune system to increase anti-tumor activity. While immunocheckpoint blockade has shown promising results, only 20–40 % of patients experience objective clinical benefit. Differences in individual tumor biology and the presence multiple immune checkpoints present a challenge for treatment. Because radiotherapy has immunomodulatory effects on the tumor microenvironment, it has the potential to synergize with immunotherapy and augment tumor response. NCT02318771 is a phase 1 clinical trial designed to investigate the immunomodulatory effects of radiation therapy in combination with pembrolizumab. Case presentation The patient is a 64-year-old male with metastatic clear cell renal cell carcinoma, Fuhrman grade 4, pathologically staged as T3 N0. Metastatic disease was well controlled for several years with sunitinib. Following disease progression, he was switched to axitinib. When disease progression continued, the patient was enrolled in NCT02318771, a phase 1 clinical trial combining radiotherapy and pembrolizumab. The patient experienced unusually rapid disease progression during treatment, which was confirmed by repeated CT scans to rule out pseudoprogression. Tissue biopsies and peripheral blood draws were obtained before, during, and after treatment. Samples were analyzed to provide plausible rationale for rapid treatment failure. Conclusions Biomarker analysis demonstrated an absence of TILs, which may be a cause of treatment failure as pembrolizumab works through T cell-dependent mechanisms. Furthermore, the presence of other non-redundant immune checkpoints in the periphery and tumor microenvironment presents a treatment challenge. Additionally, the radiation dose and fractionation schedule may have played a

  17. Long-Term Outcomes From a Prospective Trial of Stereotactic Body Radiotherapy for Low-Risk Prostate Cancer

    International Nuclear Information System (INIS)

    King, Christopher R.; Brooks, James D.; Gill, Harcharan; Presti, Joseph C.

    2012-01-01

    Purpose: Hypofractionated radiotherapy has an intrinsically different normal tissue and tumor radiobiology. The results of a prospective trial of stereotactic body radiotherapy (SBRT) for prostate cancer with long-term patient-reported toxicity and tumor control rates are presented. Methods and Materials: From 2003 through 2009, 67 patients with clinically localized low-risk prostate cancer were enrolled. Treatment consisted of 36.25 Gy in 5 fractions using SBRT with the CyberKnife as the delivery technology. No patient received hormone therapy. Patient self-reported bladder and rectal toxicities were graded on the Radiation Therapy Oncology Group scale (RTOG). Results: Median follow-up was 2.7 years. There were no grade 4 toxicities. Radiation Therapy Oncology Group Grade 3, 2, and 1 bladder toxicities were seen in 3% (2 patients), 5% (3 patients), and 23% (13 patients) respectively. Dysuria exacerbated by urologic instrumentation accounted for both patients with Grade 3 toxicity. Urinary incontinence, complete obstruction, or persistent hematuria was not observed. Rectal Grade 3, 2, and 1 toxicities were seen in 0, 2% (1 patient), and 12.5% (7 patients), respectively. Persistent rectal bleeding was not observed. Low-grade toxicities were substantially less frequent with QOD vs. QD dose regimen (p = 0.001 for gastrointestinal and p = 0.007 for genitourinary). There were two prostate-specific antigen (PSA), biopsy-proven failures with negative metastatic workup. Median PSA at follow-up was 0.5 ± 0.72 ng/mL. The 4-year Kaplan-Meier PSA relapse-free survival was 94% (95% confidence interval, 85%–102%). Conclusion: Significant late bladder and rectal toxicities from SBRT for prostate cancer are infrequent. PSA relapse-free survival compares favorably with other definitive treatments. The current evidence supports consideration of stereotactic body radiotherapy among the therapeutic options for localized prostate cancer.

  18. Long-Term Outcomes From a Prospective Trial of Stereotactic Body Radiotherapy for Low-Risk Prostate Cancer

    Energy Technology Data Exchange (ETDEWEB)

    King, Christopher R., E-mail: crking@mednet.ucla.edu [Departments of Radiation Oncology and Urology, University of California Los Angeles School of Medicine, Los Angeles, CA (United States); Brooks, James D.; Gill, Harcharan; Presti, Joseph C. [Department of Urology, Stanford University School of Medicine, Stanford, CA (United States)

    2012-02-01

    Purpose: Hypofractionated radiotherapy has an intrinsically different normal tissue and tumor radiobiology. The results of a prospective trial of stereotactic body radiotherapy (SBRT) for prostate cancer with long-term patient-reported toxicity and tumor control rates are presented. Methods and Materials: From 2003 through 2009, 67 patients with clinically localized low-risk prostate cancer were enrolled. Treatment consisted of 36.25 Gy in 5 fractions using SBRT with the CyberKnife as the delivery technology. No patient received hormone therapy. Patient self-reported bladder and rectal toxicities were graded on the Radiation Therapy Oncology Group scale (RTOG). Results: Median follow-up was 2.7 years. There were no grade 4 toxicities. Radiation Therapy Oncology Group Grade 3, 2, and 1 bladder toxicities were seen in 3% (2 patients), 5% (3 patients), and 23% (13 patients) respectively. Dysuria exacerbated by urologic instrumentation accounted for both patients with Grade 3 toxicity. Urinary incontinence, complete obstruction, or persistent hematuria was not observed. Rectal Grade 3, 2, and 1 toxicities were seen in 0, 2% (1 patient), and 12.5% (7 patients), respectively. Persistent rectal bleeding was not observed. Low-grade toxicities were substantially less frequent with QOD vs. QD dose regimen (p = 0.001 for gastrointestinal and p = 0.007 for genitourinary). There were two prostate-specific antigen (PSA), biopsy-proven failures with negative metastatic workup. Median PSA at follow-up was 0.5 {+-} 0.72 ng/mL. The 4-year Kaplan-Meier PSA relapse-free survival was 94% (95% confidence interval, 85%-102%). Conclusion: Significant late bladder and rectal toxicities from SBRT for prostate cancer are infrequent. PSA relapse-free survival compares favorably with other definitive treatments. The current evidence supports consideration of stereotactic body radiotherapy among the therapeutic options for localized prostate cancer.

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

    International Nuclear Information System (INIS)

    Nilsson, Per J; Marijnen, Corrie AM; Nagtegaal, Iris D; Wiggers, Theo; Glimelius, Bengt; Etten, Boudewijn van; Hospers, Geke AP; Påhlman, Lars; Velde, Cornelis JH van de; Beets-Tan, Regina GH; Blomqvist, Lennart; Beukema, Jannet C; Kapiteijn, Ellen

    2013-01-01

    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

  20. Stereotactic ablative radiotherapy for comprehensive treatment of oligometastatic tumors (SABR-COMET): Study protocol for a randomized phase II trial

    International Nuclear Information System (INIS)

    Palma, David A; Griffioen, GwendolynHMJ; Gaede, Stewart; Slotman, Ben; Senan, Suresh; Haasbeek, Cornelis J A; Rodrigues, George B; Dahele, Max; Lock, Michael; Yaremko, Brian; Olson, Robert; Liu, Mitchell; Panarotto, Jason

    2012-01-01

    Stereotactic ablative radiotherapy (SABR) has emerged as a new treatment option for patients with oligometastatic disease. SABR delivers precise, high-dose, hypofractionated radiotherapy, and achieves excellent rates of local control. Survival outcomes for patients with oligometastatic disease treated with SABR appear promising, but conclusions are limited by patient selection, and the lack of adequate controls in most studies. The goal of this multicenter randomized phase II trial is to assess the impact of a comprehensive oligometastatic SABR treatment program on overall survival and quality of life in patients with up to 5 metastatic cancer lesions, compared to patients who receive standard of care treatment alone. After stratification by the number of metastases (1-3 vs. 4-5), patients will be randomized between Arm 1: current standard of care treatment, and Arm 2: standard of care treatment + SABR to all sites of known disease. Patients will be randomized in a 1:2 ratio to Arm 1:Arm 2, respectively. For patients receiving SABR, radiotherapy dose and fractionation depends on the site of metastasis and the proximity to critical normal structures. This study aims to accrue a total of 99 patients within four years. The primary endpoint is overall survival, and secondary endpoints include quality of life, toxicity, progression-free survival, lesion control rate, and number of cycles of further chemotherapy/systemic therapy. This study will provide an assessment of the impact of SABR on clinical outcomes and quality of life, to determine if long-term survival can be achieved for selected patients with oligometastatic disease, and will inform the design of a possible phase III study. Clinicaltrials.gov identifier: NCT01446744

  1. Assessment of the role of chemotherapy and radiotherapy as adjuvant in the treatment of osteosarcomas of the limbs. A trial of the E. O. R. T. C. (Clinical Cooperative Group Radiotherapy/Chemotherapy) and of the S. I. O. P

    Energy Technology Data Exchange (ETDEWEB)

    van der Schueren, E; Breur, K; Cohen, P [Wilhelmina Gasthuis, Department of Radiotherapy, Amsterdam, Netherlands; Schweisguth, O; Voute, P A; Machin, D

    1979-07-01

    Since the majority of patients with osteosarcomas of the limbs develop lung metastases, radiotherapy and/or chemotherapy are used as adjuvant therapy immediately after treatment of the primary. This article questions the roles of radiotherapy and chemotherapy in this instance. A brief review of previous non-randomized studies is made. The overall conclusion seemed to be that although adjuvant chemotherapy resulted in a higher survival of patients with osteosarcoma, in comparison with historical controls, this form of treatment has not proven to be superior to the benefit achieved by lung irradiation. In the light of these studies, the Clinical Cooperative Group Radiotherapy/Chemotherapy (E.O.R.T.C.) and the International Society for Pediatric Oncology (S.I.O.P.) have initiated a prospective, randomized trial comparing chemotherapy, radiotherapy of the lungs and a combination of both treatments. The details of these treatments are given. This trial will try to answer very fundamental questions on adjuvant therapy in osteosarcomas. Active participation of as many medical centres as possible is requested.

  2. Concomitant chemo-radiotherapy for locally advanced bronchial cancer: impact of radiotherapy quality on global survival: results of a trial by the Thoracic Cancerology French-speaking Inter-group (IFCT) and Pneumo-Cancerology French Group (GFPC) 02.01; Chimioradiotherapie concomitante pour cancer bronchique localement evolue: impact de la qualite de la radiotherapie sur la survie globale: resultats de l'essai de l'Intergroupe francophone de cancerologie thoracique (IFCT) et du Groupe francais de pneumo-cancerologie (GFPC) 02.01

    Energy Technology Data Exchange (ETDEWEB)

    Martel-Lafay, I.; Montella, A.; Pommier, P. [Centre Leon-Berard, 69 - Lyon (France); Clavere, P. [CHU de Limoges, 87 - Limoges (France); Labat, J.P. [CHU de Brest, 29 - (France); Benchalal, M. [Centre Eugene-Marquis, 35 - Renne (France); Teissier, E. [Centre azureen de radiotherapie, 06 - Mougins (France); Talabard, J.N.; Fournel, P. [CHU de Saint- Etienne, 42 - Saint- Etienne (France); D' Hombres, A. [Centre hospitalier Lyon Sud, 69 - Pierre-Benite (France)

    2010-10-15

    The author report the assessment of the influence of radiotherapy quality and of its consequences on the future of 113 patients during a phase-II randomized trial of concomitant chemo-radiotherapy of bronchial cancers without stage-II non-resectable small cells. The patients have been submitted to a conformational radiotherapy and a concomitant induction of consolidation chemotherapy. Ten items are analysed: immobilisation, dose per fraction, total dose, ganglion radiotherapy, number of beams, images before and after radiotherapy, radiotherapy duration, duration without radiotherapy, dose-lung volume histogram. The study notably shows the deleterious effects of an interruption of the concomitant chemotherapy on the global survival. Short communication

  3. Acute and Late Toxicity in a Randomized Trial of Conventional Versus Hypofractionated Three-Dimensional Conformal Radiotherapy for Prostate Cancer

    International Nuclear Information System (INIS)

    Arcangeli, Giorgio; Fowler, Jack; Gomellini, Sara; Arcangeli, Stefano; Saracino, Biancamaria; Petrongari, Maria Grazia; Benassi, Marcello; Strigari, Lidia

    2011-01-01

    Purpose: To compare the toxicity between hypofractionation vs. conventional fractionation schedules in patients with high-risk prostate cancer. Methods and Materials: Between January 2003 and December 2007, 168 patients were randomized to receive either hypofractionated (62 Gy in 20 fractions within 5 weeks, 4 fractions/wk) or conventionally fractionated (80 Gy in 40 fractions within 8 weeks) three-dimensional conformal radiotherapy to the prostate and seminal vesicles. All patients had undergone a 9-month course of total androgen deprivation, with radiotherapy starting 2 months after initiation of the total androgen deprivation. Results: The median follow-up was 32 and 35 months in the hypofractionation and conventional fractionation arms, respectively. For the patients developing acute toxicity, no difference between the two fractionation groups was found in either severity or duration of gastrointestinal or genitourinary toxicity. Also, no difference was found in the incidence and severity of late gastrointestinal and genitourinary toxicity between the two treatment schedules, with a 3-year rate of Grade 2 or greater toxicity of 17% and 16% for the hypofractionation arm and 14% and 11% for the conventional fractionation arm, respectively. A statistically significant correlation between acute and late gastrointestinal toxicity was found only in the conventional fractionation group. Conclusion: Our findings suggest that the hypofractionation regimen used in our study is safe, with only a slight, nonsignificant increase in tolerable and temporary acute toxicity compared with the conventional fractionation schedule. The severity and frequency of late complications was equivalent between the two treatment groups.

  4. Classroom-based Interventions and Teachers' Perceived Job Stressors and Confidence: Evidence from a Randomized Trial in Head Start Settings.

    Science.gov (United States)

    Zhai, Fuhua; Raver, C Cybele; Li-Grining, Christine

    2011-09-01

    Preschool teachers' job stressors have received increasing attention but have been understudied in the literature. We investigated the impacts of a classroom-based intervention, the Chicago School Readiness Project (CSRP), on teachers' perceived job stressors and confidence, as indexed by their perceptions of job control, job resources, job demands, and confidence in behavior management. Using a clustered randomized controlled trial (RCT) design, the CSRP provided multifaceted services to the treatment group, including teacher training and mental health consultation, which were accompanied by stress-reduction services and workshops. Overall, 90 teachers in 35 classrooms at 18 Head Start sites participated in the study. After adjusting for teacher and classroom factors and site fixed effects, we found that the CSRP had significant effects on the improvement of teachers' perceived job control and work-related resources. We also found that the CSRP decreased teachers' confidence in behavior management and had no statistically significant effects on job demands. Overall, we did not find significant moderation effects of teacher race/ethnicity, education, teaching experience, or teacher type. The implications for research and policy are discussed.

  5. Prospective phase II trial of image-guided radiotherapy in Hodgkin lymphoma

    DEFF Research Database (Denmark)

    Petersen, Peter M; Aznar, Marianne C; Berthelsen, Anne K

    2015-01-01

    BACKGROUND: Long-term Hodgkin lymphoma (HL) survivors have an increased risk of late cardiac morbidity and secondary lung cancer after chemotherapy and mediastinal radiotherapy. In this prospective study we investigate whether radiotherapy with deep inspiration breath-hold (DIBH) can reduce...... radiation doses to the lungs, heart, and cardiac structures without compromising the target dose. PATIENTS AND METHODS: Twenty-two patients (14 female, 8 male), median age 30 years (18-65 years), with supra-diaphragmatic HL were enrolled and had a thoracic PET/CT with DIBH in addition to staging FDG...... retrospectively. Patients were treated with the technique yielding the lowest doses to normal structures. RESULTS: Nineteen patients were treated with DIBH and three with FB. DIBH reduced the mean estimated lung dose by 2.0 Gy (median: 8.5 Gy vs. 7.2 Gy) (p 4 Gy (6.0 Gy vs. 3...

  6. Phase I/II Trial of Hyperfractionated Concomitant Boost Proton Radiotherapy for Supratentorial Glioblastoma Multiforme

    International Nuclear Information System (INIS)

    Mizumoto, Masashi; Tsuboi, Koji; Igaki, Hiroshi; Yamamoto, Tetsuya; Takano, Shingo; Oshiro, Yoshiko; Hayashi, Yasutaka; Hashii, Haruko; Kanemoto, Ayae; Nakayama, Hidetsugu; Sugahara, Shinji; Sakurai, Hideyuki; Matsumura, Akira; Tokuuye, Koichi

    2010-01-01

    Purpose: To evaluate the safety and efficacy of postoperative hyperfractionated concomitant boost proton radiotherapy with nimustine hydrochloride for supratentorial glioblastoma multiforme (GBM). Methods and Materials: Twenty patients with histologically confirmed supratentorial GBM met the following criteria: (1) a Karnofsky performance status of ≥60; (2) the diameter of the enhanced area before radiotherapy was ≤40 cm; and (3) the enhanced area did not extend to the brain stem, hypothalamus, or thalamus. Magnetic resonance imaging (MRI) T 2 -weighted high area (clinical tumor volume 3 [CTV3]) was treated by x-ray radiotherapy in the morning (50.4 Gy in 28 fractions). More than 6 hours later, 250 MeV proton beams were delivered to the enhanced area plus a 10-mm margin (CTV2) in the first half of the protocol (23.1 GyE in 14 fractions) and to the enhanced volume (CTV1) in the latter half (23.1 GyE in 14 fraction). The total dose to the CTV1 was 96.6 GyE. Nimustine hydrochloride (80 mg/m2) was administered during the first and fourth weeks. Results: Acute toxicity was mainly hematologic and was controllable. Late radiation necrosis and leukoencephalopathy were each seen in one patient. The overall survival rates after 1 and 2 years were 71.1% and 45.3%, respectively. The median survival period was 21.6 months. The 1- and 2-year progression-free survival rates were 45.0% and 15.5%, respectively. The median MRI change-free survival was 11.2 months. Conclusions: Hyperfractionated concomitant boost proton radiotherapy (96.6 GyE in 56 fractions) for GBM was tolerable and beneficial if the target size was well considered. Further studies are warranted to pursue the possibility of controlling border region recurrences.

  7. Radiotherapy dosimetry audit: three decades of improving standards and accuracy in UK clinical practice and trials

    OpenAIRE

    Clark, Catharine H; Aird, Edwin GA; Bolton, Steve; Miles, Elizabeth A; Nisbet, Andrew; Snaith, Julia AD; Thomas, Russell AS; Venables, Karen; Thwaites, David I

    2015-01-01

    Dosimetry audit plays an important role in the development and safety of radiotherapy. National and large scale audits are able to set, maintain and improve standards, as well as having the potential to identify issues which may cause harm to patients. They can support implementation of complex techniques and can facilitate awareness and understanding of any issues which may exist by benchmarking centres with similar equipment. This review examines the development of dosimetry audit in the UK...

  8. Palliative radiotherapy in addition to self-expanding metal stent for improving dysphagia and survival in advanced oesophageal cancer (ROCS: Radiotherapy after Oesophageal Cancer Stenting): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Adamson, Douglas; Blazeby, Jane; Nelson, Annmarie; Hurt, Chris; Nixon, Lisette; Fitzgibbon, Jim; Crosby, Tom; Staffurth, John; Evans, Mim; Kelly, Noreen Hopewell; Cohen, David; Griffiths, Gareth; Byrne, Anthony

    2014-10-22

    The single most distressing symptom for patients with advanced esophageal cancer is dysphagia. Amongst the more effective treatments for relief of dysphagia is insertion of a self-expanding metal stent (SEMS). It is possible that the addition of a palliative dose of external beam radiotherapy may prolong the relief of dysphagia and provide additional survival benefit. The ROCS trial will assess the effect of adding palliative radiotherapy after esophageal stent insertion. The study is a randomized multicenter phase III trial, with an internal pilot phase, comparing stent alone versus stent plus palliative radiotherapy in patients with incurable esophageal cancer. Eligible participants are those with advanced esophageal cancer who are in need of stent insertion for primary management of dysphagia. Radiotherapy will be administered as 20 Gray (Gy) in five fractions over one week or 30 Gy in 10 fractions over two weeks, within four weeks of stent insertion. The internal pilot will assess rates and methods of recruitment; pre-agreed criteria will determine progression to the main trial. In total, 496 patients will be randomized in a 1:1 ratio with follow up until death. The primary outcome is time to progression of patient-reported dysphagia. Secondary outcomes include survival, toxicity, health resource utilization, and quality of life. An embedded qualitative study will explore the feasibility of patient recruitment by examining patients' motivations for involvement and their experiences of consent and recruitment, including reasons for not consenting. It will also explore patients' experiences of each trial arm. The ROCS study will be a challenging trial studying palliation in patients with a poor prognosis. The internal pilot design will optimize methods for recruitment and data collection to ensure that the main trial is completed on time. As a pragmatic trial, study strengths include collection of all follow-up data in the usual place of care, and a focus on

  9. Dexamethasone and supportive care with or without whole brain radiotherapy in treating patients with non-small cell lung cancer with brain metastases unsuitable for resection or stereotactic radiotherapy (QUARTZ): results from a phase 3, non-inferiority, randomised trial

    OpenAIRE

    Mulvenna, Paula; Nankivell, Matthew; Barton, Rachael; Faivre-Finn, Corinne; Wilson, Paula; McColl, Elaine; Moore, Barbara; Brisbane, Iona; Ardron, David; Holt, Tanya; Morgan, Sally; Lee, Caroline; Waite, Kathryn; Bayman, Neil; Pugh, Cheryl

    2016-01-01

    Summary Background Whole brain radiotherapy (WBRT) and dexamethasone are widely used to treat brain metastases from non-small cell lung cancer (NSCLC), although there have been no randomised clinical trials showing that WBRT improves either quality of life or overall survival. Even after treatment with WBRT, the prognosis of this patient group is poor. We aimed to establish whether WBRT could be omitted without a significant effect on survival or quality of life. Methods The Quality of Life a...

  10. Clinical trial of neoadjuvant chemotherapy combined with radiotherapy for primary intracranial germinomas

    International Nuclear Information System (INIS)

    Kitamura, Kei; Suzuki, Keishiro; Shirato, Hiroki; Kagei, Kenji; Aoyama, Hidefumi; Sawamura, Yutaka; Ikeda, Jun; Miyasaka, Kazuo

    1997-01-01

    Purpose/Objective: Since 1992, we have been using neoadjuvant chemotherapy to reduce the radiation dose and irradiated volume in the treatment of intracranial germinomas. This study evaluates the initial response and complications of the treatment and also the IQ score and pituitary function of patients before radiotherapy. Materials and methods: Fifteen patients with histologically confirmed intracranial germinomas were treated between 1992 and 1997. Six patients with solitary pure germinoma received 3 to 4 courses of etoposide and cisplatin (EP regimen) followed by localized irradiation of 24Gy (in 12 fractions within 3 weeks). Three patients with germinoma with syncytiotrophoblastic giant cells (STGC) and 4 patients with multifocal pure germinoma received 3 to 5 courses of ifosfamide, cisplatin and etoposide (ICE regimen), followed by localized irradiation of 24 Gy. Two patients with disseminated pure germinoma received 2 to 4 courses of ICE regimen followed by craniospinal irradiation of 24 Gy. In the planning of localized irradiation, the treatment field was determined so as to cover the tumor with a margin of 2cm. The IQ score and pituitary function before radiotherapy were also examined. MRI was performed in all patients one month after the completion of treatment and every 6 months in the follow-up study. The treatment data of our institute before 1991, as historical control, was analyzed and compared to that of the present study. Results: Complete remission (CR) was obtained in all patients after the treatment. One patient with germinoma with STGC experienced recurrence out of the field at 39 months after surgery. He was re-treated with salvage therapy including the ICE regimen and obtained a second complete remission. All patients are alive without disease with a median follow-up period of 29 months. The examination of IQ score and pituitary function before radiotherapy revealed mental retardation in 2 patients (22%) and hypopituitarism in 13 patients (86

  11. Health related quality of life in locally advanced NSCLC treated with high dose radiotherapy and concurrent chemotherapy or cetuximab – Pooled results from two prospective clinical trials

    International Nuclear Information System (INIS)

    Hallqvist, Andreas; Bergman, Bengt; Nyman, Jan

    2012-01-01

    Background: In non-small cell lung cancer (NSCLC) stage III, data on patient reported health-related quality of life (HRQL) are scarce, especially regarding concurrent chemoradiotherapy. Aims: To evaluate HRQL in patients treated with high dose radiotherapy combined with concurrent chemotherapy or the antibody cetuximab. Methods: The study population comprised all patients enroled in either of two phase II trials in locally advanced NSCLC performed in Sweden 2002–2007. The RAKET trial investigated three different ways of increasing local control (accelerated hyperfractionated treatment or concurrent daily or weekly chemotherapy). The Satellite trial evaluated the addition of cetuximab to thoracic irradiation. HRQL was measured at four time points: At baseline, before radiotherapy, 4–6 weeks after radiotherapy and at 3 months follow-up, using the EORTC QLQ-C30 and LC14 set of questionnaires. Results: 154/220 patients (65%) who completed HRQL assessments at all time points were included in the longitudinal study. There was a significant decline over time regarding most functioning measures. Dyspnoea and fatigue gradually deteriorated without recovery after completed treatment. Chemotherapy related symptoms showed a transient deterioration, whereas radiotherapy related esophagitis had not fully recovered at 3 months. Patients with stage IIIA disease tended to recover better regarding global QL, fatigue and dyspnoea compared to patients with stage IIIB. Patients with WHO performance status (PS) 0 reported improved global QL and less fatigue over time compared with PS 1. Concurrent chemotherapy was associated with more pronounced fatigue and dysphagia, and worse global QL compared with concurrent cetuximab. Baseline physical functioning was an independent predictor of overall survival. Conclusion: Patients undergoing high dose thoracic radiotherapy combined with chemotherapy or cetuximab reported a gradual deterioration in functioning, dyspnoea and fatigue, while

  12. A randomized, controlled trial of aerobic exercise for treatment-related fatigue in men receiving radical external beam radiotherapy for localized prostate carcinoma.

    Science.gov (United States)

    Windsor, Phyllis M; Nicol, Kathleen F; Potter, Joan

    2004-08-01

    Advice to rest and take things easy if patients become fatigued during radiotherapy may be detrimental. Aerobic walking improves physical functioning and has been an intervention for chemotherapy-related fatigue. A prospective, randomized, controlled trial was performed to determine whether aerobic exercise would reduce the incidence of fatigue and prevent deterioration in physical functioning during radiotherapy for localized prostate carcinoma. Sixty-six men were randomized before they received radical radiotherapy for localized prostate carcinoma, with 33 men randomized to an exercise group and 33 men randomized to a control group. Outcome measures were fatigue and distance walked in a modified shuttle test before and after radiotherapy. There were no significant between group differences noted with regard to fatigue scores at baseline (P = 0.55) or after 4 weeks of radiotherapy (P = 0.18). Men in the control group had significant increases in fatigue scores from baseline to the end of radiotherapy (P = 0.013), with no significant increases observed in the exercise group (P = 0.203). A nonsignificant reduction (2.4%) in shuttle test distance at the end of radiotherapy was observed in the control group; however, in the exercise group, there was a significant increase (13.2%) in distance walked (P = 0.0003). Men who followed advice to rest and take things easy if they became fatigued demonstrated a slight deterioration in physical functioning and a significant increase in fatigue at the end of radiotherapy. Home-based, moderate-intensity walking produced a significant improvement in physical functioning with no significant increase in fatigue. Improved physical functioning may be necessary to combat radiation fatigue.

  13. EORTC 22972-26991/MRC BR10 trial: Fractionated stereotactic boost following conventional radiotherapy of high grade gliomas

    International Nuclear Information System (INIS)

    Baumert, Brigitta G.; Brada, Michael; Bernier, Jacques; Kortmann, Rolf D.; Dehing-Oberije, Cary; Collette, Laurence; Davis, J. Bernard

    2008-01-01

    Background and purpose: The EORTC trial No. 22972 investigated the role of an additional fractionated stereotactic boost (fSRT) to conventional radiotherapy for patients with high grade gliomas. A quality-assurance (QA) programme was run in conjunction with the study and was the first within the EORTC addressing the quality of a supposedly highly accurate treatment technique such as stereotactic radiotherapy. A second aim was to investigate a possible relation between the clinical results of the stereotactic boost arm and the results of the QA. Materials and methods: The trial was closed in 2001 due to low accrual. In total, 25 patients were randomized: 14 into the experimental arm and 11 into the control arm. Six centres randomized patients, 8 centres had completed the dummy run (DR) for the stereotactic boost part. All participating centres (9) were asked to complete a quality-assurance questionnaire. The DR consisted of treatment planning according to the guidelines of the protocol on 3 different tumour volumes drawn on CT images of a humanized phantom. The SRT technique to be used was evaluated by the questionnaire. Clinical data from patients recruited to the boost arm from 6 participating centres were analysed. Results: There was a full compliance to the protocol requirements for 5 centres. Major and minor deviations in conformality were observed for 2 and 3 centres, respectively. Of the 8 centres which completed the DR, one centre did not comply with the requirements of stereotactic radiotherapy concerning accuracy, dosimetry and planning. Median follow-up and median overall survival were 39.2 and 21.4 months, respectively. Acute and late toxicities of the stereotactic boost were low. One radiation necrosis was seen for a patient who has not received the SRT boost. Three reported serious adverse events were all seizures and probably therapy-related. Conclusions: Overall compliance was good but not ideal from the point of view of this highly precise radiation

  14. The role of technology in clinical trials using stereotactic body radiotherapy

    DEFF Research Database (Denmark)

    Aznar, Marianne; Romero, Alejandra Méndez; Heijmen, Ben J.M.

    2017-01-01

    , the crucial point for the next generation of SABR clinical trials is that today's technology is used correctly and close to its optimal potential for accuracy. The credentialing procedure of SABR needs to be extensive, but this investment will benefit the trial itself, the patients and the professionals...

  15. Sexual Function After Three-Dimensional Conformal Radiotherapy for Prostate Cancer: Results From a Dose-Escalation Trial

    International Nuclear Information System (INIS)

    Wielen, Gerard J. van der; Putten, Wim van; Incrocci, Luca

    2007-01-01

    Purpose: The purpose of this study is to provide information about sexual function (SF) after three-dimensional conformal radiotherapy (3D-CRT) for prostate cancer while taking important factors into account that influence SF. Methods and Materials: Between June 1997 and February 2003, a total of 268 patients from a randomized dose-escalation trial comparing 68 Gy and 78 Gy agreed to participate in an additional part of the trial that evaluated SF. Results: At baseline 28% of patients had erectile dysfunction (ED). After 1 year, 27% of the pretreatment potent patients had developed ED. After 2 years this percentage had increased to 36%. After 3 years it almost stabilized at 38%. Satisfaction with sexual life was significantly correlated with ED. After 2 years one third of the pre-treatment potent patients still had considerable to very much sexual desire and found sex (very) important. No significant differences were found between the two dose-arms. Potency aids were used on a regular base by 14% of the patients. Conclusion: By taking adjuvant hormonal therapy (HT), HT during follow-up and potency aids into account, we found a lower percentage of ED after 3D-CRT than reported in previous prospective studies. A large group of patients still had sexual desire, considered sex important and 14% used potency aids after 3D-CRT

  16. Which patients with ES-SCLC are most likely to benefit from more aggressive radiotherapy: A secondary analysis of the Phase III CREST trial.

    Science.gov (United States)

    Slotman, Ben J; Faivre-Finn, Corinne; van Tinteren, Harm; Keijser, Astrid; Praag, John; Knegjens, Joost; Hatton, Matthew; van Dam, Iris; van der Leest, Annija; Reymen, Bart; Stigt, Jos; Haslett, Kate; Tripathi, Devashish; Smit, Egbert F; Senan, Suresh

    2017-06-01

    In ES-SCLC patients with residual intrathoracic disease after first-line chemotherapy, the addition of thoracic radiotherapy reduces the risk of intrathoracic recurrence, and improves 2-year survival. To identify patient subgroups for future trials investigating higher dose (extra)thoracic radiotherapy, we investigated the prognostic importance of number and sites of metastases in patients included in the CREST trial. Additional data on sites and numbers of metastases were collected from individual records of 260 patients from the top 9 recruiting centers in the randomized CREST trial (53% of 495 study patients), which compared thoracic radiotherapy (TRT) to no TRT in ES-SCLC patients after any response to chemotherapy. All patients received prophylactic cranial irradiation. The clinical characteristics and outcomes of the 260 patients analyzed here did not differ significantly from that of the other 235 patients included in the CREST trial, except that fewer patients had a WHO=0 performance status (24% vs 45%), and a higher proportion had WHO=2 (15% vs 5%; pradiotherapy in ES-SCLC should focus on patients with fewer than 3 distant metastases. Copyright © 2017 The Author(s). Published by Elsevier B.V. All rights reserved.

  17. A randomized controlled trial to investigate the influence of low dose radiotherapy on immune stimulatory effects in liver metastases of colorectal cancer

    International Nuclear Information System (INIS)

    Reissfelder, Christoph; Büchler, Markus W; Beckhove, Philipp; Huber, Peter E; Weitz, Jürgen; Timke, Carmen; Schmitz-Winnenthal, Hubertus; Rahbari, Nuh N; Koch, Moritz; Klug, Felix; Roeder, Falk; Edler, Lutz; Debus, Jürgen

    2011-01-01

    Insufficient migration and activation of tumor specific effector T cells in the tumor is one of the main reasons for inadequate host anti-tumor immune response. External radiation seems to induce inflammation and activate the immune response. This phase I/II clinical trial aims to evaluate whether low dose single fraction radiotherapy can improve T cell associated antitumor immune response in patients with colorectal liver metastases. This is an investigator-initiated, prospective randomised, 4-armed, controlled Phase I/II trial. Patients undergoing elective hepatic resection due to colorectal cancer liver metastasis will be enrolled in the study. Patients will receive 0 Gy, 0.5 Gy, 2 Gy or 5 Gy radiation targeted to their liver metastasis. Radiation will be applied by external beam radiotherapy using a 6 MV linear accelerator (Linac) with intensity modulated radiotherapy (IMRT) technique two days prior to surgical resection. All patients admitted to the Department of General-, Visceral-, and Transplantion Surgery, University of Heidelberg for elective hepatic resection are consecutively screened for eligibility into this trial, and written informed consent is obtained before inclusion. The primary objective is to assess the effect of active local external beam radiation dose on, tumor infiltrating T cells as a surrogate parameter for antitumor activity. Secondary objectives include radiogenic treatment toxicity, postoperative morbidity and mortality, local tumor control and recurrence patterns, survival and quality of life. Furthermore, frequencies of systemic tumor reactive T cells in blood and bone marrow will be correlated with clinical outcome. This is a randomized controlled patient blinded trial to assess the safety and efficiency of low dose radiotherapy on metastasis infiltrating T cells and thus potentially enhance the antitumor immune response. ClinicalTrials.gov: http://www.clinicaltrials.gov/ct2/show/NCT01191632

  18. A phase I trial of etanidazole and hyperfractionated radiotherapy in children with diffuse brain stem glioma

    International Nuclear Information System (INIS)

    Dutton, S.C.; Pomeroy, S.L.; Billett, A.L.; Barnes, P.; Kuhlman, C.; Riese, N.E.; Goumnerova, L.; Scott, R.M.; Coleman, C.N.; Tarbell, N.J.

    1997-01-01

    neuropathy was not seen at any dose level. The incidence of clinical improvement during HRT was 94%. The median survival from the start of treatment was 8.5 months (range 3-30 months). Only one of 18 patients is alive 30 months after treatment. Conclusion: The MTD of etanidazole in children receiving twice daily RT for brain stem glioma is 42 gm/m2 with cutaneous rash as the dose limiting toxicity. This is in contrast to the adult experience demonstrating a 24% lower MTD of 34 gm/m2 limited by peripheral neuropathy. The lack of dose limiting peripheral neuropathy in this study demonstrates the different pattern of drug toxicity in children and adults. Proof of treatment efficacy requires a phase II trial

  19. Evaluation of time, attendance of medical staff and resources for radiotherapy in pediatric and adolescent patients. The DEGRO-QUIRO trial

    Energy Technology Data Exchange (ETDEWEB)

    Zabel-du Bois, Angelika; Milker-Zabel, Stefanie; Debus, Juergen [University of Heidelberg, Department of Radiotherapy and RadioOncology, Heidelberg (Germany); Bruns, Frank; Christiansen, Hans [Medical School Hannover, Department of Radiation Oncology, Hannover (Germany); Ernst, Iris; Willich, Normann [University of Muenster, Department of Radiation Oncology, Muenster (Germany); Popp, Wolfgang [Prime Networks AG, Basel (Switzerland); Sack, Horst [University of Essen, Department of Radiation Oncology, Essen (Germany)

    2014-06-15

    The German Society of Radiation Oncology (DEGRO) initiated a multicenter trial to develop and evaluate adequate modules to assert core procedures in radiotherapy. The aim of this prospective evaluation was to methodical assess the required resources for radiotherapy in pediatric and adolescent patients. At three radiotherapy centers of excellence (University Hospitals of Heidelberg and Muenster, the Medical School of Hannover), the manpower and time required for radiotherapy in pediatric and adolescent patients was prospectively documented consistently over a 2-year period. The data were collected using specifically developed standard forms and were evaluated using specific process analysis tools. A total number of 1914 data sets were documented and carefully analyzed. The personnel time requirements for all occupational groups were calculated as total time needed for a specific procedure and mean time per person. Regarding radiotherapy in general anesthesia, the required manpower was higher. The personnel time requirements in these cases were also longer, mainly due to longer room occupancy. Overall, the required resources were remarkably similar between the three different departments and may, therefore, be considered as representative. For the first time, the personnel time requirements of a radiotherapy department for the maintenance, protection, and optimization of operational readiness for radiotherapy in pediatric and adolescent patients with and without general anesthesia were determined methodically. (orig.) [German] Die deutsche Gesellschaft fuer Radioonkologie (DEGRO) initiierte eine Multizenterstudie zur Entwicklung und Anwendung geeigneter Module zur Erhebung und Analyse von Kernprozessen bei der Radiotherapie von Kindern und Jugendlichen. Ziel dieser prospektiven Erhebung war es, die erforderlichen Ressourcen bei der Radiotherapie im Kindesalter systematisch zu evaluieren. An drei strahlentherapeutischen Kompetenzzentren (Universitaetskliniken

  20. A Double-Blind Placebo-Controlled Randomized Clinical Trial With Magnesium Oxide to Reduce Intrafraction Prostate Motion for Prostate Cancer Radiotherapy

    Energy Technology Data Exchange (ETDEWEB)

    Lips, Irene M., E-mail: i.m.lips@umcutrecht.nl [Department of Radiation Oncology, University Medical Center Utrecht, Utrecht (Netherlands); Gils, Carla H. van [Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht (Netherlands); Kotte, Alexis N.T.J. [Department of Radiation Oncology, University Medical Center Utrecht, Utrecht (Netherlands); Leerdam, Monique E. van [Department of Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam (Netherlands); Franken, Stefan P.G.; Heide, Uulke A. van der; Vulpen, Marco van [Department of Radiation Oncology, University Medical Center Utrecht, Utrecht (Netherlands)

    2012-06-01

    Purpose: To investigate whether magnesium oxide during external-beam radiotherapy for prostate cancer reduces intrafraction prostate motion in a double-blind, placebo-controlled randomized trial. Methods and Materials: At the Department of Radiotherapy, prostate cancer patients scheduled for intensity-modulated radiotherapy (77 Gy in 35 fractions) using fiducial marker-based position verification were randomly assigned to receive magnesium oxide (500 mg twice a day) or placebo during radiotherapy. The primary outcome was the proportion of patients with clinically relevant intrafraction prostate motion, defined as the proportion of patients who demonstrated in {>=}50% of the fractions an intrafraction motion outside a range of 2 mm. Secondary outcome measures included quality of life and acute toxicity. Results: In total, 46 patients per treatment arm were enrolled. The primary endpoint did not show a statistically significant difference between the treatment arms with a percentage of patients with clinically relevant intrafraction motion of 83% in the magnesium oxide arm as compared with 80% in the placebo arm (p = 1.00). Concerning the secondary endpoints, exploratory analyses demonstrated a trend towards worsened quality of life and slightly more toxicity in the magnesium oxide arm than in the placebo arm; however, these differences were not statistically significant. Conclusions: Magnesium oxide is not effective in reducing the intrafraction prostate motion during external-beam radiotherapy, and therefore there is no indication to use it in clinical practice for this purpose.

  1. Stereotactic ablative radiotherapy after concomitant chemoradiotherapy in non-small cell lung cancer: A TITE-CRM phase 1 trial.

    Science.gov (United States)

    Doyen, Jérôme; Poudenx, Michel; Gal, Jocelyn; Otto, Josiane; Guerder, Caroline; Naghavi, Arash O; Gérard, Anais; Leysalle, Axel; Cohen, Charlotte; Padovani, Bernard; Ianessi, Antoine; Schiappa, Renaud; Chamorey, Emmanuel; Bondiau, Pierre-Yves

    2018-05-01

    Platinum based chemoradiotherapy is the standard of care for inoperable non-small cell lung cancer (NSCLC). With evidence that NSCLC can have a dose dependent response with stereotactic ablative radiotherapy (SABR), we hypothesize that a SABR boost on residual tumor treated with chemoradiotherapy could increase treatment efficacy. The purpose of this study was to determine feasibility of such an approach. A prospective phase I trial was performed including 26 patients. Time-to-event continual reassessment method (TITE-CRM) was used for dose escalation which ranged from 3 × 7 to 3 × 12 Gy for the stereotactic boost, after 46 Gy (2 Gy per day) of chemoradiotherapy. Median follow-up was of 37.1 months (1.7-60.7), and 3, 4, 3, 3, 9 and 4 patients were included at the dose levels 1, 2, 3, 4, 5 and 6, respectively. During chemoradiotherapy, 9 patients experienced grade 3 toxicity. After stereotactic radiotherapy, 1 patient experienced an esophageal fistula (with local relapse) at the 3 × 11 Gy level, and 1 patient died from hemoptysis at the 3 × 12 Gy level. The 2-year rate of local control, locoregional free survival, metastasis-free survival, and overall survival was 70.3%, 55.5%, 44.5% and 50.8%, respectively. In the treatment of NSCLC with chemoradiotherapy followed by a stereotactic boost, the safe recommended dose in our protocol was a boost dose of 3 × 11 Gy. Copyright © 2018 Elsevier B.V. All rights reserved.

  2. Phase I trial of cetuximab in combination with capecitabine, weekly irinotecan, and radiotherapy as neoadjuvant therapy for rectal cancer

    International Nuclear Information System (INIS)

    Hofheinz, Ralf-Dieter; Horisberger, Karoline; Woernle, Christoph; Wenz, Frederik; Kraus-Tiefenbacher, Uta; Kaehler, Georg; Dinter, Dietmar; Grobholz, Rainer; Heeger, Steffen; Post, Stefan; Hochhaus, Andreas; Willeke, Frank

    2006-01-01

    Purpose: To establish the feasibility and efficacy of chemotherapy with capecitabine, weekly irinotecan, cetuximab, and pelvic radiotherapy for patients with locally advanced rectal cancer. Methods and materials: Twenty patients with rectal cancer (clinical Stage uT3-T4 or N+) received a standard dosing regimen of cetuximab (400 mg/m 2 on Day 1 and 250 mg/m 2 on Days 8, 15, 22, and 29) and escalating doses of irinotecan and capecitabine according to phase I methods: dose level I, irinotecan 40 mg/m 2 on Days 1, 8, 15, 22, and 29 and capecitabine 800 mg/m 2 on Days 1-38; dose level II, irinotecan 40 mg/m 2 and capecitabine 1000 mg/m 2 ; and dose level III, irinotecan 50 mg/m 2 and capecitabine 1000 mg/m 2 . Radiotherapy was given to a dose of 50.4 Gy (45 Gy plus 5.4 Gy). Resection was scheduled 4-5 weeks after termination of chemoradiotherapy. Results: On dose level I, no dose-limiting toxicities occurred; however, Grade 3 diarrhea affected 1 of 6 patients on dose level II. Of 5 patients treated at dose level III, 2 exhibited dose-limiting toxicity (diarrhea in 2 and nausea/vomiting in 1). Therefore, dose level II was determined as the recommended dose for future studies. A total of 10 patients were treated on dose level II and received a mean relative dose intensity of 100% of cetuximab, 94% of irinotecan, and 95% of capecitabine. All patients underwent surgery. Five patients had a pathologically complete remission and six had microfoci of residual tumor only. Conclusion: Preoperative chemoradiotherapy with cetuximab, capecitabine, and weekly irinotecan is feasible and well tolerated. The preliminary efficacy is very promising. Larger phase II trials are ongoing

  3. Phase III trial of high and low dose rate interstitial radiotherapy for early oral tongue cancer

    International Nuclear Information System (INIS)

    Inoue, Takehiro; Inoue, Toshihiko; Teshima, Teruki; Murayama, Shigeyuki; Shimizutani, Kimishige; Fuchihata, Hajime; Furukawa, Souhei

    1996-01-01

    Purpose: Oral tongue carcinomas are highly curable with radiotherapy. In the past, patients with tongue carcinoma have usually been treated with low dose rate (LDR) interstitial radiation. This Phase III study was designed to compare the treatment results obtained with LDR with those obtained with high dose rate (HDR) interstitial radiotherapy for tongue carcinoma. Methods and Materials: The criteria for patient selection for the Phase III study were: (a) presence of a T1T2N0 tumor that could be treated with single-plane implantation, (b) localization of tumor at the lateral tongue border, (c) tumor thickness of 10 mm or less, (d) performance status between O and 3, and (e) absence of any severe concurrent disease. From April 1992 through December 1993, 15 patients in the LDR group (70 Gy/4 to 9 days) and 14 patients in the HDR group (60 Gy/10 fractions/6 days) were accrued. The time interval between two fractions of the HDR brachytherapy was more than 6 h. Results: Local recurrence occurred in two patients treated with LDR brachytherapy but in none of the patients treated with HDR. One- and 2-year local control rates for patients in the LDR group were both 86%, compared with 100% in the HDR group (p = 0.157). There were four patients with nodal metastasis in the LDR group and three in the HDR group. Local recurrence occurred in two of the four patients with nodal metastases in the LDR group. One- and 2-year nodal control rates for patients in the LDR group are were 85%, compared with 79% in the HDR group. Conclusion: HDR fractionated interstitial brachytherapy can be an alternative to traditional LDR brachytherapy for early tongue cancer and eliminate the radiation exposure for medical staffs

  4. Radiotherapy quality assurance for the RTOG 0834/EORTC 26053-22054/NCIC CTG CEC.1/CATNON intergroup trial "concurrent and adjuvant temozolomide chemotherapy in newly diagnosed non-1p/19q deleted anaplastic glioma": Individual case review analysis.

    Science.gov (United States)

    Abrunhosa-Branquinho, André N; Bar-Deroma, Raquel; Collette, Sandra; Clementel, Enrico; Liu, Yan; Hurkmans, Coen W; Feuvret, Loïc; Van Beek, Karen; van den Bent, Martin; Baumert, Brigitta G; Weber, Damien C

    2018-03-29

    The EORTC phase III 26053-22054/ RTOG 0834/NCIC CTG CEC.1/CATNON intergroup trial was designed to evaluate the impact on concurrent and adjuvant temozolomide chemotherapy in newly diagnosed non-1p/19q deleted anaplastic gliomas. The primary endpoint was overall survival. We report the results of retrospective individual case reviews (ICRs) for the first patient randomized per institution to detect the compliance with the study protocol. Sixty-nine institutions were required to submit the radiotherapy plan of their first randomized patient. Full digital datasets uploaded to the EORTC server were assessed by three independent and blinded reviewers through the EORTC radiotherapy quality assurance platform. Sixty-two (90%) of sixty-nine ICRs were received and assessable. Of the 62 cases, 22 were evaluated as per protocol (35.5%), 11 as acceptable variation (17.7%) and 29 were classified as unacceptable variations (46.8%). Most common unacceptable variations were related to the PTV dose (n = 19, 31%) and delineation (n = 17, 27%) processes. The ICR analysis showed a significant number of unacceptable variations with potential impact on tumor control and/or toxicity profile. Prospective ICRs are encouraged for future studies to prevent and correct protocol violations before start of treatment. Copyright © 2018 Elsevier B.V. All rights reserved.

  5. A Phase 1 Trial of an Immune Checkpoint Inhibitor plus Stereotactic Ablative Radiotherapy in Patients with Inoperable Stage I Non-Small Cell Lung Cancer

    Science.gov (United States)

    2017-10-01

    with Inoperable Stage I Non-Small Cell Lung Cancer PRINCIPAL INVESTIGATOR: Karen Kelly, MD CONTRACTING ORGANIZATION: University of California...Inhibitor plus Stereotactic Ablative Radiotherapy in Patients with Inoperable Stage I Non-Small Cell Lung Cancer 5b. GRANT NUMBER W81XWH-15-2-0063...immune checkpoint inhibitor MPDL3280A (atezolizumab) in early stage inoperable non-small cell lung cancer . The trial is comprised of a traditional 3 + 3

  6. Changes in Cardiovascular Disease Risk Factors With Immediate Versus Deferred Antiretroviral Therapy Initiation Among HIV-Positive Participants in the START (Strategic Timing of Antiretroviral Treatment) Trial

    DEFF Research Database (Denmark)

    Baker, Jason V; Sharma, Shweta; Achhra, Amit C

    2017-01-01

    INTRODUCTION: HIV infection and certain antiretroviral therapy (ART) medications increase atherosclerotic cardiovascular disease risk, mediated, in part, through traditional cardiovascular disease risk factors. METHODS AND RESULTS: We studied cardiovascular disease risk factor changes in the START...... (Strategic Timing of Antiretroviral Treatment) trial, a randomized study of immediate versus deferred ART initiation among HIV-positive persons with CD4+ cell counts >500 cells/mm3. Mean change from baseline in risk factors and the incidence of comorbid conditions were compared between groups....... The characteristics among 4685 HIV-positive START trial participants include a median age of 36 years, a CD4 cell count of 651 cells/mm3, an HIV viral load of 12 759 copies/mL, a current smoking status of 32%, a median systolic/diastolic blood pressure of 120/76 mm Hg, and median levels of total cholesterol of 168 mg...

  7. FIFTEEN-YEAR RADIOTHERAPY OUTCOMES OF THE RANDOMIZED PORTEC-1 TRIAL FOR ENDOMETRIAL CARCINOMA

    NARCIS (Netherlands)

    Creutzberg, Carien L.; Nout, Remi A.; Lybeert, Marnix L. M.; Warlam-Rodenhuis, Carla C.; Jobsen, Jan J.; Mens, Jan-Willem M.; Lutgens, Ludy C. H. W.; Pras, Elisabeth; van de Poll-Franse, Lonneke V.; van Putten, Wim L. J.

    2011-01-01

    Purpose: To evaluate the very long-term results of the randomized Post Operative Radiation Therapy in Endometrial Carcinoma (PORTEC)-1 trial for patients with Stage I endometrial carcinoma (EC), focusing on the role of prognostic factors for treatment selection and the long-term risk of second

  8. Trial study on design of irradiated fields of radiotherapy in cervical and upper thoracic esophageal cancer

    International Nuclear Information System (INIS)

    Liu Hui; Zeng Zhifan; Cui Nianji; He Zhichun; Huang Shaomin

    2006-01-01

    Objective: To compare three kinds of irradiation treatment plans for cervical and upper thoracic esophageal cancer, in order to arrived at proper decision for the patient. Methods: From February 2001 to June 2004, 43 such patients were studied with three different simulated treatment plans made including conformal plan, conventional four-field plan and conventional two-field plan for every one. All plans were evaluated with iso- dose curve and dose-volume histogram. Results: GTV on 95% isodose curve was 99.5%, 98.2% and 87.4% in conformal plan, conventional four-field plan and conventional two-field plan, respectively; PTV 1 and PTV 2 on 95% isodose with 97.8%, 97.2%, 94.8% and 95.8%, 86.6%, 73.7%. The volume of > 20 Gy dose of left lung accepted was 18.6%, 17.2% and 32.3%, in conformal plan, conventional four-field plan and conventional two-field plan, respectively; the right lung received 20.5% ,19.9% and 35.5%. Conclusions: Conformal plan is the best in radiotherapy, as it can provide ideal dose distribution of irradiated target with adequate protection of the normal tissues. Conventional four-field plan, being easy to carry, out, can replace the conformal plan in most situations. Conventional two-field has the most uneven dose distribution and largest lung volume irradiated. (authors)

  9. Automated customized retrieval of radiotherapy data for clinical trials, audit and research.

    Science.gov (United States)

    Romanchikova, Marina; Harrison, Karl; Burnet, Neil G; Hoole, Andrew Cf; Sutcliffe, Michael Pf; Parker, Michael Andrew; Jena, Rajesh; Thomas, Simon James

    2018-02-01

    To enable fast and customizable automated collection of radiotherapy (RT) data from tomotherapy storage. Human-readable data maps (TagMaps) were created to generate DICOM-RT (Digital Imaging and Communications in Medicine standard for Radiation Therapy) data from tomotherapy archives, and provided access to "hidden" information comprising delivery sinograms, positional corrections and adaptive-RT doses. 797 data sets totalling 25,000 scans were batch-exported in 31.5 h. All archived information was restored, including the data not available via commercial software. The exported data were DICOM-compliant and compatible with major commercial tools including RayStation, Pinnacle and ProSoma. The export ran without operator interventions. The TagMap method for DICOM-RT data modelling produced software that was many times faster than the vendor's solution, required minimal operator input and delivered high volumes of vendor-identical DICOM data. The approach is applicable to many clinical and research data processing scenarios and can be adapted to recover DICOM-RT data from other proprietary storage types such as Elekta, Pinnacle or ProSoma. Advances in knowledge: A novel method to translate data from proprietary storage to DICOM-RT is presented. It provides access to the data hidden in electronic archives, offers a working solution to the issues of data migration and vendor lock-in and paves the way for large-scale imaging and radiomics studies.

  10. Time management in radiation oncology: evaluation of time, attendance of medical staff, and resources during radiotherapy for prostate cancer: the DEGRO-QUIRO trial.

    Science.gov (United States)

    Keilholz, L; Willner, J; Thiel, H-J; Zamboglou, N; Sack, H; Popp, W

    2014-01-01

    In order to evaluate resource requirements, the German Society of Radiation Oncology (DEGRO) recorded the times needed for core procedures in the radio-oncological treatment of various cancer types within the scope of its QUIRO trial. The present study investigated the personnel and infrastructural resources required in radiotherapy of prostate cancer. The investigation was carried out in the setting of definitive radiotherapy of prostate cancer patients between July and October 2008 at two radiotherapy centers, both with well-trained staff and modern technical facilities at their disposal. Personnel attendance times and room occupancy times required for core procedures (modules) were each measured prospectively by two independently trained observers using time measurements differentiated on the basis of professional group (physician, physicist, and technician), 3D conformal (3D-cRT), and intensity-modulated radiotherapy (IMRT). Total time requirements of 983 min for 3D-cRT and 1485 min for step-and-shoot IMRT were measured for the technician (in terms of professional group) in all modules recorded and over the entire course of radiotherapy for prostate cancer (72-76 Gy). Times needed for the medical specialist/physician were 255 min (3D-cRT) and 271 min (IMRT), times of the physicist were 181 min (3D-cRT) and 213 min (IMRT). The difference in time was significant, although variations in time spans occurred primarily as a result of various problems during patient treatment. This investigation has permitted, for the first time, a realistic estimation of average personnel and infrastructural requirements for core procedures in quality-assured definitive radiotherapy of prostate cancer. The increased time needed for IMRT applies to the step-and-shoot procedure with verification measurements for each irradiation planning.

  11. A phase I-II trial of multimodality management of bulky gynecologic malignancy. Combined chemoradiosensitization and radiotherapy

    Energy Technology Data Exchange (ETDEWEB)

    Kersh, C.R.; Constable, W.C.; Spaulding, C.A.; Hahn, S.S.; Andersen, W.A.; Taylor, P.T. (Univ. of Virginia Health Sciences Center, Charlottesville (USA))

    1990-07-01

    Between December 1983 and December 1987, there were 44 patients with bulky, nonresectable squamous cell carcinomas of the gynecologic tract (cervix, 36; vagina, eight) who were treated with concomitant chemotherapy and radiotherapy. Chemotherapy consisted of 5-fluorouracil (5-FU) 1g/m2 given by continuous intravenous infusion on days 1 through 4 and mitomycin C 10 mg/m2 given intravenously on day 1. External-beam irradiation was started on day 1 with a total calculated dose of 5000 cGy in 25 fractions employed. This was followed by brachytherapy. With a mean follow-up of 30.3 months and a median of 28 months, local control has been achieved in 32 of 44 patients (73%). The overall response rate was 88% (3-month partial response, 43%; 3-month complete response, 45%; 8-month partial response, 15%; 8-month complete response, 73%). Analysis of complications by Radiation Therapy Oncology Group (RTOG) criteria did not demonstrate an increase in acute or late complications.

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

    Energy Technology Data Exchange (ETDEWEB)

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

    1993-01-01

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

  13. Phase III trial of high- vs. low-dose-rate interstitial radiotherapy for early mobile tongue cancer

    International Nuclear Information System (INIS)

    Inoue, Takehiro; Inoue, Toshihiko; Yoshida, Ken; Yoshioka, Yasuo; Shimamoto, Shigetoshi; Tanaka, Eiichi; Yamazaki, Hideya; Shimizutani, Kimishige; Teshima, Teruki; Furukawa, Souhei

    2001-01-01

    Purpose: Early mobile tongue cancer can be controlled with interstitial radiotherapy (ISRT). We carried out a Phase III trial to compare the treatment results of low-dose-rate (Ld) ISRT and high-dose-rate (HDR) ISRT for early mobile tongue cancer. Methods and Materials: From April 1992 through October 1996, 59 patients with cancer of the early mobile tongue were registered in this Phase III study. Eight patients were excluded from the evaluation because of violations of the requirements for this study. Of 51 eligible patients, 26 patients were treated with LDR-ISRT (70 Gy/4-9 days) and 25 patients with HDR-ISRT (60 Gy/10 fractions/1 week). For the hyperfractionated HDR-ISRT, the time interval between 2 fractions was more than 6 h. Results: Five-year local control rates of the LDR and HDR groups were 84% and 87% respectively. Nodal metastasis occurred in 6 patients in each group. Five-year nodal control rates of the LDR and HDR groups were 77% and 76%, respectively. Conclusion: Hyperfractionated HDR-ISRT for early mobile tongue cancer has the same local control compared with continuous LDR-ISRT. Hyperfractionated HDR-ISRT is an alternative treatment for continuous LDR-ISRT

  14. Pain relief and quality of life following radiotherapy for bone metastases: a randomised trial of two fractionation schedules

    International Nuclear Information System (INIS)

    Gaze, Mark N.; Kelly, Charles G.; Kerr, Gillian R.; Cull, Ann; Cowie, Valerie J.; Gregor, Anna; Howard, Grahame C.W.; Rodger, Alan

    1997-01-01

    Background: The optimum dose and fractionation schedule for the palliative irradiation of painful bone metastases is controversial. Purpose: To compare the efficacy, side-effects and effect on quality of life of two commonly used radiotherapy schedules in the management of painful bone metastases. Materials and methods: In a prospective trial, 280 patients were randomised to receive either a single 10 Gy treatment or a course of 22.5 Gy in five daily fractions for the relief of localised metastatic bone pain. Results: Response rates have been calculated from 240 assessable treated sites of pain. The overall response rates were 83.7% (single treatment) and 89.2% (five fractions). The complete response rates were 38.8% (single treatment) and 42.3% (five fractions). The median duration of pain control was 13.5 weeks (single treatment) and 14.0 weeks (five fractions). None of these differences was statistically significant. There were no differences between the groups in the effect of treatment on a variety of quality of life parameters. Conclusions: It is concluded that a single 10 Gy treatment is as effective as a course of 22.5 Gy in five fractions in the management of painful bone metastases

  15. Target volume for postoperative radiotherapy in non-small cell lung cancer: Results from a prospective trial

    International Nuclear Information System (INIS)

    Kępka, Lucyna; Bujko, Krzysztof; Bujko, Magdalena; Matecka-Nowak, Mirosława; Salata, Andrzej; Janowski, Henryk; Rogowska, Danuta; Cieślak-Żerańska, Ewa; Komosińska, Katarzyna; Zawadzka, Anna

    2013-01-01

    Background and purpose: A previous prospective trial reported that three-dimensional conformal postoperative radiotherapy (PORT) for pN2 NSCLC patients using a limited clinical target volume (CTV) had a late morbidity rate and pulmonary function that did not differ from those observed in pN1 patients treated with surgery without PORT. The aim of this study was to assess locoregional control and localization of failure in patients treated with PORT. Materials and methods: The pattern of locoregional failure was evaluated retrospectively in 151 of 171 patients included in the PORT arm. The CTV included the involved lymph node stations and those with a risk of invasion >10%. Competing risk analysis was used to assess the incidence of locoregional failure and its location outside the CTV. Results: Overall survival at 5 years was 27.1% with a median follow-up of 67 months for 40 living patients. The 5-year cumulative incidence of locoregional failure was 19.4% (95% CI: 18.2–20.5%) including a failure rate of 2% (95% CI: 0–17%) in locations outside or at the border of the CTV. Conclusions: The use of limited CTV was associated with acceptable risk of geographic miss. Overall locoregional control was similar to that reported by other studies using PORT for pN2 patients

  16. Normal tissue sparing in a phase II trial on daily adaptive plan selection in radiotherapy for urinary bladder cancer.

    Science.gov (United States)

    Vestergaard, Anne; Muren, Ludvig P; Lindberg, Henriette; Jakobsen, Kirsten L; Petersen, Jørgen B B; Elstrøm, Ulrik V; Agerbæk, Mads; Høyer, Morten

    2014-08-01

    Background: Patients with urinary bladder cancer often display large changes in the shape and size of their bladder target during a course of radiotherapy (RT), making adaptive RT (ART) appealing for this tumour site. We are conducting a clinical phase II trial of daily plan selection-based ART for bladder cancer and here report dose-volume data from the first 20 patients treated in the trial. All patients received 60 Gy in 30 fractions to the bladder; in 13 of the patients the pelvic lymph nodes were simultaneously treated to 48 Gy. Daily patient set-up was by use of cone beam computed tomography (CBCT) guidance. The first 5 fractions were delivered with large, population-based (non-adaptive) margins. The bladder contours from the CBCTs acquired in the first 4 fractions were used to create a patient-specific library of three plans, corresponding to a small, medium and large size bladder. From fraction 6, daily online plan selection was performed, where the smallest plan covering the bladder was selected prior to each treatment delivery. A total of 600 treatment fractions in the 20 patients were evaluated. Small, medium and large size plans were used almost equally often, with an average of 10, 9 and 11 fractions, respectively. The median volume ratio of the course-averaged PTV (PTV-ART) relative to the non-adaptive PTV was 0.70 (range: 0.46-0.89). A linear regression analysis showed a 183 cm(3) (CI 143-223 cm(3)) reduction in PTV-ART compared to the non-adaptive PTV (R(2) = 0.94). Daily adaptive plan selection in RT of bladder cancer results in a considerable normal tissue sparing, of a magnitude that we expect will translate into a clinically significant reduction of the treatment-related morbidity.

  17. Target volume definition in conformal radiotherapy for prostate cancer: quality assurance in the MRC RT-01 trial

    International Nuclear Information System (INIS)

    Seddon, B.S.; Wilson, J.; Khoo, V.; Dearnaley, D.; Bidmead, M.

    2000-01-01

    Prior to randomization of patients into the UK Medical Research Council multicentre randomized trial (RT-01) of conformal radiotherapy (CFRT) in prostate cancer, clinicians at participating centres were required to complete a quality assurance (QA) clinical planning exercise to enable an investigation of inter-observer variability in gross target volume (GTV) and normal structure outlining. Thirteen participating centres and two investigators completed the clinical planning exercise of three practice planning cases. Clinicians were asked to draw outlines of the GTV, rectum and bladder on hard-copy computerized tomography (CT) films of the pelvis, which were transferred onto the Cadplan computer planning system by a single investigator. Centre, inferior and superior CT levels of GTV, rectum and bladder were noted, and volume calculations performed. Planning target volumes (PTV) were generated using automatic volume expansion of GTVs by a 1 cm margin. Anterior, right and left lateral beam eye views (BEV) of the PTVs were generated. Using a common central point, the BEV PTVs were superimposed for each beam direction of each case. Radial PTV variation was investigated by measurement of a novel parameter, termed the radial line measurement variation (RLMV). GTV central slice and length were defined with reasonable consistency. The RLMV analysis showed that the main part of the prostate gland, bladder and inferior rectum were outlined with good consistency among clinicians. However, the outlining of the prostatic apex, superior aspect of the prostate projecting into the bladder, seminal vesicles, the base of seminal vesicles and superior rectum were more variable. This exercise has demonstrated adequate consistency of GTV definition. The RLMV method of analysis indicates particular regions of clinician uncertainty. Appropriate feedback has been given to all participating clinicians, and the final RT-01 trial protocol has been modified to accommodate these findings

  18. Quality assurance audit: a prospective non-randomised trial of chemotherapy and radiotherapy for osteolymphoma (TROG 99.04/ALLG LY02).

    Science.gov (United States)

    Christie, D; Le, T; Watling, K; Cornes, D; O'Brien, P; Hitchins, R

    2009-04-01

    A quality assurance (QA) audit of the Trans Tasman Radiation Oncology Group and Australasian Lymphoma and Leukaemia Group trial (TROG 99.04/ALLG LY02) began after accrual of 25 patients. The trial is a prospective non-randomized study of standard treatment for osteolymphoma. Data relating to informed consent, eligibility, chemotherapy and radiotherapy were reviewed. The audit showed a relatively low level of major variations from the protocol, with an overall rate of 3.6%. As this trial has accrued slowly over a long period, the concept of QA has also developed. Amendments were made to the protocol accordingly. In the future, QA procedures should be predetermined, conducted rapidly in real time, and appropriately funded in order to be relevant to the ongoing conduct of the trial.

  19. Short- and long-term risks of cardiovascular disease following radiotherapy in rectal cancer in four randomized controlled trials and a population-based register.

    Science.gov (United States)

    Chen, Lingjing; Eloranta, Sandra; Martling, Anna; Glimelius, Ingrid; Neovius, Martin; Glimelius, Bengt; Smedby, Karin E

    2018-03-01

    A population-based cohort and four randomized trials enriched with long-term register data were used to clarify if radiotherapy in combination with rectal cancer surgery is associated with increased risks of cardiovascular disease (CVD). We identified 14,901 rectal cancer patients diagnosed 1995-2009 in Swedish nationwide registers, of whom 9227 were treated with preoperative radiotherapy. Also, we investigated 2675 patients with rectal cancer previously randomized to preoperative radiotherapy or not followed by surgery in trials conducted 1980-1999. Risks of CVD overall and subtypes were estimated based on prospectively recorded hospital visits during relapse-free follow-up using multivariable Cox regression. Maximum follow-up was 18 and 33 years in the register and trials, respectively. We found no association between preoperative radiotherapy and overall CVD risk in the register (Incidence Rate Ratio, IRR = 0.99, 95% confidence interval (CI) 0.92-1.06) or in the pooled trials (IRR = 1.07, 95% CI 0.93-1.24). We noted an increased risk of venous thromboembolism among irradiated patients in both cohorts (IRR register  = 1.41, 95% CI 1.15-2.72; IRR trials  = 1.41, 95% CI 0.97-2.04), that remained during the first 6 months following surgery among patients treated 2006-2009, after the introduction of antithrombotic treatment (IRR 6 months  = 2.30, 95% CI 1.01-5.21). However, the absolute rate difference of venous thromboembolism attributed to RT was low (10 cases per 1000 patients and year). Preoperative radiotherapy did not affect rectal cancer patients' risk of CVD overall. Although an excess risk of short-term venous thromboembolism was noted, the small increase in absolute numbers does not call for general changes in routine prophylactic treatment, but might do so for patients already at high risk of venous thromboembolism. Copyright © 2017 Elsevier B.V. All rights reserved.

  20. Heavy particle clinical radiotherapy trial at Lawrence Berkeley Laboratory. Progress report, July 1975-July 1979

    International Nuclear Information System (INIS)

    Castro, J.R.

    1979-01-01

    The primary objectives of the clinical radiotherapy program are: to evaluate the potential of improved dose localization particularly as exemplified by helium ion irradiation; and to evaluate the combined potential of improved dose localization and increased biologic effect available with heavier ions such as carbon, neon, and argon. It was possible to make modifications rapidly to provide for large field, fractionated, Bragg peak irradiation at the 184-inch cyclotron with the helium ion beam. This allowed the opportunity to gain experience with charged particle irradiation treatment techniques, patient immobilization techniques, treatment planning and dosimetry studies including the utilization of CT scanning for tumor localization and charged particle dose distributions as well as beginning studies in compensating for tissue inhomogeneities in the beam path. These treatment techniques have been directly transferable to the Bevalac facility where a similar patient positioner has been installed for human irradiation with heavier particles. For the studies both with helium and now with heavier particles, patients with multiple skin and subcutaneous metastatic nodules for evaluation of skin RBE data and patients with locally advanced and/or unresectable tumors unlikely to be effectively treated by any conventional modality were sought. In order to facilitate intercomparison with megavoltage irradiation techniques, a conventional dose fractionation scheme has been adopted. A few exceptions to this dose specification scheme have been patients in which pulmonary, subcutaneous or skin nodules have been irradiated with larger fraction sizes ranging up to 400 rads per fraction in order to obtain clinical RBE studies in 8 to 10 fractions of heavy particles

  1. Health-related quality of life in survivors of stage I-II breast cancer: randomized trial of post-operative conventional radiotherapy and hypofractionated tomotherapy

    Directory of Open Access Journals (Sweden)

    Versmessen Harijati

    2012-10-01

    Full Text Available Abstract Background Health-related quality of life (HRQOL assessment is a key component of clinical oncology trials. However, few breast cancer trials comparing adjuvant conventional radiotherapy (CR and hypofractionated tomotherapy (TT have investigated HRQOL. We compared HRQOL in stage I-II breast cancer patients who were randomized to receive either CR or TT. Tomotherapy uses an integrated computed tomography scanner to improve treatment accuracy, aiming to reduce the adverse effects of radiotherapy. Methods A total of 121 stage I–II breast cancer patients who had undergone breast conserving surgery (BCS or mastectomy (MA were randomly assigned to receive either CR or TT. CR patients received 25 × 2 Gy over 5 weeks, and BCS patients also received a sequential boost of 8 × 2 Gy over 2 weeks. TT patients received 15 × 2.8 Gy over 3 weeks, and BCS patients also received a simultaneous integrated boost of 15 × 0.6 Gy over 3 weeks. Patients completed the EORTC QLQ-C30 and BR23 questionnaires. The mean score (± standard error was calculated at baseline, the end of radiotherapy, and at 3 months and 1, 2, and 3 years post-radiotherapy. Data were analyzed by the 'intention-to-treat' principle. Results On the last day of radiotherapy, patients in both treatment arms had decreased global health status and functioning scores; increased fatigue (clinically meaningful in both treatment arms, nausea and vomiting, and constipation; decreased arm symptoms; clinically meaningful increased breast symptoms in CR patients and systemic side effects in TT patients; and slightly decreased body image and future perspective. At 3 months post-radiotherapy, TT patients had a clinically significant increase in role- and social-functioning scores and a clinically significant decrease in fatigue. The post-radiotherapy physical-, cognitive- and emotional-functioning scores improved faster in TT patients than CR patients. TT patients also had a better

  2. Health-related quality of life in survivors of stage I-II breast cancer: randomized trial of post-operative conventional radiotherapy and hypofractionated tomotherapy

    International Nuclear Information System (INIS)

    Versmessen, Harijati; Vinh-Hung, Vincent; Van Parijs, Hilde; Miedema, Geertje; Voordeckers, Mia; Adriaenssens, Nele; Storme, Guy; De Ridder, Mark

    2012-01-01

    Health-related quality of life (HRQOL) assessment is a key component of clinical oncology trials. However, few breast cancer trials comparing adjuvant conventional radiotherapy (CR) and hypofractionated tomotherapy (TT) have investigated HRQOL. We compared HRQOL in stage I-II breast cancer patients who were randomized to receive either CR or TT. Tomotherapy uses an integrated computed tomography scanner to improve treatment accuracy, aiming to reduce the adverse effects of radiotherapy. A total of 121 stage I–II breast cancer patients who had undergone breast conserving surgery (BCS) or mastectomy (MA) were randomly assigned to receive either CR or TT. CR patients received 25 × 2 Gy over 5 weeks, and BCS patients also received a sequential boost of 8 × 2 Gy over 2 weeks. TT patients received 15 × 2.8 Gy over 3 weeks, and BCS patients also received a simultaneous integrated boost of 15 × 0.6 Gy over 3 weeks. Patients completed the EORTC QLQ-C30 and BR23 questionnaires. The mean score (± standard error) was calculated at baseline, the end of radiotherapy, and at 3 months and 1, 2, and 3 years post-radiotherapy. Data were analyzed by the 'intention-to-treat' principle. On the last day of radiotherapy, patients in both treatment arms had decreased global health status and functioning scores; increased fatigue (clinically meaningful in both treatment arms), nausea and vomiting, and constipation; decreased arm symptoms; clinically meaningful increased breast symptoms in CR patients and systemic side effects in TT patients; and slightly decreased body image and future perspective. At 3 months post-radiotherapy, TT patients had a clinically significant increase in role- and social-functioning scores and a clinically significant decrease in fatigue. The post-radiotherapy physical-, cognitive- and emotional-functioning scores improved faster in TT patients than CR patients. TT patients also had a better long-term recovery from fatigue than CR patients. ANOVA

  3. Pancreatitis, very early compared with normal start of enteral feeding (PYTHON trial): design and rationale of a randomised controlled multicenter trial

    NARCIS (Netherlands)

    Bakker, O.J.; van Santvoort, H.C.; van Brunschot, S.; Ali, U.A.; Besselink, M.G.; Boermeester, M.A.; Bollen, T.L.; Bosscha, K.; Brink, M.A.; Dejong, C.H.; van Geenen, E.J.; van Goor, H.; Heisterkamp, J.; Houdijk, A.P.; Jansen, J.M.; Karsten, T.M.; Manusama, E.R.; Nieuwenhuijs, V.B.; van Ramshorst, B.; Schaapherder, A.F.; van der Schelling, G.P.; Spanier, M.B.M.; Tan, A.; Vecht, J.; Weusten, B.L.; Witteman, B.J.; Akkermans, L.M.; Gooszen, H.G.

    2011-01-01

    ABSTRACT: BACKGROUND: In predicted severe acute pancreatitis, infections have a negative effect on clinical outcome. A start of enteral nutrition (EN) within 24 hours of onset may reduce the number of infections as compared to the current practice of starting an oral diet and EN if necessary at 3-4

  4. Thoracic radiotherapy in stereotactic conditions: difficulties met when starting up and proposed solutions; Radiotherapie thoracique en conditions stereotaxiques: difficultes rencontrees lors de la mise en route et solutions proposees

    Energy Technology Data Exchange (ETDEWEB)

    Halley, A.; Assouline, A.; Belghith, B.; Hemery, C.; Cuenca, X.; Lang, P.; Boisserie, G.; Simon, J.M.; Mazeron, J.J.; Feuvret, L. [Groupe hospitalier Pitie-Salpetriere, assistance Publique-Hopitaux de Paris, Paris (France)

    2011-10-15

    The authors report the study of difficulties met when starting up a thoracic irradiation in stereotactic conditions with respiratory feedback by means of a spirometry system. Eight patients have been selected. Images have been acquired in deep-inspiration breath-hold. Various dose levels have delivered in four sessions on the 80-per-cent isodose. It appears that this technique is constrained by the patient's physical capacities and the available technical means. Solutions are the use of a suitable support system, the screening of harmful positioning, and a training phase to respiratory feedback. Short communication

  5. Xerostomia and quality of life after intensity-modulated radiotherapy vs. conventional radiotherapy for early-stage nasopharyngeal carcinoma: Initial report on a randomized controlled clinical trial

    International Nuclear Information System (INIS)

    Pow, Edmond; Kwong, Dora; McMillan, Anne S.; Wong, May; Sham, Jonathan; Leung, Lucullus; Leung, W. Keung

    2006-01-01

    Purpose: To compare directly the effect of intensity-modulated radiotherapy (IMRT) vs. conventional radiotherapy (CRT) on salivary flow and quality of life (QoL) in patients with early-stage nasopharyngeal carcinoma (NPC). Methods and Materials: Fifty-one patients with T2, N0/N1, M0 NPC took part in a randomized controlled clinical study and received IMRT or CRT. Stimulated whole (SWS) and parotid (SPS) saliva flow were measured and Medical Outcomes Short Form 36 (SF-36), European Organization for Research and Treatment of Cancer (EORTC) core quetionnaire, and EORTC head-and-neck module (QLQ-H and N35) were completed at baseline and 2, 6, and 12 months after radiotherapy. Results: Forty-six patients (88%) were in disease remission 12 months after radiotherapy. At 12 months postradiotherapy, 12 (50.0%) and 20 patients (83.3%) in the IMRT group had recovered at least 25% of preradiotherapy SWS and SPS flow respectively, compared with 1 (4.8%) and 2 patients (9.5%), respectively, in the CRT group. Global health scores showed continuous improvement in QoL after both treatments (p < 0.001). However, after 12 months subscale scores for role-physical, bodily pain, and physical function were significantly higher in the IMRT group, indicating a better condition (p < 0.05). Dry mouth and sticky saliva were problems in both groups 2 months after treatment. In the IMRT group, there was consistent improvement over time with xerostomia-related symptoms significantly less common than in the CRT group at 12 months postradiotherapy. Conclusions: IMRT was significantly better than CRT in terms of parotid sparing and improved QoL for early-stage disease. The findings support the case for assessment of health-related QoL in relation to head-and-neck cancer using a site-specific approach

  6. Randomized trial addressing risk features and time factors of surgery plus radiotherapy in advanced head-and-neck cancer

    International Nuclear Information System (INIS)

    Ang, K. Kian; Trotti, Andy; Brown, Barry W.; Garden, Adam S.; Foote, Robert L.; Morrison, William H.; Geara, Fady B.; Klotch, Douglas W.; Goepfert, Helmuth; Peters, Lester J.

    2001-01-01

    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

  7. S-1 plus cisplatin with concurrent radiotherapy versus cisplatin alone with concurrent radiotherapy for stage III non-small cell lung cancer: a pilot randomized controlled trial

    International Nuclear Information System (INIS)

    Yao, Lei; Xu, Shidong; Xu, Jianyu; Yang, Chaoyang; Wang, Junfeng; Sun, Dawei

    2015-01-01

    We investigated the efficacy and safety of S-1 and cisplatin with concurrent thoracic radiation (SCCR) over cisplatin alone plus concurrent thoracic radiation (CCR) for unresectable stage III non-small-cell lung cancer (NSCLC). Between January 2009 and November 2011, 40 eligible patients with NSCLC were included and divided randomly into two groups. Twenty patients received SCCR with S-1 (orally at 40 mg/m 2 per dose, b.i.d.) on days 1 through 14, cisplatin (60 mg/m 2 on day 1) every 4 weeks for two cycles, and radiotherapy (60 Gy/30 fractions over 6 weeks) beginning on day 1. Twenty subjects received CCR (cisplatin and radiotherapy, the same as for SCCR). The 3-year overall response rate was 59.3% and 52.4% for the SCCR and CCR groups, respectively, and the difference was statistically significant, while the median overall survival was 33 months (range, 4–41 months) and 24 months (range, 2–37 months), respectively (P = 0.048). The median progression-free survival was 31 months for SCCR (range, 5–39 months), whereas it was 20 months (range, 2–37 months) for CCR (P = 0.037). The toxicity profile was similar in both groups. In summary, we demonstrated that S-1 and cisplatin with concurrent thoracic radiation was more effective than cisplatin plus radiotherapy in NSCLC patients with acceptable toxicity

  8. CpG plus radiotherapy: a review of preclinical works leading to clinical trial

    International Nuclear Information System (INIS)

    Mason, Kathy A.; Hunter, Nancy R.

    2012-01-01

    Studies performed three decades ago in our laboratory supported the hypothesis that radiation efficacy may be augmented by bacterial extracts that stimulate non-specific systemic antitumor immune responses. Application to the clinic was halted by unacceptable side effects and toxicities resulting from exposure to whole bacterial pathogens. Later scientific advances demonstrated that DNA isolated from bacteria was immunostimulatory and could be reproduced with synthetic oligodeoxynucleotides (ODNs), thus fueling the transition from bugs to drugs. Unmethylated CpG motifs within bacterial DNA induce activation of Toll-like receptor 9 and subsequently activate antigen-specific cellular immune responses. CpG ODNs have demonstrated favorable toxicity profiles in phase I clinical trials. We showed that this potent immunoadjuvant can be used in combination with radiation therapy to enhance local and systemic responses of several murine tumors. Studies demonstrated that enhanced tumor response is mediated in part by the host immune system. Antitumor efficacy was diminished in immunocompromised mice. Animals cured by combination of radiation and CpG ODN were resistant to subsequent tumor rechallenge. This body of work contributes to our understanding of the dynamic interplay between tumor irradiation and the host immune system and may facilitate translation to clinical trials.

  9. CpG plus radiotherapy: a review of preclinical works leading to clinical trial

    Energy Technology Data Exchange (ETDEWEB)

    Mason, Kathy A.; Hunter, Nancy R., E-mail: kmason@mdanderson.org [Department of Experimental Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, TX (United States)

    2012-08-14

    Studies performed three decades ago in our laboratory supported the hypothesis that radiation efficacy may be augmented by bacterial extracts that stimulate non-specific systemic antitumor immune responses. Application to the clinic was halted by unacceptable side effects and toxicities resulting from exposure to whole bacterial pathogens. Later scientific advances demonstrated that DNA isolated from bacteria was immunostimulatory and could be reproduced with synthetic oligodeoxynucleotides (ODNs), thus fueling the transition from bugs to drugs. Unmethylated CpG motifs within bacterial DNA induce activation of Toll-like receptor 9 and subsequently activate antigen-specific cellular immune responses. CpG ODNs have demonstrated favorable toxicity profiles in phase I clinical trials. We showed that this potent immunoadjuvant can be used in combination with radiation therapy to enhance local and systemic responses of several murine tumors. Studies demonstrated that enhanced tumor response is mediated in part by the host immune system. Antitumor efficacy was diminished in immunocompromised mice. Animals cured by combination of radiation and CpG ODN were resistant to subsequent tumor rechallenge. This body of work contributes to our understanding of the dynamic interplay between tumor irradiation and the host immune system and may facilitate translation to clinical trials.

  10. Critical appraisal of arguments for the delayed-start design proposed as alternative to the parallel-group randomized clinical trial design in the field of rare disease.

    Science.gov (United States)

    Spineli, Loukia M; Jenz, Eva; Großhennig, Anika; Koch, Armin

    2017-08-17

    A number of papers have proposed or evaluated the delayed-start design as an alternative to the standard two-arm parallel group randomized clinical trial (RCT) design in the field of rare disease. However the discussion is felt to lack a sufficient degree of consideration devoted to the true virtues of the delayed start design and the implications either in terms of required sample-size, overall information, or interpretation of the estimate in the context of small populations. To evaluate whether there are real advantages of the delayed-start design particularly in terms of overall efficacy and sample size requirements as a proposed alternative to the standard parallel group RCT in the field of rare disease. We used a real-life example to compare the delayed-start design with the standard RCT in terms of sample size requirements. Then, based on three scenarios regarding the development of the treatment effect over time, the advantages, limitations and potential costs of the delayed-start design are discussed. We clarify that delayed-start design is not suitable for drugs that establish an immediate treatment effect, but for drugs with effects developing over time, instead. In addition, the sample size will always increase as an implication for a reduced time on placebo resulting in a decreased treatment effect. A number of papers have repeated well-known arguments to justify the delayed-start design as appropriate alternative to the standard parallel group RCT in the field of rare disease and do not discuss the specific needs of research methodology in this field. The main point is that a limited time on placebo will result in an underestimated treatment effect and, in consequence, in larger sample size requirements compared to those expected under a standard parallel-group design. This also impacts on benefit-risk assessment.

  11. Randomized controlled trial to evaluate the effects of progressive resistance training compared to progressive muscle relaxation in breast cancer patients undergoing adjuvant radiotherapy: the BEST study

    International Nuclear Information System (INIS)

    Potthoff, Karin; Steindorf, Karen; Schmidt, Martina E; Wiskemann, Joachim; Hof, Holger; Klassen, Oliver; Habermann, Nina; Beckhove, Philipp; Debus, Juergen; Ulrich, Cornelia M

    2013-01-01

    Cancer-related fatigue (CRF) is one of the most common and distressing side effects of cancer and its treatment. During and after radiotherapy breast cancer patients often suffer from CRF which frequently impairs quality of life (QoL). Despite the high prevalence of CRF in breast cancer patients and the severe impact on the physical and emotional well-being, effective treatment methods are scarce. Physical activity for breast cancer patients has been reported to decrease fatigue, to improve emotional well-being and to increase physical strength. The pathophysiological and molecular mechanisms of CRF and the molecular-biologic changes induced by exercise, however, are poorly understood. In the BEST trial we aim to assess the effects of resistance training on fatigue, QoL and physical fitness as well as on molecular, immunological and inflammatory changes in breast cancer patients during adjuvant radiotherapy. The BEST study is a prospective randomized, controlled intervention trial investigating the effects of a 12-week supervised progressive resistance training compared to a 12-week supervised muscle relaxation training in 160 patients with breast cancer undergoing adjuvant radiotherapy. To determine the effect of exercise itself beyond potential psychosocial group effects, patients in the control group perform a group-based progressive muscle relaxation training. Main inclusion criterion is histologically confirmed breast cancer stage I-III after lumpectomy or mastectomy with indication for adjuvant radiotherapy. Main exclusion criteria are acute infectious diseases, severe neurological, musculosceletal or cardiorespiratory disorders. The primary endpoint is cancer-related fatigue; secondary endpoints include immunological and inflammatory parameters analyzed in peripheral blood, saliva and urine. In addition, QoL, depression, physical performance and cognitive capacity will be assessed. The BEST study is the first randomized controlled trial comparing progressive

  12. Compliance to the prescribed dose and overall treatment time in five randomized clinical trials of altered fractionation in radiotherapy for head-and-neck carcinomas

    International Nuclear Information System (INIS)

    Khalil, Azza A.; Bentzen, Soeren M.; Bernier, Jacques; Saunders, Michele I.; Horiot, Jean-Claude; Bogaert, Walter van den; Cummings, Bernard J.; Dische, Stanley

    2003-01-01

    Purpose: To investigate compliance to the prescribed dose-fractionation schedule in five randomized controlled trials of altered fractionation in radiotherapy for head-and-neck carcinoma. Methods and Materials: Individual patient data from 2566 patients participating in the European Organization for Research and Treatment of Cancer (EORTC) 22791, EORTC 22811, EORTC 22851, Princess Margaret Hospital (PMH), and continuous hyperfractionated accelerated radiotherapy (CHART) head-and-neck trials were merged in the fractionation IMPACT (Intergroup Merger of Patient data from Altered or Conventional Treatment schedules) study database. The ideal treatment time was defined as the minimum time required to deliver a prescribed schedule. Compliance to the prescribed overall treatment time was quantified as the difference between the actual and the ideal overall time. An overall measure of compliance in an individual patient, the total dose lost (TDL), was calculated as the dose lost due to prolongation of therapy (assuming a D prolif of 0.64 Gy/day) plus the difference between the prescribed and the actual dose given. Results: The time in excess of the ideal ranged up to 97 days (average 3.9 days), and 25% of the patients had delays of 6 days or more. World Health Organization (WHO) performance status and nodal stage had a significant effect on TDL. TDL was significantly higher in the conventional than in the altered arm of the EORTC 22851 and CHART trials. In the PMH trial, TDL was significantly higher in the hyperfractionation than in the conventional arm. Centers participating in the three EORTC trials varied significantly in their compliance. There was a significant improvement in compliance in patients treated more recently. Conclusions: Even in randomized controlled trials, compliance to the prescribed radiation therapy schedule may be relatively poor, especially after conventional fractionation. This affects the interpretation of the outcome of these trials

  13. A randomized controlled trial investigating the use of a predictive nomogram for the selection of the FSH starting dose in IVF/ICSI cycles.

    Science.gov (United States)

    Allegra, Adolfo; Marino, Angelo; Volpes, Aldo; Coffaro, Francesco; Scaglione, Piero; Gullo, Salvatore; La Marca, Antonio

    2017-04-01

    The number of oocytes retrieved is a relevant intermediate outcome in women undergoing IVF/intracytoplasmic sperm injection (ICSI). This trial compared the efficiency of the selection of the FSH starting dose according to a nomogram based on multiple biomarkers (age, day 3 FSH, anti-Müllerian hormone) versus an age-based strategy. The primary outcome measure was the proportion of women with an optimal number of retrieved oocytes defined as 8-14. At their first IVF/ICSI cycle, 191 patients underwent a long gonadotrophin-releasing hormone agonist protocol and were randomized to receive a starting dose of recombinant (human) FSH, based on their age (150 IU if ≤35 years, 225 IU if >35 years) or based on the nomogram. Optimal response was observed in 58/92 patients (63%) in the nomogram group and in 42/99 (42%) in the control group (+21%, 95% CI = 0.07 to 0.35, P = 0.0037). No significant differences were found in the clinical pregnancy rate or the number of embryos cryopreserved per patient. The study showed that the FSH starting dose selected according to ovarian reserve is associated with an increase in the proportion of patients with an optimal response: large trials are recommended to investigate any possible effect on the live-birth rate. Copyright © 2017 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.

  14. Progressive resistance training rebuilds lean body mass in head and neck cancer patients after radiotherapy – Results from the randomized DAHANCA 25B trial

    International Nuclear Information System (INIS)

    Lønbro, Simon; Dalgas, Ulrik; Primdahl, Hanne; Johansen, Jørgen; Nielsen, Jakob Lindberg; Aagaard, Per; Hermann, Anne Pernille; Overgaard, Jens; Overgaard, Kristian

    2013-01-01

    Purpose: The critical weight loss observed in head and neck squamous cell carcinoma (HNSCC) patients following radiotherapy is mainly due to loss of lean body mass. This is associated with decreases in muscle strength, functional performance and Quality of Life (QoL). The present study investigated the effect of progressive resistance training (PRT) on lean body mass, muscle strength and functional performance in HNSCC patients following radiotherapy. Patients and methods: Following radiotherapy HNSCC patients were randomized into two groups: Early Exercise (EE, n = 20) initiated 12 weeks of PRT followed by 12 weeks of self-chosen physical activity. Delayed Exercise (DE, n = 21) initiated 12 weeks of self-chosen physical activity followed by 12 weeks of PRT. Lean body mass, muscle strength, functional performance and QoL were evaluated at baseline and after week 12 and 24. Results: In the first 12 weeks lean body mass increased by 4.3% in EE after PRT and in the last 12 weeks by 4.2% in DE after PRT. These increases were significantly larger than the changes after self-chosen physical activity (p ⩽ 0.005). Regardless of PRT start-up time, the odds ratio of increasing lean body mass by more than 4% after PRT was 6.26 (p < 0.05). PRT significantly increased muscle strength, whereas functional performance increased significantly more than after self-chosen physical activity only after delayed onset of PRT. Overall QoL improved significantly more in EE than DE from baseline to week 12. Conclusion: PRT effectively increased lean body mass and muscle strength in HNSCC patients following radiotherapy, irrespectively of early or delayed start-up

  15. The role of accelerated hyperfractionated radiotherapy in the treatment of inoperable non-small cell lung cancer: a controlled clinical trial

    International Nuclear Information System (INIS)

    Reinfuss, M.; Kowalska, T.; Glinski, C.

    2000-01-01

    Radiotherapy remains the basic form of treatment in cases of non-small cell lung cancer (NSCLC) but there still exist controversies concerning optimal radiotherapy regimen and in particular, the total dose and fractionation schedules. To prove whether the question: if using an unconventional dose fractionation regimen (accelerated hyperfractionation) could improve the results of palliative teleradiotherapy patients with NSCLC. Between 1997 and 2000 in the Cancer Centre in Cracow (COOK) a controlled clinical trial was conducted in a group of 150 patients with locally advanced (III Deg) inoperable and unsuitable for radical radiotherapy NSCLC, with no major symptoms of the disease. In 76 patients conventionally fractionated radiotherapy was performed - 50 Gy in 25 fractions during 5 weeks (CF). 74 patients were irradiated twice a day (AHF); the dose per fraction was 1.25 Gy and the minimum interval between fractions - 6 hours. The total dose was 50 Gy in 40 fractions during 26 days. The probability of 12 months survival was 47.4% in the CF arm and 45.9% in the AHF arm; the probability of 24 months survival was 16.2% and 15.8%, respectively. In all 76 patients in CF arm the treatment was carried out in prescribed time without breaks. Out of 74 patients in the A HF group 8 (10,8%) did not complete the treatment and 2 of then died in 3rd and 4th week of treatment. The use of accelerated hyperfractionation does not improve the results of palliative teleradiotherapy in patients with locally advanced NSCLC without severe symptoms related to intrathoracic tumor. The treatment of choice in this group of patients os conventionally fractionated radiotherapy with a total dose of 50 Gy in 25 fractions in 5 week of treatment. (author)

  16. A Phase III placebo-controlled trial of oral pilocarpine in patients undergoing radiotherapy for head-and-neck cancer

    International Nuclear Information System (INIS)

    Warde, Padraig; O'Sullivan, Brian; Aslanidis, Julie; Kroll, Barbaranne; Lockwood, Gina; Waldron, John; Payne, David; Bayley, Andrew; Ringash, Jolie; Kim, John; Liu, F.-F.; Maxymiw, Walter; Sprague, Shelley; Cummings, Bernard J.

    2002-01-01

    Purpose: To test the hypothesis that the use of oral pilocarpine during and after radiotherapy (RT) for head-and-neck cancer would reduce the symptoms of post-RT xerostomia. Methods and Materials: One hundred thirty patients were randomized in a double-blind method to receive either pilocarpine (5-mg tablets) or placebo three times daily starting on Day 1 of RT and continuing for 1 month after treatment. The eligibility criteria included a planned dose of >50 Gy as radical or postoperative RT for head-and-neck cancer, with at least 50% of both parotid glands included in the treatment fields. The primary outcome measure was the severity of xerostomia as assessed by a patient-completed linear analog scale 3 months after RT. Secondary outcome measures included quality of life during therapy (as assessed by the McMaster University Head-and-Neck Questionnaire) and severity of mucositis during RT (as assessed using Radiation Therapy Oncology Group scales). Results: No difference was observed between the pilocarpine-treated patients and the placebo group in the severity of xerostomia score as assessed by linear analog scale at baseline and 1, 3, and 6 months after treatment (repeated measures analysis, p=0.92). No difference was apparent in the severity of mucositis during RT; 56.3% of patients receiving pilocarpine had Grade III/IV mucositis compared with 50.8% treated with placebo. No difference in quality of life was noted between the treatment groups during or after RT. The questionnaire score at 3 months after RT was 5.0 (SD 1.0). in the pilocarpine group and 4.9 (SD 0.9) in the placebo group. Conclusion: We were unable to detect a beneficial effect of pilocarpine on RT-induced xerostomia when administered during RT for head-and-neck cancer

  17. Results of a multicentric in silico clinical trial (ROCOCO): comparing radiotherapy with photons and protons for non-small cell lung cancer.

    Science.gov (United States)

    Roelofs, Erik; Engelsman, Martijn; Rasch, Coen; Persoon, Lucas; Qamhiyeh, Sima; de Ruysscher, Dirk; Verhaegen, Frank; Pijls-Johannesma, Madelon; Lambin, Philippe

    2012-01-01

    This multicentric in silico trial compares photon and proton radiotherapy for non-small cell lung cancer patients. The hypothesis is that proton radiotherapy decreases the dose and the volume of irradiated normal tissues even when escalating to the maximum tolerable dose of one or more of the organs at risk (OAR). Twenty-five patients, stage IA-IIIB, were prospectively included. On 4D F18-labeled fluorodeoxyglucose-positron emission tomography-computed tomography scans, the gross tumor, clinical and planning target volumes, and OAR were delineated. Three-dimensional conformal radiotherapy (3DCRT) and intensity-modulated radiotherapy (IMRT) photon and passive scattered conformal proton therapy (PSPT) plans were created to give 70 Gy to the tumor in 35 fractions. Dose (de-)escalation was performed by rescaling to the maximum tolerable dose. Protons resulted in the lowest dose to the OAR, while keeping the dose to the target at 70 Gy. The integral dose (ID) was higher for 3DCRT (59%) and IMRT (43%) than for PSPT. The mean lung dose reduced from 18.9 Gy for 3DCRT and 16.4 Gy for IMRT to 13.5 Gy for PSPT. For 10 patients, escalation to 87 Gy was possible for all 3 modalities. The mean lung dose and ID were 40 and 65% higher for photons than for protons, respectively. The treatment planning results of the Radiation Oncology Collaborative Comparison trial show a reduction of ID and the dose to the OAR when treating with protons instead of photons, even with dose escalation. This shows that PSPT is able to give a high tumor dose, while keeping the OAR dose lower than with the photon modalities.

  18. Dose-Volume Constraints to Reduce Rectal Side Effects From Prostate Radiotherapy: Evidence From MRC RT01 Trial ISRCTN 47772397

    International Nuclear Information System (INIS)

    Gulliford, Sarah L.; Foo, Kerwyn; Morgan, Rachel C.; Aird, Edwin G.; Bidmead, A. Margaret; Critchley, Helen; Evans, Philip M. D.Phil.; Gianolini, Stefano; Mayles, W. Philip; Moore, A. Rollo; Sanchez-Nieto, Beatriz; Partridge, Mike; Sydes, Matthew R. C.Stat; Webb, Steve; Dearnaley, David P.

    2010-01-01

    Purpose: Radical radiotherapy for prostate cancer is effective but dose limited because of the proximity of normal tissues. Comprehensive dose-volume analysis of the incidence of clinically relevant late rectal toxicities could indicate how the dose to the rectum should be constrained. Previous emphasis has been on constraining the mid-to-high dose range (≥50 Gy). Evidence is emerging that lower doses could also be important. Methods and Materials: Data from a large multicenter randomized trial were used to investigate the correlation between seven clinically relevant rectal toxicity endpoints (including patient- and clinician-reported outcomes) and an absolute 5% increase in the volume of rectum receiving the specified doses. The results were quantified using odds ratios. Rectal dose-volume constraints were applied retrospectively to investigate the association of constraints with the incidence of late rectal toxicity. Results: A statistically significant dose-volume response was observed for six of the seven endpoints for at least one of the dose levels tested in the range of 30-70 Gy. Statistically significant reductions in the incidence of these late rectal toxicities were observed for the group of patients whose treatment plans met specific proposed dose-volume constraints. The incidence of moderate/severe toxicity (any endpoint) decreased incrementally for patients whose treatment plans met increasing numbers of dose-volume constraints from the set of V30≤80%, V40≤65%, V50≤55%, V60≤40%, V65≤30%, V70≤15%, and V75≤3%. Conclusion: Considering the entire dose distribution to the rectum by applying dose-volume constraints such as those tested here in the present will reduce the incidence of late rectal toxicity.

  19. Australasian Gastrointestinal Trials Group (AGITG) Contouring Atlas and Planning Guidelines for Intensity-Modulated Radiotherapy in Anal Cancer

    International Nuclear Information System (INIS)

    Ng, Michael; Leong, Trevor; Chander, Sarat; Chu, Julie; Kneebone, Andrew; Carroll, Susan; Wiltshire, Kirsty; Ngan, Samuel; Kachnic, Lisa

    2012-01-01

    Purpose: To develop a high-resolution target volume atlas with intensity-modulated radiotherapy (IMRT) planning guidelines for the conformal treatment of anal cancer. Methods and Materials: A draft contouring atlas and planning guidelines for anal cancer IMRT were prepared at the Australasian Gastrointestinal Trials Group (AGITG) annual meeting in September 2010. An expert panel of radiation oncologists contoured an anal cancer case to generate discussion on recommendations regarding target definition for gross disease, elective nodal volumes, and organs at risk (OARs). Clinical target volume (CTV) and planning target volume (PTV) margins, dose fractionation, and other IMRT-specific issues were also addressed. A steering committee produced the final consensus guidelines. Results: Detailed contouring and planning guidelines and a high-resolution atlas are provided. Gross tumor and elective target volumes are described and pictorially depicted. All elective regions should be routinely contoured for all disease stages, with the possible exception of the inguinal and high pelvic nodes for select, early-stage T1N0. A 20-mm CTV margin for the primary, 10- to 20-mm CTV margin for involved nodes and a 7-mm CTV margin for the elective pelvic nodal groups are recommended, while respecting anatomical boundaries. A 5- to 10-mm PTV margin is suggested. When using a simultaneous integrated boost technique, a dose of 54 Gy in 30 fractions to gross disease and 45 Gy to elective nodes with chemotherapy is appropriate. Guidelines are provided for OAR delineation. Conclusion: These consensus planning guidelines and high-resolution atlas complement the existing Radiation Therapy Oncology Group (RTOG) elective nodal ano-rectal atlas and provide additional anatomic, clinical, and technical instructions to guide radiation oncologists in the planning and delivery of IMRT for anal cancer.

  20. Phase I/II trial of weekly docetaxel and concomitant radiotherapy for squamous cell carcinoma of the head and neck

    International Nuclear Information System (INIS)

    Fujii, Masato; Tsukuda, Mamoru; Kubota, Akira; Kida, Akinori; Okami, Kenji

    2003-01-01

    Docetaxel (DOC) is one of the most promising drugs for head and neck cancer (HNSCC). A phase I/II trial of concurrent DOC and radiation for HNSCC was conducted to estimate the recommended dose schedule of DOC, and then to evaluate the therapeutic benefit based on the response and toxicity of the recommended dose schedule. Patients with squamous cell carcinomas of the head and neck were entered. All the patients received radiation with 2.0 Gy single daily fractions up to 60 Gy. DOC was administered weekly for 6 consecutive weeks during radiotherapy. Dose-limiting toxicities, grade 3/4 mucositis and grade 3 pain, manifested in four patients in level 2, and that dose of DOC, 15 mg/m 2 , was considered the maximum tolerated dose (MTD). The recommended dose was decided as 10 mg/m 2 . The phase II study was conducted using DOC at 10 mg/m 2 . Thirty-nine patients with stage II, III or IV were registered, and 35 patients were eligible, 32 patients were evaluable for the response and 34 patients for the toxicity. The overall response rate was 96.9%. The prognoses of the complete response (CR) patients were statistically better than for the partial response (PR) patients. Grade 3 or 4 adverse events consisted of lymphopenia in 64.7%, mucositis in 41.2% and anorexia in 20.6% of the patients. Thirty-two of the 35 eligible patients showed high compliance of over 90%, and their toxicities were manageable. Even low-dose DOC shows a strong effect on HNSCC in combination with radiation, with high survival rates in CR patients. The effect on survival will be assessed by further follow-up. (author)

  1. Radiotherapy for pediatric brain tumors: Standard of care, current clinical trials and new directions

    International Nuclear Information System (INIS)

    Kun, Larry E.

    1997-01-01

    Objectives: To review the clinical characteristics of childhood brain tumors, including neurologic signs, neuroimaging and neuropathology. To critically assess indications for therapy relevant to presenting characteristics, age, and disease status. To discuss current management strategies including neurosurgery, radiation therapy, and chemotherapy. To analyze current clinical trials and future directions of clinical research. Brain tumors account for 20% of neoplastic diseases in children. The most common tumors include astrocytoma and malignant gliomas, medulloblastoma and supratentorial PNET's, ependymoma, craniopharyngioma, and intracranial germ cell tumors. The clinical characteristics and disease extent largely determine the relative merits of available 'standard' and investigational therapeutic approaches. Treatment outcome, including disease control and functional integrity, is dependent upon tumor type and site, age at presentation, and disease extent. An understanding of the clinical, neuroimaging, and histologic characteristics as they relate to decisions regarding therapy is critical to the radiation oncologist. Appropriate radiation therapy is central to curative therapy for a majority of pediatric brain tumor presentations. Technical advances in neurosurgery provide greater safety for 'gross total resection' in a majority of hemispheric astrocytomas and medulloblastomas. The relative roles of radiation therapy and chemotherapy for centrally located astrocytomas (e.g., diencephalic, optic pathway) need to be analyzed in the context of initial and overall disease control, neurotoxicities, and potential modifications in the risk:benefit ratio apparent in the introduction of 3-dimensional radiation techniques. Modifications in radiation delivery are important components of current investigations in medulloblastoma; the rationale for contemporary cooperative group trials will be presented as well as the background data re surgical, radiotherapeutic, and

  2. Radiotherapy for pediatric brain tumors: Standard of care, current clinical trials, and new directions

    International Nuclear Information System (INIS)

    Kun, Larry E.

    1996-01-01

    Objectives: To review the clinical characteristics of childhood brain tumors, including neurologic signs, neuroimaging and neuropathology. To critically assess indications for therapy relevant to presenting characteristics, age, and disease status. To discuss current management strategies including neurosurgery, radiation therapy, and chemotherapy. To analyze current clinical trials and future directions of clinical research. Brain tumors account for 20% of neoplastic diseases in children. The most common tumors include astrocytoma and malignant gliomas, medulloblastoma and supratentorial PNET's, ependymoma, craniopharyngioma, and intracranial germ cell tumors. Tumor type and clinical course are often correlated with age at presentation and anatomic site. The clinical characteristics and disease extent largely determine the relative merits of available 'standard' and investigational therapeutic approaches. Treatment outcome, including disease control and functional integrity, is dependent upon age at presentation, tumor type, and disease extent. An understanding of the clinical, neuroimaging, and histologic characteristics as they relate to decisions regarding therapy is critical to the radiation oncologist. Appropriate radiation therapy is central to curative therapy for a majority of pediatric brain tumor presentations. Technical advances in neurosurgery provide greater safety for 'gross total resection' in a majority of hemispheric astrocytomas and medulloblastomas. The relative roles of 'standard' radiation therapy and evolving chemotherapy for centrally located astrocytomas (e.g., diencephalic, optic pathway) need to be analyzed in the context of initial and overall disease control, neurotoxicities, and potential modifications in the risk:benefit ratio apparent in the introduction of precision radiation techniques. Modifications in radiation delivery are fundamental to current investigations in medulloblastoma; the rationale for contemporary and projected

  3. Randomized multicenter follow-up trial on the effect of radiotherapy for plantar fasciitis (painful heels spur) depending on dose and fractionation – a study protocol

    International Nuclear Information System (INIS)

    Holtmann, Henrik; Niewald, Marcus; Prokein, Benjamin; Graeber, Stefan; Ruebe, Christian

    2015-01-01

    An actual clinical trial showed the effect of low dose radiotherapy in painful heel spur (plantar fasciitis) with single doses of 1.0 Gy and total doses of 6.0 Gy applied twice weekly. Furthermore, a lot of animal experimental and in vitro data reveals the effect of lower single doses of 0.5 Gy which may be superior in order to ease pain and reduce inflammation in patients with painful heel spur. Our goal is therefore to transfer this experimentally found effect into a randomized multicenter trial. This was a controlled, prospective, two-arm phase III-multicenter trial. The standard arm consisted of single fractions of 1.0 Gy applied two times a week, for a total dose of 6.0 Gy (total therapy time: 3 weeks). The experimental arm consisted of single fractions of 0.5 Gy applied 3 times a week, for a total dose of 6.0 Gy (total therapy time: 4 weeks). Following a statistical power calculation, there were 120 patients for each investigation arm. The main inclusion criteria were: age > = 40 years, clinical and radiologically diagnosed painful heel spur (plantar fasciitis), and current symptoms for at least 6 months. The main exclusion criteria were: former local trauma, surgery or radiotherapy of the heel; pregnant or breastfeeding women; and a pre-existing severe psychiatric or psychosomatic disorder. After approving a written informed consent the patients are randomized by a statistician into one of the trial arms. After radiotherapy, the patients are seen after six weeks, after twelve weeks and then every twelve weeks up to 48 weeks. Additionally, they receive a questionnaire every six weeks after the follow-up examinations up to 48 weeks. The effect is measured using the visual analogue scale of pain (VAS), the calcaneodynia score according to Rowe and the SF-12 score. The primary endpoint is the pain relief three months after therapy. Patients of both therapy arms with an insufficient result are offered a second radiotherapy series applying the standard dose

  4. Adjuvant chemotherapy for rectal cancer patients treated with preoperative (chemo)radiotherapy and total mesorectal excision: a Dutch Colorectal Cancer Group (DCCG) randomized phase III trial.

    Science.gov (United States)

    Breugom, A J; van Gijn, W; Muller, E W; Berglund, Å; van den Broek, C B M; Fokstuen, T; Gelderblom, H; Kapiteijn, E; Leer, J W H; Marijnen, C A M; Martijn, H; Meershoek-Klein Kranenbarg, E; Nagtegaal, I D; Påhlman, L; Punt, C J A; Putter, H; Roodvoets, A G H; Rutten, H J T; Steup, W H; Glimelius, B; van de Velde, C J H

    2015-04-01

    The discussion on the role of adjuvant chemotherapy for rectal cancer patients treated according to current guidelines is still ongoing. A multicentre, randomized phase III trial, PROCTOR-SCRIPT, was conducted to compare adjuvant chemotherapy with observation for rectal cancer patients treated with preoperative (chemo)radiotherapy and total mesorectal excision (TME). The PROCTOR-SCRIPT trial recruited patients from 52 hospitals. Patients with histologically proven stage II or III rectal adenocarcinoma were randomly assigned (1:1) to observation or adjuvant chemotherapy after preoperative (chemo)radiotherapy and TME. Radiotherapy consisted of 5 × 5 Gy. Chemoradiotherapy consisted of 25 × 1.8-2 Gy combined with 5-FU-based chemotherapy. Adjuvant chemotherapy consisted of 5-FU/LV (PROCTOR) or eight courses capecitabine (SCRIPT). Randomization was based on permuted blocks of six, stratified according to centre, residual tumour, time between last irradiation and surgery, and preoperative treatment. The primary end point was overall survival. Of 470 enrolled patients, 437 were eligible. The trial closed prematurely because of slow patient accrual. Patients were randomly assigned to observation (n = 221) or adjuvant chemotherapy (n = 216). After a median follow-up of 5.0 years, 5-year overall survival was 79.2% in the observation group and 80.4% in the chemotherapy group [hazard ratio (HR) 0.93, 95% confidence interval (CI) 0.62-1.39; P = 0.73]. The HR for disease-free survival was 0.80 (95% CI 0.60-1.07; P = 0.13). Five-year cumulative incidence for locoregional recurrences was 7.8% in both groups. Five-year cumulative incidence for distant recurrences was 38.5% and 34.7%, respectively (P = 0.39). The PROCTOR-SCRIPT trial could not demonstrate a significant benefit of adjuvant chemotherapy with fluoropyrimidine monotherapy after preoperative (chemo)radiotherapy and TME on overall survival, disease-free survival, and recurrence rate. However, this trial did not complete

  5. Malignant astrocytoma: hyperfractionated and standard radiotherapy with chemotherapy in a randomized prospective clinical trial

    International Nuclear Information System (INIS)

    Payne, D.G.; Simpson, W.J.; Keen, C.; Platts, M.E.

    1982-01-01

    A prospective randomized trial of 157 patients with malignant astrocytomas (Grade III or IV) was carried out at a single institution. The minimization technique ensured balanced distribution of prognostic factors between the treatment groups. All received oral lomustine (CCNU, 80 mg/m 2 ) six weekly and hydroxyurea (HU, 3.5 gm/m 2 over 5 days) three weekly, for one year or until recurrence, with doses adjusted for myelosuppression. Patients were randomized to daily (5000 rad in 25 fractions (fr) in 5 weeks) or Q3h (every 3 hours) Cobalt 60 irradiation (3600-4000 rad in 36-40 fr of 100 rad each, given 4 fr per day at 3-hour intervals over two weeks). Steroid therapy (up to 16 mg day dexamethasone) was permitted. Complications were moderate and equivalent in the two groups. No significant survival or toxicity differences were seen between the two groups. Age, initial performance status, and extent of surgical resection were found to be significant (P<0.01) prognostic factors for survival. Median survival of the whole group was 48 weeks with a minimum follow-up of one year. There was no advantage to large radiation fields. The hyperfractionation and daily regimes had similar efficacy and toxicity. Hyperfractionation with chemotherapy offers a useful alternative approach in the management of this disease

  6. Non-randomized therapy trial to determine the safety and efficacy of heavy ion radiotherapy in patients with non-resectable osteosarcoma

    Directory of Open Access Journals (Sweden)

    Bischof Marc

    2010-03-01

    Full Text Available Abstract Background Osteosarcoma is the most common primary malignant bone tumor in children and adolescents. For effective treatment, local control of the tumor is absolutely critical, because the chances of long term survival are EURAMOS1. Local photon radiotherapy has previously been used in small series and in an uncontrolled, highly individualized fashion, which, however, documented that high dose radiotherapy can, in principle, be used to achieve local control. Generally the radiation dose that is necessary for a curative approach can hardly be achieved with conventional photon radiotherapy in patients with non-resectable tumors that are usually located near radiosensitive critical organs such as the brain, the spine or the pelvis. In these cases particle Radiotherapy (proton therapy (PT/heavy ion therapy (HIT may offer a promising new alternative. Moreover, compared with photons, heavy ion beams provide a higher physical selectivity because of their finite depth coverage in tissue. They achieve a higher relative biological effectiveness. Phase I/II dose escalation studies of HIT in adults with non-resectable bone and soft tissue sarcomas have already shown favorable results. Methods/Design This is a monocenter, single-arm study for patients ≥ 6 years of age with non-resectable osteosarcoma. Desired target dose is 60-66 Cobalt Gray Equivalent (Gy E with 45 Gy PT (proton therapy and a carbon ion boost of 15-21 GyE. Weekly fractionation of 5-6 × 3 Gy E is used. PT/HIT will be administered exclusively at the Ion Radiotherapy Center in Heidelberg. Furthermore, FDG-PET imaging characteristics of non-resectable osteosarcoma before and after PT/HIT will be investigated prospectively. Systemic disease before and after PT/HIT is targeted by standard chemotherapy protocols and is not part of this trial. Discussion The primary objectives of this trial are the determination of feasibility and toxicity of HIT. Secondary objectives are tumor response

  7. Results of the Tremplin trial proposing an induction chemotherapy followed by concomitant radiotherapy with cisplatin ou cetuximab in order to protect the larynx; Resultats de l'essai Tremplin proposant une chimiotherapie d'induction suivie d'une radiotherapie concomitante avec cisplatine ou cetuximab dans le but de preserver le larynx

    Energy Technology Data Exchange (ETDEWEB)

    Pointreau, Y.; Calais, G. [Service de radiotherapie, Centre regional universitaire de cancerologie Henry-S.-Kaplan, Hopital Bretonneau, CHU de Tours, 37 (France); Pointreau, Y.; Calais, G. [Universite Francois-Rabelais de Tours, 37 (France); Pointreau, Y. [CNRS, UMR 6239 - Genetique, immunotherapie, chimie et cancer - et Laboratoire de pharmacologie-toxicologie, CHRU de Tours, 37 (France); Rolland, F.; Bardet, E. [Centre Rene-Gauducheau, 44 - Nantes (France); Alfonsi, M. [Clinique Sainte-Catherine, 84 - Avignon (France); Baudoux, A. [Clinique Sainte-Elisabeth, Namur (Belgium); Sire, G. [Centre hospitalier de Lorient, 56 (France); De Raucourt, D. [Centre Francois-Baclesse, 14 - Caen (France); Tuchais, C. [Centre Paul-Papin, 49 - Angers (France); Lefebvre, J.L. [Centre Oscar-Lambret, 59 - Lille (France)

    2010-10-15

    The authors report a randomized phase II trial which aimed at comparing over three months the laryngeal protection after a TPF-based induction chemotherapy followed by radiotherapy in combination with cisplatin or cetuximab. Over two years, 153 patients have been concerned. The TPF-based induction chemotherapy followed by radiotherapy with cetuximab seems to be the less toxic. A longer monitoring is needed to get better information in terms of laryngeal protection rate, life quality, and laryngeal functionality. Short communication

  8. Neurological outcome after emergency radiotherapy in MSCC of patients with non-small cell lung cancer - a prospective trial

    International Nuclear Information System (INIS)

    Rief, Harald; Heinhold, Rita C; Petersen, Lina C; Rieken, Stefan; Bruckner, Thomas; Moghaddam-Alvandi, Arash; Debus, Jürgen; Sterzing, Florian

    2013-01-01

    The aim of this trial was to investigate neurological outcome after emergency RT in MSCC of NSCLC patients with acute neurological deficit. This pilot trial was prospective, non-randomized, and monocentre, ten patients were treated from July 2012 until June 2013. After onset of neurological symptoms RT was started within 12 hours. The neurological outcome was assessed at baseline, and six weeks after RT using the ASIA Impairment Scale (AIS). The results showed an improved neurological outcome in one patient (10%), one patient (10%) had a decreased, and five patients (50%) a constant outcome after six weeks. Three patients (30%) died within the first six weeks following RT, additional 4 patients (40%) died within 4 month due to tumor progression. In this group of NSCLC patients we were able to show that emergency RT in MSCC with acute neurological deficit had no considerable benefit in neurological outcome. Therefore, short-course regime or best supportive care due to poor survival should be considered for these patients with additional distant metastases. Patients with favorable prognosis may be candidates for long-course RT

  9. Measuring Time to Biochemical Failure in the TROG 96.01 Trial: When Should the Clock Start Ticking?

    International Nuclear Information System (INIS)

    Denham, James W.; Steigler, Allison; Kumar, Mahesh; Lamb, David S.; Joseph, David; Spry, Nigel A.; Tai, Keen-Hun; Atkinson, Chris; Turner, Sandra FRANZCR; Greer, Peter B.; Gleeson, Paul S.; D'Este, Catherine

    2009-01-01

    Purpose: We sought to determine whether short-term neoadjuvant androgen deprivation (STAD) duration influences the optimal time point from which Phoenix fail (time to biochemical failure; TTBF) should be measured. Methods and Materials: In the Trans-Tasman Radiation Oncology Group 96.01 trial, men with locally advanced prostate cancer were randomized to 3 or 6 months STAD before and during prostatic irradiation (XRT) or to XRT alone. The prognostic value of TTBF measured from the end of radiation (ERT) and randomization were compared using Cox models. Results: Between 1996 and 2000, 802 eligible patients were randomized. In 436 men with Phoenix failure, TTBF measured from randomization was a powerful predictor of prostate cancer-specific survival and marginally more accurate than TTBF measured from ERT in Cox models. Insufficient data were available to confirm that TTBF measured from testosterone recovery may also be a suitable option. Conclusions: TTBF measured from randomization (commencement of therapy) performed well in this trial dataset and will be a convenient option if this finding holds in other datasets that include long-term androgen deprivation data.

  10. Long-term side effects of radiotherapy for pediatric localized neuroblastoma. Results from clinical trials NB90 and NB94

    Energy Technology Data Exchange (ETDEWEB)

    Ducassou, Anne [Institut Claudius Regaud, Departement de Radiotherapie, Toulouse (France); Gambart, Marion; Munzer, Caroline; Rubie, Herve [Hopital des Enfants, Departement d' Onco-Hematologie Pediatrique, Toulouse (France); Padovani, Laetitia [Centre Hospitalier et Universitaire, Departement de Radiotherapie, Marseille (France); Carrie, Christian; Claude, Line [Centre Leon Berard, IHOP, Departement de Radiotherapie, Lyon (France); Haas-Kogan, Daphne [University of California, Department of Radiation Oncology, San Francisco (United States); Bernier-Chastagner, Valerie [Centre Alexis Vautrin, Departement de Radiotherapie, Nancy (France); Demoor, Charlotte [Centre Rene Gauducheau, Departement de Radiotherapie, Nantes (France); Helfre, Sylvie [Institut Curie, Departement de Radiotherapie, Paris (France); Bolle, Stephanie [Institut Gustave Roussy, Departement de Radiotherapie, Villejuif (France); Leseur, Julie [Centre Eugene Marquis, Departement de Radiotherapie, Rennes (France); Huchet, Aymeri [Centre Hospitalier et Universitaire, Departement de Radiotherapie, Bordeaux (France); Valteau-Couanet, Dominique [Institut Gustave Roussy, Departement d' Onco-Hematologie Pediatrique, Villejuif (France); Schleiermacher, Gudrun [Institut Curie, Departement d' Onco-Hematologie Pediatrique, Paris (France); Coze, Carole [Aix-Marseille Univ et APHM, Hopital d' Enfants de la Timone, Departement d' hemato-Oncologie Pediatrique, Marseille (France); Defachelles, Anne-Sophie [Centre Oscar Lambret, Departement d' Onco-Hematologie Pediatrique, Lille (France); Marabelle, Aurelien [IHOP, Departement d' Onco-Hematologie Pediatrique, Lyon (France); Ducassou, Stephane [Hopital des Enfants, Departement d' Onco-Hematologie Pediatrique, Bordeaux (France); Devalck, Christine [Hopital des enfants Reine Fabiola, Departement d' Onco-hematologie Pediatrique, Bruxelles (Belgium); Gandemer, Virginie [Centre hospitalier, Departement d' Onco-Hematologie Pediatrique, Rennes (France); Munzer, Martine [Centre hospitalier, Departement d' Onco-hematologie Pediatrique, Reims (France); Laprie, Anne [Institut Claudius Regaud, Departement de Radiotherapie, Toulouse (France); Universite Toulouse III Paul Sabatier, Toulouse (France); INSERM, Toulouse (France); Collaboration: Neuroblastoma study group and radiotherapy group of the French Society of Children with Cancer (SFCE)

    2015-07-15

    Neuroblastoma (NB) is the most frequent indication for extracranial pediatric radiotherapy. As long-term survival of high-risk localized NB has greatly improved, we reviewed treatment-related late toxicities in pediatric patients who received postoperative radiotherapy (RT) for localized NB within two French prospective clinical trials: NB90 and NB94. From 1990-2000, 610 children were enrolled. Among these, 35 were treated with induction chemotherapy, surgery, and RT. The recommended RT dose was 24 Gy at ≤ 2 years, 34 Gy at > 2 years, ± a 5 Gy boost in both age groups. The 22 patients still alive after 5 years were analyzed. The median follow-up time was 14 years (range 5-21 years). Late effects after therapy occurred in 73 % of patients (16/22), within the RT field for 50 % (11/22). The most frequent in-field effects were musculoskeletal abnormalities (n = 7) that occurred only with doses > 31 Gy/1.5 Gy fraction (p = 0.037). Other effects were endocrine in 3 patients and second malignancies in 2 patients. Four patients presented with multiple in-field late effects only with doses > 31 Gy. After a median follow-up of 14 years, late effects with multimodality treatment were frequent. The most frequent effects were musculoskeletal abnormalities and the threshold for their occurrence was 31 Gy. (orig.) [German] Das Neuroblastom (NB) ist die haeufigste Indikation fuer eine extrakranielle paediatrische Strahlentherapie. Da sich beim lokalisierten Hochrisiko-NB das langfristige Ueberleben stark verbessert hat, ueberprueften wir die behandlungsbedingte spaete Toxizitaet bei paediatrischen Patienten, die im Rahmen zweier prospektiver klinischer Studien in Frankreich (NB90 und NB94) eine postoperative Strahlentherapie (RT) bei lokalisiertem NB erhalten hatten. Von 1990-2000 wurden 610 Kinder eingeschlossen. Von diesen wurden 35 mit Chemotherapie, Chirurgie und RT behandelt. Die empfohlene Bestrahlungsdosis war 24 Gy bei ≤ 2 Jahren, 34 Gy bei > 2 Jahren, ± 5-Gy

  11. Gastro-intestinal and genito-urinary morbidity after 3D conformal radiotherapy of prostate cancer: observations of a randomized trial

    International Nuclear Information System (INIS)

    Koper, Peter C.; Jansen, Peter; Putten, Wim van; Os, Marjolein van; Wijnmaalen, Arend J.; Lebesque, Joos V.; Levendag, Peter C.

    2004-01-01

    Background and purpose: The late morbidity of a randomized study was analyzed after a follow up of 2 years. The difference in intestinal morbidity was analyzed as a function of the treatment arm and dose volume parameters. The correlation with acute toxicity and (pre-existing) bowel complaints was investigated. Patients and methods: 266 T1-4N0M0 prostate cancer patients were randomized for conventional (open fields) and 3D conformal radiotherapy using beams eye view blocked fields with the same dose (66 Gy) and gross target volume-planning target volume margin (15 mm). Apart from the RTOG toxicity scoring system a patient self-assessment questionnaire was used to obtain detailed information on morbidity. Results: At 2 years there is only a trend for less rectal toxicity (grade≥1) in favor of the conformal radiotherapy (grade 1, 47 versus 40% and grade 2, 10 versus 7% for conventional and conformal radiotherapy, respectively (P=0.1). A significant relation was found between late rectal toxicity (grade≥1) and the volume of the anus and rectum exposed to≥90% tumor dose (TD). A highly significant relationship is observed between acute rectum and anal toxicity and late rectal toxicity. The patient self-assessment questionnaire analysis revealed that patients are most bothered by compliance related symptoms like urgency, soiling and fecal loss. In a multivariate analysis, all other variables loose significance, when anal volume exposed to≥90% TD and pre-treatment defaecation frequency are accounted for. Late anal toxicity is low and related only to acute anal toxicity. Late bladder toxicity is related solely to pre-treatment frequency and overall urological symptoms. The incidence of grade 2 toxicity increases with a factor 2.5-4 when (stool or urine) frequency is unfavorable at the start of treatment. Conclusions: Conformal radiotherapy at the dose level of 66 Gy does not significantly decrease the incidence of rectal, anal and bladder toxicity compared to

  12. Prospective randomised multicenter trial on single fraction radiotherapy (8 Gyx1) versus multiple fractions (3 Gyx10) in the treatment of painful bone metastases

    International Nuclear Information System (INIS)

    Kaasa, Stein; Brenne, Elisabeth; Lund, Jo-Asmund; Fayers, Peter; Falkmer, Ursula; Holmberg, Matts; Lagerlund, Magnus; Bruland, Oivind

    2006-01-01

    Background and purpose: To investigate whether single-fraction radiotherapy is equal to multiple fractions in the treatment of painful metastases. Patients and methods: The study planned to recruit 1000 patients with painful bone metastases from four Norwegian and six Swedish hospitals. Patients were randomized to single-fraction (8 Gyx1) or multiple-fraction (3 Gyx10) radiotherapy. The primary endpoint of the study was pain relief, with fatigue and global quality of life as the secondary endpoints. Results: The data monitoring committee recommended closure of the study after 376 patients had been recruited because interim analyses indicated that, as in two other recently published trials, the treatment groups had similar outcomes. Both groups experienced similar pain relief within the first 4 months, and this was maintained throughout the 28-week follow-up. No differences were found for fatigue and global quality of life. Survival was similar in both groups, with median survival of 8-9 months. Conclusions: Single-fraction 8 Gy and multiple-fraction radiotherapy provide similar pain benefit. These results, confirming those of other studies, indicate that single-fraction 8 Gy should be standard management policy for these patients

  13. Regional hyperthermia combined with radiotherapy for locally advanced non-small cell lung cancers. A multi-institutional prospective randomized trial of the International Atomic Energy Agency

    International Nuclear Information System (INIS)

    Mitsumori, Michihide; Hiraoka, Masahiro; Zeng Zhifan; Oliynychenko, P.; Park, Jeong-Ho; Choi, Ihl-Bohng; Tatsuzaki, Hideo; Tanaka, Yoshiaki

    2007-01-01

    An International Atomic Energy Agency (IAEA)-sponsored, multi-institutional prospective randomized trial was conducted to clarify whether the combination of hyperthermia and radiotherapy improves the local response rate of locally advanced non-small cell lung cancer (NSCLC) compared with that obtained by radiotherapy alone. Between October 1998 and April 2002, 80 patients with locally advanced NSCLC were randomized to receive either standard radiation therapy alone (RT) or radiation therapy combined with hyperthermia (RT+HT). The primary endpoint was the local response rate. The secondary endpoints were local progression-free survival and overall survival. The median follow-up period was 204 days for all patients and 450 days for surviving patients. There were no significant differences between the two arms with regard to local response rate (P=0.49) or overall survival rate (P=0.868). However, local progression-free survival was significantly better in the RT+HT arm (P=0.036). Toxicity was generally mild and no grade 3 late toxicity was observed in either arm. Although improvement of local progression-free survival was observed in the RT+HT arm, this prospective randomized study failed to show any substantial benefit from the addition of hyperthermia to radiotherapy in the treatment of locally advanced NSCLC. (author)

  14. Radiotherapy of abdomen with precise renal assessment with SPECT/CT imaging (RAPRASI): design and methodology of a prospective trial to improve the understanding of kidney radiation dose response

    International Nuclear Information System (INIS)

    Lopez-Gaitan, Juanita; O’Mara, Brenton; Chu, Julie; Faggian, Jessica; Williams, Luke; Hofman, Michael S; Spry, Nigel A; Ebert, Martin A; Robins, Peter; Boucek, Jan; Leong, Trevor; Willis, David; Bydder, Sean; Podias, Peter; Waters, Gemma

    2013-01-01

    of the SPECT/CT provides the anatomical reference of the kidney’s position. The data is intended to reveal changes in regional kidney function over the study period after the radiotherapy. These SPECT/CT scans, co-registered with the radiotherapy treatment plan, will provide spatial correlation between the radiation dose and regional renal function as assessed by SPECT/CT. From this correlation, renal response patterns will likely be identified with the purpose of developing a predictive model. Australian New Zealand Clinical Trials Registry: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id

  15. Prevention of potentially inappropriate prescribing for elderly patients: a randomized controlled trial using STOPP/START criteria.

    LENUS (Irish Health Repository)

    Gallagher, P F

    2011-06-01

    Inappropriate prescribing is particularly common in older patients and is associated with adverse drug events (ADEs), hospitalization, and wasteful utilization of resources. We randomized 400 hospitalized patients aged ≥ 65 years to receive either the usual pharmaceutical care (control) or screening with STOPP\\/START criteria followed up with recommendations to their attending physicians (intervention). The Medication Appropriateness Index (MAI) and Assessment of Underutilization (AOU) index were used to assess prescribing appropriateness, both at the time of discharge and for 6 months after discharge. Unnecessary polypharmacy, the use of drugs at incorrect doses, and potential drug-drug and drug-disease interactions were significantly lower in the intervention group at discharge (absolute risk reduction 35.7%, number needed to screen to yield improvement in MAI = 2.8 (95% confidence interval 2.2-3.8)). Underutilization of clinically indicated medications was also reduced (absolute risk reduction 21.2%, number needed to screen to yield reduction in AOU = 4.7 (95% confidence interval 3.4-7.5)). Significant improvements in prescribing appropriateness were sustained for 6 months after discharge.

  16. Prospective trial of preoperative concomitant boost radiotherapy with continuous infusion 5-fluorouracil for locally advanced rectal cancer

    International Nuclear Information System (INIS)

    Janjan, Nora A.; Crane, Christopher N.; Feig, Barry W.; Cleary, Karen; Dubrow, Ronelle; Curley, Steven A.; Ellis, Lee M.; Vauthey, Jean-Nicolas; Lenzi, Renato; Lynch, Patrick; Wolff, Robert; Brown, Thomas; Pazdur, Richard; Abbruzzese, James; Hoff, Paulo M.; Allen, Pamela; Brown, Barry; Skibber, John

    2000-01-01

    Rationale: To evaluate the response to a concomitant boost given during standard chemoradiation for locally advanced rectal cancer. Methods and Materials: Concomitant boost radiotherapy was administered preoperatively to 45 patients with locally advanced rectal cancer in a prospective trial. Treatment consisted of 45 Gy to the pelvis with 18 mV photons at 1.8 Gy/fraction using a 3-field belly board technique with continuous infusion 5FU chemotherapy (300mg/m 2 ) 5 days per week. The boost was given during the last week of therapy with a 6-hour inter-fraction interval to the tumor plus a 2-3 cm margin. The boost dose equaled 7.5 Gy/5 fractions (1.5 Gy/fraction); a total dose of 52.5 Gy/5 weeks was given to the primary tumor. Pretreatment tumor stage, determined by endorectal ultrasound and CT scan, included 29 with T3N0 [64%], 11 T3N1, 1 T3Nx, 2 T4N0, 1 T4N3, and 1 with TxN1 disease. Mean distance from the anal verge was 5 cm (range 0-13 cm). Median age was 55 years (range 33-77 years). The population consisted of 34 males and 11 females. Median time of follow-up is 8 months (range 1-24 months). Results: Sphincter preservation (SP) has been accomplished in 33 of 42 (79%) patients resected to date. Three patients did not undergo resection because of the development of metastatic disease in the interim between the completion of chemoradiation (CTX/XRT) and preoperative evaluation. The surgical procedures included proctectomy and coloanal anastomosis (n = 16), low anterior resection (n = 13), transanal resection (n = 4). Tumor down-staging was pathologically confirmed in 36 of the 42 (86%) resected patients, and 13 (31%) achieved a pathologic CR. Among the 28 tumors (67%) located <6 cm from the anal verge, SP was accomplished in 21 cases (75%). Although perioperative morbidity was higher, toxicity rates during CTX/XRT were comparable to that seen with conventional fractionation. Compared to our contemporary experience with conventional CTX/XRT (45Gy; 1.8 Gy per

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

    International Nuclear Information System (INIS)

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

    1997-01-01

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

  18. Assessment of community-level effects of intermittent preventive treatment for malaria in schoolchildren in Jinja, Uganda (START-IPT trial): a cluster-randomised trial.

    Science.gov (United States)

    Staedke, Sarah G; Maiteki-Sebuguzi, Catherine; Rehman, Andrea M; Kigozi, Simon P; Gonahasa, Samuel; Okiring, Jaffer; Lindsay, Steve W; Kamya, Moses R; Chandler, Clare I R; Dorsey, Grant; Drakeley, Chris

    2018-06-01

    Intermittent preventive treatment (IPT) is a well established malaria control intervention. Evidence that delivering IPT to schoolchildren could provide community-level benefits is limited. We did a cluster-randomised controlled trial to assess the effect of IPT of primary schoolchildren with dihydroartemisinin-piperaquine (DP) on indicators of malaria transmission in the community, in Jinja, Uganda. We included 84 clusters, each comprising one primary school and the 100 closest available households. The clusters were randomly assigned 1:1 to receive IPT with DP or standard care (control) by restricted randomisation to ensure balance by geography and school type. Children in intervention schools received IPT monthly for up to six rounds (June to December, 2014). We did cross-sectional community surveys in randomly selected households at baseline and in January to April, 2015, during which we measured participants' temperatures and obtained finger-prick blood smears for measurement of parasite prevalence by microscopy. We also did entomological surveys 1 night per month in households from 20 randomly selected IPT and 20 control clusters. The primary trial outcome was parasite prevalence in the final community survey. The primary entomological survey outcome was the annual entomological inoculation rate (aEIR) from July, 2014, to April, 2015. This trial is registered at ClinicalTrials.gov, number NCT02009215. Among 23 280 students registered in the 42 intervention schools, 10 079 (43%) aged 5-20 years were enrolled and received at least one dose of DP. 9286 (92%) of 10 079 received at least one full course of DP (three doses). Community-level parasite prevalence was lower in the intervention clusters than in the control clusters (19% vs 23%, adjusted risk ratio 0·85, 95% CI 0·73-1·00, p=0·05). The aEIR was lower in the intervention group than in the control group, but not significantly so (10·1 vs 15·2 infective bites per person, adjusted incidence rate

  19. Fresh Start, a postpartum weight loss intervention for diverse low-income women: design and methods for a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Milagros C. Rosal

    2016-09-01

    Full Text Available Abstract Background Overweight and obesity are prevalent among young women and are greater among minority and low-income women. The postpartum period is critical in women’s weight trajectories as many women do not lose their pregnancy weight, and others lose some and then plateau or experience weight gain. Excess weight puts women at greater risk of chronic disease and thus weight loss in the postpartum period may be key to the long-term health of young women. This paper describes the design and methods of a randomized clinical trial of Fresh Start, an innovative narrative-based group intervention aimed at promoting postpartum weight loss among low-income, diverse women. Methods/design Study participants were recruited from the five sites of the Women, Infants and Children (WIC program in central Massachusetts. Participants were English-speaking, age ≥ 18 years, 6 weeks to 6 months postpartum, with a body mass index (BMI ≥ 27 kg/m2. The Fresh Start postpartum weight loss intervention, adapted from the Diabetes Prevention Program (DPP in collaboration with WIC staff and clients, consisted of an 8-week group-based curriculum followed by nine monthly telephone calls. It included a narrative component (i.e., storytelling, group discussions, print materials and access to exercise facilities. The study is a two-arm randomized controlled trial. The control condition included print materials and access to exercise facilities. In-person assessments were conducted at baseline and at 6 and 12 months following the eight-week intervention phase. Discussion The Fresh Start intervention translated key elements of an evidence-based weight loss protocol into a format that is hypothesized to be relevant, acceptable and effective for the target audience of low-SES postpartum women. This novel intervention was developed in collaboration with WIC to be sustainable within the context of its clinics, which reach approximately 9 million individuals

  20. Effectiveness of fentanyl transdermal patch (fentanyl-TTS, durogegic) for radiotherapy induced pain and cancer pain: multi-center trial

    International Nuclear Information System (INIS)

    Shin, Seong Soo; Choi, Eun Kyung; Huh, Seung Jae

    2006-01-01

    To evaluate the effectiveness and safety of fentanyl-TTS in the management of radiotherapy induced acute pain and cancer pain treated with radiotherapy. Our study was open labelled prospective phase IV multi-center study, the study population included patients with more 4 numeric rating scale (NRS) score pain although managed with other analgesics or more than 6 NRS score pain without analgesics. Patients divided into two groups: patients with radiotherapy induced pain (Group A) and patients with cancer pain treated with radiotherapy (Group B). All patients received 25 ug/hr of fentanyl transdermal patch. Primary end point was pain relief: second end points were change in patient quality of life, a degree of satisfaction for patients and clinician, side effects. Between March 2005 and June 2005, 312 patients from 26 participating institutes were registered, but 249 patients completed this study. Total number of patients in each group was 185 in Group A, 64 in Group B. Mean age was 60 years and male to female ratio was 76:24. Severe pain NRS score at 2 weeks after the application of fentanyl was decreased from 7.03 to 4.01, ρ = 0.003. There was a significant improvement in insomnia, social functioning, and quality of life. A degree of satisfaction for patients and clinician was very high. The most common reasons of patients' satisfactions was good pain control. Ninety six patients reported side effect. Nausea was the most common side effect. There was no serious side effect. Fentanyl-TTS was effective in both relieving pain with good tolerability and improving the quality of life for patients with radiotherapy induced acute pain and cancer pain treated with radiotherapy. The satisfaction of the patients and doctors was good. There wa no major side effect

  1. Effectiveness of fentanyl transdermal patch (fentanyl-TTS, durogegic) for radiotherapy induced pain and cancer pain: multi-center trial

    Energy Technology Data Exchange (ETDEWEB)

    Shin, Seong Soo; Choi, Eun Kyung [University of Ulsan College of Medicine, Seoul (Korea, Republic of); Huh, Seung Jae [Sungkyunkwan University College of Medicine, Seoul (Korea, Republic of)] (and others)

    2006-12-15

    To evaluate the effectiveness and safety of fentanyl-TTS in the management of radiotherapy induced acute pain and cancer pain treated with radiotherapy. Our study was open labelled prospective phase IV multi-center study, the study population included patients with more 4 numeric rating scale (NRS) score pain although managed with other analgesics or more than 6 NRS score pain without analgesics. Patients divided into two groups: patients with radiotherapy induced pain (Group A) and patients with cancer pain treated with radiotherapy (Group B). All patients received 25 ug/hr of fentanyl transdermal patch. Primary end point was pain relief: second end points were change in patient quality of life, a degree of satisfaction for patients and clinician, side effects. Between March 2005 and June 2005, 312 patients from 26 participating institutes were registered, but 249 patients completed this study. Total number of patients in each group was 185 in Group A, 64 in Group B. Mean age was 60 years and male to female ratio was 76:24. Severe pain NRS score at 2 weeks after the application of fentanyl was decreased from 7.03 to 4.01, {rho} = 0.003. There was a significant improvement in insomnia, social functioning, and quality of life. A degree of satisfaction for patients and clinician was very high. The most common reasons of patients' satisfactions was good pain control. Ninety six patients reported side effect. Nausea was the most common side effect. There was no serious side effect. Fentanyl-TTS was effective in both relieving pain with good tolerability and improving the quality of life for patients with radiotherapy induced acute pain and cancer pain treated with radiotherapy. The satisfaction of the patients and doctors was good. There wa no major side effect.

  2. START NOW - a comprehensive skills training programme for female adolescents with oppositional defiant and conduct disorders: study protocol for a cluster-randomised controlled trial.

    Science.gov (United States)

    Kersten, Linda; Prätzlich, Martin; Mannstadt, Sandra; Ackermann, Katharina; Kohls, Gregor; Oldenhof, Helena; Saure, Daniel; Krieger, Katrin; Herpertz-Dahlmann, Beate; Popma, Arne; Freitag, Christine M; Trestman, Robert L; Stadler, Christina

    2016-12-01

    In Europe, the number of females exhibiting oppositional defiant disorder (ODD) and conduct disorder (CD) is growing. Many of these females live in youth welfare institutions. Consequently, there is a great need for evidence-based interventions within youth welfare settings. A recently developed approach targeting the specific needs of girls with ODD and CD in residential care is START NOW. The aim of this group-based behavioural skills training programme is to specifically enhance emotional regulation capacities to enable females with CD or ODD to appropriately deal with daily-life demands. It is intended to enhance psychosocial adjustment and well-being as well as reduce oppositional and aggressive behaviour. We present the study protocol (version 4.1; 10 February 2016) of the FemNAT-CD intervention trial titled 'Group-Based Treatment of Adolescent Female Conduct Disorders: The Central Role of Emotion Regulation'. The study is a prospective, confirmatory, cluster-randomised, parallel-group, multi-centre, randomised controlled trial with 128 institutionalised female adolescents who fulfil the diagnostic criteria of ODD and/or CD. Institutions/wards will be randomised either to provide the 12-week skills training as an add-on intervention or to provide treatment as usual. Once the first cycle is completed, each institution will run a second cycle with the opposite condition. Primary endpoints are the pre-post change in number of CD/ODD symptoms as assessed by a standardised, semi-structured psychiatric interview (Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime, CD/ODD section) between baseline and the end of intervention, as well as between baseline and a 3-month follow-up point. Secondary objectives include pre-post change in CD/ODD-related outcome measures, most notably emotional regulation on a behavioural and neurobiological level after completion of START NOW compared with treatment as usual. To our

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

    International Nuclear Information System (INIS)

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

    1999-01-01

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

  4. Radiotherapy versus concurrent 5-day cisplatin and radiotherapy in locally advanced cervical carcinoma. Long-term results of a Phase III randomized trial

    Energy Technology Data Exchange (ETDEWEB)

    Nagy, Viorica; Coza, Ovidiu; Ghilezan, Nicolae [' Ion Chiricuta' Cancer Institute, Cluj-Napoca (Romania). Dept. of Radiation Oncology; ' Iuliu Hatieganu' Univ. of Medicine and Pharmacy, Cluj-Napoca (Romania); Ordeanu, Claudia; Todor, Nicolae [' Ion Chiricuta' Cancer Institute, Cluj-Napoca (Romania). Dept. of Radiation Oncology; Traila, Alexandru [' Ion Chiricuta' Cancer Institute, Cluj-Napoca (Romania). Dept. of Surgery; Rancea, Alin [' Iuliu Hatieganu' Univ. of Medicine and Pharmacy, Cluj-Napoca (Romania); ' Ion Chiricuta' Cancer Institute, Cluj-Napoca (Romania). Dept. of Surgery

    2009-03-15

    Purpose: To prove the superiority of concurrent radiochemotherapy (RTCT) over radiotherapy (RT) alone in locally advanced cervical carcinoma. Patients and Methods: In this randomized monocentric phase III study, 566 patients with squamous cell carcinoma of the cervix were included: 284 in arm A (RT) and 282 in arm B (concurrent RTCT with cisplatin 20 mg/m{sup 2} x 5 days). 238 patients (42%) were in stage IIB, 209 (37%) in stage IIIA, and 119 (21%) in stage IIIB. The median follow-up was 62.8 months. RT to the pelvis was delivered to a dose of 46 Gy/23 fractions. A cervical boost was given using the X-ray arch technique or high-dose-rate intracavitary brachytherapy at a dose of 10 Gy. Thereafter, patients were evaluated: those with good response optionally underwent surgery and the others continued RT until 64 Gy/pelvis (with or without CT according to randomization) and 14 Gy/central tumor volume. Results: The 5-year survival rate was statistically significantly superior in the concurrent RTCT group (74%) versus the RT group (64%; p < 0.05). In patients undergoing surgery after RT or RTCT, superior results were obtained, compared to the nonoperated patients: 5-year survival rate 86% versus 53% (p < 0.01). 192 failures were recorded: 109 (38%) after RT alone versus 83 (29%) after concurrent RTCT (p < 0.01). Conclusion: The results of this study prove the obvious superiority of concurrent RTCT with 5-day cisplatin compared to RT alone in patients with locally advanced cervical carcinoma, regarding local control (78% vs. 67%) and 5-year survival rates (74% vs. 64%). (orig.)

  5. Results from an experimental trial at a Head Start center to evaluate two meal service approaches to increase fruit and vegetable intake of preschool aged children

    Directory of Open Access Journals (Sweden)

    Harnack Lisa J

    2012-04-01

    Full Text Available Abstract Background Strategies to increase fruit and vegetable consumption of preschool aged children are needed. Objectives Evaluate the independent effects of the following meal service strategies on intake of fruits and vegetables of preschool children: 1. Serving fruits and vegetables in advance of other menu items as part of traditional family style meal service; and 2. Serving meals portioned and plated by providers. Methods Fifty-three preschool aged children completed a randomized crossover experiment conducted at a Head Start center in Minneapolis, MN. Over a six week trial period each of the experimental meal service strategies (serving fruits and vegetable first and serving meals portioned by providers was implemented during lunch service for two one-week periods. Two one-week control periods (traditional family style meal service with all menu items served at once were also included over the six week trial period. Childrens lunch intake was observed as a measure of food and nutrient intake during each experimental condition. Results Fruit intake was significantly higher (p Conclusions Serving fruits in advance of other meal items may be a low cost easy to implement strategy for increasing fruit intake in young children. However, serving vegetables first does not appear to increase vegetable intake. Results provide support for current recommendations for traditional family style meal service in preschool settings.

  6. Capecitabine and Oxaliplatin Before, During, and After Radiotherapy for High-Risk Rectal Cancer

    DEFF Research Database (Denmark)

    Larsen, Finn Ole; Markussen, Alice; Jensen, Benny V

    2017-01-01

    PURPOSE: To evaluate the effect of capecitabine and oxaliplatin before, during, and after radiotherapy for high-risk rectal cancer. PATIENTS AND METHODS: Patients with rectum cancer T4 or T3 involving the mesorectal fascia was included in a prospective phase 2 trial. Liver or lung metastases were...... accepted if the surgeons found them resectable. The patients received 6 weeks of capecitabine and oxaliplatin before chemoradiotherapy (CRT), continued capecitabine and oxaliplatin during radiotherapy, and received 4 weeks of capecitabine and oxaliplatin after CRT. The patients received radiotherapy...... as intensity-modulated radiotherapy. Total mesorectal excision was planned 8 weeks after CRT. The patients were evaluated with magnetic resonance imaging (MRI) before start of treatment, after 6 weeks of chemotherapy, and again just before the operation. The European Organization for Research and Treatment...

  7. Why START?

    International Nuclear Information System (INIS)

    Mendelsohn, J.

    1991-01-01

    Barring some major unexpected downturn in US-Soviet relations, it seems likely that the long-awaited Strategic Arms Reduction Talks (START) treaty will be signed sometime in 1991. Under negotiation for the past nine years, public acceptance and Senate approval of a START treaty will be facilitated by the generally less confrontational East-West relationship which has evolved over that time, by the growing constraints on the US defense budget, and by the obvious merits of the treaty itself. Not only will the nearly complete START treaty be an extremely useful and powerful arms control agreement, it is also decidedly advantageous to US security interests. First and foremost, a START treaty will cap and reduce the steady buildup of nuclear weapons that has characterized the last 30 years of the US-Soviet strategic relationship. As a result of the basic outline originally agreed to at the Reykjavik summit, START will take a 25 to 35 percent bite out of existing nuclear arsenals, impose approximately a 50 percent cut in overall Soviet ballistic missile warheads and throw-weight (lifting power or payload capacity), and produce an exact 50 percent cut in Soviet SS-18 missiles

  8. Long-Term Outcome and Quality of Life of Patients With Endometrial Carcinoma Treated With or Without Pelvic Radiotherapy in the Post Operative Radiation Therapy in Endometrial Carcinoma 1 (PORTEC-1) Trial

    NARCIS (Netherlands)

    Nout, Remi A.; van de Poll-Franse, Lonneke V.; Lybeert, Marnix L. M.; Warlam-Rodenhuis, Carla C.; Jobsen, Jan J.; Mens, Jan Willem M.; Lutgens, Ludy C. H. W.; Pras, Betty; van Putten, Wim L. J.; Creutzberg, Carien L.

    2011-01-01

    Purpose To determine the long-term outcome and health-related quality of life (HRQL) of patients with endometrial carcinoma (EC) treated with or without pelvic radiotherapy in the Post Operative Radiation Therapy in Endometrial Carcinoma 1 (PORTEC-1) trial. Patients and Methods Between 1990 and

  9. Surrogate endpoints for overall survival in chemotherapy and radiotherapy trials in operable and locally advanced lung cancer: a re-analysis of meta-analyses of individual patients' data

    NARCIS (Netherlands)

    Mauguen, Audrey; Pignon, Jean-Pierre; Burdett, Sarah; Domerg, Caroline; Fisher, David; Paulus, Rebecca; Mandrekar, Samithra J.; Belani, Chandra P.; Shepherd, Frances A.; Eisen, Tim; Pang, Herbert; Collette, Laurence; Sause, William T.; Dahlberg, Suzanne E.; Crawford, Jeffrey; O'Brien, Mary; Schild, Steven E.; Parmar, Mahesh; Tierney, Jayne F.; Le Pechoux, Cécile; Michiels, Stefan; Burdett, S.; Fisher, D.; Le Péchoux, C.; Mauguen, A.; Michiels, S.; Pignon, J. P.; Tierney, J. F.; Belani, C. P.; Collette, L.; Dahlberg, S.; Eisen, T.; Mandrekar, S.; O'Brien, M.; Parmar, M.; Pang, H.; Paulus, R.; Crawford, J.; Sause, W.; Schild, S. E.; Shepherd, F.; Arriagada, R.; Atagi, S.; Auperin, A.; Ball, D.; Baumann, M.; Behrendt, K.; Belderbos, J.; Koning, C. C. E.; Uitterhoeve, A.

    2013-01-01

    The gold standard endpoint in clinical trials of chemotherapy and radiotherapy for lung cancer is overall survival. Although reliable and simple to measure, this endpoint takes years to observe. Surrogate endpoints that would enable earlier assessments of treatment effects would be useful. We

  10. Toxicity and quality of life after adjuvant chemoradiotherapy versus radiotherapy alone for women with high-risk endometrial cancer (PORTEC-3) : an open-label, multicentre, randomised, phase 3 trial

    NARCIS (Netherlands)

    de Boer, Stephanie M.; Powell, Melanie E.; Mileshkin, Linda; Katsaros, Dionyssios; Bessette, Paul; Haie-Meder, Christine; Ottevanger, Petronella B.; Ledermann, Jonathan A.; Khaw, Pearly; Colombo, Alessandro; Fyles, Anthony; Baron, Marie-Helene; Kitchener, Henry C.; Nijman, Hans W.; Kruitwagen, Roy F.; Nout, Remi A.; Verhoeven-Adema, Karen W.; Smit, Vincent T.; Putter, Hein; Creutzberg, Carien L.

    Background About 15% of patients with endometrial cancer have high-risk features and are at increased risk of distant metastases and endometrial cancer-related death. We designed the PORTEC-3 trial to investigate the benefit of adjuvant chemoradiotherapy compared with radiotherapy alone for women

  11. Toxicity and quality of life after adjuvant chemoradiotherapy versus radiotherapy alone for women with high-risk endometrial cancer (PORTEC-3): an open-label, multicentre, randomised, phase 3 trial

    NARCIS (Netherlands)

    Boer, S.M. de; Powell, M.E.; Mileshkin, L.; Katsaros, D.; Bessette, P.; Haie-Meder, C.; Ottevanger, P.B.; Ledermann, J.A.; Khaw, P.; Colombo, A.; Fyles, A.; Baron, M.H.; Kitchener, H.C.; Nijman, H.W.; Kruitwagen, R.F.; Nout, R.A.; Verhoeven-Adema, K.W.; Smit, V.T.; Putter, H.; Creutzberg, C.L.

    2016-01-01

    BACKGROUND: About 15% of patients with endometrial cancer have high-risk features and are at increased risk of distant metastases and endometrial cancer-related death. We designed the PORTEC-3 trial to investigate the benefit of adjuvant chemoradiotherapy compared with radiotherapy alone for women

  12. Phase I/II trial evaluating combined radiotherapy and in situ gene therapy with or without hormonal therapy in the treatment of prostate cancer--A preliminary report

    International Nuclear Information System (INIS)

    Teh, Bin S.; Aguilar-Cordova, Estuardo; Kernen, Kenneth; Chou, C.-C.; Shalev, Moshe; Vlachaki, Maria T.; Miles, Brian; Kadmon, Dov; Mai, W.-Y.; Caillouet, James; Davis, Maria; Ayala, Gustavo; Wheeler, Thomas; Brady, Jett; Carpenter, L. Steve; Lu, Hsin H.; Chiu, J. Kam; Woo, Shiao Y.; Thompson, Timothy; Butler, E. Brian

    2001-01-01

    Purpose: To report the preliminary results of a Phase I/II study combining radiotherapy and in situ gene therapy (adenovirus/herpes simplex virus thymidine kinase gene/valacyclovir) with or without hormonal therapy in the treatment of prostate cancer. Methods and Materials: Arm A: low-risk patients (T1-T2a, Gleason score <7, pretreatment PSA <10) were treated with combined radio-gene therapy. A mean dose of 76 Gy was delivered to the prostate with intensity-modulated radiotherapy. Arm B: high-risk patients (T2b-T3, Gleason score ≥7, pretreatment PSA ≥10) were treated with combined radio-gene therapy and hormonal therapy. Hormonal therapy was comprised of a 4-month leuprolide injection and 2-week use of flutamide. Arm C: Stage D1 (positive pelvic lymph node) patients received the same regimen as Arm B, with the additional 45 Gy to the pelvic lymphatics. Treatment-related toxicity was assessed using Cancer Therapy Evaluation Program common toxicity score and Radiation Therapy Oncology Group (RTOG) toxicity score. Results: Thirty patients (13 in Arm A, 14 in Arm B, and 3 in Arm C) completed the trial. Median follow-up was 5.5 months. Eleven patients (37%) developed flu-like symptoms (Cancer Therapy Evaluation Program Grade 1) of fatigue and chills/rigors after gene therapy injection but recovered within 24 h. Four patients (13%) and 2 patients (7%) developed Grade 1 and 2 fever, respectively. There was no patient with weight loss. One patient in Arm B developed Grade 3 elevation in liver enzyme, whereas 11 and 2 patients developed Grade 1 and 2 abnormal liver function tests. There was no Grade 2 or above hematologic toxicity. Three patients had transient rise in creatinine. There was no RTOG Grade 3 or above lower gastrointestinal toxicity. Toxicity levels were as follows: 4 patients (13%), Grade 2; 6 patients (20%), Grade 1; and 20 patients (67%), no toxicity. There was 1 patient with RTOG Grade 3 genitourinary toxicity, 12 patients (40%) with Grade 2, 8 patients

  13. Randomized Clinical Trial of Weekly vs. Triweekly Cisplatin-Based Chemotherapy Concurrent With Radiotherapy in the Treatment of Locally Advanced Cervical Cancer

    Energy Technology Data Exchange (ETDEWEB)

    Ryu, Sang-Young, E-mail: ryu@kcch.re.kr [Department of Obstetrics and Gynecology, Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences, Seoul (Korea, Republic of); Lee, Won-Moo; Kim, Kidong [Department of Obstetrics and Gynecology, Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences, Seoul (Korea, Republic of); Park, Sang-Il [Department of Gynecologic Oncology, Dongnam Institute of Radiological and Medical Sciences, Busan (Korea, Republic of); Kim, Beob-Jong; Kim, Moon-Hong; Choi, Seok-Cheol [Department of Obstetrics and Gynecology, Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences, Seoul (Korea, Republic of); Cho, Chul-Koo [Department of Radiation Oncology, Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences, Seoul (Korea, Republic of); Nam, Byung-Ho [Cancer Biostatistics Branch, Research Institute and Hospital, National Cancer Center, Goyang (Korea, Republic of); Lee, Eui-Don [Department of Gynecologic Oncology, Dongnam Institute of Radiological and Medical Sciences, Busan (Korea, Republic of)

    2011-11-15

    Purpose: To compare compliance, toxicity, and outcome of weekly and triweekly cisplatin administration concurrent with radiotherapy in locally advanced cervical cancer. Methods and Materials: In this open-label, randomized trial, 104 patients with histologically proven Stage IIB-IVA cervical cancer were randomly assigned by a computer-generated procedure to weekly (weekly cisplatin 40 mg/m{sup 2}, six cycles) and triweekly (cisplatin 75 mg/m{sup 2} every 3 weeks, three cycles) chemotherapy arms during concurrent radiotherapy. The difference of compliance and the toxicity profiles between the two arms were investigated, and the overall survival rate was analyzed after 5 years. Results: All patients tolerated both treatments very well, with a high completion rate of scheduled chemotherapy cycles. There was no statistically significant difference in compliance between the two arms (86.3% in the weekly arm, 92.5% in the triweekly arm, p > 0.05). Grade 3-4 neutropenia was more frequent in the weekly arm (39.2%) than in the triweekly arm (22.6%) (p = 0.03). The overall 5-year survival rate was significantly higher in the triweekly arm (88.7%) than in the weekly arm (66.5%) (hazard ratio 0.375; 95% confidence interval 0.154-0.914; p = 0.03). Conclusions: Triweekly cisplatin 75-mg/m{sup 2} chemotherapy concurrent with radiotherapy is more effective and feasible than the conventional weekly cisplatin 40-mg/m{sup 2} regimen and may be a strong candidate for the optimal cisplatin dose and dosing schedule in the treatment of locally advanced cervical cancer.

  14. Phase II Trial of Preoperative Irinotecan-Cisplatin Followed by Concurrent Irinotecan-Cisplatin and Radiotherapy for Resectable Locally Advanced Gastric and Esophagogastric Junction Adenocarcinoma

    International Nuclear Information System (INIS)

    Rivera, Fernando; Galan, Maica; Tabernero, Josep; Cervantes, Andres; Vega-Villegas, M. Eugenia; Gallego, Javier; Laquente, Berta; Rodriguez, Edith; Carrato, Alfredo; Escudero, Pilar; Massuti, Bartomeu; Alonso-Orduna, Vicente; Cardenal, Adelaida; Saenz, Alberto; Giralt, Jordi; Yuste, Ana Lucia

    2009-01-01

    Purpose: To determine in a Phase II trial whether preoperative irinotecan-cisplatin (IC) followed by concurrent IC therapy and radiotherapy (IC/RT) improved outcome in patients with resectable, locally advanced gastric adenocarcinoma (GC) or esophagogastric junction cancer (EGJC). Patients and Methods: Patients with resectable Stage II-IV, M0 GC or EGJC made up the study population. The primary endpoint was pathologic complete response (pCR). Two courses of IC (irinotecan, 65mg/m 2 ; cisplatin, 30mg/m 2 on Days 1 and 8 every 21 days) were given. Patients without progression then received IC/RT, consisting of daily radiotherapy (45Gy) with concurrent IC (irinotecan, 65mg/m 2 ; cisplatin, 30mg/m 2 on Days 1, 8, 15, and 22). Surgical resection was performed, if feasible, 5-8 weeks after the end of radiotherapy. Results: Twenty-three patients were included in the study: 10 with EGJC and 13 with GC. Two patients (9%) achieved pCR. The incidences of Grade 3-4 toxicities were as follows: IC: neutropenia 35% (febrile 13%), anemia 22%, diarrhea 22%, emesis 8%; IC/RT: neutropenia 52% (febrile 5%), asthenia 19%, anemia 9%, emesis 9%, diarrhea 5%, cardiotoxicity 5%. No patients died during IC or IC/RT. R0 resection was achieved in 15 patients (65%). Median survival was 14.5 months, and the actuarial 2-year survival rate was 35%. Conclusions: Preoperative IC followed by IC/RT resulted in moderate response and resection rates with mild toxicity in patients with GC and EGJC.

  15. Starting out

    NARCIS (Netherlands)

    Ans Merens; Freek Bucx

    2018-01-01

    Original title: Werken aan de start Women in the Netherlands have been outperforming men in education for many years now. However, this superior educational achievement does not translate into a better position on the labour market. More women work today than in the past, but still fewer than men.

  16. In vivo cell kinetic measurements in a randomized trial of continuous hyperfractionated accelerated radiotherapy with or without mitomycin C in head-and-neck cancer

    International Nuclear Information System (INIS)

    Dobrowsky, Werner; Dobrowsky, Eva; Wilson, George D.

    2003-01-01

    Purpose: Tumor cell repopulation is still considered to be a major cause of failure in radiotherapy. In this study, we investigated the influence of cell kinetic parameters on the outcome of patients treated in a randomized trial of accelerated fractionation, with or without mitomycin C, vs. conventional fractionation. Methods and Materials: Sixty-two patients were studied using administration of bromodeoxyuridine (BrdUrd), and cell kinetic parameters were measured using flow cytometry. The patients were treated with either 70 Gy for 7 weeks or 55.3 Gy for 17 continuous days (V-CHART) with or without 20 mg/m 2 mitomycin C on day 5. Results: The potential doubling time (Tpot) and labeling index (LI) failed to provide any prognostic information with regard to local control or survival. However, the duration of the S phase (Ts) revealed patients whose tumors had a long Ts had significantly worse local control (p = 0.028) and survival (p = 0.034) irrespective of treatment. A similar trend was evident within the different treatment arms particularly associated with overall survival. Conclusions: The Ts values of head-and-neck squamous cell cancers provided prognostic information that predicted clinical outcome irrespective of treatment schedule in this study. This neglected parameter of the Tpot method might provide information related to redistribution of cells during fractionated radiotherapy

  17. Long-term quality of life in patients with rectal cancer treated with preoperative (chemo)-radiotherapy within a randomized trial

    International Nuclear Information System (INIS)

    Tiv, M.; Puyraveau, M.; Mercier, M.; Bosset, J.F.; Puyraveau, M.; Mineur, L.; Calais, G.; Maingon, P.; Bardet, E.; Mercier, M.; Bosset, J.F.

    2010-01-01

    Purpose: Few studies have evaluated the quality of life (QoL) of patients with rectal cancer. This report describes the quality of life of French patients who entered the 22921 EORTC trial that investigated the role and place of chemotherapy (CT) added to preoperative radiotherapy (preop-RT). Patients and Methods: Patients without recurrences were evaluated with EORTC QLQ-C30 and QLQ-CR38 questionnaires, after a median time of 4.6 years from randomization. Results: All the scores of QLQ-C30 functions were high, from 78 up to 88, with those of global health quality of life scale (GHQL) status being 73. The mean scores of symptoms were low except for diarrhea. For QLQ-CR38, the mean scores for 'body image' and 'future perspective' were high at 79.6 and 69.7 respectively. The scores for 'sexual functioning' and 'enjoyment' were low. Men had more sexual problems than females (62.5 vs 25 mean scores respectively). Chemotherapy was associated with more diarrhea complaints, lower 'role', lower 'social functioning' and lower global health quality of life scale. Conclusion: The overall quality of life of patients with rectal cancer is quite good 4.6 years after the beginning preoperative treatments. However, adding chemotherapy to preoperative radiotherapy has a negative effect on diarrhea complaints and some quality of life dimensions. (authors)

  18. A Randomized Trial (Irish Clinical Oncology Research Group 97-01) Comparing Short Versus Protracted Neoadjuvant Hormonal Therapy Before Radiotherapy for Localized Prostate Cancer.

    LENUS (Irish Health Repository)

    Armstrong, John G

    2010-08-24

    PURPOSE: To examine the long-term outcomes of a randomized trial comparing short (4 months; Arm 1) and long (8 months; Arm 2) neoadjuvant hormonal therapy before radiotherapy for localized prostate cancer. METHODS AND MATERIALS: Between 1997 and 2001, 276 patients were enrolled and the data from 261 were analyzed. The stratification risk factors were prostate-specific antigen level >20 ng\\/mL, Gleason score >\\/=7, and Stage T3 or more. The intermediate-risk stratum had one factor and the high-risk stratum had two or more. Staging was done from the bone scan and computed tomography findings. The primary endpoint was biochemical failure-free survival. RESULTS: The median follow-up was 102 months. The overall survival, biochemical failure-free survival. and prostate cancer-specific survival did not differ significantly between the two treatment arms, overall or at 5 years. The cumulative probability of overall survival at 5 years was 90% (range, 87-92%) in Arm 1 and 83% (range, 80-86%) in Arm 2. The biochemical failure-free survival rate at 5 years was 66% (range, 62-71%) in Arm 1 and 63% (range, 58-67%) in Arm 2. CONCLUSION: No statistically significant difference was found in biochemical failure-free survival between 4 months and 8 months of neoadjuvant hormonal therapy before radiotherapy for localized prostate cancer.

  19. Phase I Trial of Gross Total Resection, Permanent Iodine-125 Brachytherapy, and Hyperfractionated Radiotherapy for Newly Diagnosed Glioblastoma Multiforme

    International Nuclear Information System (INIS)

    Chen, Allen M.; Chang, Susan; Pouliot, Jean; Sneed, Penny K.; Prados, Michael D.; Lamborn, Kathleen R.; Malec, Mary K.; McDermott, Michael W.; Berger, Mitchell S.; Larson, David A.

    2007-01-01

    Purpose: To evaluate the feasibility of gross total resection and permanent I-125 brachytherapy followed by hyperfractionated radiotherapy for patients with newly diagnosed glioblastoma. Methods and Materials: From April 1999 to May 2002, 21 patients with glioblastoma multiforme were enrolled on a Phase I protocol investigating planned gross total resection and immediate placement of permanent I-125 seeds, followed by postoperative hyperfractionated radiotherapy to a dose of 60 Gy at 100 cGy b.i.d., 5 days per week. Median age and Karnofsky performance status were 50 years (range, 32-65 years) and 90 (range, 70-100), respectively. Toxicity was assessed according to Radiation Therapy Oncology Group criteria. Results: Eighteen patients completed treatment according to protocol. The median preoperative tumor volume on magnetic resonance imaging was 18.6 cm 3 (range, 4.4-41.2 cm 3 ). The median brachytherapy dose measured 5 mm radially outward from the resection cavity was 400 Gy (range, 200-600 Gy). Ten patients underwent 12 reoperations, with 11 of 12 reoperations demonstrating necrosis without evidence of tumor. Because of high toxicity, the study was terminated early. Median progression-free survival and overall survival were 57 and 114 weeks, respectively, but not significantly improved compared with historical patients treated at University of California, San Francisco, with gross total resection and radiotherapy without brachytherapy. Conclusions: Treatment with gross total resection and permanent I-125 brachytherapy followed by hyperfractionated radiotherapy as performed in this study results in high toxicity and reoperation rates, without demonstrated improvement in survival

  20. Discrete Trial Teaching: Getting Started

    Science.gov (United States)

    Gongola, Leah; Sweeney, Jennifer

    2012-01-01

    Current special education law mandates that educators use scientifically based practices, and in addition, educators should deliver refined instruction for learners with disabilities. Applied behavior analysis, based on the premise of increasing socially significant behaviors, embodies many interventions that adhere to evidence-based teaching…

  1. WE-FG-201-04: Cloud-Based Collaboration for Radiotherapy Clinical Trials, Research and Training

    International Nuclear Information System (INIS)

    Palta, J.

    2016-01-01

    Many low- and middle-income countries lack the resources and services to manage cancer, from screening and diagnosis to radiation therapy planning, treatment and quality assurance. The challenges in upgrading or introducing the needed services are enormous, and include severe shortages in equipment and trained staff. In this symposium, we will describe examples of technology and scientific research that have the potential to impact all these areas. These include: (1) the development of high-quality/low-cost colposcopes for cervical cancer screening, (2) the application of automated radiotherapy treatment planning to reduce staffing shortages, (3) the development of a novel radiotherapy treatment unit, and (4) utilizing a cloud-based infrastructure to facilitate collaboration and QA. Learning Objectives: Understand some of the issues in cancer care in low- resource environments, including shortages in staff and equipment, and inadequate physical infrastructure for advanced radiotherapy. Understand the challenges in developing and deploying diagnostic and treatment devices and services for low-resource environments. Understand some of the emerging technological solutions for cancer management in LMICs. NCI; L. Court, NIH, Varian, Elekta; I. Feain, Ilana Feain is founder and CTO of Nano-X Pty Ltd

  2. Evaluation of time, attendance of medical staff, and resources during radiotherapy for breast cancer patients. The DEGRO-QUIRO trial

    International Nuclear Information System (INIS)

    Blank, E.; Wenz, F.; Sack, H.

    2012-01-01

    To conform to recommendations regarding the treatment of breast cancer, an estimation of costs and personnel to assure treatment is required. To date no recommendations based on real time measurements are available. The DEGRO (German Society of Radiation Oncology), therefore, initiated a prospective multicenter evaluation of core procedures of radiotherapy. In this analysis, the results regarding human resources and room occupation during the treatment of breast cancer are presented. Three academic radiation oncology centers (Erlangen, Muenster, Mannheim) prospectively documented their workflow and working time for all breast cancer patients from July-October 2008. Subsequently, a statistical analysis was performed. The longest working time of physicians was the definition of the target volume and organs at risk (mean 33 min). Furthermore, physicians needed much time for general tasks, which included conversations. Physicists needed the most time for treatment planning and authorization (64 min), whereas technicians were mostly needed in day-to-day radiotherapy treatment (15 min, 31 min including verification). Despite significant differences in specific steps between centers, overall working times and room occupation were comparable and representative. Special procedures (intraoperative radiotherapy/multicatheter brachytherapy) required considerable amounts of additional working time of physicians and physicists. In this prospective analysis, data of human resources and room occupation during treatment of breast cancer are presented for the first time. Each patient consumes about 12 h of human resources for treatment and 3.75 h for general tasks (physicians 4.7 h, physicists 1.8 h, and technicians 9.2 h). (orig.)

  3. WE-FG-201-04: Cloud-Based Collaboration for Radiotherapy Clinical Trials, Research and Training

    Energy Technology Data Exchange (ETDEWEB)

    Palta, J. [Virginia Commonwealth University (United States)

    2016-06-15

    Many low- and middle-income countries lack the resources and services to manage cancer, from screening and diagnosis to radiation therapy planning, treatment and quality assurance. The challenges in upgrading or introducing the needed services are enormous, and include severe shortages in equipment and trained staff. In this symposium, we will describe examples of technology and scientific research that have the potential to impact all these areas. These include: (1) the development of high-quality/low-cost colposcopes for cervical cancer screening, (2) the application of automated radiotherapy treatment planning to reduce staffing shortages, (3) the development of a novel radiotherapy treatment unit, and (4) utilizing a cloud-based infrastructure to facilitate collaboration and QA. Learning Objectives: Understand some of the issues in cancer care in low- resource environments, including shortages in staff and equipment, and inadequate physical infrastructure for advanced radiotherapy. Understand the challenges in developing and deploying diagnostic and treatment devices and services for low-resource environments. Understand some of the emerging technological solutions for cancer management in LMICs. NCI; L. Court, NIH, Varian, Elekta; I. Feain, Ilana Feain is founder and CTO of Nano-X Pty Ltd.

  4. A JASTRO study group report. A randomized phase III trial of hyperthermia in combination with radiotherapy for superficial tumors

    International Nuclear Information System (INIS)

    Hiraoka, Masahiro; Nishimura, Yasumasa; Mitsumori, Michihide

    1998-01-01

    Result of study about local effect of hyperthermia in combination with radiotherapy for superficial tumors was reported. The irradiation was more than 90% isodose for lesion, and total dose was 60 Gy in cases with anamnesis and 40-50 Gy and without anamnesis at a rate of five times a week and 2 Gy at one time. Hyperthermia was carried out four times; once a week, at 42.5 degrees on tumor side edge, and for 40 minutes. Total 53 cases (neck lymph node metastasis 30 cases, relapse breast cancer 11, advanced breast cancer 1, other superficial tumor 11) were divided into 2 groups. Radiotherapy without hyperthermia (group R) was 27 cases, radiotherapy with hyperthermia (group H) was 26 cases. CR and CR+PR within 2 months after treatment were as follows: Group R: 50%, 85%, Group H: 64%, 100%. The CR+PR was superior in group H (p=0.0497). The CR at maximum effect after treatment was 65% of group R and 86% of group H (p=0.17). The local control rate after CR was not different in both groups. (K.H.)

  5. Results of an RTOG phase III trial (RTOG 85-27) comparing radiotherapy plus etanidazole with radiotherapy alone for locally advanced head and neck carcinomas

    Energy Technology Data Exchange (ETDEWEB)

    Dingjen, Lee; Cosmatos, Dennis; Marcial, Victor A; Fu, Karen K; Rotman, Marvin; Cooper, Jay S; Ortiz, Hernando G; Beitler, Jonathan J; Abrams, Ross A; Curran, Walter J; Coleman, C Norman; Wasserman, Todd H

    1995-06-15

    Purpose: The objectives of this study were to determine the efficacy and toxicity of Etanidazole (ETA), a hypoxic cell sensitizer, when combined with conventional radiotherapy (RT) in the management of advanced head and neck carcinomas. Methods and Materials: From March 1988 to September 1991, 521 patients who had Stage III or IV head and neck carcinomas were randomized to receive conventional RT alone (66 Gy in 33 fractions to 74 Gy in 37 fractions, 5 fractions per week) or RT + ETA (2.0 g/m{sup 2} thrice weekly for 17 doses), of whom 504 were eligible and analyzable. Treatment assignments were stratified before randomization according to the primary site (oral cavity + hypopharynx vs. supraglottic larynx + oropharynx + nasopharynx), T-stage (T1-3 vs. T4), and N-stage (N0-2 vs. N3). Pretreatment characteristics were balanced. In the RT-alone arm, 39% of patients had T3 and 34% had T4 disease, whereas in the RT + ETA arm, 42% of patients had T3 and 33% had T4 disease. Thirty-eight percent of the RT-alone patients and 37% of the RT + ETA patients had N3 disease. The median follow-up of surviving patients was 3.38 years, with a range between 0.96 and 5.63 years. Results: One hundred and ninety-four of the 252 (77%) RT + ETA patients received at least 14 doses of the drug. Overall RT protocol compliance rate was 82% in the RT-alone arm and 86% in the RT + ETA arm. No Grade 3 or 4 central nervous system or peripheral neuropathy was observed in the RT + ETA arm. Eighteen percent of the patients developed Grade 1 and 5% developed Grade 2 peripheral neuropathy. Other drug related toxicities included nausea/vomiting (27%), low blood counts (15%), and allergy (9%). Most of these toxicities were Grade 1 and 2. The incidence of severe acute and late radiation effects were similar between the two arms. The 2-year actuarial local-regional control rate (LCR) was 40% for the RT-alone arm and 40% for the RT + ETA arm. Two-year actuarial survival was 41% for the RT-alone arm and 43

  6. Results of an RTOG phase III trial (RTOG 85-27) comparing radiotherapy plus etanidazole with radiotherapy alone for locally advanced head and neck carcinomas

    International Nuclear Information System (INIS)

    Lee Dingjen; Cosmatos, Dennis; Marcial, Victor A.; Fu, Karen K.; Rotman, Marvin; Cooper, Jay S.; Ortiz, Hernando G.; Beitler, Jonathan J.; Abrams, Ross A.; Curran, Walter J.; Coleman, C. Norman; Wasserman, Todd H.

    1995-01-01

    Purpose: The objectives of this study were to determine the efficacy and toxicity of Etanidazole (ETA), a hypoxic cell sensitizer, when combined with conventional radiotherapy (RT) in the management of advanced head and neck carcinomas. Methods and Materials: From March 1988 to September 1991, 521 patients who had Stage III or IV head and neck carcinomas were randomized to receive conventional RT alone (66 Gy in 33 fractions to 74 Gy in 37 fractions, 5 fractions per week) or RT + ETA (2.0 g/m 2 thrice weekly for 17 doses), of whom 504 were eligible and analyzable. Treatment assignments were stratified before randomization according to the primary site (oral cavity + hypopharynx vs. supraglottic larynx + oropharynx + nasopharynx), T-stage (T1-3 vs. T4), and N-stage (N0-2 vs. N3). Pretreatment characteristics were balanced. In the RT-alone arm, 39% of patients had T3 and 34% had T4 disease, whereas in the RT + ETA arm, 42% of patients had T3 and 33% had T4 disease. Thirty-eight percent of the RT-alone patients and 37% of the RT + ETA patients had N3 disease. The median follow-up of surviving patients was 3.38 years, with a range between 0.96 and 5.63 years. Results: One hundred and ninety-four of the 252 (77%) RT + ETA patients received at least 14 doses of the drug. Overall RT protocol compliance rate was 82% in the RT-alone arm and 86% in the RT + ETA arm. No Grade 3 or 4 central nervous system or peripheral neuropathy was observed in the RT + ETA arm. Eighteen percent of the patients developed Grade 1 and 5% developed Grade 2 peripheral neuropathy. Other drug related toxicities included nausea/vomiting (27%), low blood counts (15%), and allergy (9%). Most of these toxicities were Grade 1 and 2. The incidence of severe acute and late radiation effects were similar between the two arms. The 2-year actuarial local-regional control rate (LCR) was 40% for the RT-alone arm and 40% for the RT + ETA arm. Two-year actuarial survival was 41% for the RT-alone arm and 43% for

  7. The utility of e-Learning to support training for a multicentre bladder online adaptive radiotherapy trial (TROG 10.01-BOLART).

    Science.gov (United States)

    Foroudi, Farshad; Pham, Daniel; Bressel, Mathias; Tongs, David; Rolfo, Aldo; Styles, Colin; Gill, Suki; Kron, Tomas

    2013-10-01

    An e-Learning programme appeared useful for providing training and information regarding a multi-centre image guided radiotherapy trial. The aim of this study is to demonstrate the utility of this e-Learning programme. Modules were created on relevant pelvic anatomy, Cone Beam CT soft tissue recognition and trial details. Radiation therapist participants' knowledge and confidence were evaluated before, at the end of, and after at least 6 weeks of e-Learning (long term). One hundred and eighty-five participants were recruited from 12 centres, with 118 in the first, and 67 in the second cohort. One hundred and forty-six participants had two tests (pre and post e-Learning) and 39 of these had three tests (pre, post, and long term). There was an increase confidence after completion of modules (pe-Learning for a multi-centre clinical trial was feasible and improved confidence and knowledge. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  8. The utility of e-Learning to support training for a multicentre bladder online adaptive radiotherapy trial (TROG 10.01-BOLART)

    International Nuclear Information System (INIS)

    Foroudi, Farshad; Pham, Daniel; Bressel, Mathias; Tongs, David; Rolfo, Aldo; Styles, Colin; Gill, Suki; Kron, Tomas

    2013-01-01

    Background and purpose: An e-Learning programme appeared useful for providing training and information regarding a multi-centre image guided radiotherapy trial. The aim of this study is to demonstrate the utility of this e-Learning programme. Materials and methods: Modules were created on relevant pelvic anatomy, Cone Beam CT soft tissue recognition and trial details. Radiation therapist participants’ knowledge and confidence were evaluated before, at the end of, and after at least 6 weeks of e-Learning (long term). Results: One hundred and eighty-five participants were recruited from 12 centres, with 118 in the first, and 67 in the second cohort. One hundred and forty-six participants had two tests (pre and post e-Learning) and 39 of these had three tests (pre, post, and long term). There was an increase confidence after completion of modules (p < 0.001). The first cohort pre scores increased from 67 ± 11 to 79 ± 8 (p < 0.001) post. The long term same question score was 73 ± 14 (p = 0.025, comparing to pre-test), and different questions’ score was 77 ± 13 (p = 0.014). In the second cohort, pre-test scores were 64 ± 10, post-test same question score 78 ± 9 (p < 0.001) and different questions’ score 81 ± 11 (p < 0.001). Conclusions: e-Learning for a multi-centre clinical trial was feasible and improved confidence and knowledge

  9. 8 Gy single-dose radiotherapy is effective in metastatic spinal cord compression: Results of a phase III randomized multicentre Italian trial

    International Nuclear Information System (INIS)

    Maranzano, Ernesto; Trippa, Fabio; Casale, Michelina; Costantini, Sara; Lupattelli, Marco; Bellavita, Rita; Marafioti, Luigi; Pergolizzi, Stefano; Santacaterina, Anna; Mignogna, Marcello; Silvano, Giovanni; Fusco, Vincenzo

    2009-01-01

    Background and purpose: In a previous randomized trial we showed that the short-course radiotherapy (RT) regimen of 8 Gy x 2 was feasible in patients with metastatic spinal cord compression (MSCC) and short life expectancy. This phase III trial was planned to determine whether in the same category of patients 8 Gy single-dose is as effective as 8 Gy x 2. Materials and methods: Three hundred and twenty-seven patients with MSCC and short life expectancy were randomly assigned to a short-course of 8 Gy x 2 or to 8 Gy single-dose RT. Median follow-up was 31 months (range, 4-58). Results: A total of 303 (93%) patients are assessable, 150 treated with the short-course and 153 with the single-dose RT. No difference in response was found between the two RT schedules adopted. Median duration of response was 5 and 4.5 months for short-course and single-dose RT (p = 0.4), respectively. The median overall survival was 4 months for all cases. Light acute toxicity was registered in a minority of cases. Late toxicity was never recorded. Conclusions: Both RT schedules adopted were effective. As already shown in several trials evaluating RT regimens in uncomplicated painful bone metastases, also MSCC patients may achieve palliation with minimal toxicity and inconvenience with a single-dose of 8 Gy.

  10. A randomized phase III prospective trial of bethanechol to prevent mucositis, candidiasis, and taste loss in patients with head and neck cancer undergoing radiotherapy. A secondary analysis

    International Nuclear Information System (INIS)

    Jham, B.C.; Chen, H.; Carvalho, A.L.; Freire, A.R.

    2009-01-01

    The aim of this study was to determine the impact of bethanechol administration concomitant to radiotherapy (RT) on oral mucositis, candidiasis and taste loss. We performed a secondary analysis of a previously conducted prospective randomized trial which evaluated the effect of bethanechol on salivary gland dysfunction before, during, and after RT for head and neck cancer (HNC), in comparison to artificial saliva. Mucositis, candidiasis and taste loss were analyzed in 36 patients. Mucositis was scored using the World Health Organization (WHO) method; candidiasis was diagnosed by means of clinical examination, whereas taste loss was assessed by the patients' subjective report of absence of taste. No significant differences were observed between groups in relation to frequency and severity of mucositis or frequency of candidiasis and taste loss. In conclusion, bethanechol does not appear to reduce the incidence of mucositis, candidiasis, and taste loss when administered during RT. (author)

  11. A versatile phantom for quality assurance in the UK Medical Research Council (MRC) RT01 trial (ISRCTN47772397) in conformal radiotherapy for prostate cancer

    International Nuclear Information System (INIS)

    Rollo Moore, A.; Jim Warrington, A.P.; Aird, Edwin G.A.; Margaret Bidmead, A.; Dearnaley, David P.

    2006-01-01

    Within the UK RT01 trial the MRC also funded a quality assurance (QA) programme. This included a planning and dosimetry audit at participating centres using a purpose built phantom. Geometrical setup was visually assessed via field shaping around the phantom GTV (to within the order of 1 mm). Within the phantom, ion chamber positional uncertainties were estimated as 0.6 mm (95% CL, k = 2). This was the basis for ion chamber measurements in a variety of dose gradients around the PTV closely simulating a patient case. The design provides a representative but reproducible system for QA in the prostate radiotherapy process, from CT scan to treatment. Setup errors are not eliminated, but minimised and estimated

  12. Dexamethasone and supportive care with or without whole brain radiotherapy in treating patients with non-small cell lung cancer with brain metastases unsuitable for resection or stereotactic radiotherapy (QUARTZ): results from a phase 3, non-inferiority, randomised trial.

    Science.gov (United States)

    Mulvenna, Paula; Nankivell, Matthew; Barton, Rachael; Faivre-Finn, Corinne; Wilson, Paula; McColl, Elaine; Moore, Barbara; Brisbane, Iona; Ardron, David; Holt, Tanya; Morgan, Sally; Lee, Caroline; Waite, Kathryn; Bayman, Neil; Pugh, Cheryl; Sydes, Benjamin; Stephens, Richard; Parmar, Mahesh K; Langley, Ruth E

    2016-10-22

    Whole brain radiotherapy (WBRT) and dexamethasone are widely used to treat brain metastases from non-small cell lung cancer (NSCLC), although there have been no randomised clinical trials showing that WBRT improves either quality of life or overall survival. Even after treatment with WBRT, the prognosis of this patient group is poor. We aimed to establish whether WBRT could be omitted without a significant effect on survival or quality of life. The Quality of Life after Treatment for Brain Metastases (QUARTZ) study is a non-inferiority, phase 3 randomised trial done at 69 UK and three Australian centres. NSCLC patients with brain metastases unsuitable for surgical resection or stereotactic radiotherapy were randomly assigned (1:1) to optimal supportive care (OSC) including dexamethasone plus WBRT (20 Gy in five daily fractions) or OSC alone (including dexamethasone). The dose of dexamethasone was determined by the patients' symptoms and titrated downwards if symptoms improved. Allocation to treatment group was done by a phone call from the hospital to the Medical Research Council Clinical Trials Unit at University College London using a minimisation programme with a random element and stratification by centre, Karnofsky Performance Status (KPS), gender, status of brain metastases, and the status of primary lung cancer. The primary outcome measure was quality-adjusted life-years (QALYs). QALYs were generated from overall survival and patients' weekly completion of the EQ-5D questionnaire. Treatment with OSC alone was considered non-inferior if it was no more than 7 QALY days worse than treatment with WBRT plus OSC, which required 534 patients (80% power, 5% [one-sided] significance level). Analysis was done by intention to treat for all randomly assigned patients. The trial is registered with ISRCTN, number ISRCTN3826061. Between March 2, 2007, and Aug 29, 2014, 538 patients were recruited from 69 UK and three Australian centres, and were randomly assigned to

  13. Phase I study evaluating the treatment of patients with locally advanced pancreatic cancer with carbon ion radiotherapy: the PHOENIX-01 trial

    International Nuclear Information System (INIS)

    Combs, Stephanie E; Debus, Jürgen; Habermehl, Daniel; Kieser, Meinhard; Dreher, Constantin; Werner, Jens; Haselmann, Renate; Jäkel, Oliver; Jäger, Dirk; Büchler, Markus W

    2013-01-01

    Treatment options for patients with locally advanced pancreatic cancer include surgery, chemotherapy as well as radiotherapy. In many cases, surgical resection is not possible, and therefore treatment alternatives have to be performed. Chemoradiation has been established as a convincing treatment alternative for locally advanced pancreatic cancer. Carbon ions offer physical and biological characteristics. Due to their inverted dose profile and the high local dose deposition within the Bragg peak precise dose application and sparing of normal tissue is possible. Moreover, in comparison to photons, carbon ions offer an increased relative biological effectiveness (RBE), which can be calculated between 1.16 and 2.46 depending on the pancreatic cancer cell line as well as the endpoint analyzed. Japanese Data on the evaluation of carbon ion radiation therapy showed promising results for patients with pancreatic cancer. The present PHOENIX-01 trial evaluates carbon ion radiotherapy using the active rasterscanning technique in patients with advanced pancreatic cancer in combination with weekly gemcitabine and adjuvant gemcitabine. Primary endpoint is toxicity, secondary endpoints are overall survival, progression-free survival and response. The physical and biological properties of the carbon ion beam promise to improve the therapeutic ratio in patients with pancreatic cancer: Due to the inverted dose profile dose deposition in the entry channel of the beam leads to sparing of normal tissue; the Bragg peak can be directed into the defined target volume, and the sharp dose fall-off thereafter again spares normal tissue behind the target volume. The higher RBE of carbon ions, which has been shown also for pancreatic cancer cell lines in the preclinical setting, is likely to contribute to an increase in local control, and perhaps in OS. Early data from Japanese centers have shown promising results. In conclusion, this is the first trial to evaluate actively delivered carbon

  14. Changes in Cardiovascular Disease Risk Factors With Immediate Versus Deferred Antiretroviral Therapy Initiation Among HIV-Positive Participants in the START (Strategic Timing of Antiretroviral Treatment) Trial.

    Science.gov (United States)

    Baker, Jason V; Sharma, Shweta; Achhra, Amit C; Bernardino, Jose Ignacio; Bogner, Johannes R; Duprez, Daniel; Emery, Sean; Gazzard, Brian; Gordin, Jonathan; Grandits, Greg; Phillips, Andrew N; Schwarze, Siegfried; Soliman, Elsayed Z; Spector, Stephen A; Tambussi, Giuseppe; Lundgren, Jens

    2017-05-22

    HIV infection and certain antiretroviral therapy (ART) medications increase atherosclerotic cardiovascular disease risk, mediated, in part, through traditional cardiovascular disease risk factors. We studied cardiovascular disease risk factor changes in the START (Strategic Timing of Antiretroviral Treatment) trial, a randomized study of immediate versus deferred ART initiation among HIV-positive persons with CD4 + cell counts >500 cells/mm 3 . Mean change from baseline in risk factors and the incidence of comorbid conditions were compared between groups. The characteristics among 4685 HIV-positive START trial participants include a median age of 36 years, a CD4 cell count of 651 cells/mm 3 , an HIV viral load of 12 759 copies/mL, a current smoking status of 32%, a median systolic/diastolic blood pressure of 120/76 mm Hg, and median levels of total cholesterol of 168 mg/dL, low-density lipoprotein cholesterol of 102 mg/dL, and high-density lipoprotein cholesterol of 41 mg/dL. Mean follow-up was 3.0 years. The immediate and deferred ART groups spent 94% and 28% of follow-up time taking ART, respectively. Compared with patients in the deferral group, patients in the immediate ART group had increased total cholesterol and low-density lipoprotein cholesterol and higher use of lipid-lowering therapy (1.2%; 95% CI, 0.1-2.2). Concurrent increases in high-density lipoprotein cholesterol with immediate ART resulted in a 0.1 lower total cholesterol to high-density lipoprotein cholesterol ratio (95% CI, 0.1-0.2). Immediate ART resulted in 2.3% less BP-lowering therapy use (95% CI, 0.9-3.6), but there were no differences in new-onset hypertension or diabetes mellitus. Among HIV-positive persons with preserved immunity, immediate ART led to increases in total cholesterol and low-density lipoprotein cholesterol but also concurrent increases in high-density lipoprotein cholesterol and decreased use of blood pressure medications. These opposing effects suggest that, in

  15. Effect of the Children's Health Activity Motor Program on Motor Skills and Self-Regulation in Head Start Preschoolers: An Efficacy Trial.

    Science.gov (United States)

    Robinson, Leah E; Palmer, Kara K; Bub, Kristen L

    2016-01-01

    Self-regulatory skills are broadly defined as the ability to manage emotions, focus attention, and inhibit some behaviors while activating others in accordance with social expectations and are an established indicator of academic success. Growing evidence links motor skills and physical activity to self-regulation. This study examined the efficacy of a motor skills intervention (i.e., the Children's Health Activity Motor Program, CHAMP) that is theoretically grounded in Achievement Goal Theory on motor skill performance and self-regulation in Head Start preschoolers. A sample of 113 Head Start preschoolers (Mage = 51.91 ± 6.5 months; 49.5% males) were randomly assigned to a treatment (n = 68) or control (n = 45) program. CHAMP participants engaged in 15, 40-min sessions of a mastery climate intervention that focused on the development of motor skills over 5 weeks while control participants engaged in their normal outdoor recess period. The Delay of Gratification Snack Task was used to measure self-regulation and the Test of Gross Motor Development-2nd Edition was used to assess motor skills. All measures were assessed prior to and following the intervention. Linear mixed models were fit for both self-regulation and motor skills. Results revealed a significant time × treatment interaction (p motor skills, post hoc comparisons found that all children improved their motor skills (p skills associated with healthy development in children (i.e., motor skills and self-regulation). This efficacy trial provided evidence that CHAMP helped maintain delay of gratification in preschool age children and significantly improved motor skills while participating in outdoor recess was not effective. CHAMP could help contribute to children's learning-related skills and physical development and subsequently to their academic success.

  16. Effect of the Children’s Health Activity Motor Program on Motor Skills and Self-Regulation in Head Start Preschoolers: An Efficacy Trial

    Science.gov (United States)

    Robinson, Leah E.; Palmer, Kara K.; Bub, Kristen L.

    2016-01-01

    Self-regulatory skills are broadly defined as the ability to manage emotions, focus attention, and inhibit some behaviors while activating others in accordance with social expectations and are an established indicator of academic success. Growing evidence links motor skills and physical activity to self-regulation. This study examined the efficacy of a motor skills intervention (i.e., the Children’s Health Activity Motor Program, CHAMP) that is theoretically grounded in Achievement Goal Theory on motor skill performance and self-regulation in Head Start preschoolers. A sample of 113 Head Start preschoolers (Mage = 51.91 ± 6.5 months; 49.5% males) were randomly assigned to a treatment (n = 68) or control (n = 45) program. CHAMP participants engaged in 15, 40-min sessions of a mastery climate intervention that focused on the development of motor skills over 5 weeks while control participants engaged in their normal outdoor recess period. The Delay of Gratification Snack Task was used to measure self-regulation and the Test of Gross Motor Development-2nd Edition was used to assess motor skills. All measures were assessed prior to and following the intervention. Linear mixed models were fit for both self-regulation and motor skills. Results revealed a significant time × treatment interaction (p motor skills, post hoc comparisons found that all children improved their motor skills (p skills associated with healthy development in children (i.e., motor skills and self-regulation). This efficacy trial provided evidence that CHAMP helped maintain delay of gratification in preschool age children and significantly improved motor skills while participating in outdoor recess was not effective. CHAMP could help contribute to children’s learning-related skills and physical development and subsequently to their academic success. PMID:27660751

  17. Clinical differences between younger and older adults with HIV/AIDS starting antiretroviral therapy in Uganda and Zimbabwe: a secondary analysis of the DART trial.

    Directory of Open Access Journals (Sweden)

    Sujal M Parikh

    Full Text Available Clinical and immunological data about HIV in older adults from low and middle income countries is scarce. We aimed to describe differences between younger and older adults with HIV starting antiretroviral therapy in two low-income African countries.HIV clinics in Uganda and Zimbabwe.Secondary exploratory cross-sectional analysis of the DART randomized controlled trial.Clinical and laboratory characteristics were compared between adults aged 18-49 years (younger and ≥ 50 years (older, using two exploratory multivariable logistic regression models, one with HIV viral load (measured in a subset pre-ART and one without.A total of 3316 eligible participants enrolled in DART were available for analysis; 219 (7% were ≥ 50 years and 1160 (35% were male. Across the two adjusted regression models, older adults had significantly higher systolic blood pressure, lower creatinine clearance and were consistently less likely to be females compared to younger adults with HIV. Paradoxically, the models separately suggested that older adults had statistically significant (but not clinically important higher CD4+ cell counts and higher plasma HIV-1 viral copies at initiation. Crude associations between older age and higher baseline hemoglobin, body mass index, diastolic blood pressure and lower WHO clinical stage were not sustained in the adjusted analysis.Our study found clinical and immunological differences between younger and older adults, in a cohort of Africans starting antiretroviral therapy. Further investigations should explore how these differences could be used to ensure equity in service delivery and affect outcomes of antiretroviral therapy.

  18. Effects of the Healthy Start randomized intervention trial on physical activity among normal weight preschool children predisposed to overweight and obesity.

    Directory of Open Access Journals (Sweden)

    Mina Nicole Händel

    Full Text Available There is limited evidence to support the effectiveness of primary interventions aiming to prevent excess weight gain among young children. Evaluating behavioral changes, such as physical activity (PA, may add to future development of efficient interventions. The objective was to evaluate the effect on PA outcomes of the 15 month Healthy Start intervention that focused on changing diet, PA, sleep and stress management among normal weight but obesity-prone preschool children. Children were defined as obesity-prone if they had a birth weight > 4,000 g, mothers with a pre-pregnancy body mass index of > 28 kg/m2, or mothers with ≤ 10 years of schooling.From a baseline study population of 635 normal weight 2-6 year old preschool children from the greater Copenhagen area, parents of 307 children had given information on PA at both the baseline and follow-up examinations. PA was obtained from a 7 days recording in the Children's Physical Activity Questionnaire. Time used for sport activities were combined with outdoor playing time to achieve a proxy of total PA level of moderate to vigorous intensity.Linear regression analyses revealed that at follow-up the intervention group spent more time on sports and outdoor activities combined per week than the control group (ITT analyses: intervention: 400 min/week; 95% confidence interval (CI: 341, 459 versus control: 321 min/week; 95% CI: 277, 366; p = 0.02, although no significant intervention effects were seen for each of the subcategories, e.g. sports participation, outdoor activities, screen time, or commuting frequency.Our results suggest that the overall time spent on sports and outdoor activities combined was increased at follow-up among normal weight obesity-prone children, as a result of the Healthy Start intervention.ClinicalTrials.gov NCT01583335.

  19. Effects of the Healthy Start randomized intervention trial on physical activity among normal weight preschool children predisposed to overweight and obesity.

    Science.gov (United States)

    Händel, Mina Nicole; Larsen, Sofus Christian; Rohde, Jeanett Friis; Stougaard, Maria; Olsen, Nanna Julie; Heitmann, Berit Lilienthal

    2017-01-01

    There is limited evidence to support the effectiveness of primary interventions aiming to prevent excess weight gain among young children. Evaluating behavioral changes, such as physical activity (PA), may add to future development of efficient interventions. The objective was to evaluate the effect on PA outcomes of the 15 month Healthy Start intervention that focused on changing diet, PA, sleep and stress management among normal weight but obesity-prone preschool children. Children were defined as obesity-prone if they had a birth weight > 4,000 g, mothers with a pre-pregnancy body mass index of > 28 kg/m2, or mothers with ≤ 10 years of schooling. From a baseline study population of 635 normal weight 2-6 year old preschool children from the greater Copenhagen area, parents of 307 children had given information on PA at both the baseline and follow-up examinations. PA was obtained from a 7 days recording in the Children's Physical Activity Questionnaire. Time used for sport activities were combined with outdoor playing time to achieve a proxy of total PA level of moderate to vigorous intensity. Linear regression analyses revealed that at follow-up the intervention group spent more time on sports and outdoor activities combined per week than the control group (ITT analyses: intervention: 400 min/week; 95% confidence interval (CI): 341, 459 versus control: 321 min/week; 95% CI: 277, 366; p = 0.02), although no significant intervention effects were seen for each of the subcategories, e.g. sports participation, outdoor activities, screen time, or commuting frequency. Our results suggest that the overall time spent on sports and outdoor activities combined was increased at follow-up among normal weight obesity-prone children, as a result of the Healthy Start intervention. ClinicalTrials.gov NCT01583335.

  20. Radiotherapy physics

    International Nuclear Information System (INIS)

    Chen, G.T.Y.; Collier, J.M.; Lyman, J.T.; Pitluck, S.

    1982-01-01

    The Radiotherapy Physics Group works on the physical and biophysical aspects of charged particle radiotherapy. Our activities include the development of isosurvival beams (beams of uniform biological effect), computerized treatment planning development for charged particle radiotherapy, design of compensation to shape dose distributions, and development of dosimetry techniques to verify planned irradiations in both phantoms and patients

  1. Press Start

    Science.gov (United States)

    Harteveld, Casper

    This level sets the stage for the design philosophy called “Triadic Game Design” (TGD). This design philosophy can be summarized with the following sentence: it takes two to tango, but it takes three to design a meaningful game or a game with a purpose. Before the philosophy is further explained, this level will first delve into what is meant by a meaningful game or a game with a purpose. Many terms and definitions have seen the light and in this book I will specifically orient at digital games that aim to have an effect beyond the context of the game itself. Subsequently, a historical overview is given of the usage of games with a serious purpose which starts from the moment we human beings started to walk on our feet till our contemporary society. It turns out that we have been using games for all kinds of non-entertainment purposes for already quite a long time. With this introductory material in the back of our minds, I will explain the concept of TGD by means of a puzzle. After that, the protagonist of this book, the game Levee Patroller, is introduced. Based on the development of this game, the idea of TGD, which stresses to balance three different worlds, the worlds of Reality, Meaning, and Play, came into being. Interested? Then I suggest to quickly “press start!”

  2. A prospective randomized comparative clinical trial comparing the efficacy between ondansetron and metoclopramide for prevention of nausea and vomiting in patients undergoing fractionated radiotherapy to the abdominal region

    Energy Technology Data Exchange (ETDEWEB)

    Park, Hee Chul; Suh, Chang Ok; Seong, Jin Sil; Cho, Jae Ho; Lim, John Jihoon; Park, Won; Song, Jae Seok; Kim, Gwi Eon [College of Medicine, Yonsei Univ., Seoul (Korea, Republic of)

    2001-06-01

    This study is a prospective randomized clinical trial comparing the efficacy and complication of anti-emetic drugs for prevention of nausea and vomiting after radiotherapy which has moderate emetogenic potential. The aim of this study was to investigate whether the anti-emetic efficacy at ondansetron(Zofran) 8 mg bid dose (Group O) is better than the efficacy of metoclopramide 5 mg tid dose (Group M) in patients undergoing fractionated radiotherapy to the abdominal region. Study entry was restricted to those patients who met the following eligibility criteria: histologically confirmed malignant disease; no distant metastasis; performance status of not more than ECOG grade 2; no previous chemotherapy and radiotherapy. Between March 1997 and February 1998, 60 patients enrolled in this study. All patients signed a written statement of informed consent prior to enrollment. Blinding was maintained by dosing identical number of tables including one dose of matching placebo for Group O. The extent of nausea, appetite loss, and the number of emetic episodes were recorded everyday using diary card. The mean score of nausea, appetite loss and the mean number of emetic episodes were obtained in a weekly interval. Prescription error occurred in one patient. And diary cards have not returned in 3 patients due to premature refusal of treatment. Card from one patient was excluded from the analysis because she had a history of treatment for neurosis. As a result, the analysis consisted of 55 patients. Patient characteristics and radiotherapy characteristics were similar except mean age was 52.9{+-} 11.2 in group M, 46.5{+-}9.6 in group O. The difference of age was statistically significant. The mean score of nausea, appetite loss and emetic episodes in a weekly interval was higher in group M than O. In group M, the symptoms were most significant at 5th week. In a panel data analysis using mixed procedure, treatment group was only significant factor detecting the difference of

  3. A prospective randomized comparative clinical trial comparing the efficacy between ondansetron and metoclopramide for prevention of nausea and vomiting in patients undergoing fractionated radiotherapy to the abdominal region

    International Nuclear Information System (INIS)

    Park, Hee Chul; Suh, Chang Ok; Seong, Jin Sil; Cho, Jae Ho; Lim, John Jihoon; Park, Won; Song, Jae Seok; Kim, Gwi Eon

    2001-01-01

    This study is a prospective randomized clinical trial comparing the efficacy and complication of anti-emetic drugs for prevention of nausea and vomiting after radiotherapy which has moderate emetogenic potential. The aim of this study was to investigate whether the anti-emetic efficacy at ondansetron(Zofran) 8 mg bid dose (Group O) is better than the efficacy of metoclopramide 5 mg tid dose (Group M) in patients undergoing fractionated radiotherapy to the abdominal region. Study entry was restricted to those patients who met the following eligibility criteria: histologically confirmed malignant disease; no distant metastasis; performance status of not more than ECOG grade 2; no previous chemotherapy and radiotherapy. Between March 1997 and February 1998, 60 patients enrolled in this study. All patients signed a written statement of informed consent prior to enrollment. Blinding was maintained by dosing identical number of tables including one dose of matching placebo for Group O. The extent of nausea, appetite loss, and the number of emetic episodes were recorded everyday using diary card. The mean score of nausea, appetite loss and the mean number of emetic episodes were obtained in a weekly interval. Prescription error occurred in one patient. And diary cards have not returned in 3 patients due to premature refusal of treatment. Card from one patient was excluded from the analysis because she had a history of treatment for neurosis. As a result, the analysis consisted of 55 patients. Patient characteristics and radiotherapy characteristics were similar except mean age was 52.9± 11.2 in group M, 46.5±9.6 in group O. The difference of age was statistically significant. The mean score of nausea, appetite loss and emetic episodes in a weekly interval was higher in group M than O. In group M, the symptoms were most significant at 5th week. In a panel data analysis using mixed procedure, treatment group was only significant factor detecting the difference of weekly

  4. Risk-adapted targeted intraoperative radiotherapy versus whole-breast radiotherapy for breast cancer

    DEFF Research Database (Denmark)

    Vaidya, Jayant S; Wenz, Frederik; Bulsara, Max

    2014-01-01

    The TARGIT-A trial compared risk-adapted radiotherapy using single-dose targeted intraoperative radiotherapy (TARGIT) versus fractionated external beam radiotherapy (EBRT) for breast cancer. We report 5-year results for local recurrence and the first analysis of overall survival....

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

    International Nuclear Information System (INIS)

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

    2000-01-01

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

  6. The BIG 2.04 MRC/EORTC SUPREMO Trial: pathology quality assurance of a large phase 3 randomised international clinical trial of postmastectomy radiotherapy in intermediate-risk breast cancer.

    Science.gov (United States)

    Thomas, J S; Hanby, A M; Russell, N; van Tienhoven, G; Riddle, K; Anderson, N; Cameron, D A; Bartlett, J M S; Piper, T; Cunningham, C; Canney, P; Kunkler, I H

    2017-05-01

    SUPREMO is a phase 3 randomised trial evaluating radiotherapy post-mastectomy for intermediate-risk breast cancer. 1688 patients were enrolled from 16 countries between 2006 and 2013. We report the results of central pathology review carried out for quality assurance. A single recut haematoxylin and eosin (H&E) tumour section was assessed by one of two reviewing pathologists, blinded to the originally reported pathology and patient data. Tumour type, grade and lymphovascular invasion were reviewed to assess if they met the inclusion criteria. Slides from potentially ineligible patients on central review were scanned and reviewed online together by the two pathologists and a consensus reached. A subset of 25 of these cases was double-reported independently by the pathologists prior to the online assessment. The major contributors to the trial were the UK (75%) and the Netherlands (10%). There is a striking difference in lymphovascular invasion (LVi) rates (41.6 vs. 15.1% (UK); p = grade 3 carcinomas (54.0 vs. 42.0% (UK); p = grade and/or lymphovascular invasion status. Following online consensus review, this fell to 70 cases (16.3% of N- cases, 4.1% of all cases). These data have important implications for the design, powering and interpretation of outcomes from this and future clinical trials. If critical pathology criteria are determinants for trial entry, serious consideration should be given to up-front central pathology review.

  7. Randomized phase III trial of concurrent chemoradiotherapy vs accelerated hyperfractionation radiotherapy in locally advanced head and neck cancer

    International Nuclear Information System (INIS)

    Chitapanarux, Imjai; Kamnerdsupaphon, Pimkhuan; Pukanhapan, Nantaka; Tharavichitkul, Ekkasit; Vongtama, Roy

    2013-01-01

    The aim of this study was to compare the efficacy and safety of concurrent chemoradiotherapy (CCRT) vs accelerated hyperfractionation with concomitant boost (CCB) as a primary treatment for patients with Stage III-IV squamous cell carcinoma of head and neck (SCCHN). A total of 85 non-metastatic advanced SCCHN patients were accrued from January 2003 to December 2007. Of these, 48 and 37 patients received CCRT and CCB, respectively. The patients were randomized to receive either three cycles of carboplatin and 5-fluorouracil plus conventional radiotherapy (CCRT, 66 Gy in 6.5 weeks) or hybrid accelerated radiotherapy (CCB, 70 Gy in 6 weeks). The primary endpoint was determined by locoregional control rate. The secondary endpoints were overall survival and toxicity. With a median follow-up of 43 months (range, 3-102), the 5-year locoregional control rate was 69.6% in the CCRT arm vs 55.0% in the CCB arm (P = 0.184). The 5-year overall survival rate was marginally significantly different (P = 0.05): 76.1% in the CCRT arm vs 63.5% in the CCB arm. Radiotherapy treatment interruptions of more than three days were 60.4% and 40.5% in the CCRT arm and CCB arm, respectively. The median total treatment time was 55.5 days in the CCRT arm and 49 days in the CCB arm. The rate of Grade 3 - 4 acute mucositis was significantly higher in the CCB arm (67.6% vs 41.7%, P = 0.01), but no high grade hematologic toxicities were found in the CCB arm (27.2% vs 0%). CCRT has shown a trend of improving outcome over CCB irradiation in locoregionally advanced head and neck cancer. (author)

  8. to start

    Indian Academy of Sciences (India)

    Click here to start. Table of contents. Slide 1 · Slide 2 · Slide 3 · Slide 4 · Slide 5 · Slide 6 · Slide 7 · Slide 8 · Slide 9 · Slide 10 · Slide 11 · Slide 12 · Slide 13 · Slide 14 · Slide 15 · Slide 16 · Slide 17 · Slide 18 · Slide 19 · Slide 20 · Slide 21 · Slide 22 · Slide 23 · Slide 24 · Slide 25 · Slide 26 · Slide 27 · Slide 28 · Slide 29 · Slide 30.

  9. Starting electronics

    CERN Document Server

    Brindley, Keith

    2005-01-01

    Starting Electronics is unrivalled as a highly practical introduction for hobbyists, students and technicians. Keith Brindley introduces readers to the functions of the main component types, their uses, and the basic principles of building and designing electronic circuits. Breadboard layouts make this very much a ready-to-run book for the experimenter; and the use of multimeter, but not oscilloscopes, puts this practical exploration of electronics within reach of every home enthusiast's pocket. The third edition has kept the simplicity and clarity of the original. New material

  10. Does transfusion improve the outcome for HNSCC patients treated with radiotherapy? - Results from the randomized DAHANCA 5 and 7 trials

    DEFF Research Database (Denmark)

    Hoff, Camilla Molich; Lassen, Pernille; Eriksen, Jesper Grau

    2011-01-01

    of transfusion by the results from the randomized DAHANCA 5 trial, including 414 patients in the analysis. Aim of the current analysis was to gain additional power by adding patients from the continued subrandomization in the DAHANCA 7 trial, now including a total of almost 1200 patients. Material and methods...

  11. Induction Chemotherapy and Continuous Hyperfractionated Accelerated Radiotherapy (CHART) for Patients With Locally Advanced Inoperable Non-Small-Cell Lung Cancer: The MRC INCH Randomized Trial

    International Nuclear Information System (INIS)

    Hatton, Matthew; Nankivell, Matthew; Lyn, Ethan; Falk, Stephen; Pugh, Cheryl; Navani, Neal; Stephens, Richard; Parmar, Mahesh

    2011-01-01

    Purpose: Recent clinical trials and meta-analyses have shown that both CHART (continuous hyperfractionated accelerated radiation therapy) and induction chemotherapy offer a survival advantage over conventional radical radiotherapy for patients with inoperable non-small cell-lung cancer (NSCLC). This multicenter randomized controlled trial (INCH) was set up to assess the value of giving induction chemotherapy before CHART. Methods and Materials: Patients with histologically confirmed, inoperable, Stage I-III NSCLC were randomized to induction chemotherapy (ICT) (three cycles of cisplatin-based chemotherapy followed by CHART) or CHART alone. Results: Forty-six patients were randomized (23 in each treatment arm) from 9 UK centers. As a result of poor accrual, the trial was closed in December 2007. Twenty-eight patients were male, 28 had squamous cell histology, 34 were Stage IIIA or IIIB, and all baseline characteristics were well balanced between the two treatment arms. Seventeen (74%) of the 23 ICT patients completed the three cycles of chemotherapy. All 42 (22 CHART + 20 ICT) patients who received CHART completed the prescribed treatment. Median survival was 17 months in the CHART arm and 25 months in the ICT arm (hazard ratio of 0.60 [95% CI 0.31-1.16], p = 0.127). Grade 3 or 4 adverse events (mainly fatigue, dysphagia, breathlessness, and anorexia) were reported for 13 (57%) CHART and 13 (65%) ICT patients. Conclusions: This small randomized trial indicates that ICT followed by CHART is feasible and well tolerated. Despite closing early because of poor accrual, and so failing to show clear evidence of a survival benefit for the additional chemotherapy, the results suggest that CHART, and ICT before CHART, remain important options for the treatment of inoperable NSCLC and deserve further study.

  12. Breast-conserving surgery with or without radiotherapy in women with ductal carcinoma in situ: a meta-analysis of randomized trials

    Directory of Open Access Journals (Sweden)

    Leon Paola G

    2007-08-01

    Full Text Available Abstract Background To investigate whether Radiation therapy (RT should follow breast conserving surgery in women with ductal carcinoma in situ from breast cancer (DCIS with objective of decreased mortality, invasive or non invasive recurrence, distant metastases and contralateral breast cancer rates. We have done a meta-analysis of these results to give a more balanced view of the total evidence and to increase statistical precision. Methods A meta-analysis of randomized controlled trials (RCT was performed comparing RT treatment for DCIS of breast cancer to observation. The MEDLINE, EMBASE, CANCERLIT, Cochrane Library databases, Trial registers, bibliographic databases, and recent issues of relevant journals were searched. Relevant reports were reviewed by two reviewers independently and the references from these reports were searched for additional trials, using guidelines set by QUOROM statement criteria. Results The reviewers identified four large RCTs, yielding 3665 patients. Pooled results from this four randomized trials of adjuvant radiotherapy showed a significant reduction of invasive and DCIS ipsilateral breast cancer with odds ratio (OR of 0.40 (95% CI 0.33 – 0.60, p Conclusion The conclusion from our meta-analysis is that the addition of radiation therapy to lumpectomy results in an approximately 60% reduction in breast cancer recurrence, no benefit for survival or distant metastases compared to excision alone. Patients with high-grade DCIS lesions and positive margins benefited most from the addition of radiation therapy. It is not yet clear which patients can be successfully treated with lumpectomy alone; until further prospective studies answer this question, radiation should be recommended after lumpectomy for all patients without contraindications.

  13. Clinical outcomes of adjuvant external-beam radiotherapy for differentiated thyroid cancer. Results after 874 patient-years of follow-up in the MSDS-trial

    Energy Technology Data Exchange (ETDEWEB)

    Biermann, M. [Haukeland University Hospital, Bergen (Norway). Dept. of Radiology; Pixberg, M.K.; Riemann, B.; Schober, O. [Muenster Univ. (Germany). Dept. of Nuclear Medicine; Schuck, A.; Willich, N. [Muenster Univ. (Germany). Dept. of Radiooncology; Heinecke, A. [Muenster Univ. (Germany). Dept. of Biometrics; Schmid, K.W. [University Hospital of Essen, West German Cancer Center (Germany). Inst. of Pathology and Neuropathology; Dralle, H. [Halle-Wittenberg Univ. (Germany). Dept. of General Surgery

    2009-07-01

    Evaluate the clinical benefit of external beam radiotherapy (RTx) for locally invasive thyroid carcinoma with follicular cell differentiation (DTC). The Multicentre Study on Differentiated Thyroid Cancer (MSDS) was planned as a prospective multicenter trial on the benefit of adjuvant RTx in locally invasive DTC (pT4; UICC 1997) with or without lymph node metastases and no known distant metastases. All patients were treated with thyroidectomy, {sup 131}I-therapy, and TSH-suppression and were randomized to receive additional RTx or not. In 4/2003 the trial became a prospective cohort study after only 45 of then 311 patients had consented to randomization. 351 of 422 patients met the trial's inclusion criteria. Age was 48 {+-} 12 years (mean {+-} SD). 25% were men. Tumours were papillary in 90% and follicular in 10%. Of 47 patients randomized or allocated to RTx, 26 actually received RTx. Mean follow-up was 930 days. In an actual treatment analysis, 96% (25/26) of the RTx-patients reached complete remission (CR) vs. 86% in the non-RTx patients. Recurrences occurred in 0 vs. 3 % of patients: 6 reoperated for regional lymph node metastases, 1 tracheal invasion treated with tracheoplasty, 1 local invasion necessitating laryngectomy, 2 distant metastases (1 lung, 1 lung + bone). Serious chronic RTx toxicity occurred in 1/26 patients. The MSDS trial showed low mortality and recurrence rates and a weak benefit of RTx in terms of local control that did however not reach statistical significance. Routine RTx in locally invasive DTC can no longer be recommended. (orig.)

  14. Clinical outcomes of adjuvant external-beam radiotherapy for differentiated thyroid cancer. Results after 874 patient-years of follow-up in the MSDS-trial

    International Nuclear Information System (INIS)

    Biermann, M.; Pixberg, M.K.; Riemann, B.; Schober, O.; Schuck, A.; Willich, N.; Heinecke, A.; Schmid, K.W.; Dralle, H.

    2009-01-01

    Evaluate the clinical benefit of external beam radiotherapy (RTx) for locally invasive thyroid carcinoma with follicular cell differentiation (DTC). The Multicentre Study on Differentiated Thyroid Cancer (MSDS) was planned as a prospective multicenter trial on the benefit of adjuvant RTx in locally invasive DTC (pT4; UICC 1997) with or without lymph node metastases and no known distant metastases. All patients were treated with thyroidectomy, 131 I-therapy, and TSH-suppression and were randomized to receive additional RTx or not. In 4/2003 the trial became a prospective cohort study after only 45 of then 311 patients had consented to randomization. 351 of 422 patients met the trial's inclusion criteria. Age was 48 ± 12 years (mean ± SD). 25% were men. Tumours were papillary in 90% and follicular in 10%. Of 47 patients randomized or allocated to RTx, 26 actually received RTx. Mean follow-up was 930 days. In an actual treatment analysis, 96% (25/26) of the RTx-patients reached complete remission (CR) vs. 86% in the non-RTx patients. Recurrences occurred in 0 vs. 3 % of patients: 6 reoperated for regional lymph node metastases, 1 tracheal invasion treated with tracheoplasty, 1 local invasion necessitating laryngectomy, 2 distant metastases (1 lung, 1 lung + bone). Serious chronic RTx toxicity occurred in 1/26 patients. The MSDS trial showed low mortality and recurrence rates and a weak benefit of RTx in terms of local control that did however not reach statistical significance. Routine RTx in locally invasive DTC can no longer be recommended. (orig.)

  15. Adjuvant radiotherapy and 5-fluorouracil after curative resection of cancer of the pancreas and periampullary region: phase III trial of the EORTC gastrointestinal tract cancer cooperative group

    NARCIS (Netherlands)

    Klinkenbijl, J. H.; Jeekel, J.; Sahmoud, T.; van Pel, R.; Couvreur, M. L.; Veenhof, C. H.; Arnaud, J. P.; Gonzalez, D. G.; de Wit, L. T.; Hennipman, A.; Wils, J.

    1999-01-01

    The survival benefit of adjuvant radiotherapy and 5-fluorouracil versus observation alone after surgery was investigated in patients with pancreatic head and periampullary cancers. A previous study of adjuvant radiotherapy and chemotherapy in these cancers by the Gastrointestinal Tract Cancer

  16. Previous radiotherapy and the clinical activity and toxicity of pembrolizumab in the treatment of non-small-cell lung cancer: a secondary analysis of the KEYNOTE-001 phase 1 trial.

    Science.gov (United States)

    Shaverdian, Narek; Lisberg, Aaron E; Bornazyan, Krikor; Veruttipong, Darlene; Goldman, Jonathan W; Formenti, Silvia C; Garon, Edward B; Lee, Percy

    2017-07-01

    Preclinical studies have found radiotherapy enhances antitumour immune responses. We aimed to assess disease control and pulmonary toxicity in patients who previously received radiotherapy for non-small-cell lung cancer (NSCLC) before receiving pembrolizumab. We assessed patients with advanced NSCLC treated on the phase 1 KEYNOTE-001 trial at a single institution (University of California, Los Angeles, CA, USA). Patients were aged 18 years or older, had an Eastern Cooperative Oncology Group performance status of 1 or less, had adequate organ function, and no history of pneumonitis. Patients received pembrolizumab at a dose of either 2 mg/kg of bodyweight or 10 mg/kg every 3 weeks, or 10 mg/kg every 2 weeks, until disease progression, unacceptable toxicity, or other protocol-defined reasons for discontinuation. Disease response and pulmonary toxicity were prospectively assessed by Immune-related Response Criteria and Common Terminology Criteria for Adverse Events version 4.0. The primary objective of the KEYNOTE-001 trial was to assess the safety, side-effect profile, and antitumour activity of pembrolizumab. For our secondary analysis, patients were divided into subgroups to compare patients who previously received radiotherapy with patients who had not. Our primary objective was to determine whether previous radiotherapy affected progression-free survival, overall survival, and pulmonary toxicity in the intention-to-treat population. The KEYNOTE-001 trial was registered with ClinicalTrials.gov, number NCT01295827. Between May 22, 2012, and July 11, 2014, 98 patients were enrolled and received their first cycle of pembrolizumab. One patient was lost to follow-up. 42 (43%) of 97 patients had previously received any radiotherapy for the treatment of NSCLC before the first cycle of pembrolizumab. 38 (39%) of 97 patients received extracranial radiotherapy and 24 (25%) of 97 patients received thoracic radiotherapy. Median follow-up for surviving patients was 32·5

  17. Early stage ovarian cancer: a randomized clinical trial comparing whole abdominal radiotherapy, melphalan, and intraperitoneal chromic phosphate: a National Cancer Institute of Canada Clinical Trials Group report

    International Nuclear Information System (INIS)

    Klaassen, D.; Shelley, W.; Starreveld, A.

    1988-01-01

    Two hundred fifty-seven eligible patients with stage I, IIA high risk ovarian carcinoma and IIB, IIIO (disease confined to pelvis), were randomized to either total abdominal radiotherapy (arm A) 2,250 rad in 20 fractions (107 patients), melphalan (arm B) 8 mg/m2/d X 4 every 4 weeks X 18 courses (106 patients), or intraperitoneal chromic phosphate (arm C) 10 to 20 mCi (44 patients). All patients were initially treated with pelvic radiotherapy; arm A, 2,250 rad in ten fractions; and arms B and C, 4,500 rad in 20 fractions. Entry to arm C was discontinued early because of toxicity. In a multifactor analysis using proportional hazards models, no significant difference in survival was observed although there was a marginally significant difference in disease-free survival (P = .015) with arm B being superior to arm A. Stage (P less than .0001), grade (P less than .0001), and histology (P less than .008) were predictors of survival in the multifactor analysis. Performance status, age, and residual disease were significant predictors in the single factor analysis but were not predictive when correction was made for the effects of stage, grade, and histology. Five-year survival rates are 62% for arm A, 61% for arm B, and 66% for arm C. Median duration of follow-up is 8 years. Long-term complications of radiotherapy were seen in 19 patients on arm A, 11 on arm B, and 11 on arm C. Four patients who had received melphalan developed either a myelodysplastic syndrome or acute leukemia. Violations in covering the whole abdominal target volume were correlated with survival

  18. A phase II randomized trial comparing radiotherapy with concurrent weekly cisplatin or weekly paclitaxel in patients with advanced cervical cancer

    International Nuclear Information System (INIS)

    Geara, Fady B; Shamseddine, Ali; Khalil, Ali; Abboud, Mirna; Charafeddine, Maya; Seoud, Muhieddine

    2010-01-01

    This is a prospective comparison of weekly cisplatin to weekly paclitaxel as concurrent chemotherapy with standard radiotherapy for locally advanced cervical carcinoma. Between May 2000 and May 2004, 31 women with FIGO stage IB2-IVA cervical cancer or with postsurgical pelvic recurrence were enrolled into this phase II study and randomized to receive on a weekly basis either 40 mg/m 2 Cisplatin (group I; 16 patients) or 50 mg/m 2 paclitaxel (group II; 15 patients) concurrently with radiotherapy. Median total dose to point A was 74 Gy (range: 66-92 Gy) for group I and 66 Gy (range: 40-98 Gy) for group II. Median follow-up time was 46 months. Patient and tumor characteristics were similar in both groups. The mean number of chemotherapy cycles was also comparable with 87% and 80% of patients receiving at least 4 doses in groups I and II, respectively. Seven patients (44%) of group I and 8 patients (53%) of group II developed tumor recurrence. The Median Survival time was not reached for Group I and 53 months for group II. The proportion of patients surviving at 2 and 5 years was 78% and 54% for group I and 73% and 43% for group II respectively. This small prospective study shows that weekly paclitaxel does not provide any clinical advantage over weekly cisplatin for concurrent chemoradiation for advanced carcinoma of the cervix

  19. Randomized controlled trial of live lactobacillus acidophilus plus bifidobacterium bifidum in prophylaxis of diarrhea during radiotherapy in cervical cancer patients

    International Nuclear Information System (INIS)

    Chitapanarux, Imjai; Chitapanarux, Taned; Traisathit, Patrinee; Kudumpee, Sudkaneung; Tharavichitkul, Ekkasit; Lorvidhaya, Vicharn

    2010-01-01

    Radiation-induced diarrhea is frequently observed during pelvic radiotherapy. This study was performed to determine the ability of a probiotic containing live lactobacillus acidophilus plus bifidobacterium bifidum to reduce the incidence of radiation-induced diarrhea in locally advanced cervical cancer patients. Patients who were undergoing pelvic radiotherapy concurrent with weekly cisplatin were randomly assigned to a study drug or placebo, in a double-blind study. Diarrhea was graded weekly according the Common Toxicity Criteria (CTC) system. Stool consistency and white and red blood cell count in stool were also assessed. The primary endpoint was to reduce the incidence of diarrhea, defined by a CTC grade 2 or more, and the need for anti-diarrheal medication. A total of 63 patients were enrolled. Grade 2 -3 diarrhea was observed in 45% of the placebo group (n = 31) and 9% of the study drug group (n = 32) (p = 0.002). Anti-diarrheal medication use was significantly reduced in the placebo group (p = 0.03). The patients in the study drug group had a significantly improved stool consistency (p < 0.001). Live lactobacillus acidophilus plus bifidobacterium bifidum reduced the incidence of radiation-induced diarrhea and the need for anti-diarrheal medication and had a significant benefits on stool consistency

  20. Phase II trial of Uracil/Tegafur plus leucovorin and celecoxib combined with radiotherapy in locally advanced pancreatic cancer

    International Nuclear Information System (INIS)

    Morak, Marjolein J.M.; Richel, Dick J.; Eijck, Casper H.J. van; Nuyttens, Joost J.M.E.; Gaast, Ate van der; Vervenne, Walter L.; Padmos, Esther E.; Schaake, Eva E.; Busch, Olivier R.C.; Tienhoven, Geertjan van

    2011-01-01

    Background and purpose: To investigate the efficacy and toxicity of a short intensive Uracil/Tegafur (UFT) based chemoradiotherapy scheme combined with celecoxib in locally advanced pancreatic cancer. Material and methods: The Academic Medical Centre, Amsterdam and the Erasmus Medical Centre, Rotterdam enrolled 83 eligible patients with unresectable pancreatic cancer in a prospective multicentre phase II study. Median age was 62 years, median tumour size 40 mm and the majority of the patients (85%) had pancreatic head cancers. Treatment consisted of 20 x 2.5 Gy radiotherapy combined with UFT 300 mg/m 2 per day, leucovorin (folinic acid) 30 mg and celecoxib 800 mg for 28 days concomitant with radiotherapy. Four patients were lost to follow-up. Results: Full treatment compliance was achieved in 55% of patients, 80% received at least 3 weeks of treatment. No partial or complete response was observed. Median survival was 10.6 months and median time to progression 6.9 months. Toxicity was substantial with 28% grades III and IV gastro-intestinal toxicity and two early toxic deaths. Conclusions: Based on the lack of response, the substantial toxicity of mainly gastro-intestinal origin and the reported mediocre overall and progression free survival, we cannot advise our short intensive chemoradiotherapy schedule combined with celecoxib as the standard treatment.

  1. Epigenetics in radiotherapy: Where are we heading?

    International Nuclear Information System (INIS)

    Smits, Kim M.; Melotte, Veerle; Niessen, Hanneke E.C.; Dubois, Ludwig; Oberije, Cary; Troost, Esther G.C.; Starmans, Maud H.W.; Boutros, Paul C.; Vooijs, Marc; Engeland, Manon van; Lambin, Philippe

    2014-01-01

    Radiotherapy is an important component of anti-cancer treatment. However, not all cancer patients respond to radiotherapy, and with current knowledge clinicians are unable to predict which patients are at high risk of recurrence after radiotherapy. There is therefore an urgent need for biomarkers to guide clinical decision-making. Although the importance of epigenetic alterations is widely accepted, their application as biomarkers in radiotherapy has not been studied extensively. In addition, it has been suggested that radiotherapy itself introduces epigenetic alterations. As epigenetic alterations can potentially be reversed by drug treatment, they are interesting candidate targets for anticancer therapy or radiotherapy sensitizers. The application of demethylating drugs or histone deacetylase inhibitors to sensitize patients for radiotherapy has been studied in vitro, in vivo as well as in clinical trials with promising results. This review describes the current knowledge on epigenetics in radiotherapy

  2. Oral mucositis and selective elimination of oral flora in head and neck cancer patients receiving radiotherapy : a double-blind randomised clinical trial

    NARCIS (Netherlands)

    Stokman, MA; Spijkervet, FKL; Burlage, FR; Dijkstra, PU; Manson, WL; de Vries, EGE; Roodenburg, JLN

    2003-01-01

    Mucositis is an acute inflammation of the oral mucosa because of radiotherapy and/or chemotherapy. All patients receiving radiotherapy in the head and neck region develop oral mucositis. The aim of this study was to analyse the effects of selective oral flora elimination on radiotherapy-induced oral

  3. A randomised trial of accelerated and conventional radiotherapy for stage III and IV squamous carcinoma of the head and neck: a Trans-Tasman Radiation Oncology Group Study

    International Nuclear Information System (INIS)

    Poulsen, Michael G.; Denham, James W.; Peters, Lester J.; Lamb, David S.; Spry, Nigel A.; Hindley, Andrew; Krawitz, Hedley; Hamilton, Chris; Keller, Jacqui; Tripcony, Lee; Walker, Quenten

    2001-01-01

    Purpose: The aims of this randomized controlled trial were to determine whether there were differences in the disease-free survival (DFS) and toxicity between conventional radiotherapy (CRT) and a continuous 3 week accelerated radiotherapy regimen (ART) in stage III and IV squamous cell carcinoma of the oral cavity, oropharynx, larynx and hypopharynx. Patients and methods: Patients from 14 centres throughout Australia and New Zealand were randomly assigned to either CRT, using a single 2 Gy/day to a dose of 70 Gy in 35 fractions in 49 days or to ART, using 1.8 Gy twice a day to a dose of 59.4 Gy in 33 fractions in 24 days. Treatment allocation was stratified for site and stage. The accrual began in 1991 and the trial was closed in 1998 when the target of 350 patients was reached. Results: The median potential follow-up time was 53 months (range, 14-101). The DFS at 5 years was 41% (95% CI, 33-50%) for ART and 35% (95% CI, 27-43%) for CRT (P=0.323) and the hazard ratio was 0.87 in favour of ART (95% CI, 0.66-1.15). The 5-year disease-specific survival rates were 40% for CRT and 46% for ART (P=0.398) and the loco-regional control was 47% for CRT vs. 52% for ART (P=0.300). The respective hazard ratios were 0.88 (95% CI, 0.65-1.2) and 0.85 (0.62-1.16), favouring the accelerated arm. In the ART arm, confluent mucositis was more severe (94 vs. 71%; P<0.001) and peaked about 3 weeks earlier than in the CRT arm, but healing appeared complete in all cases. There were statistically significant reductions in the probability of grade 2 or greater late soft tissue effects over time in the ART arm (P<0.05), except for the mucous membrane where late effects were similar in both arms. Conclusions: Differences in DFS, disease-specific survival and loco-regional control have not been demonstrated. ART resulted in more acute mucosal toxicity, but this did not result in greater prolongation of the treatment time compared with the CRT arm. There were less late effects in the ART arm

  4. Effect of the Children’s Health Activity Motor Program on Motor Skills and Self-Regulation in Head Start Preschoolers: An Efficacy Trial

    Directory of Open Access Journals (Sweden)

    Leah Elizabeth Robinson

    2016-09-01

    Full Text Available Self-regulatory skills are broadly defined as the ability to manage emotions, focus attention, and inhibit some behaviors while activating others in accordance with social expectations and are an established indicator of academic success. Growing evidence links motor skills and physical activity to self-regulation. This study examined the efficacy of a motor skills intervention (i.e., the Children’s Health Activity Motor Program, CHAMP that is theoretically grounded in Achievement Goal Theory on motor skill performance and self-regulation in Head Start preschoolers. A sample of 113 Head Start preschoolers (Mage = 51.91 + 6.5 months; 49.5% males were randomly assigned to a treatment (n = 68 or control (n = 45 program. CHAMP participants engaged in 15, 40-minute sessions of a mastery climate intervention that focused on the development of motor skills over 5 weeks while control participants engaged in their normal outdoor recess period. The Delay of Gratification Snack Task was used to measure self-regulation and the Test of Gross Motor Development - 2nd Edition was used to assess motor skills. All measures were assessed prior to and following the intervention. Linear mixed models were fit for both self-regulation and motor skills. Results revealed a significant time*treatment interaction (p < .001. In regards to motor skills, post hoc comparisons found that all children improved their motor skills (p < .05, but the CHAMP group improved significantly more than the control group (p < .001. Children in CHAMP maintained their self-regulation scores across time while children in the control group scored significantly lower than the CHAMP group at the posttest (p < .05. CHAMP is a mastery climate movement program that may be an approach to enhance skills associated with healthy development in children (i.e., motor skills and self-regulation. This efficacy trial provided evidence that CHAMP helped maintain delay of gratification in preschool age

  5. The Safety and Immunogenicity of Live Zoster Vaccination in Patients With Rheumatoid Arthritis Before Starting Tofacitinib: A Randomized Phase II Trial.

    Science.gov (United States)

    Winthrop, Kevin L; Wouters, Ann G; Choy, Ernest H; Soma, Koshika; Hodge, Jennifer A; Nduaka, Chudy I; Biswas, Pinaki; Needle, Elie; Passador, Sherry; Mojcik, Christopher F; Rigby, William F

    2017-10-01

    Patients with rheumatoid arthritis (RA) are at increased risk of herpes zoster, and vaccination is recommended for patients ages 50 years and older, prior to starting treatment with biologic agents or tofacitinib. Tofacitinib is an oral JAK inhibitor for the treatment of RA. We evaluated its effect on the immune response and safety of live zoster vaccine (LZV). In this phase II, 14-week, placebo-controlled trial, patients ages 50 years and older who had active RA and were receiving background methotrexate were given LZV and randomized to receive tofacitinib 5 mg twice daily or placebo 2-3 weeks postvaccination. We measured humoral responses (varicella zoster virus [VZV]-specific IgG level as determined by glycoprotein enzyme-linked immunosorbent assay) and cell-mediated responses (VZV-specific T cell enumeration, as determined by enzyme-linked immunospot assay) at baseline and 2 weeks, 6 weeks, and 14 weeks postvaccination. End points included the geometric mean fold rise (GMFR) in VZV-specific IgG levels (primary end point) and T cells (number of spot-forming cells/10 6 peripheral blood mononuclear cells) at 6 weeks postvaccination. One hundred twelve patients were randomized to receive tofacitinib (n = 55) or placebo (n = 57). Six weeks postvaccination, the GMFR in VZV-specific IgG levels was 2.11 in the tofacitinib group and 1.74 in the placebo group, and the VZV-specific T cell GMFR was similar in the tofacitinib group and the placebo group (1.50 and 1.29, respectively). Serious adverse events occurred in 3 patients in the tofacitinib group (5.5%) and 0 patients (0.0%) in the placebo group. One patient, who lacked preexisting VZV immunity, developed cutaneous vaccine dissemination 2 days after starting tofacitinib (16 days postvaccination). This resolved after tofacitinib was discontinued and the patient received antiviral treatment. Patients who began treatment with tofacitinib 2-3 weeks after receiving LZV had VZV-specific humoral and cell

  6. Concurrent chemoradiotherapy was associated with a higher severe late toxicity rate in nasopharyngeal carcinoma patients compared with radiotherapy alone: a meta-analysis based on randomized controlled trials

    International Nuclear Information System (INIS)

    Du, Cheng-run; Ying, Hong-mei; Kong, Fang-fang; Zhai, Rui-ping; Hu, Chao-su

    2015-01-01

    To investigate the incidence and risk of severe late toxicity with concurrent chemoradiotherapy (CCRT) in nasopharyngeal carcinoma patients. Eligible studies included prospective randomized controlled trials (RCTs) evaluating CCRT versus radiotherapy alone in patients with nasopharyngeal carcinoma and in which data on severe late toxicities were available. Random effects or fixed effect models were applied to obtain the summary incidence, relative risks (RRs) and 95% confidence intervals (CIs). Five RCTs with 1102 patients with NPC were included in this analysis. The summary incidence of overall severe late toxicities in patients receiving CCRT was 30.7% (95% CI, 18–47.2%) and the incidence of radiotherapy alone group was 21.7% (95% CI, 13.3–33.4%). The use of concurrent chemotherapy was associated with an increased risk of severe late toxicities, with a RR of 1.349 (95% CI, 1.108–1.643; P = 0.005). As for specific late toxicity, CCRT significantly increased the risk of ear deafness/otitis (RR = 1.567; 95% CI, 1.192–2.052), but other late toxicities were not significantly different. Patients receiving concurrent chemotherapy regimens with 3-week high-dose cisplatin (HC) have a higher risk of ear deafness/otitis (RR = 1.672; 95% CI, 1.174–2.382; P = 0.026). However, there was no significant increase in the RR of severe ear complication with the addition of non-3-week high-dose cisplatin (nonHC) regimens (RR = 1.433; 95% CI, 0.946–2.171; P = 0.095). With the present evidence, the addition of concurrent chemotherapy seems to increase the risk of severe late toxicities in patients with NPC, especially when using HC regimen for the occurrence of severe ototoxicity

  7. SU-E-CAMPUS-J-04: Image Guided Radiation Therapy (IGRT): Review of Technical Standards and Credentialing in Radiotherapy Clinical Trials

    International Nuclear Information System (INIS)

    Giaddui, T; Chen, W; Yu, J; Gong, Y; Galvin, J; Xiao, Y; Cui, Y; Yin, F; Craig, T; Dawson, L; Al-Hallaq, H; Chmura, S

    2014-01-01

    Purpose: To review IGRT credentialing experience and unexpected technical issues encountered in connection with advanced radiotherapy technologies as implemented in RTOG clinical trials. To update IGRT credentialing procedures with the aim of improving the quality of the process, and to increase the proportion of IGRT credentialing compliance. To develop a living disease site-specific IGRT encyclopedia. Methods: Numerous technical issues were encountered during the IGRT credentialing process. The criteria used for credentialing review were based on: image quality; anatomy included in fused data sets and shift results. Credentialing requirements have been updated according to the AAPM task group reports for IGRT to ensure that all required technical items are included in the quality review process. Implementation instructions have been updated and expanded for recent protocols. Results: Technical issues observed during the credentialing review process include, but are not limited to: poor quality images; inadequate image acquisition region; poor data quality; shifts larger than acceptable; no soft tissue surrogate. The updated IGRT credentialing process will address these issues and will also include the technical items required from AAPM: TG 104; TG 142 and TG 179 reports. An instruction manual has been developed describing a remote credentialing method for reviewers. Submission requirements are updated, including images/documents as well as facility questionnaire. The review report now includes summary of the review process and the parameters that reviewers check. We have reached consensus on the minimum IGRT technical requirement for a number of disease sites. RTOG 1311(NRG-BR002A Phase 1 Study of Stereotactic Body Radiotherapy (SBRT) for the Treatment of Multiple Metastases) is an example, here; the protocol specified the minimum requirement for each anatomical sites (with/without fiducials). Conclusion: Technical issues are identified and reported. IGRT

  8. SU-E-QI-21: Iodinated Contrast Agent Time Course In Human Brain Metastasis: A Study For Stereotactic Synchrotron Radiotherapy Clinical Trials

    Energy Technology Data Exchange (ETDEWEB)

    Obeid, L; Esteve, F; Adam, J [Grenoble Institut des Neurosciences, La Tronche, Isere (France); Tessier, A; Balosso, J [Centre Hospitalier Universitaire, La Tronche, Isere (France)

    2014-06-15

    Purpose: Synchrotron stereotactic radiotherapy (SSRT) is an innovative treatment combining the selective accumulation of heavy elements in tumors with stereotactic irradiations using monochromatic medium energy x-rays from a synchrotron source. Phase I/II clinical trials on brain metastasis are underway using venous infusion of iodinated contrast agents. The radiation dose enhancement depends on the amount of iodine in the tumor and its time course. In the present study, the reproducibility of iodine concentrations between the CT planning scan day (Day 0) and the treatment day (Day 10) was assessed in order to predict dose errors. Methods: For each of days 0 and 10, three patients received a biphasic intravenous injection of iodinated contrast agent (40 ml, 4 ml/s, followed by 160 ml, 0.5 ml/s) in order to ensure stable intra-tumoral amounts of iodine during the treatment. Two volumetric CT scans (before and after iodine injection) and a multi-slice dynamic CT of the brain were performed using conventional radiotherapy CT (Day 0) or quantitative synchrotron radiation CT (Day 10). A 3D rigid registration was processed between images. The absolute and relative differences of absolute iodine concentrations and their corresponding dose errors were evaluated in the GTV and PTV used for treatment planning. Results: The differences in iodine concentrations remained within the standard deviation limits. The 3D absolute differences followed a normal distribution centered at zero mg/ml with a variance (∼1 mg/ml) which is related to the image noise. Conclusion: The results suggest that dose errors depend only on the image noise. This study shows that stable amounts of iodine are achievable in brain metastasis for SSRT treatment in a 10 days interval.

  9. Acute Toxicity Profile and Compliance to Accelerated Radiotherapy Plus Carbogen and Nicotinamide for Clinical Stage T2–4 Laryngeal Cancer: Results of a Phase III Randomized Trial

    International Nuclear Information System (INIS)

    Janssens, Geert O.; Terhaard, Chris H.; Doornaert, Patricia A.; Bijl, Hendrik P.; Ende, Piet van den; Chin, Alim; Pop, Lucas A.; Kaanders, Johannes H.

    2012-01-01

    Purpose: To report the acute toxicity profile and compliance from a randomized Phase III trial comparing accelerated radiotherapy (AR) with accelerated radiotherapy plus carbogen and nicotinamide (ARCON) in laryngeal cancer. Methods and Materials: From April 2001 to February 2008, 345 patients with cT2–4 squamous cell laryngeal cancer were randomized to AR (n = 174) and ARCON (n = 171). Acute toxicity was scored weekly until Week 8 and every 2–4 weeks thereafter. Compliance to carbogen and nicotinamide was reported. Results: Between both treatment arms (AR vs. ARCON) no statistically significant difference was observed for incidence of acute skin reactions (moist desquamation: 56% vs. 58%, p = 0.80), acute mucosal reactions (confluent mucositis: 79% vs. 85%, p = 0.14), and symptoms related to acute mucositis (severe pain on swallowing: 53% vs. 58%, p = 0.37; nasogastric tube feeding: 28% vs. 28%, p = 0.98; narcotic medicines required: 58% vs. 58%, p = 0.97). There was a statistically significant difference in median duration of confluent mucositis in favor of AR (2.0 vs 3.0 weeks, p = 0.01). There was full compliance with carbogen breathing and nicotinamide in 86% and 80% of the patients, with discontinuation in 6% and 12%, respectively. Adjustment of antiemesis prophylaxis was needed in 42% of patients. Conclusion: With the exception of a slight increase in median duration of acute confluent mucositis, the present data reveal a similar acute toxicity profile between both regimens and a good compliance with ARCON for clinical stage T2–4 laryngeal cancers. Treatment outcome and late morbidity will determine the real therapeutic benefit.

  10. SU-E-CAMPUS-J-04: Image Guided Radiation Therapy (IGRT): Review of Technical Standards and Credentialing in Radiotherapy Clinical Trials

    Energy Technology Data Exchange (ETDEWEB)

    Giaddui, T; Chen, W; Yu, J; Gong, Y; Galvin, J; Xiao, Y [Thomas Jefferson University, Philadelphia, PA (United States); Cui, Y; Yin, F [Duke University Medical Center, Durham, NC (United States); Craig, T; Dawson, L [The Princess Margaret Cancer Centre - UHN, Toronto, ON (Canada); Al-Hallaq, H; Chmura, S [The University of Chicago, Chicago, IL. (United States)

    2014-06-15

    Purpose: To review IGRT credentialing experience and unexpected technical issues encountered in connection with advanced radiotherapy technologies as implemented in RTOG clinical trials. To update IGRT credentialing procedures with the aim of improving the quality of the process, and to increase the proportion of IGRT credentialing compliance. To develop a living disease site-specific IGRT encyclopedia. Methods: Numerous technical issues were encountered during the IGRT credentialing process. The criteria used for credentialing review were based on: image quality; anatomy included in fused data sets and shift results. Credentialing requirements have been updated according to the AAPM task group reports for IGRT to ensure that all required technical items are included in the quality review process. Implementation instructions have been updated and expanded for recent protocols. Results: Technical issues observed during the credentialing review process include, but are not limited to: poor quality images; inadequate image acquisition region; poor data quality; shifts larger than acceptable; no soft tissue surrogate. The updated IGRT credentialing process will address these issues and will also include the technical items required from AAPM: TG 104; TG 142 and TG 179 reports. An instruction manual has been developed describing a remote credentialing method for reviewers. Submission requirements are updated, including images/documents as well as facility questionnaire. The review report now includes summary of the review process and the parameters that reviewers check. We have reached consensus on the minimum IGRT technical requirement for a number of disease sites. RTOG 1311(NRG-BR002A Phase 1 Study of Stereotactic Body Radiotherapy (SBRT) for the Treatment of Multiple Metastases) is an example, here; the protocol specified the minimum requirement for each anatomical sites (with/without fiducials). Conclusion: Technical issues are identified and reported. IGRT

  11. Correlation in Rectal Cancer Between Clinical Tumor Response After Neoadjuvant Radiotherapy and Sphincter or Organ Preservation: 10-Year Results of the Lyon R 96-02 Randomized Trial

    Energy Technology Data Exchange (ETDEWEB)

    Ortholan, Cecile [Department of Radiation Oncology, Antoine Lacassagne Cancer Center, Nice, UNSA (Universite de Nice Sophia-Antipolis) (France); Department of Oncology-Radiotherapy, Hopital Princesse Grace, Monaco (France); Romestaing, Pascale [Hopital Prive Jean Mermoz, Lyon (France); Chapet, Olivier [Department of Radiation Oncology, Lyon Sud University Hospital, Hospices Civils de Lyon, Lyon (France); Gerard, Jean Pierre, E-mail: jean-pierre.gerard@nice.unicancer.fr [Department of Radiation Oncology, Antoine Lacassagne Cancer Center, Nice, UNSA (Universite de Nice Sophia-Antipolis) (France)

    2012-06-01

    Purpose: To investigate, in rectal cancer, the benefit of a neoadjuvant radiation dose escalation with endocavitary contact radiotherapy (CXRT) in addition to external beam radiotherapy (EBRT). This article provides an update of the Lyon R96-02 Phase III trial. Methods and Materials: A total of 88 patients with T2 to T3 carcinoma of the lower rectum were randomly assigned to neoadjuvant EBRT 39 Gy in 13 fractions (43 patients) vs. the same EBRT with CXRT boost, 85 Gy in three fractions (45 patients). Median follow-up was 132 months. Results: The 10-year cumulated rate of permanent colostomy (CRPC) was 63% in the EBRT group vs. 29% in the EBRT+CXRT group (p < 0.001). The 10-year rate of local recurrence was 15% vs. 10% (p = 0.69); 10-year disease-free survival was 54% vs. 53% (p = 0.99); and 10-year overall survival was 56% vs. 55% (p = 0.85). Data of clinical response (CR) were available for 78 patients (36 in the EBRT group and 42 in the EBRT+CXRT group): 12 patients were in complete CR (1 patient vs. 11 patients), 53 patients had a CR {>=}50% (24 patients vs. 29 patients), and 13 patients had a CR <50% (11 patients vs. 2 patients) (p < 0.001). Of the 65 patients with CR {>=}50%, 9 had an organ preservation procedure (meaning no rectal resection) taking advantage of major CR. The 10-year CRPC was 17% for patients with complete CR, 42% for patients with CR {>=}50%, and 77% for patients with CR <50% (p = 0.014). Conclusion: In cancer of the lower rectum, CXRT increases the complete CR, turning in a significantly higher rate of long-term permanent sphincter and organ preservation.

  12. Postoperative Concurrent Chemoradiotherapy Versus Postoperative Radiotherapy in High-Risk Cutaneous Squamous Cell Carcinoma of the Head and Neck: The Randomized Phase III TROG 05.01 Trial.

    Science.gov (United States)

    Porceddu, Sandro Virgilio; Bressel, Mathias; Poulsen, Michael Geoffrey; Stoneley, Adam; Veness, Michael John; Kenny, Lizbeth Moira; Wratten, Chris; Corry, June; Cooper, Stephen; Fogarty, Gerald Blaise; Collins, Marnie; Collins, Michael Kevin; Macann, Andrew Martin John; Milross, Christopher Gerard; Penniment, Michael Gordon; Liu, Howard Yu-Hao; King, Madeleine Trudy; Panizza, Benedict James; Rischin, Danny

    2018-05-01

    Purpose To report the results of the Trans Tasman Radiation Oncology Group randomized phase III trial designed to determine whether the addition of concurrent chemotherapy to postoperative radiotherapy (CRT) improved locoregional control in patients with high-risk cutaneous squamous cell carcinoma of the head and neck. Patients and Methods The primary objective was to determine whether there was a difference in freedom from locoregional relapse (FFLRR) between 60 or 66 Gy (6 to 6.5 weeks) with or without weekly carboplatin (area under the curve 2) after resection of gross disease. Secondary efficacy objectives were to compare disease-free survival and overall survival. Results Three hundred twenty-one patients were randomly assigned, with 310 patients commencing allocated treatment (radiotherapy [RT] alone, n = 157; CRT, n = 153). Two hundred thirty-eight patients (77%) had high-risk nodal disease, 59 (19%) had high-risk primary or in-transit disease, and 13 (4%) had both. Median follow-up was 60 months. Median RT dose was 60 Gy, with 84% of patients randomly assigned to CRT completing six cycles of carboplatin. The 2- and 5-year FFLRR rates were 88% (95% CI, 83% to 93%) and 83% (95% CI, 77% to 90%), respectively, for RT and 89% (95% CI, 84% to 94%) and 87% (95% CI, 81% to 93%; hazard ratio, 0.84; 95% CI, 0.46 to 1.55; P = .58), respectively, for CRT. There were no significant differences in disease-free or overall survival. Locoregional failure was the most common site of first treatment failure, with isolated distant metastases as the first site of failure seen in 7% of both arms. Treatment was well tolerated in both arms, with no observed enhancement of RT toxicity with carboplatin. Grade 3 or 4 late toxicities were infrequent. Conclusion Although surgery and postoperative RT provided excellent FFLRR, there was no observed benefit with the addition of weekly carboplatin.

  13. Residual Prostate Cancer in Patients Treated With Endocrine Therapy With or Without Radical Radiotherapy: A Side Study of the SPCG-7 Randomized Trial

    International Nuclear Information System (INIS)

    Solberg, Arne; Haugen, Olav A.; Viset, Trond; Bergh, Anders; Tasdemir, Ilker; Ahlgren, Goeran; Widmark, Anders; Angelsen, Anders

    2011-01-01

    Purpose: The Scandinavian Prostate Cancer Group-7 randomized trial demonstrated a survival benefit of combined endocrine therapy and external-beam radiotherapy over endocrine therapy alone in patients with high-risk prostate cancer. In a subset of the study population, the incidence and clinical implications of residual prostate cancer in posttreatment prostate biopsy specimens was evaluated. Methods and Materials: Biopsy specimens were obtained from 120 of 875 men in the Scandinavian Prostate Cancer Group-7 study. Results: Biopsies were performed at median of 45 months follow-up. In 63 patients receiving endocrine treatment only and 57 patients receiving combined treatment, residual cancer was found in 66% (n = 41) and 22% (n = 12), respectively (p < 0.0001). The vast majority of residual tumors were poorly differentiated (Gleason score ≥8). Endocrine therapy alone was predictive of residual prostate cancer: odds ratio 7.49 (3.18-17.7), p < 0.0001. In patients with positive vs. negative biopsy the incidences of clinical events were as follows: biochemical recurrence 74% vs. 27% (p < 0.0001), local progression 26% vs. 4.7% (p = 0.002), distant recurrence 17% vs. 9.4% (p = 0.27), clinical recurrence 36% vs. 13% (p = 0.006), cancer-specific death 19% vs. 9.7% (p = 0.025). In multivariable analysis, biochemical recurrence was significantly associated with residual cancer: hazard ratio 2.69 (1.45-4.99), p = 0.002, and endocrine therapy alone hazard ratio 3.45 (1.80-6.62), p < 0.0001. Conclusions: Radiotherapy combined with hormones improved local tumor control in comparison with endocrine therapy alone. Residual prostate cancer was significantly associated with serum prostate-specific antigen recurrence, local tumor progression, clinical recurrence, and cancer-specific death in univariable analysis. Residual cancer was predictive of prostate-specific antigen recurrence in multivariable analysis.

  14. Late Gastrointestinal Toxicity After Dose-Escalated Conformal Radiotherapy for Early Prostate Cancer: Results From the UK Medical Research Council RT01 Trial (ISRCTN47772397)

    International Nuclear Information System (INIS)

    Syndikus, Isabel; Morgan, Rachel C.; Sydes, Matthew R.; Graham, John D.; Dearnaley, David P.

    2010-01-01

    Purpose: In men with localized prostate cancer, dose-escalated conformal radiotherapy (CFRT) improves efficacy outcomes at the cost of increased toxicity. We present a detailed analysis to provide further information about the incidence and prevalence of late gastrointestinal side effects. Methods and Materials: The UK Medical Research Council RT01 trial included 843 men with localized prostate cancer, who were treated for 6 months with neoadjuvant radiotherapy and were randomly assigned to either 64-Gy or 74-Gy CFRT. Toxicity was evaluated before CFRT and during long-term follow-up using Radiation Therapy Oncology Group (RTOG) grading, the Late Effects on Normal Tissue: Subjective, Objective, Management (LENT/SOM) scale, and Royal Marsden Hospital assessment scores. Patients regularly completed Functional Assessment of Cancer Therapy--Prostate (FACT-P) and University of California, Los Angeles, Prostate Cancer Index (UCLA-PCI) questionnaires. Results: In the dose-escalated group, the hazard ratio (HR) for rectal bleeding (LENT/SOM grade ≥2) was 1.55 (95% CI, 1.17-2.04); for diarrhea (LENT/SOM grade ≥2), the HR was 1.79 (95% CI, 1.10-2.94); and for proctitis (RTOG grade ≥2), the HR was 1.64 (95% CI, 1.20-2.25). Compared to baseline scores, the prevalence of moderate and severe toxicities generally increased up to 3 years and than lessened. At 5 years, the cumulative incidence of patient-reported severe bowel problems was 6% vs. 8% (standard vs. escalated, respectively) and severe distress was 4% vs. 5%, respectively. Conclusions: There is a statistically significant increased risk of various adverse gastrointestinal events with dose-escalated CFRT. This remains at clinically acceptable levels, and overall prevalence ultimately decreases with duration of follow-up.

  15. Topical Hyaluronic Acid vs. Standard of Care for the Prevention of Radiation Dermatitis After Adjuvant Radiotherapy for Breast Cancer: Single-Blind Randomized Phase III Clinical Trial

    Energy Technology Data Exchange (ETDEWEB)

    Pinnix, Chelsea; Perkins, George H.; Strom, Eric A.; Tereffe, Welela; Woodward, Wendy; Oh, Julia L.; Arriaga, Lisa [Department of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, TX (United States); Munsell, Mark F. [Department of Biostatistics, University of Texas MD Anderson Cancer Center, Houston, TX (United States); Kelly, Patrick; Hoffman, Karen E.; Smith, Benjamin D.; Buchholz, Thomas A. [Department of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, TX (United States); Yu, T. Kuan, E-mail: tkyu@houstonprecisioncc.com [Houston Precision Cancer Center, Houston, TX (United States)

    2012-07-15

    Purpose: To determine the efficacy of an emulsion containing hyaluronic acid to reduce the development of {>=}Grade 2 radiation dermatitis after adjuvant breast radiation compared with best supportive care. Methods and Materials: Women with breast cancer who had undergone lumpectomy and were to receive whole-breast radiotherapy to 50 Gy with a 10- to 16-Gy surgical bed boost were enrolled in a prospective randomized trial to compare the effectiveness of a hyaluronic acid-based gel (RadiaPlex) and a petrolatum-based gel (Aquaphor) for preventing the development of dermatitis. Each patient was randomly assigned to use hyaluronic acid gel on the medial half or the lateral half of the irradiated breast and to use the control gel on the other half. Dermatitis was graded weekly according to the Common Terminology Criteria v3.0 by the treating physician, who was blinded as to which gel was used on which area of the breast. The primary endpoint was development of {>=}Grade 2 dermatitis. Results: The study closed early on the basis of a recommendation from the Data and Safety Monitoring Board after 74 of the planned 92 patients were enrolled. Breast skin treated with the hyaluronic acid gel developed a significantly higher rate of {>=}Grade 2 dermatitis than did skin treated with petrolatum gel: 61.5% (40/65) vs. 47.7% (31/65) (p = 0.027). Only 1ne patient developed Grade 3 dermatitis using either gel. A higher proportion of patients had worse dermatitis in the breast segment treated with hyaluronic acid gel than in that treated with petrolatum gel at the end of radiotherapy (42% vs. 14%, p = 0.003). Conclusion: We found no benefit from the use of a topical hyaluronic acid-based gel for reducing the development of {>=}Grade 2 dermatitis after adjuvant radiotherapy for breast cancer. Additional studies are needed to determine the efficacy of hyaluronic acid-based gel in controlling radiation dermatitis symptoms after they develop.

  16. Topical Hyaluronic Acid vs. Standard of Care for the Prevention of Radiation Dermatitis After Adjuvant Radiotherapy for Breast Cancer: Single-Blind Randomized Phase III Clinical Trial

    International Nuclear Information System (INIS)

    Pinnix, Chelsea; Perkins, George H.; Strom, Eric A.; Tereffe, Welela; Woodward, Wendy; Oh, Julia L.; Arriaga, Lisa; Munsell, Mark F.; Kelly, Patrick; Hoffman, Karen E.; Smith, Benjamin D.; Buchholz, Thomas A.; Yu, T. Kuan

    2012-01-01

    Purpose: To determine the efficacy of an emulsion containing hyaluronic acid to reduce the development of ≥Grade 2 radiation dermatitis after adjuvant breast radiation compared with best supportive care. Methods and Materials: Women with breast cancer who had undergone lumpectomy and were to receive whole-breast radiotherapy to 50 Gy with a 10- to 16-Gy surgical bed boost were enrolled in a prospective randomized trial to compare the effectiveness of a hyaluronic acid–based gel (RadiaPlex) and a petrolatum-based gel (Aquaphor) for preventing the development of dermatitis. Each patient was randomly assigned to use hyaluronic acid gel on the medial half or the lateral half of the irradiated breast and to use the control gel on the other half. Dermatitis was graded weekly according to the Common Terminology Criteria v3.0 by the treating physician, who was blinded as to which gel was used on which area of the breast. The primary endpoint was development of ≥Grade 2 dermatitis. Results: The study closed early on the basis of a recommendation from the Data and Safety Monitoring Board after 74 of the planned 92 patients were enrolled. Breast skin treated with the hyaluronic acid gel developed a significantly higher rate of ≥Grade 2 dermatitis than did skin treated with petrolatum gel: 61.5% (40/65) vs. 47.7% (31/65) (p = 0.027). Only 1ne patient developed Grade 3 dermatitis using either gel. A higher proportion of patients had worse dermatitis in the breast segment treated with hyaluronic acid gel than in that treated with petrolatum gel at the end of radiotherapy (42% vs. 14%, p = 0.003). Conclusion: We found no benefit from the use of a topical hyaluronic acid–based gel for reducing the development of ≥Grade 2 dermatitis after adjuvant radiotherapy for breast cancer. Additional studies are needed to determine the efficacy of hyaluronic acid–based gel in controlling radiation dermatitis symptoms after they develop

  17. Individualized Dose Prescription for Hypofractionation in Advanced Non-Small-Cell Lung Cancer Radiotherapy: An in silico Trial

    Energy Technology Data Exchange (ETDEWEB)

    Hoffmann, Aswin L.; Troost, Esther G.C.; Huizenga, Henk; Kaanders, Johannes H.A.M. [Radboud University Nijmegen Medical Centre, Department of Radiation Oncology, Nijmegen (Netherlands); Bussink, Johan, E-mail: j.bussink@rther.umcn.nl [Radboud University Nijmegen Medical Centre, Department of Radiation Oncology, Nijmegen (Netherlands)

    2012-08-01

    Purpose: Local tumor control and outcome remain poor in patients with advanced non-small-cell lung cancer (NSCLC) treated by external beam radiotherapy. We investigated the therapeutic gain of individualized dose prescription with dose escalation based on normal tissue dose constraints for various hypofractionation schemes delivered with intensity-modulated radiation therapy. Methods and Materials: For 38 Stage III NSCLC patients, the dose level of an existing curative treatment plan with standard fractionation (66 Gy) was rescaled based on dose constraints for the lung, spinal cord, esophagus, brachial plexus, and heart. The effect on tumor total dose (TTD) and biologic tumor effective dose in 2-Gy fractions (TED) corrected for overall treatment time (OTT) was compared for isotoxic and maximally tolerable schemes given in 15, 20, and 33 fractions. Rescaling was accomplished by altering the dose per fraction and/or the number of fractions while keeping the relative dose distribution of the original treatment plan. Results: For 30 of the 38 patients, dose escalation by individualized hypofractionation yielded therapeutic gain. For the maximally tolerable dose scheme in 33 fractions (MTD{sub 33}), individualized dose escalation resulted in a 2.5-21% gain in TTD. In the isotoxic schemes, the number of fractions could be reduced with a marginal increase in TED. For the maximally tolerable dose schemes, the TED could be escalated up to 36.6%, and for all patients beyond the level of the isotoxic and the MTD{sub 33} schemes (range, 3.3-36.6%). Reduction of the OTT contributed to the therapeutic gain of the shortened schemes. For the maximally tolerable schemes, the maximum esophageal dose was the dominant dose-limiting constraint in most patients. Conclusions: This modeling study showed that individualized dose prescription for hypofractionation in NSCLC radiotherapy, based on scaling of existing treatment plans up to normal tissue dose constraints, enables dose

  18. A Web-based, computer-tailored smoking prevention program to prevent children from starting to smoke after transferring to secondary school: randomized controlled trial.

    Science.gov (United States)

    Cremers, Henricus-Paul; Mercken, Liesbeth; Candel, Math; de Vries, Hein; Oenema, Anke

    2015-03-09

    1730 out of the original 3213 (53.84%). No significant program effects were observed for any of the intervention groups compared to the control group at T1 for the intention to engage in smoking-prompt, OR 0.67 (95% CI 0.30-1.50), no-prompt, OR 0.76 (95% CI 0.34-1.67)-or for smoking behavior-prompt, OR 1.13 (95% CI 0.13-9.98), no-prompt, OR 0.50 (95% CI 0.04-5.59). Similar nonsignificant program effects were found at T2 for the intention to start smoking-prompt, OR 0.78 (95% CI 0.26-2.32), no-prompt, OR 1.31 (95% CI 0.45-3.82)-and smoking behavior-prompt, OR 0.53 (95% CI 0.12-2.47), no-prompt, OR 1.01 (95% CI 0.24-4.21). This study showed that the Web-based, computer-tailored feedback messages with and without prompt messages were not effective in modifying children's smoking intentions and smoking behavior as compared to no information. Future smoking prevention interventions are recommended to start closer to the age of actual smoking uptake. Furthermore, future studies on Web-based, computer-tailored smoking prevention programs should focus on assessing and controlling exposure to the educational content and the response to the prompt messages. Netherlands Trial Register NTR3116; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3116 (Archived by WebCite at http://www.webcitation.org/6O0wQYuPI).

  19. Hair-sparing whole brain radiotherapy with volumetric arc therapy in patients treated for brain metastases: dosimetric and clinical results of a phase II trial

    International Nuclear Information System (INIS)

    De Puysseleyr, Annemieke; Ost, Piet; Van De Velde, Joris; Speleers, Bruno; Vercauteren, Tom; Goedgebeur, Anneleen; Van Hoof, Tom; Boterberg, Tom; De Neve, Wilfried; De Wagter, Carlos

    2014-01-01

    To report the dosimetric results and impact of volumetric arc therapy (VMAT) on temporary alopecia and hair-loss related quality of life (QOL) in whole brain radiotherapy (WBRT). The potential of VMAT-WBRT to reduce the dose to the hair follicles was assessed. A human cadaver was treated with both VMAT-WBRT and conventional opposed field (OF) WBRT, while the subcutaneously absorbed dose was measured by radiochromic films and calculated by the planning system. The impact of these dose reductions on temporary alopecia was examined in a prospective phase II trial, with the mean score of hair loss at 1 month after VMAT-WBRT (EORTC-QOL BN20) as a primary endpoint and delivering a dose of 20 Gy in 5 fractions. An interim analysis was planned after including 10 patients to rule out futility, defined as a mean score of hair loss exceeding 56.7. A secondary endpoint was the global alopecia areata severity score measured with the “Severity of Alopecia Tool” (SALT) with a scale of 0 (no hair loss) to 100 (complete alopecia). For VMAT-WBRT, the cadaver measurements demonstrated a dose reduction to the hair follicle volume of 20.5% on average and of 41.8% on the frontal-vertex-occipital medial axis as compared to OF-WBRT. In the phase II trial, a total of 10 patients were included before the trial was halted due to futility. The EORTC BN20 hair loss score following WBRT was 95 (SD 12.6). The average median dose to the hair follicle volume was 12.6 Gy (SD 0.9), corresponding to a 37% dose reduction compared to the prescribed dose. This resulted in a mean SALT-score of 75. Compared to OF-WBRT, VMAT-WBRT substantially reduces hair follicle dose. These dose reductions could not be related to an improved QOL or SALT score

  20. Whither radiotherapy

    Energy Technology Data Exchange (ETDEWEB)

    Ross, W M

    1987-03-01

    The 1986 Glyn Evans Memorial Lecture, given at the Joint Provincial Meeting of the Royal College of Radiologists, Sheffield, September 1986, sketches an outline of the history of radiotherapy and discusses the future development of the art. Topics included are siting of centres, training needs, the relationship of radiotherapy to other medical specialities, and the advantages and disadvantages of radiotherapy practitioners forming a separate medical College. (U.K.)

  1. Early-stage squamous cell carcinoma of the oropharynx: Radiotherapy vs. Trans-Oral Robotic Surgery (ORATOR) – study protocol for a randomized phase II trial

    International Nuclear Information System (INIS)

    Nichols, Anthony C; Kuruvilla, Sara; Chen, Jeff; Corsten, Martin; Odell, Michael; Eapen, Libni; Theurer, Julie; Doyle, Philip C; Wehrli, Bret; Kwan, Keith; Palma, David A; Yoo, John; Hammond, J Alex; Fung, Kevin; Winquist, Eric; Read, Nancy; Venkatesan, Varagur; MacNeil, S Danielle; Ernst, D Scott

    2013-01-01

    The incidence of oropharyngeal squamous cell carcinoma (OPSCC) has markedly increased over the last three decades due to newly found associations with human papillomavirus (HPV) infection. Primary radiotherapy (RT) is the treatment of choice for OPSCC at most centers, and over the last decade, the addition of concurrent chemotherapy has led to a significant improvement in survival, but at the cost of increased acute and late toxicity. Transoral robotic surgery (TORS) has emerged as a promising alternative treatment, with preliminary case series demonstrating encouraging oncologic, functional, and quality of life (QOL) outcomes. However, comparisons of TORS and RT in a non-randomized fashion are susceptible to bias. The goal of this randomized phase II study is to compare QOL, functional outcomes, toxicity profiles, and survival following primary RT (± chemotherapy) vs. TORS (± adjuvant [chemo] RT) in patients with OPSCC. The target patient population comprises OPSCC patients who would be unlikely to require chemotherapy post-resection: Tumor stage T1-T2 with likely negative margins at surgery; Nodal stage N0-2, ≤3 cm in size, with no evidence of extranodal extension on imaging. Participants will be randomized in a 1:1 ratio between Arm 1 (RT ± chemotherapy) and Arm 2 (TORS ± adjuvant [chemo] RT). In Arm 1, patients with N0 disease will receive RT alone, whereas N1-2 patients will receive concurrent chemoradiation. In Arm 2, patients will undergo TORS along with selective neck dissections, which may be staged. Pathologic high-risk features will be used to determine the requirement for adjuvant radiotherapy +/- chemotherapy. The primary endpoint is QOL score using the M.D. Anderson Dysphagia Inventory (MDADI), with secondary endpoints including survival, toxicity, other QOL outcomes, and swallowing function. A sample of 68 patients is required. This study, if successful, will provide a much-needed randomized comparison of the conventional strategy of primary RT

  2. Does transfusion improve the outcome for HNSCC patients treated with radiotherapy? - results from the randomized DAHANCA 5 and 7 trials

    DEFF Research Database (Denmark)

    Hoff, Camilla; Lassen, Pernille; Eriksen, Jesper Grau

    2011-01-01

    Patients with head and neck squamous cell carcinoma (HNSCC) and a low level of hemoglobin often have a poor response to radiation that may be related to hypoxia-induced radioresistance. We have previously published the importance of hemoglobin level and the effect of transfusion by the results fr...... the randomized DAHANCA 5 trial, including 414 patients in the analysis. Aim of the current analysis was to gain additional power by adding patients from the continued subrandomization in the DAHANCA 7 trial, now including a total of almost 1200 patients....

  3. Audiovisual biofeedback breathing guidance for lung cancer patients receiving radiotherapy: a multi-institutional phase II randomised clinical trial.

    Science.gov (United States)

    Pollock, Sean; O'Brien, Ricky; Makhija, Kuldeep; Hegi-Johnson, Fiona; Ludbrook, Jane; Rezo, Angela; Tse, Regina; Eade, Thomas; Yeghiaian-Alvandi, Roland; Gebski, Val; Keall, Paul J

    2015-07-18

    There is a clear link between irregular breathing and errors in medical imaging and radiation treatment. The audiovisual biofeedback system is an advanced form of respiratory guidance that has previously demonstrated to facilitate regular patient breathing. The clinical benefits of audiovisual biofeedback will be investigated in an upcoming multi-institutional, randomised, and stratified clinical trial recruiting a total of 75 lung cancer patients undergoing radiation therapy. To comprehensively perform a clinical evaluation of the audiovisual biofeedback system, a multi-institutional study will be performed. Our methodological framework will be based on the widely used Technology Acceptance Model, which gives qualitative scales for two specific variables, perceived usefulness and perceived ease of use, which are fundamental determinants for user acceptance. A total of 75 lung cancer patients will be recruited across seven radiation oncology departments across Australia. Patients will be randomised in a 2:1 ratio, with 2/3 of the patients being recruited into the intervention arm and 1/3 in the control arm. 2:1 randomisation is appropriate as within the interventional arm there is a screening procedure where only patients whose breathing is more regular with audiovisual biofeedback will continue to use this system for their imaging and treatment procedures. Patients within the intervention arm whose free breathing is more regular than audiovisual biofeedback in the screen procedure will remain in the intervention arm of the study but their imaging and treatment procedures will be performed without audiovisual biofeedback. Patients will also be stratified by treating institution and for treatment intent (palliative vs. radical) to ensure similar balance in the arms across the sites. Patients and hospital staff operating the audiovisual biofeedback system will complete questionnaires to assess their experience with audiovisual biofeedback. The objectives of this

  4. Accelerated hyperfractionated radiotherapy for malignant gliomas

    International Nuclear Information System (INIS)

    Buatti, John M.; Marcus, Robert B.; Mendenhall, William M.; Friedman, William A.; Bova, Francis J.

    1996-01-01

    Purpose: To evaluate accelerated hyperfractionated radiotherapy for the treatment of malignant gliomas. Methods and Materials: Between April 1985 and June 1994, 70 adult patients with pathologically confirmed malignant glioma (75% glioblastoma multiforme, 25% anaplastic astrocytoma) suitable for high-dose therapy were selected for treatment with accelerated hyperfractionated radiotherapy, 1.5 Gy twice daily to a total target dose of 60 Gy. Two patients were excluded from analysis (one patient had a fatal pulmonary embolism after 18 Gy; one patient discontinued therapy after 28.5 Gy against medical advice and without sequelae or progression). The 68 patients in the study group had a median age of 52 years and a median Karnofsky performance status of 90. Stereotactic implant ( 125 I) or stereotactic radiosurgery boosts were delivered to 16 patients (24%) in the study group. Minimum follow-up was 6 months. Results: Median survival was 13.8 months and median progression-free survival was 7.4 months. The absolute Kaplan-Meier survival rate was 16% at 2 years and 4% at 5 years. Multivariate analysis for the prognostic impact of age, gender, histology, Karnofsky performance status, symptomatology, surgical resection vs. biopsy, and boost vs nonboost therapy revealed that Karnofsky performance status ≥ 90, boost therapy, and surgical excision predicted significantly improved outcome. No severe toxicity occurred in patients treated with accelerated hyperfractionated radiotherapy alone, although 5% required steroids temporarily for edema. Progression occurred during treatment in one patient (1.5%). Conclusion: This regimen of accelerated hyperfractionated radiotherapy is well tolerated and leads to results comparable with those of standard therapy. The rate of disease progression during treatment is significantly better (p = 0.001) than is reported for patients treated with standard fractionation, with or without chemotherapy. This regimen is a reasonable starting point

  5. Low body weight and type of protease inhibitor predict discontinuation and treatment-limiting adverse drug reactions among HIV-infected patients starting a protease inhibitor regimen: consistent results from a randomized trial and an observational cohort

    DEFF Research Database (Denmark)

    Kirk, O; Gerstoft, J; Pedersen, C

    2001-01-01

    OBJECTIVES: To assess predictors for discontinuation and treatment-limiting adverse drug reactions (TLADR) among patients starting their first protease inhibitor (PI). METHODS: Data on patients starting a PI regimen (indinavir, ritonavir, ritonavir/saquinavir and saquinavir hard gel) in a randomi......OBJECTIVES: To assess predictors for discontinuation and treatment-limiting adverse drug reactions (TLADR) among patients starting their first protease inhibitor (PI). METHODS: Data on patients starting a PI regimen (indinavir, ritonavir, ritonavir/saquinavir and saquinavir hard gel....... Low body weight and initiation of ritonavir relative to other PIs were associated with an increased risk of TLADRs. Very consistent results were found in a randomized trial and an observational cohort....

  6. A randomised controlled trial to evaluate both the role and the optimal fractionation of radiotherapy in the conservative management of early breast cancer.

    Science.gov (United States)

    Spooner, D; Stocken, D D; Jordan, S; Bathers, S; Dunn, J A; Jevons, C; Dodson, L; Morrison, J M; Oates, G D; Grieve, R J

    2012-12-01

    Postoperative radiotherapy is routinely used in early breast cancer employing either 50 Gy in 25 daily fractions (long course) or 40 Gy in 15 daily fractions (short course). The role of radiotherapy and shorter fractionation regimens require validation. Patients with clinical stage I and II disease were randomised to receive immediate radiotherapy or delayed salvage treatment (no radiotherapy). Patients receiving radiotherapy were further randomised between long (50 Gy in 25 daily fractions) or short (40 Gy in 15 daily fractions) regimens. The primary outcome measure was time to first locoregional relapse. Reported results are at a median follow-up of 16.9 years (interquartile range 15.4-18.8). In total, 707 women were recruited between 1985 and 1992: median age 59 years (range 28-80), 68% postmenopausal, median tumour size 2.0 cm (range 0.12-8.0); 271 patients have relapsed: 110 radiotherapy, 161 no radiotherapy. The site of first relapse was locoregional158 (64%) and distant 87 (36%). There was an estimated 24% reduction in the risk of any competing event (local relapse, distant relapse or death) with radiotherapy (hazard ratio = 0.76; 95% confidence interval 0.65, 0.88). The benefit of radiotherapy treatment for all competing event types was statistically significant (X(Wald)(2) = 36.04, P < 0.001). Immediate radiotherapy reduced the risk of locoregional relapse by 62% (hazard ratio = 0.38; 95% confidence interval 0.27, 0.53), consistent across prognostic subgroups. No differences were seen between either radiotherapy fractionation schedules. This study confirmed better locoregional control for patients with early breast cancer receiving radiotherapy. A radiotherapy schedule of 40 Gy in 15 daily fractions is an efficient and effective regimen that is at least as good as the international conventional regimen of 50 Gy in 25 daily fractions. Copyright © 2012. Published by Elsevier Ltd.

  7. Surgical excision and immediate postoperative radiotherapy versus cryotherapy and intralesional steroids in the management of keloids: a prospective clinical trial.

    Science.gov (United States)

    Emad, Maryam; Omidvari, Shapour; Dastgheib, Ladan; Mortazavi, Afshin; Ghaem, Haleh

    2010-01-01

    To compare the efficacy and tolerability of surgical excision and radiotherapy with those of cryotherapy and intralesional steroid treatment of keloids. Twenty-six patients with a total of 76 keloids were enrolled in this study. Nineteen patients with 44 keloids underwent surgical excision combined with immediate 12-Gy irradiation (group A) while the remaining 9 patients with 32 keloids received multiple sessions of intralesional steroid treatment after cryotherapy which continued until flattening of lesion(s) occurred (group B). Two patients were included in both treatment groups. All patients were followed up at regular intervals for at least 1 year. In both treatment groups, keloids responded well without any major side effect. While patients of group A were all satisfied, those of group B (with a mean number of treatment sessions of 5.84 +/- 2.51) experienced more side effects, a more prolonged course, a higher recurrence rate and less satisfaction. This study showed that surgery plus immediate postoperative irradiation was an effective and relatively safe choice for treatment of keloids. Although cryotherapy combined with intralesional steroids was associated with more side effects and higher relapse rates, it could be a good choice for small and newly formed keloids. Copyright 2010 S. Karger AG, Basel.

  8. Whole Brain Radiotherapy and RRx-001: Two Partial Responses in Radioresistant Melanoma Brain Metastases from a Phase I/II Clinical Trial: A TITE-CRM Phase I/II Clinical Trial.

    Science.gov (United States)

    Kim, Michelle M; Parmar, Hemant; Cao, Yue; Pramanik, Priyanka; Schipper, Matthew; Hayman, James; Junck, Larry; Mammoser, Aaron; Heth, Jason; Carter, Corey A; Oronsky, Arnold; Knox, Susan J; Caroen, Scott; Oronsky, Bryan; Scicinski, Jan; Lawrence, Theodore S; Lao, Christopher D

    2016-04-01

    Kim et al. report two patients with melanoma metastases to the brain that responded to treatment with RRx-001 and whole brain radiotherapy (WBRT) without neurologic or systemic toxicity in the context of a phase I/II clinical trial. RRx-001 is an reactive oxygen and reactive nitrogen species (ROS/RNS)-dependent systemically nontoxic hypoxic cell radiosensitizer with vascular normalizing properties under investigation in patients with various solid tumors including those with brain metastases. Metastatic melanoma to the brain is historically associated with poor outcomes and a median survival of 4 to 5 months. WBRT is a mainstay of treatment for patients with multiple brain metastases, but no significant therapeutic advances for these patients have been described in the literature. To date, candidate radiosensitizing agents have failed to demonstrate a survival benefit in patients with brain metastases, and in particular, no agent has demonstrated improved outcome in patients with metastatic melanoma. Kim et al. report two patients with melanoma metastases to the brain that responded to treatment with novel radiosensitizing agent RRx-001 and WBRT without neurologic or systemic toxicity in the context of a phase I/II clinical trial. Published by Elsevier Inc.

  9. A prospective randomized double-blind trial comparing ondansetron versus prochlorperazine for the prevention of nausea and vomiting in patients undergoing fractionated radiotherapy

    International Nuclear Information System (INIS)

    Priestman, T.J.; Roberts, J.T.; Upadhyaya, B.K.

    1993-01-01

    In a multicentre, international double-blind trial, patients undergoing courses of five or more daily radiotherapy treatments to the upper abdomen were randomized to receive either oral ondansetron 8 mg t.d.s. or oral prochlorperazine 10 mg t.d.s. throughout their radiation course in order to try to prevent nausea and vomiting. A total of 192 patients were recruited, 135 of whom were included in the efficacy analysis; of these, 70 received ondansetron and 65 prochlorperazine. Forty-three (61%) of the patients prescribed ondansetron and 23 (35%) of those given prochlorperazine had a complete response, with no emetic episodes throughout their treatment course. There was, however, no significant difference between the two groups with respect to the incidence and severity of nausea. Seventeen (24%) of the patients on ondansetron and 19 (29%) of those given prochlorperazine were treatment failures, experiencing more than five emetic episodes on their worst day during the study. Both drugs were well tolerated, although constipation was seen more commonly with ondansetron. (author)

  10. Prospective Preference Assessment of Patients' Willingness to Participate in a Randomized Controlled Trial of Intensity-Modulated Radiotherapy Versus Proton Therapy for Localized Prostate Cancer

    International Nuclear Information System (INIS)

    Shah, Anand; Efstathiou, Jason A.; Paly, Jonathan J.; Halpern, Scott D.; Bruner, Deborah W.; Christodouleas, John P.; Coen, John J.; Deville, Curtiland; Vapiwala, Neha; Shipley, William U.; Zietman, Anthony L.; Hahn, Stephen M.; Bekelman, Justin E.

    2012-01-01

    Purpose: To investigate patients’ willingness to participate (WTP) in a randomized controlled trial (RCT) comparing intensity-modulated radiotherapy (IMRT) with proton beam therapy (PBT) for prostate cancer (PCa). Methods and Materials: We undertook a qualitative research study in which we prospectively enrolled patients with clinically localized PCa. We used purposive sampling to ensure a diverse sample based on age, race, travel distance, and physician. Patients participated in a semi-structured interview in which they reviewed a description of a hypothetical RCT, were asked open-ended and focused follow-up questions regarding their motivations for and concerns about enrollment, and completed a questionnaire assessing characteristics such as demographics and prior knowledge of IMRT or PBT. Patients’ stated WTP was assessed using a 6-point Likert scale. Results: Forty-six eligible patients (33 white, 13 black) were enrolled from the practices of eight physicians. We identified 21 factors that impacted patients’ WTP, which largely centered on five major themes: altruism/desire to compare treatments, randomization, deference to physician opinion, financial incentives, and time demands/scheduling. Most patients (27 of 46, 59%) stated they would either “definitely” or “probably” participate. Seventeen percent (8 of 46) stated they would “definitely not” or “probably not” enroll, most of whom (6 of 8) preferred PBT before their physician visit. Conclusions: A substantial proportion of patients indicated high WTP in a RCT comparing IMRT and PBT for PCa.

  11. Stereotactic Body Radiotherapy for Recurrent Squamous Cell Carcinoma of the Head and Neck: Results of a Phase I Dose-Escalation Trial

    International Nuclear Information System (INIS)

    Heron, Dwight E.; Ferris, Robert L.; Karamouzis, Michalis; Andrade, Regiane S.; Deeb, Erin L.; Burton, Steven; Gooding, William E.; Branstetter, Barton F.; Mountz, James M.; Johnson, Jonas T.; Argiris, Athanassios; Grandis, Jennifer R.; Lai, Stephen Y.

    2009-01-01

    Purpose: To evaluate the safety and efficacy of stereotactic body radiotherapy (SBRT) in previously irradiated patients with squamous cell carcinoma of the head and neck (SCCHN). Patients and Methods: In this Phase I dose-escalation clinical trial, 25 patients were treated in five dose tiers up to 44 Gy, administered in 5 fractions over a 2-week course. Response was assessed according to the Response Evaluation Criteria in Solid Tumors and [ 18 F]-fluorodeoxyglucose standardized uptake value change on positron emission tomography-computed tomography (PET-CT). Results: No Grade 3/4 or dose-limiting toxicities occurred. Four patients had Grade 1/2 acute toxicities. Four objective responses were observed, for a response rate of 17% (95% confidence interval 2%-33%). The maximum duration of response was 4 months. Twelve patients had stable disease. Median time to disease progression was 4 months, and median overall survival was 6 months. Self-reported quality of life was not significantly affected by treatment. Fluorodeoxyglucose PET was a more sensitive early-measure response to treatment than CT volume changes. Conclusion: Reirradiation up to 44 Gy using SBRT is well tolerated in the acute setting and warrants further evaluation in combination with conventional and targeted therapies.

  12. Tamoxifen added to radiotherapy and surgery for the treatment of ductal carcinoma in situ of the breast: A meta-analysis of 2 randomized trials

    International Nuclear Information System (INIS)

    Petrelli, Fausto; Barni, Sandro

    2011-01-01

    Background: Surgical excision with adequate margins is the treatment of choice for ductal, in situ carcinoma of the breast (DCIS). The addition of radiotherapy (RT) halved local in situ and invasive recurrence. The purpose of our meta-analysis is to evaluate the reduction in recurrence (in situ or invasive) with the addition of tamoxifen (T), in particular in patients with DCIS treated with surgery + RT. Patients and methods: The eligible studies (NSABP-B24 and UK ANZ DCIS trials) included prospective, randomized, controlled trials in which the addition of T had been compared with surgery + RT without T in women with DCIS of the breast. Relative risks (RRs) with 95% confidence intervals (CIs) were calculated for both in situ and invasive recurrence (local and controlateral). Results: Tamoxifen does not reduce breast cancer-specific or overall mortality when added to loco-regional therapy for DCIS of the breast (surgery plus or minus RT). Tamoxifen reduces overall breast cancer recurrence by 29% in all patients and by 33% in those treated with both surgery and RT. Only ipsilateral invasive (RR 0.61 [95% CI 0.41, 0.92]; p = 0.02) and controlateral in situ relapses (RR 0.40 [95% CI 0.16, 0.96]; p = 0.04) are significantly lowered when T is added to RT. Tamoxifen seems to exert a local synergistic effect with RT. Both young and older women ( 50 years) achieve some benefit from the addition of T (RR 0.6 and 0.74, respectively). Conclusion: The addition of T to surgery and RT for DCIS of the breast reduces the risk of local invasive and controlateral in situ relapses, but not the survival. The benefit is independent of age. In conclusion, surgery associated with RT and T is the treatment of choice for patients with (estrogen-receptor positive) DCIS of the breast.

  13. On the Importance of Accounting for Competing Risks in Pediatric Cancer Trials Designed to Delay or Avoid Radiotherapy: I. Basic Concepts and First Analyses

    International Nuclear Information System (INIS)

    Tai, Bee-Choo; Grundy, Richard G.; Machin, David

    2010-01-01

    Purpose: In trials designed to delay or avoid irradiation among children with malignant brain tumor, although irradiation after disease progression is an important event, patients who have disease progression may decline radiotherapy (RT), or those without disease progression may opt for elective RT. To accurately describe the cumulative need for RT in such instances, it is crucial to account for these distinct events and to evaluate how each contributes to the delay or advancement of irradiation via a competing risks analysis. Methods and Materials: We describe the summary of competing events in such trials using competing risks methods based on cumulative incidence functions and Gray's test. The results obtained are contrasted with standard survival methods based on Kaplan-Meier curves, cause-specific hazard functions and log-rank test. Results: The Kaplan-Meier method overestimates all event-specific rates. The cause-specific hazard analysis showed reduction in hazards for all events (A: RT after progression; B: no RT after progression; C: elective RT) among children with ependymoma. For event A, a higher cumulative incidence was reported for ependymoma. Although Gray's test failed to detect any difference (p = 0.331) between histologic subtypes, the log-rank test suggested marginal evidence (p = 0.057). Similarly, for event C, the log-rank test found stronger evidence of reduction in hazard among those with ependymoma (p = 0.005) as compared with Gray's test (p = 0.086). Conclusions: To evaluate treatment differences, failing to account for competing risks using appropriate methodology may lead to incorrect interpretations.

  14. Long-Term Improvement in Treatment Outcome After Radiotherapy and Hyperthermia in Locoregionally Advanced Cervix Cancer: An Update of the Dutch Deep Hyperthermia Trial

    International Nuclear Information System (INIS)

    Franckena, Martine; Stalpers, Lukas J.A.; Koper, Peter C.M.; Wiggenraad, Ruud G.J.; Hoogenraad, Wim J.; Dijk, Jan D.P. van; Warlam-Rodenhuis, Carla C.; Jobsen, Jan J.; Rhoon, Gerard C. van; Zee, Jacoba van der

    2008-01-01

    Purpose: The local failure rate in patients with locoregionally advanced cervical cancer is 41-72% after radiotherapy (RT) alone, whereas local control is a prerequisite for cure. The Dutch Deep Hyperthermia Trial showed that combining RT with hyperthermia (HT) improved 3-year local control rates of 41-61%, as we reported earlier. In this study, we evaluate long-term results of the Dutch Deep Hyperthermia Trial after 12 years of follow-up. Methods and Materials: From 1990 to 1996, a total of 114 women with locoregionally advanced cervical carcinoma were randomly assigned to RT or RT + HT. The RT was applied to a median total dose of 68 Gy. The HT was given once weekly. The primary end point was local control. Secondary end points were overall survival and late toxicity. Results: At the 12-year follow-up, local control remained better in the RT + HT group (37% vs. 56%; p = 0.01). Survival was persistently better after 12 years: 20% (RT) and 37% (RT + HT; p = 0.03). World Health Organization (WHO) performance status was a significant prognostic factor for local control. The WHO performance status, International Federation of Gynaecology and Obstetrics (FIGO) stage, and tumor diameter were significant for survival. The benefit of HT remained significant after correction for these factors. European Organization for Research and Treatment of Cancer Grade 3 or higher radiation-induced late toxicities were similar in both groups. Conclusions: For locoregionally advanced cervical cancer, the addition of HT to RT resulted in long-term major improvement in local control and survival without increasing late toxicity. This combined treatment should be considered for patients who are unfit to receive chemotherapy. For other patients, the optimal treatment strategy is the subject of ongoing research

  15. Dose-Volume Parameters of the Corpora Cavernosa Do Not Correlate With Erectile Dysfunction After External Beam Radiotherapy for Prostate Cancer: Results From a Dose-Escalation Trial

    International Nuclear Information System (INIS)

    Wielen, Gerard J. van der; Hoogeman, Mischa S.; Dohle, Gert R.; Putten, Wim L.J. van; Incrocci, Luca

    2008-01-01

    Purpose: To analyze the correlation between dose-volume parameters of the corpora cavernosa and erectile dysfunction (ED) after external beam radiotherapy (EBRT) for prostate cancer. Methods and Materials: Between June 1997 and February 2003, a randomized dose-escalation trial comparing 68 Gy and 78 Gy was conducted. Patients at our institute were asked to participate in an additional part of the trial evaluating sexual function. After exclusion of patients with less than 2 years of follow-up, ED at baseline, or treatment with hormonal therapy, 96 patients were eligible. The proximal corpora cavernosa (crura), the superiormost 1-cm segment of the crura, and the penile bulb were contoured on the planning computed tomography scan and dose-volume parameters were calculated. Results: Two years after EBRT, 35 of the 96 patients had developed ED. No statistically significant correlations between ED 2 years after EBRT and dose-volume parameters of the crura, the superiormost 1-cm segment of the crura, or the penile bulb were found. The few patients using potency aids typically indicated to have ED. Conclusion: No correlation was found between ED after EBRT for prostate cancer and radiation dose to the crura or penile bulb. The present study is the largest study evaluating the correlation between ED and radiation dose to the corpora cavernosa after EBRT for prostate cancer. Until there is clear evidence that sparing the penile bulb or crura will reduce ED after EBRT, we advise to be careful in sparing these structures, especially when this involves reducing treatment margins

  16. Stereotactic radiotherapy for vestibular schwannoma

    DEFF Research Database (Denmark)

    Muzevic, Dario; Legcevic, Jelena; Splavski, Bruno

    2014-01-01

    BACKGROUND: Vestibular schwannomas (acoustic neuromas) are common benign tumours that arise from the Schwann cells of the vestibular nerve. Management options include observation with neuroradiological follow-up, microsurgical resection and stereotactic radiotherapy. OBJECTIVES: To assess...... the effect of stereotactic radiotherapy compared to observation, microsurgical resection, any other treatment modality, or a combination of two or more of the above approaches for vestibular schwannoma. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials; PubMed; EMBASE; CINAHL......; Web of Science; CAB Abstracts; ISRCTN and additional sources for published and unpublished trials. The date of the search was 24 July 2014. SELECTION CRITERIA: Randomised controlled trials (RCTs) exploring the efficacy of stereotactic radiotherapy compared with observation alone, microsurgical...

  17. Carbon ion radiotherapy for localized primary sarcoma of the extremities: Results of a phase I/II trial

    International Nuclear Information System (INIS)

    Sugahara, Shinji; Kamada, Tadashi; Imai, Reiko; Tsuji, Hiroshi; Kameda, Noriaki; Okada, Tohru; Tsujii, Hirohiko; Tatezaki, Shinichirou

    2012-01-01

    Purpose: To determine the effectiveness of carbon ion radiotherapy (CIRT) for localized primary sarcomas of the extremities in a prospective study. Patients and materials: From April 2000 to May 2010, 17 (male/female: 12/5) patients with localized primary sarcoma of the extremities received CIRT. The median age was 53 years (range: 14–87 years). Nine patients had primary diseases and eight had recurrent diseases. Of the 17 patients, eight refused amputation, and the remaining nine refused surgical resection. Tumors were located in the upper limbs in four patients and lower limbs in 13. Histological diagnosis was osteosarcoma in three patients, liposarcoma in two, synovial sarcoma in two, rhabdomyosarcoma in two, pleomorphic sarcoma in two, and miscellaneous in six. The CIRT dose to the limb was 52.8 GyE for one patient, 64 GyE for three, 70.4 GyE for 13 in 16 fixed fractions over 4 weeks. Records were reviewed and outcomes including radiologic response, local control (progression-free), and survival were analyzed. Results: The median follow-up was 37 months (range: 11–97 months). Radiological response rate was 65% (PR in 11, SD in 5, and PD in 1). The local control rate at 5 years was 76%. The overall survival rate at 5 years was 56%. Of the 17 patients, 10 survived without disease progression. Four patients had local recurrences, one was salvaged by repeated CIRT and the other three died due to systemic diseases. Distant failure was observed in six patients. One patient suffered from femoral fracture (grade 3) and received surgical fixation 27 months after CIRT. No other severe reactions (grade 3) were observed. Conclusions: CIRT is suggested to be an effective and safe treatment for patients who refuse surgery for localized primary sarcomas of the extremities.

  18. Quality of life, anorectal and sexual functions after preoperative radiotherapy for rectal cancer: Report of a randomised trial

    International Nuclear Information System (INIS)

    Pietrzak, Lucyna; Bujko, Krzysztof; Nowacki, Marek P.; Kepka, Lucyna; Oledzki, Janusz; Rutkowski, Andrzej; Szmeja, Jacek; Kladny, Jozef; Dymecki, Dariusz; Wieczorek, Andrzej; Pawlak, Mariusz; Lesniak, Tadeusz; Kowalska, Teresa; Richter, Piotr

    2007-01-01

    Background and purpose: Patients (N = 316) with resectable cT3-4 low-lying and mid-rectal cancer were randomised to receive either preoperative 5 x 5 Gy irradiation with subsequent surgery performed within 7 days or chemoradiation (50.4, 1.8 Gy per fraction plus boluses of 5-fluorouracil and leucovorin) followed by surgery after 4-6 weeks. No differences were found in sphincter preservation, survival, local control and late complications. Early complications were less frequent in the short-course group. The aim of this report is to find out whether large doses per fraction of short-course schedule result in more severe anorectal and sexual dysfunction and quality of life (QoL) impairment. Materials and method: Patients who were free of disease were asked to answer the QLQ-C30 and those without stoma were, additionally, asked to fill in a questionnaire of anorectal (19 items) and sexual function (1 item). Results: Two hundred and twenty-two patients (86% response rate) completed the QLQ-C30 and 118 (86% response rate) the anorectal-sexual function questionnaire. The median time from surgery to filling in the QLQ-C30 questionnaire was 12 months, and to filling in the anorectal-sexual function questionnaire - 13 months. We did not find significant differences between the randomised groups regarding QoL and the anorectal and sexual functions. Approximately two-thirds of patients had anorectal function impairment. Approximately 20% of patients stated that this considerably influenced their QoL. Conclusions: QoL and the anorectal and sexual functioning did not differ in patients receiving short-course radiotherapy, as compared to those receiving chemoradiation

  19. Phase I trial of gefitinib with concurrent radiotherapy and fixed 2-h gemcitabine infusion, in locally advanced pancreatic cancer

    International Nuclear Information System (INIS)

    Maurel, Joan; Martin-Richard, Marta; Conill, Carlos; Sanchez, Marcelo; Petriz, Lourdes; Gines, Angels; Miquel, Rosa; Gallego, Rosa; Cajal, Rosana; Ayuso, Carmen; Navarro, Salvador; Marmol, Maribel; Nadal, Cristina; Auge, Josep Maria; Fernandez-Cruz, Laureano; Gascon, Pere

    2006-01-01

    Purpose: Pancreatic cancers are resistant to radiotherapy (RT) and current chemotherapy agents. Epidermal growth factor receptor is overexpressed in pancreatic cancer, and in vitro studies have shown that epidermal growth factor receptor inhibitors can overcome radio- and chemoresistance. The aim of the study was to determine whether the addition of gefitinib to RT and gemcitabine for patients with locally advanced pancreatic carcinoma (LAPC) was feasible and safe. Methods and Materials: Eighteen patients with pathologically proven LAPC, based on major vascular invasion based on helical computed tomography (CT) and endoscopic ultrasound, were entered into the study. The targeted irradiated volume included the tumor and 2-cm margin. Prophylactic irradiation of regional nodes was not allowed. Patients with >500 cm 3 of planning tumor volume were excluded. An initial cohort of 6 patients was treated with RT (45 Gy/25 fractions/5 weeks) plus concomitant gefitinib (250 mg/day). Successive cohorts of patients received 100, 150, and 200 mg/m 2 /day of gemcitabine in a 2-h infusion over Weeks 1, 2, 3, 4, and 5 with gefitinib (250 mg/day) and RT. Gefitinib was continued after RT until progression. A pharmacodynamic study of angiogenic markers was also performed to evaluate a possible antiangiogenic effect. Results: There were no dose-limiting toxicities. Common toxicities were mild neutropenia, asthenia, diarrhea, cutaneous rash and nausea/vomiting. The median (95% confidence interval [CI]) progression-free survival was 3.7 (95% CI = 1.9-5.5) months, and the median overall survival was 7.5 (95% CI 5.2-9.9) months. No significant reduction of vascular endothelial growth factor and interleukin-8 was observed after treatment. Conclusion: Our results support that the combination of gefitinib, RT, and gemcitabine has an acceptable toxicity but with modest activity in LAPC

  20. A review of clinical trials of cetuximab combined with radiotherapy for non-small cell lung cancer

    International Nuclear Information System (INIS)

    Nieder, Carsten; Pawinski, Adam; Dalhaug, Astrid; Andratschke, Nicolaus

    2012-01-01

    Treatment of non-small cell lung cancer (NSCLC) is challenging in many ways. One of the problems is disappointing local control rates in larger volume disease. Moreover, the likelihood of both nodal and distant spread increases with primary tumour (T-) stage. Many patients are elderly and have considerable comorbidity. Therefore, aggressive combined modality treatment might be contraindicated or poorly tolerated. In many cases with larger tumour volume, sufficiently high radiation doses can not be administered because the tolerance of surrounding normal tissues must be respected. Under such circumstances, simultaneous administration of radiosensitizing agents, which increase tumour cell kill, might improve the therapeutic ratio. If such agents have a favourable toxicity profile, even elderly patients might tolerate concomitant treatment. Based on sound preclinical evidence, several relatively small studies have examined radiotherapy (RT) with cetuximab in stage III NSCLC. Three different strategies were pursued: 1) RT plus cetuximab (2 studies), 2) induction chemotherapy followed by RT plus cetuximab (2 studies) and 3) concomitant RT and chemotherapy plus cetuximab (2 studies). Radiation doses were limited to 60-70 Gy. As a result of study design, in particular lack of randomised comparison between cetuximab and no cetuximab, the efficacy results are difficult to interpret. However, strategy 1) and 3) appear more promising than induction chemotherapy followed by RT and cetuximab. Toxicity and adverse events were more common when concomitant chemotherapy was given. Nevertheless, combined treatment appears feasible. The role of consolidation cetuximab after RT is uncertain. A large randomised phase III study of combined RT, chemotherapy and cetuximab has been initiated

  1. Adjuvant chemotherapy and radiotherapy in triple-negative breast carcinoma: A prospective randomized controlled multi-center trial

    International Nuclear Information System (INIS)

    Wang, Jianhua; Shi, Mei; Ling, Rui; Xia Yuesheng; Luo Shanquan; Fu Xuehai; Xiao Feng; Li Jianping; Long Xiaoli; Wang Jianguo; Hou Zengxia; Chen Yunxia; Zhou Bin; Xu, Man

    2011-01-01

    Background and purpose: Triple-negative breast cancer (TNBC) presents a high risk breast cancer that lacks the benefit from hormone treatment, chemotherapy is the main strategy even though it exists in poor prognosis. Use of adjuvant radiation therapy, which significantly decreases breast cancer mortality, has not been well described among poor TNBC women. The aim of this study was to evaluate whether the combination of chemotherapy and radiotherapy could significantly increase survival outcomes in TNBC women after mastectomy. Patients and methods: A prospective randomized controlled multi-center study was performed between February 2001 and February 2006 and comprised 681 women with triple-negative stage I-II breast cancer received mastectomy, of them, 315 cases received systemic chemotherapy alone, 366 patients received radiation after the course of chemotherapy. Recurrence-free survival (RFS) and overall survival (OS) were estimated. Simultaneously local and systemic toxicity were observed. Results: After a median follow-up of 86.5 months, five-year RFS rates were 88.3% and 74.6% for adjuvant chemotherapy plus radiation and adjuvant chemotherapy alone, respectively, with significant difference between the two groups (HR 0.77 [95% CI 0.72, 0.98]; P = 0.02). Five-year OS significantly improved in adjuvant chemotherapy plus radiation group compared with chemotherapy alone (90.4% and 78.7%) (HR 0.79 [95% CI 0.74, 0.97]; P = 0.03). No severe toxicity was reported. Conclusions: Patients received standard adjuvant chemotherapy plus radiation therapy was more effective than chemotherapy alone in women with triple-negative early-stage breast cancer after mastectomy.

  2. Report on a randomized trial comparing two forms of immobilization of the head for fractionated stereotactic radiotherapy

    International Nuclear Information System (INIS)

    Bednarz, Greg; Machtay, Mitchell; Werner-Wasik, Maria; Downes, Beverly; Bogner, Joachim; Hyslop, Terry; Galvin, James; Evans, James; Curran, Walter Jr.; Andrews, David

    2009-01-01

    Fractionated stereotactic radiotherapy (SRT) requires accurate and reproducible immobilization of the patient's head. This randomized study compared the efficacy of two commonly used forms of immobilization used for SRT. Two routinely used methods of immobilization, which differ in their approach to reproduce the head position from day to day, are the Gill-Thomas-Cosman (GTC) frame and the BrainLab thermoplastic mask. The GTC frame fixates on the patient's upper dentition and thus is in direct mechanical contact with the cranium. The BrainLab mask is a two-part masking system custom fitted to the front and back of the patient's head. After patients signed an IRB-approved informed consent form, eligible patients were randomized to either GTC frame or mask for their course of SRT. Patients were treated as per standard procedure; however, prior to each treatment a set of digital kilovolt images (ExacTrac, BrainLabAB, Germany) was taken. These images were fused with reference digitally reconstructed radiographs obtained from treatment planning CT to yield lateral, longitudinal, and vertical deviations of isocenter and head rotations about respective axes. The primary end point of the study was to compare the two systems with respect to mean and standard deviations using the distance to isocenter measure. A total of 84 patients were enrolled (69 patients evaluable with detailed positioning data). A mixed-effect linear regression and two-tiled t test were used to compare the distance measure for both the systems. There was a statistically significant (p<0.001) difference between mean distances for these systems, suggesting that the GTC frame was more accurate. The mean 3D displacement and standard deviations were 3.17+1.95 mm for mask and 2.00+1.04 mm for frame. Both immobilization techniques were highly effective, but the GTC frame was more accurate. To optimize the accuracy of SRT, daily kilovolt image guidance is recommended with either immobilization system.

  3. Audiovisual biofeedback breathing guidance for lung cancer patients receiving radiotherapy: a multi-institutional phase II randomised clinical trial

    International Nuclear Information System (INIS)

    Pollock, Sean; O’Brien, Ricky; Makhija, Kuldeep; Hegi-Johnson, Fiona; Ludbrook, Jane; Rezo, Angela; Tse, Regina; Eade, Thomas; Yeghiaian-Alvandi, Roland; Gebski, Val; Keall, Paul J

    2015-01-01

    There is a clear link between irregular breathing and errors in medical imaging and radiation treatment. The audiovisual biofeedback system is an advanced form of respiratory guidance that has previously demonstrated to facilitate regular patient breathing. The clinical benefits of audiovisual biofeedback will be investigated in an upcoming multi-institutional, randomised, and stratified clinical trial recruiting a total of 75 lung cancer patients undergoing radiation therapy. To comprehensively perform a clinical evaluation of the audiovisual biofeedback system, a multi-institutional study will be performed. Our methodological framework will be based on the widely used Technology Acceptance Model, which gives qualitative scales for two specific variables, perceived usefulness and perceived ease of use, which are fundamental determinants for user acceptance. A total of 75 lung cancer patients will be recruited across seven radiation oncology departments across Australia. Patients will be randomised in a 2:1 ratio, with 2/3 of the patients being recruited into the intervention arm and 1/3 in the control arm. 2:1 randomisation is appropriate as within the interventional arm there is a screening procedure where only patients whose breathing is more regular with audiovisual biofeedback will continue to use this system for their imaging and treatment procedures. Patients within the intervention arm whose free breathing is more regular than audiovisual biofeedback in the screen procedure will remain in the intervention arm of the study but their imaging and treatment procedures will be performed without audiovisual biofeedback. Patients will also be stratified by treating institution and for treatment intent (palliative vs. radical) to ensure similar balance in the arms across the sites. Patients and hospital staff operating the audiovisual biofeedback system will complete questionnaires to assess their experience with audiovisual biofeedback. The objectives of this

  4. Dose Escalation and Quality of Life in Patients With Localized Prostate Cancer Treated With Radiotherapy: Long-Term Results of the Dutch Randomized Dose-Escalation Trial (CKTO 96-10 Trial)

    International Nuclear Information System (INIS)

    Al-Mamgani, Abrahim; Putten, Wim L.J. van; Wielen, Gerard J. van der; Levendag, Peter C.; Incrocci, Luca

    2011-01-01

    Purpose: To assess the impact of dose escalation of radiotherapy on quality of life (QoL) in prostate cancer patients. Patients and Methods: Three hundred prostate cancer patients participating in the Dutch randomized trial (CKTO 69-10) comparing 68 Gy with 78 Gy were the subject of this analysis. These patients filled out the SF-36 QoL questionnaire before radiotherapy (baseline) and 6, 12, 24, and 36 months thereafter. Changes in QoL over time of ≥10 points were considered clinically relevant. Repeated-measures regression analyses were applied to estimate and test the QoL changes over time, the differences between the two arms, and for association with a number of covariates. Results: At 3-year follow-up, the summary score physical health was 73.2 for the 68-Gy arm vs. 71.6 for the 78-Gy arm (p = 0.81), and the summary score mental health was 76.7 for the 68-Gy arm vs. 76.1 for the 78-Gy arm (p = 0.97). Statistically significant (p 10 points) was seen for only two scales. None of the tested covariates were significantly correlated with QoL scores. Conclusion: Dose escalation did not result in significant deterioration of QoL in prostate cancer patients. In both randomization arms, statistically significant decreases in QoL scores over time were seen in six scales. The deterioration of QoL was more pronounced in the physical than in the mental health domain and in some scales more in the high- than in the low-dose arm, but the differences between arms were not statistically significant.

  5. Non-randomised phase II trial of hyperbaric oxygen therapy in patients with chronic arm lymphoedema and tissue fibrosis after radiotherapy for early breast cancer

    International Nuclear Information System (INIS)

    Gothard, Lone; Stanton, Anthony; MacLaren, Julie; Lawrence, David; Hall, Emma; Mortimer, Peter; Parkin, Eileen; Pritchard, Joyce; Risdall, Jane; Sawyer, Robert; Woods, Mary; Yarnold, John

    2004-01-01

    Background: Radiation-induced arm lymphoedema is a common and distressing complication of curative treatment for early breast cancer. Hyperbaric oxygen (HBO 2 ) therapy promotes healing in bone rendered ischaemic by radiotherapy, and may help some soft-tissue injuries too, but is untested in arm lymphoedema. Methods: Twenty-one eligible research volunteers with a minimum 30% increase in arm volume in the years after axillary/supraclavicular radiotherapy (axillary surgery in 18/21 cases) were treated with HBO 2 . The volunteers breathed 100% oxygen at 2.4 ATA for 100 min in a multiplace hyperbaric chamber on 30 occasions over a period of 6 weeks. The volume of the ipsilateral limb, measured opto-electronically by a perometer and expressed as a percentage of contralateral limb volume, was selected as the primary endpoint. A secondary endpoint was local lymph drainage expressed as fractional removal rate of radioisotopic tracer, measured using lymphoscintigraphy. Results: Three out of 19 evaluable patients experienced >20% reduction in arm volume at 12 months. Six out of 13 evaluable patients experienced a >25% improvement in 99 Tc-nanocolloid clearance rate from the ipsilateral forearm measured by quantitative lymphoscintigraphy at 12 months. Overall, there was a statistically significant, but clinically modest, reduction in ipsilateral arm volume at 12 months follow-up compared with baseline (P=0.005). The mean percentage reduction in arm volume from baseline at 12 months was 7.51. Moderate or marked lessening of induration in the irradiated breast, pectoral fold and/or supraclavicular fossa was recorded clinically in 8/15 evaluable patients. Twelve out of 19 evaluable patients volunteered that their arms felt softer, and six reported improvements in shoulder mobility at 12 months. No significant improvements were noted in patient self-assessments of quality of life. Conclusion: Interpretation is limited by the absence of a control group. However, measurement of

  6. Effect of edaravone on radiation-induced brain necrosis in patients with nasopharyngeal carcinoma after radiotherapy: a randomized controlled trial.

    Science.gov (United States)

    Tang, Yamei; Rong, Xiaoming; Hu, Weihan; Li, Guoqian; Yang, Xiaoxia; Yang, Jianhua; Xu, Pengfei; Luo, Jinjun

    2014-11-01

    Excessive generation of free radicals plays a critical role in the pathogenesis of radiation-induced brain injury. This study was designed to evaluate the protective effect of edaravone, a free radical scavenger, on radiation-induced brain necrosis in patients with nasopharyngeal carcinoma. Eligible patients were randomized 1:1 to the control group and the edaravone group (intravenous 30 mg twice per day for 2 weeks). Both groups received intravenous conventional steroid therapy and were monitored by brain MRI and LENT/SOMA scales prior to the entry of the trial and at 3-months after completing the trial. The primary end point was a 3-month response rate of the proportional changes determined by MRI. The trial is registered at Clinicaltrials.gov Identifier: NCT01865201. Between 2009 and 2012, we enrolled 154 patients. Of whom 137 were eligible for analysis. The volumes of necrosis estimated on T(2)-weighted image showed that 55.6 % edaravone-treated patients (40 out of 72) showed edema decreases ≥25 %, which was significantly higher than that in the control group (35.4 %, 23 out of 65, p = 0.025). Forty-four patients treated with edaravone (61.1 %) reported improvement in neurologic symptoms and signs evaluated by LENT/SOMA scales, while the rate was 38.5 % in the control group (p = 0.006). MRI of the edaravone group showed a significant decrease in area of T(1)-weighted contrast enhancement (1.67 ± 4.69 cm(2), p = 0.004) and the T(2)-weighted edema (5.08 ± 10.32 cm(2), p = 0.000). Moreover, compared with those in control group, patients with edaravone exhibited significantly better radiological improvement measured by T(2)-weighted image (p = 0.042). Administration of edaravone, in adjunct to steroid regimen, might provide a better outcome in patients with radiation-induced brain necrosis.

  7. Chest radiotherapy in limited-stage small cell lung cancer: facts, questions, prospects

    International Nuclear Information System (INIS)

    De Ruysscher, D.; Vansteenkiste, J.

    2000-01-01

    Limited-disease small cell lung cancer (LD-SCLC) is initially very sensitive to both radiotherapy and chemotherapy. However, the 5-year survival is generally only 10-15%, with most patients failing with therapy refractory relapses, both locally and in distant sites. The addition of chest irradiation to chemotherapy increases the absolute survival by approximately 5%. We reviewed the many controversies regarding optimal timing and irradiation technique. No strong data support total radiation doses over 50 Gy. According to one phase III trial and several retrospective studies, increasing the volume of the radiation fields to the pre-chemotherapy turnout volume instead of the post-chemotherapy volume does not improve local control. The total time in which the entire combined-modality treatment is delivered may be important. From seven randomized trials, it can be concluded that the timing of the radiotherapy as such is not very important. Some phase III trials support the use of accelerated chest radiation together with cisplatin-etoposide chemotherapy, delivered from the first day of treatment, although no firm conclusions can be drawn from the available data. The best results are reported in studies in which the time from the start of treatment to the end of the radiotherapy was less than 30 days. This has to be taken into consideration when treatment modalities incorporating new chemotherapeutic agents and radiotherapy are considered. (author)

  8. Accelerated partial breast irradiation using intensity-modulated radiotherapy versus whole breast irradiation: 5-year survival analysis of a phase 3 randomised controlled trial.

    Science.gov (United States)

    Livi, Lorenzo; Meattini, Icro; Marrazzo, Livia; Simontacchi, Gabriele; Pallotta, Stefania; Saieva, Calogero; Paiar, Fabiola; Scotti, Vieri; De Luca Cardillo, Carla; Bastiani, Paolo; Orzalesi, Lorenzo; Casella, Donato; Sanchez, Luis; Nori, Jacopo; Fambrini, Massimiliano; Bianchi, Simonetta

    2015-03-01

    Accelerated partial breast irradiation (APBI) has been introduced as an alternative treatment method for selected patients with early stage breast cancer (BC). Intensity-modulated radiotherapy (IMRT) has the theoretical advantage of a further increase in dose conformity compared with three-dimensional techniques, with more normal tissue sparing. The aim of this randomised trial is to compare the local recurrence and survival of APBI using the IMRT technique after breast-conserving surgery to conventional whole-breast irradiation (WBI) in early stage BC. This study was performed at the University of Florence (Florence, Italy). Women aged more than 40years affected by early BC, with a maximum pathological tumour size of 25mm, were randomly assigned in a 1:1 ratio to receive either WBI or APBI using IMRT. Patients in the APBI arm received a total dose of 30 Gy to the tumour bed in five daily fractions. The WBI arm received 50Gy in 25 fractions, followed by a boost on the tumour bed of 10Gy in five fractions. The primary end-point was occurrence of ipsilateral breast tumour recurrences (IBTRs); the main analysis was by intention-to-treat. This trial is registered with ClinicalTrials.gov, number NCT02104895. A total of 520 patients were randomised (260 to external WBI and 260 to APBI with IMRT) between March 2005 and June 2013. At a median follow-up of 5.0 years (Interquartile Range (IQR) 3.4-7.0), the IBTR rate was 1.5% (three cases) in the APBI group (95% confidence interval (CI) 0.1-3.0) and in the WBI group (three cases; 95% CI 0.0-2.8). No significant difference emerged between the two groups (log rank test p=0.86). We identified seven deaths in the WBI group and only one in the APBI group (p=0.057). The 5-year overall survival was 96.6% for the WBI group and 99.4% for the APBI group. The APBI group presented significantly better results considering acute (p=0.0001), late (p=0.004), and cosmetic outcome (p=0.045). To our knowledge, this is the first randomised

  9. Prospective comparison of breast pain in patients participating in a randomized trial of breast-conserving surgery and tamoxifen with or without radiotherapy

    International Nuclear Information System (INIS)

    Rayan, Gamal; Dawson, Laura A.; Bezjak, Andrea; Lau, Anthea; Fyles, Anthony W.; Yi, Q.-L.; Merante, Pat; Vallis, Katherine A.

    2003-01-01

    Purpose: To determine whether breast pain affects quality of life (QOL) after breast-conserving surgery and tamoxifen (TAM) with or without adjuvant breast radiotherapy (RT). Methods and Materials: A randomized clinical trial was carried out at the Princess Margaret Hospital between 1992 and 2000 to evaluate the need for breast RT in addition to TAM in women ≥50 years treated with breast-conserving surgery for T1-T2N0 breast cancer. A companion study to assess breast pain was carried out during the last 2 years of the randomized clinical trial. The short-form McGill Pain Questionnaire (SF-MPQ), the European Organization for Research and Treatment of Cancer (EORTC) QOL (QLQ-C30) and EORTC breast cancer module (QLQ-BR23) questionnaires were completed by patients within 1 week of randomization in the randomized clinical trial (baseline) and at 3, 6, and 12 months. Results: Eighty-six patients participated in the breast pain study; 41 received RT plus TAM and 45 received TAM alone. The median age was 70 years (range 51-80). The baseline pain and QOL scores were similar for the two groups. No significant difference was found between the two groups for each scale of the QLQ-C30 and QLQ-BR23 questionnaires at 3, 6, or 12 months (p>0.100), except that at 12 months, the score for role function (QLQ-C30) was higher in the RT plus TAM group than in the RT-only group (p=0.02). At 3 months, the difference between the mean scores for the SF-MPQ was 0.553 (p=0.47). At 12 months, the pain scores had decreased in both groups; the difference was 0.199 (p=0.71). The number of breast operations or surgical complications did not correlate with breast pain in either group. Acute RT toxicity scores did not correlate with breast pain or QOL scores at 12 months. Conclusion: These results suggest that breast RT does not significantly contribute to breast pain or adversely impact the QOL up to 12 months after treatment in postmenopausal patients with node-negative breast cancer who take

  10. Intensified hyperfractionated accelerated radiotherapy limits the additional benefit of simultaneous chemotherapy--results of a multicentric randomized German trial in advanced head-and-neck cancer.

    Science.gov (United States)

    Staar, S; Rudat, V; Stuetzer, H; Dietz, A; Volling, P; Schroeder, M; Flentje, M; Eckel, H E; Mueller, R P

    2001-08-01

    To demonstrate the efficacy of radiochemotherapy (RCT) as the first choice of treatment for advanced unresectable head-and-neck cancer. To prove an expected benefit of simultaneously given chemotherapy, a two-arm randomized study with hyperfractionated accelerated radiochemotherapy (HF-ACC-RCT) vs. hyperfractionated accelerated radiotherapy (HF-ACC-RT) was initiated. The primary endpoint was 1-year survival with local control (SLC). Patients with Stage III and IV (UICC) unresectable oro- and hypopharyngeal carcinomas were randomized for HF-ACC-RCT with 2 cycles of 5-FU (600 mg/m(2)/day)/carboplatinum (70 mg/m(2)) on days 1--5 and 29--33 (arm A) or HF-ACC-RT alone (arm B). In both arms, there was a second randomization for testing the effect of prophylactically given G-CSF (263 microg, days 15--19) on mucosal toxicity. Total RT dose in both arms was 69.9 Gy in 38 days, with a concomitant boost regimen (weeks 1--3: 1.8 Gy/day, weeks 4 and 5: b.i.d. RT with 1.8 Gy/1.5 Gy). Between July 1995 and May 1999, 263 patients were randomized (median age 56 years; 96% Stage IV tumors, 4% Stage III tumors). This analysis is based on 240 patients: 113 patients with RCT and 127 patients with RT, qualified for protocol and starting treatment. There were 178 oropharyngeal and 62 hypopharyngeal carcinomas. Treatment was tolerable in both arms, with a higher mucosal toxicity after RCT. Restaging showed comparable nonsignificant different CR + PR rates of 92.4% after RCT and 87.9% after RT (p = 0.29). After a median observed time of 22.3 months, l- and 2-year local-regional control (LRC) rates were 69% and 51% after RCT and 58% and 45% after RT (p = 0.14). There was a significantly better 1-year SLC after RCT (58%) compared with RT (44%, p = 0.05). Patients with oropharyngeal carcinomas showed significantly better SLC after RCT (60%) vs. RT (40%, p = 0.01); the smaller group of hypopharyngeal carcinomas had no statistical benefit of RCT (p = 0.84). For both tumor locations

  11. Intensified hyperfractionated accelerated radiotherapy limits the additional benefit of simultaneous chemotherapy--results of a multicentric randomized German trial in advanced head-and-neck cancer

    International Nuclear Information System (INIS)

    Staar, Susanne; Rudat, Volker; Stuetzer, Hartmut; Dietz, Andreas; Volling, Peter; Schroeder, Michael; Flentje, Michael; Eckel, Hans Edmund; Mueller, Rolf-Peter

    2001-01-01

    Purpose: To demonstrate the efficacy of radiochemotherapy (RCT) as the first choice of treatment for advanced unresectable head-and-neck cancer. To prove an expected benefit of simultaneously given chemotherapy, a two-arm randomized study with hyperfractionated accelerated radiochemotherapy (HF-ACC-RCT) vs. hyperfractionated accelerated radiotherapy (HF-ACC-RT) was initiated. The primary endpoint was 1-year survival with local control (SLC). Methods and Materials: Patients with Stage III and IV (UICC) unresectable oro- and hypopharyngeal carcinomas were randomized for HF-ACC-RCT with 2 cycles of 5-FU (600 mg/m 2 /day)/carboplatinum (70 mg/m 2 ) on days 1-5 and 29-33 (arm A) or HF-ACC-RT alone (arm B). In both arms, there was a second randomization for testing the effect of prophylactically given G-CSF (263 μg, days 15-19) on mucosal toxicity. Total RT dose in both arms was 69.9 Gy in 38 days, with a concomitant boost regimen (weeks 1-3: 1.8 Gy/day, weeks 4 and 5: b.i.d. RT with 1.8 Gy/1.5 Gy). Between July 1995 and May 1999, 263 patients were randomized (median age 56 years; 96% Stage IV tumors, 4% Stage III tumors). Results: This analysis is based on 240 patients: 113 patients with RCT and 127 patients with RT, qualified for protocol and starting treatment. There were 178 oropharyngeal and 62 hypopharyngeal carcinomas. Treatment was tolerable in both arms, with a higher mucosal toxicity after RCT. Restaging showed comparable nonsignificant different CR + PR rates of 92.4% after RCT and 87.9% after RT (p=0.29). After a median observed time of 22.3 months, l- and 2-year local-regional control (LRC) rates were 69% and 51% after RCT and 58% and 45% after RT (p=0.14). There was a significantly better 1-year SLC after RCT (58%) compared with RT (44%, p=0.05). Patients with oropharyngeal carcinomas showed significantly better SLC after RCT (60%) vs. RT (40%, p=0.01); the smaller group of hypopharyngeal carcinomas had no statistical benefit of RCT (p=0.84). For both

  12. Five compared with six fractions per week of conventional radiotherapy of squamous-cell carcinoma of head and neck: DAHANCA 6 and 7 randomised controlled trial

    DEFF Research Database (Denmark)

    Overgaard, Jens; Hansen, Hanne Sand; Specht, Lena

    2003-01-01

    Although head and neck cancer can be cured by radiotherapy, the optimum treatment time for locoregional control is unclear. We aimed to find out whether shortening of treatment time by use of six instead of five radiotherapy fractions per week improves the tumour response in squamous-cell carcinoma....

  13. Adjuvant radiotherapy versus observation alone for patients at risk of lymph-node field relapse after therapeutic lymphadenectomy for melanoma : a randomised trial

    NARCIS (Netherlands)

    Burmeister, Bryan H.; Henderson, Michael A.; Ainslie, Jill; Fisher, Richard; Di Iulio, Juliana; Smithers, B. Mark; Hong, Angela; Shannon, Kerwin; Scolyer, Richard A.; Carruthers, Scott; Coventry, Brendon J.; Babington, Scott; Duprat, Joao; Hoekstra, Harald J.; Thompson, John F.

    Background The use of radiotherapy after therapeutic lymphadenectomy for patients with melanoma at high risk of further lymph-node field and distant recurrence is controversial. Decisions for radiotherapy in this setting are made on the basis of retrospective, non-randomised studies. We did this

  14. A dose-escalation trial with the adaptive radiotherapy process as a delivery system in localized prostate cancer: Analysis of chronic toxicity

    International Nuclear Information System (INIS)

    Brabbins, Donald; Martinez, Alvaro; Yan Di; Lockman, David; Wallace, Michell; Gustafson, Gary; Chen, Peter; Vicini, Frank; Wong, John

    2005-01-01

    Purpose: To evaluate the validity of the chosen adaptive radiotherapy (ART) dose-volume constraints while testing the hypothesis that toxicity would not be greater at higher tumor dose levels. Materials and methods: In the ART dose escalation/selection trial, treatment was initiated with a generic planning target volume (PTV) formed as a 1-cm expansion of the clinical target volume (CTV). After the first week of therapy, the patient was replanned with a patient-specific PTV, constructed with CT and electronic portal images obtained in the first 4 days of treatment. A new multileaf collimator beam aperture was used. A minimum dose prescribed to the patient-specific PTV, ranging 70.2-79.2 Gy, was determined on the basis of the following rectal and bladder constraints: 82 Gy, 75.6 Gy, 75.6 Gy, and the maximum bladder dose is 85 Gy. A conformal four-field and/or intensity-modulated radiotherapy (IMRT) technique was used. Independent reviewers scored toxicities. The worst toxicity score seen was used as per the Common Toxicity Criteria grade scale (version 2). We divided the patients into three separate groups: 70.2-72 Gy, >72-75.6 Gy, and >75.6-79.2 Gy. Toxicities in each group were quantified and compared by the Pearson chi-squared test to validate our dose escalation/selection model. Grades 0, 1, 2, and 3 were censored as none vs. each category and none vs. any. Results: We analyzed patients with follow-up greater than 1 year. The mean duration of follow-up was 29 months (range, 12-46 months). We report on 280 patients, mean age 72 years (range, 51-87 years). Only 60 patients received adjuvant hormones. Mean pretreatment prostate-specific antigen level was 9.3 ng/mL (range, 0.6-120 ng/mL). Mean Gleason score was 6 (range, 3-9). The lowest dose level was given to 49 patients, the intermediate dose to 131 patients, and 100 patients received the highest dose escalation. One hundred eighty-one patients (65%) were treated to a prostate field only and 99 patients (35%) to

  15. Individualized FSH dosing based on ovarian reserve testing in women starting IVF/ICSI: a multicentre trial and cost-effectiveness analysis.

    Science.gov (United States)

    van Tilborg, Theodora C; Oudshoorn, Simone C; Eijkemans, Marinus J C; Mochtar, Monique H; van Golde, Ron J T; Hoek, Annemieke; Kuchenbecker, Walter K H; Fleischer, Kathrin; de Bruin, Jan Peter; Groen, Henk; van Wely, Madelon; Lambalk, Cornelis B; Laven, Joop S E; Mol, Ben Willem J; Broekmans, Frank J M; Torrance, Helen L

    2017-12-01

    Is there a difference in live birth rate and/or cost-effectiveness between antral follicle count (AFC)-based individualized FSH dosing or standard FSH dosing in women starting IVF or ICSI treatment? In women initiating IVF/ICSI, AFC-based individualized FSH dosing does not improve live birth rates or reduce costs as compared to a standard FSH dose. In IVF or ICSI, ovarian reserve testing is often used to adjust the FSH dose in order to normalize ovarian response and optimize live birth rates. However, no robust evidence for the (cost-)effectiveness of this practice exists. Between May 2011 and May 2014 we performed a multicentre prospective cohort study with two embedded RCTs in women scheduled for IVF/ICSI. Based on the AFC, women entered into one of the two RCTs (RCT1: AFC 15) or the cohort (AFC 11-15). The primary outcome was ongoing pregnancy achieved within 18 months after randomization resulting in a live birth (delivery of at least one live foetus after 24 weeks of gestation). Data from the cohort with weight 0.5 were combined with both RCTs in order to conduct a strategy analysis. Potential half-integer numbers were rounded up. Differences in costs and effects between the two treatment strategies were compared by bootstrapping. In both RCTs women were randomized to an individualized (RCT1:450/225 IU, RCT2:100 IU) or standard FSH dose (150 IU). Women in the cohort all received the standard dose (150 IU). Anti-Müllerian hormone (AMH) was measured to assess AMH post-hoc as a biomarker to individualize treatment. For RCT1 dose adjustment was allowed in subsequent cycles based on pre-specified criteria in the standard group only. For RCT2 dose adjustment was allowed in subsequent cycles in both groups. Both effectiveness and cost-effectiveness of the strategies were evaluated from an intention-to-treat perspective. We included 1515 women, of whom 483 (31.9%) entered the cohort, 511 (33.7%) RCT1 and 521 (34.4%) RCT2. Live births occurred in 420/747 (56.3%) women

  16. Combined radiotherapy and chemotherapy for head and neck cancer

    International Nuclear Information System (INIS)

    Inuyama, Yukio; Fujii, Masato; Tanaka, Juichi; Takaoka, Tetsuro; Hosoda, Hyonosuke; Kawaura, Mitsuhiro; Toji, Masao

    1988-01-01

    There are 4 modalities of combined radiotherapy and chemotherapy which include (1) concurrent radiotherapy and chemotherapy, (2) sequential use of radiotherapy and chemotherapy (pre-radiation chemotherapy), (3) pre-radiation chemotherapy followed by concurrent radiation and chemotherapy, and (4) alternating use of radiotherapy and chemotherapy based upon Looney's hypothesis. We studied concurrent use of radiotherapy and UFT by means of animal experimentation and clinical trials. The results obtained revealed that UFT was a most suitable agent together with 5-fluorouracil for concurrent application of radiotherapy and chemotherapy. Neo-adjuvant chemotherapy including pre-radiation chemotherapy was also studied in cases of maxillary sinus carcinoma and nasopharyngeal carcinoma. From the results, it seemed desirable to use cisplatin and bleomycin analogs sequentially in combined chemotherapy and radiotherapy. Neo-adjuvant chemotherapy should be studied successively to improve local tumor control rates and prevent distant metastases. For future perspectives, new trials of alternating radiotherapy and chemotherapy based upon Looney's hypothesis seem necessary. (author)

  17. SUPREMO (Selective Use of Postoperative Radiotherapy aftEr MastectOmy) - a phase III randomised trial assessing the role of postmastectomy chest wall irradiation in 'intermediate risk' women with operable breast cancer receiving adjuvant systemic therapy

    International Nuclear Information System (INIS)

    Kunkler, I.H.; Price, A.; Dixon, M.; Canney, P.; Prescott, R.; Sainsbury, R.; Aird, E.

    2003-01-01

    Danish and Canadian randomised trials of postmastectomy radiotherapy (PMRT) have shown the importance of loco-regional control to survival in 'high risk' pre and postmenopausal women receiving adjuvant systemic therapy. The effects of radiotherapy (RT) in terms of improving survival are similar to those of systemic therapy. International consensus now supports the use of postmastectomy chest wall irradiation in women with 4 or more involved axillary nodes or primary tumour size=/> 5cm. The role of PMRT in women at intermediate risk' with 1-3 involved nodes or node negative with other risk factors is controversial. The absolute reduction in risk of loco-regional recurrence varies widely (3-23%) in trials of PMRT in women with 1-3 involved nodes receiving systemic therapy. A UK survey of clinical oncologists (Kunkler et al,The Breast 1999;8:235) showed wide variations in opinion on the use of radiotherapy in these subgroups. It is possible that while RT may confer most benefit in loco-regional control, a greater survival benefit might accrue in patients with smaller tumours and fewer involved nodes. The 2000 Oxford overview of randomised trials of postoperative RT identifies non breast cancer deaths from RT related vascular morbidity as counterbalancing the benefits of RT in reducing breast cancer mortality. With the more extensive use of potentially cardiotoxic anthracycline containing adjuvant systemic therapy there are concerns about greater cardiac morbidity in patients receiving PMRT in addition. A large randomised international trial (SUPREMO) is proposed to recruit 3500 patients with (a) 1-3 involved axillary nodes or (b) node negative with other risk factors (grade 3 or lymphovascular invasion) treated by mastectomy, axillary clearance and appropriate systemic therapy for T0-3,N0-1,MO breast cancer. The primary endpoint is overall survival. Secondary endpoints are disease free survival, quality of life, morbidity (including cardiac), cost per life year saved

  18. Benefits of a clinical data warehouse with data mining tools to collect data for a radiotherapy trial.

    Science.gov (United States)

    Roelofs, Erik; Persoon, Lucas; Nijsten, Sebastiaan; Wiessler, Wolfgang; Dekker, André; Lambin, Philippe

    2013-07-01

    Collecting trial data in a medical environment is at present mostly performed manually and therefore time-consuming, prone to errors and often incomplete with the complex data considered. Faster and more accurate methods are needed to improve the data quality and to shorten data collection times where information is often scattered over multiple data sources. The purpose of this study is to investigate the possible benefit of modern data warehouse technology in the radiation oncology field. In this study, a Computer Aided Theragnostics (CAT) data warehouse combined with automated tools for feature extraction was benchmarked against the regular manual data-collection processes. Two sets of clinical parameters were compiled for non-small cell lung cancer (NSCLC) and rectal cancer, using 27 patients per disease. Data collection times and inconsistencies were compared between the manual and the automated extraction method. The average time per case to collect the NSCLC data manually was 10.4 ± 2.1 min and 4.3 ± 1.1 min when using the automated method (pdata collected for NSCLC and 5.3% for rectal cancer, there was a discrepancy between the manual and automated method. Aggregating multiple data sources in a data warehouse combined with tools for extraction of relevant parameters is beneficial for data collection times and offers the ability to improve data quality. The initial investments in digitizing the data are expected to be compensated due to the flexibility of the data analysis. Furthermore, successive investigations can easily select trial candidates and extract new parameters from the existing databases. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  19. Benefits of a clinical data warehouse with data mining tools to collect data for a radiotherapy trial

    International Nuclear Information System (INIS)

    Roelofs, Erik; Persoon, Lucas; Nijsten, Sebastiaan; Wiessler, Wolfgang; Dekker, André; Lambin, Philippe

    2013-01-01

    Introduction: Collecting trial data in a medical environment is at present mostly performed manually and therefore time-consuming, prone to errors and often incomplete with the complex data considered. Faster and more accurate methods are needed to improve the data quality and to shorten data collection times where information is often scattered over multiple data sources. The purpose of this study is to investigate the possible benefit of modern data warehouse technology in the radiation oncology field. Material and methods: In this study, a Computer Aided Theragnostics (CAT) data warehouse combined with automated tools for feature extraction was benchmarked against the regular manual data-collection processes. Two sets of clinical parameters were compiled for non-small cell lung cancer (NSCLC) and rectal cancer, using 27 patients per disease. Data collection times and inconsistencies were compared between the manual and the automated extraction method. Results: The average time per case to collect the NSCLC data manually was 10.4 ± 2.1 min and 4.3 ± 1.1 min when using the automated method (p < 0.001). For rectal cancer, these times were 13.5 ± 4.1 and 6.8 ± 2.4 min, respectively (p < 0.001). In 3.2% of the data collected for NSCLC and 5.3% for rectal cancer, there was a discrepancy between the manual and automated method. Conclusions: Aggregating multiple data sources in a data warehouse combined with tools for extraction of relevant parameters is beneficial for data collection times and offers the ability to improve data quality. The initial investments in digitizing the data are expected to be compensated due to the flexibility of the data analysis. Furthermore, successive investigations can easily select trial candidates and extract new parameters from the existing databases

  20. Ipilimumab versus placebo after radiotherapy in patients with metastatic castration-resistant prostate cancer that had progressed after docetaxel chemotherapy (CA184-043): a multicentre, randomised, double-blind, phase 3 trial

    DEFF Research Database (Denmark)

    Kwon, Eugene D; Drake, Charles G; Scher, Howard I

    2014-01-01

    BACKGROUND: Ipilimumab is a fully human monoclonal antibody that binds cytotoxic T-lymphocyte antigen 4 to enhance antitumour immunity. Our aim was to assess the use of ipilimumab after radiotherapy in patients with metastatic castration-resistant prostate cancer that progressed after docetaxel...... chemotherapy. METHODS: We did a multicentre, randomised, double-blind, phase 3 trial in which men with at least one bone metastasis from castration-resistant prostate cancer that had progressed after docetaxel treatment were randomly assigned in a 1:1 ratio to receive bone-directed radiotherapy (8 Gy in one...... fraction) followed by either ipilimumab 10 mg/kg or placebo every 3 weeks for up to four doses. Non-progressing patients could continue to receive ipilimumab at 10 mg/kg or placebo as maintenance therapy every 3 months until disease progression, unacceptable toxic effect, or death. Patients were randomly...

  1. Late gastrointestinal and urogenital side-effects after radiotherapy – Incidence and prevalence. Subgroup-analysis within the prospective Austrian–German phase II multicenter trial for localized prostate cancer

    International Nuclear Information System (INIS)

    Schmid, Maximilian P.; Pötter, Richard; Bombosch, Valentin; Sljivic, Samir; Kirisits, Christian; Dörr, Wolfgang; Goldner, Gregor

    2012-01-01

    Purpose: In general late side-effects after prostate cancer radiotherapy are presented by the use of actuarial incidence rates. The aim of this analysis was to describe additional relevant aspects of late side effects after prostate cancer radiotherapy. Materials and methods: All 178 primary prostate-cancer patients were treated within the Austrian–German multicenter trial by three-dimensional radiotherapy up to a local dose of 70 Gy (low/intermediate-risk) or 74 Gy (high-risk), respectively. Late gastrointestinal/urogenital (GI/GU) side-effects were prospectively assessed by the use of EORTC/RTOG score. Maximum side-effects, actuarial incidence rate and prevalence rates, initial appearance and duration of ⩾grade 2 toxicity were evaluated. Results: Median follow-up was 74 months. Late GI/GU side-effects ⩾grade 2 were detected in 15% (27/178) and 22% (40/178). The corresponding 5-year actuarial incidence rates for GI/GU side-effects were 19% and 23%, whereas the prevalence was 1–2% and 2–7% after 5 years, respectively. Late side effects ⩾grade 2 appeared within 5 years after radiotherapy in all patients with GI side-effects (27/27) and in 85% (34/40) of the patients with GU side-effects, respectively and lasted for less than 3 years in 90% (GI) and 98% (GU). Conclusions: This study demonstrates that the majority of late GI and GU side effects after primary external beam radiotherapy for prostate cancer are transient. Using only actuarial incidence rates for reporting side effects may lead to misinterpretation or overestimation. The combination of incidence and prevalence rates provides a more comprehensive view on the complex issue of late side effects.

  2. Role of radiotherapy fractionation in head and neck cancers (MARCH)

    DEFF Research Database (Denmark)

    Lacas, Benjamin; Bourhis, Jean; Overgaard, Jens

    2017-01-01

    BACKGROUND: The Meta-Analysis of Radiotherapy in squamous cell Carcinomas of Head and neck (MARCH) showed that altered fractionation radiotherapy is associated with improved overall and progression-free survival compared with conventional radiotherapy, with hyperfractionated radiotherapy showing...... the greatest benefit. This update aims to confirm and explain the superiority of hyperfractionated radiotherapy over other altered fractionation radiotherapy regimens and to assess the benefit of altered fractionation within the context of concomitant chemotherapy with the inclusion of new trials. METHODS......: For this updated meta-analysis, we searched bibliography databases, trials registries, and meeting proceedings for published or unpublished randomised trials done between Jan 1, 2009, and July 15, 2015, comparing primary or postoperative conventional fractionation radiotherapy versus altered fractionation...

  3. Preliminary results of a randomized trial of mitomycin C as an adjunct to radical radiotherapy in the treatment of locally advanced squamous cell carcinoma of the cervix

    International Nuclear Information System (INIS)

    Roberts, Kenneth B.; Urdaneta, Nelson; Vera, Raul; Vera, Andres; Gutierrez, Enrique; Rockwell, Sara; Sartorelli, Alan C.; Fischer, Diana B.; Fischer, James J.

    1996-01-01

    Purpose/Objective: To determine the efficacy of Mitomycin C (MC) in combination with radiotherapy (RT) for the treatment of carcinoma of the cervix Materials and Methods: A Phase III randomized study of MC + RT (CMT) vs. RT was initiated in 1990 to test whether or not a bioreductive alkylating agent would improve the cure of squamous cell carcinoma of the cervix (CCa), a tumor for which hypoxia is known to be a strong prognostic factor. As of March 1996, 157 patients have been enrolled. After excluding 8 patients (pts) for protocol violations (3 in CMT group and 5 in RT group), the 110 analyzable pts having at least two years of partial follow-up were used for the preliminary analysis reported here. Intravenous MC, 15 mg/M 2 , was given on the 1st and 6th week of treatment. Before randomization between CMT and RT, patients were stratified by standardized radiotherapy prescriptions of both brachytherapy and external beam RT dose, as dictated by tumor stage. Results: The 58 pts in the CMT group and 52 pts in the RT group have a mean follow-up of 27.1 months, and a comparable distribution by age and stage (mean age 48.3 years; stage IB 2%, IIA 14%, IIB 47%, IIIA 1%, IIIB 34%, IVA 3%). The three year actuarial survival rates for CMT and RT were 77% and 58%, respectively (p=0.15). Three months following completion of therapy, complete response (CR) was achieved in 51 pts (88%) of the CMT group and in 47 pts (90%) of the RT group (p=NS). Of those with CR, the three year actuarial local recurrence free survivals for CMT and RT were 84% and 68%, respectively (p=0.12). There were no treatment-related deaths. Mild hematologic toxicity was seen only in the CMT group, with 4 pts having a nadir WBC <1.5 (but none below 1.0) and with 1 pt having a nadir platelet count below 25K. Grade 3 skin toxicity was seen in 3 pts receiving CMT and 1 pt receiving RT alone. Grade 3 cystitis was seen in one RT pt. Grade 3 and 4 GI toxicities were seen in two RT pts. No excess in non

  4. SU-F-P-52: A Meta-Analysis of Controlled Clinical Trials Comparing Elective Nodal Irradiation with Involved-Field Irradiation for Conformal Or Intensity-Modulated Radiotherapy in Patients with Esophageal Cancer

    Energy Technology Data Exchange (ETDEWEB)

    Bai, W; Zhang, R; Zhou, Z; Qiao, X [The Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei (China)

    2016-06-15

    Purpose: To compare elective nodal irradiation with involved-field irradiation for three-dimensional conformal radiotherapy or intensity-modulated radiotherapy in patients with esophageal cancer by a metaanalysis. Methods: Wanfang, CNKI, VIP, CBM databases, PubMed, Embase and Cochrane Library were searched to identify the controlled clinical trials of elective nodal irradiation with involved-field irradiation for three-dimensional conformal radiotherapy or intensity-modulated radiotherapy in patients with esophageal cancer. The obtained data were analyzed using Stata 11.0. The difference between two groups was estimated by calculating the odds ratio (OR) with 95% confidence interval (95% CI). Results: A total of 12 controlled clinical trials involving 1095 esophageal cancer patients, which were selected according to inclusion and exclusion criteria, were included in this meta-analysis. The meta-analysis showed that the elective nodal irradiation group reduced the rates of out-field failure comparing with involved-field irradiation group (OR=3.727, P=0.007). However, the rates of ≥grades 3 acute radiation pneumonitis and esophagitis were significantly higher in the elective nodal irradiation group than in the involved-field irradiation group (OR=0.348, P=0.001, OR=0.385, P=0.000). 1-, 2-, 3-year local control rates (OR=0.966, P=0.837, OR=0.946, P=0.781; OR=0.732P=0.098) and 1-, 3-, 5-year survival rates were similar in the two groups ( OR=0.966, P=0.837; OR=0.946, P=0.781; OR=0.732, P=0.098; OR=0.952, P=0.756; OR=1.149, P=0.422; OR=0.768, P=0.120). It is the same with the rates of distant metastasis (OR=0.986, P=0.937). Conclusion: Compared with involved-field irradiation, the elective nodal irradiation can reduce the rates of out-field failure for three-dimensional conformal radiotherapy or intensity-modulated radiotherapy in patients with esophageal cancer. However, its advantage of local control and survival rates is not obvious and it increases the incidence

  5. Quality assurance of radiotherapy in the ongoing EORTC 22042–26042 trial for atypical and malignant meningioma: results from the dummy runs and prospective individual case Reviews

    International Nuclear Information System (INIS)

    Coskun, Mehtap; Straube, William; Hurkmans, Coen W; Melidis, Christos; Haan, Patricia F de; Villà, Salvador; Collette, Sandra; Weber, Damien C

    2013-01-01

    The ongoing EORTC 22042–26042 trial evaluates the efficacy of high-dose radiotherapy (RT) in atypical/malignant meningioma. The results of the Dummy Run (DR) and prospective Individual Case Review (ICR) were analyzed in this Quality Assurance (QA) study. Institutions were requested to submit a protocol compliant treatment plan for the DR and ICR, respectively. DR-plans (n=12) and ICR-plans (n=50) were uploaded to the Image-Guided Therapy QA Center of Advanced Technology Consortium server (http://atc.wustl.edu/) and were assessed prospectively. Major deviations were observed in 25% (n=3) of DR-plans while no minor deviations were observed. Major and minor deviations were observed in 22% (n=11) and 10% (n=5) of the ICR-plans, respectively. Eighteen% of ICRs could not be analyzed prospectively, as a result of corrupted or late data submission. CTV to PTV margins were respected in all cases. Deviations were negatively associated with the number of submitted cases per institution (p=0.0013), with a cutoff of 5 patients per institutions. No association (p=0.12) was observed between DR and ICR results, suggesting that DR’s results did not predict for an improved QA process in accrued brain tumor patients. A substantial number of protocol deviations were observed in this prospective QA study. The number of cases accrued per institution was a significant determinant for protocol deviation. These data suggest that successful DR is not a guarantee for protocol compliance for accrued patients. Prospective ICRs should be performed to prevent protocol deviations

  6. Once-weekly versus every-other-day stereotactic body radiotherapy in patients with prostate cancer (PATRIOT): A phase 2 randomized trial.

    Science.gov (United States)

    Quon, Harvey C; Ong, Aldrich; Cheung, Patrick; Chu, William; Chung, Hans T; Vesprini, Danny; Chowdhury, Amit; Panjwani, Dilip; Pang, Geordi; Korol, Renee; Davidson, Melanie; Ravi, Ananth; McCurdy, Boyd; Zhang, Liying; Mamedov, Alexandre; Deabreu, Andrea; Loblaw, Andrew

    2018-05-01

    Prostate stereotactic body radiotherapy (SBRT) regimens differ in time, dose, and fractionation. We completed a multicentre, randomized phase II study to investigate the impact of overall treatment time on quality of life (QOL). Men with low and intermediate-risk prostate cancer were randomly assigned to 40 Gy in 5 fractions delivered once per week (QW) vs. every other day (EOD). QOL was assessed using the Expanded Prostate Cancer Index Composite. The primary endpoint was the proportion with a minimum clinically important change (MCIC) in bowel QOL during the acute (≤12 week) period, and analysis was by intention-to-treat. ClinicalTrials.gov NCT01423474. 152 men from 3 centres were randomized with median follow-up of 47 months. Patients treated QW had superior acute bowel QOL with 47/69 (68%) reporting a MCIC compared to 63/70 (90%) treated EOD (p = 0.002). Fewer patients treated QW reported moderate-severe problems with bowel QOL during the acute period compared with EOD (14/70 [20%] vs. 40/70 [57%], p < 0.001). Acute urinary QOL was also better in the QW arm, with 52/67 (78%) vs 65/69 (94%) experiencing a MCIC (p = 0.006). There were no significant differences in late urinary or bowel QOL at 2 years or last follow-up. Prostate SBRT delivered QW improved acute bowel and urinary QOL compared to EOD. Patients should be counselled regarding the potential for reduced short-term toxicity and improved QOL with QW prostate SBRT. Copyright © 2018 Elsevier B.V. All rights reserved.

  7. Stereotactic hypofractionated accurate radiotherapy of the prostate (SHARP), 33.5 Gy in five fractions for localized disease: First clinical trial results

    International Nuclear Information System (INIS)

    Madsen, Berit L.; Hsi, R. Alex; Pham, Huong T.; Fowler, Jack F.; Esagui, Laura C.; Corman, John

    2007-01-01

    Purpose: To evaluate the feasibility and toxicity of stereotactic hypofractionated accurate radiotherapy (SHARP) for localized prostate cancer. Methods and Materials: A Phase I/II trial of SHARP performed for localized prostate cancer using 33.5 Gy in 5 fractions, calculated to be biologically equivalent to 78 Gy in 2 Gy fractions (α/β ratio of 1.5 Gy). Noncoplanar conformal fields and daily stereotactic localization of implanted fiducials were used for treatment. Genitourinary (GU) and gastrointestinal (GI) toxicity were evaluated by American Urologic Association (AUA) score and Common Toxicity Criteria (CTC). Prostate-specific antigen (PSA) values and self-reported sexual function were recorded at specified follow-up intervals. Results: The study includes 40 patients. The median follow-up is 41 months (range, 21-60 months). Acute toxicity Grade 1-2 was 48.5% (GU) and 39% (GI); 1 acute Grade 3 GU toxicity. Late Grade 1-2 toxicity was 45% (GU) and 37% (GI). No late Grade 3 or higher toxicity was reported. Twenty-six patients reported potency before therapy; 6 (23%) have developed impotence. Median time to PSA nadir was 18 months with the majority of nadirs less than 1.0 ng/mL. The actuarial 48-month biochemical freedom from relapse is 70% for the American Society for Therapeutic Radiology and Oncology definition and 90% by the alternative nadir + 2 ng/mL failure definition. Conclusions: SHARP for localized prostate cancer is feasible with minimal acute or late toxicity. Dose escalation should be possible

  8. A randomised phase II trial of Stereotactic Ablative Fractionated radiotherapy versus Radiosurgery for Oligometastatic Neoplasia to the lung (TROG 13.01 SAFRON II)

    International Nuclear Information System (INIS)

    Siva, Shankar; Kron, Tomas; Bressel, Mathias; Haas, Marion; Mai, Tao; Vinod, Shalini; Sasso, Giuseppe; Wong, Wenchang; Le, Hien; Eade, Thomas; Hardcastle, Nicholas; Chesson, Brent; Pham, Daniel; Høyer, Morten; Montgomery, Rebecca; Ball, David

    2016-01-01

    Stereotactic ablative body radiotherapy (SABR) is emerging as a non-invasive method for precision irradiation of lung tumours. However, the ideal dose/fractionation schedule is not yet known. The primary purpose of this study is to assess safety and efficacy profile of single and multi-fraction SABR in the context of pulmonary oligometastases. The TROG 13.01/ALTG 13.001 clinical trial is a multicentre unblinded randomised phase II study. Eligible patients have up to three metastases to the lung from any non-haematological malignancy, each < 5 cm in size, non-central targets, and have all primary and extrathoracic disease controlled with local therapies. Patients are randomised 1:1 to a single fraction of 28Gy versus 48Gy in four fractions of SABR. The primary objective is to assess the safety of each treatment arm, with secondary objectives including assessment of quality of life, local efficacy, resource use and costs, overall and disease free survival and time to distant failure. Outcomes will be stratified by number of metastases and origin of the primary disease (colorectal versus non-colorectal primary). Planned substudies include an assessment of the impact of online e-Learning platforms for lung SABR and assessment of the effect of SABR fractionation on the immune responses. A total of 84 patients are required to complete the study. Fractionation schedules have not yet been investigated in a randomised fashion in the setting of oligometastatic disease. Assuming the likelihood of similar clinical efficacy in both arms, the present study design allows for exploration of the hypothesis that cost implications of managing potentially increased toxicities from single fraction SABR will be outweighed by costs associated with delivering multiple-fraction SABR

  9. Clinical evaluation of misonidazole combined with radiotherapy in the treatment of carcinoma of the esophagus. A double-blind randomized trial

    Energy Technology Data Exchange (ETDEWEB)

    Irie, Goro (Hokkaido Univ., Sapporo (Japan). School of Medicine); Sakurai, Tomoyasu; Kikuchi, Yuzo

    1984-10-01

    A double-blind trial of misonidazole in esophageal cancer was undertaken from January 1981 to October 1982 as collaborative effort of the department of radiology of 18 institutions. The purposes of this study were: (1) To establish whether misonidazole can increase the effect of radiation in the treatment of patients with inoperable esophageal cancer and (2) to assess the toxic effects of misonidazole. A total 119 patients were enrolled in this study and 104 (misonidazole group : 48 patients, control group : 56 patients) were determined as eligible for evaluation. The patients were randomly allocated into two groups receiving either misonidazole or placebo. The patients were irradiated with 2 Gy/fraction, 5 times a week to a total dose of 40--75 Gy (mostly 60 Gy). 0.5g/m/sup 2/ of misonidazole was given 4 hours before each radiotherapy up to 10g/m/sup 2/. The effect of the treatment was evaluated as a decrease in the volume of the tumors. Histological types of the tumors were squamous cell carcinoma except a case with adenocarcinoma. The distribution of patients according to the stage and tumor type on X-ray images was equivalent in both groups. 85.4% of the patients in the misonidazole group obtained a complete response (CR) or a partial response (PR) as compared to 83.9% in the control group. No difference was demonstrated in the tumor regression comparing the two groups. Four patients in the misonidazole group (8%) developed central or peripheral neuropathy. There have been no severe complications in any of the patients. This study has failed to demonstrate any advantage for the addition of misonidazole in the radiation therapy of esophageal cancer. Possible reasons for the failure to demonstrate any therapeutic gain from misonidazole were discussed.

  10. F-18-FDG-PET Confined Radiotherapy of Locally Advanced NSCLC With Concomitant Chemotherapy: Results of the PET-PLAN Pilot Trial

    Energy Technology Data Exchange (ETDEWEB)

    Fleckenstein, Jochen [Department of Radiotherapy and Radiation Oncology, Saarland University Medical School, Homburg (Germany); Hellwig, Dirk [Department of Nuclear Medicine, Saarland University Medical School, Homburg (Germany); Kremp, Stephanie [Department of Radiotherapy and Radiation Oncology, Saarland University Medical School, Homburg (Germany); Grgic, Aleksandar [Department of Nuclear Medicine, Saarland University Medical School, Homburg (Germany); Groeschel, Andreas [Department of Internal Medicine V, Saarland University Medical School, Homburg (Germany); Kirsch, Carl-Martin [Department of Nuclear Medicine, Saarland University Medical School, Homburg (Germany); Nestle, Ursula [Department of Nuclear Medicine, Saarland University Medical School, Homburg (Germany); Clinic for Radiotherapy, University Hospital, Freiburg (Germany); Ruebe, Christian, E-mail: christian.ruebe@uks.eu [Department of Radiotherapy and Radiation Oncology, Saarland University Medical School, Homburg (Germany)

    2011-11-15

    Purpose: The integration of fluoro-deoxy-D-glucose positron emission tomography (FDG-PET) in the process of radiotherapy (RT) planning of locally advanced non-small-cell lung cancer (NSCLC) may improve diagnostic accuracy and minimize interobserver variability compared with target volume definition solely based on computed tomography. Furthermore, irradiating only FDG-PET-positive findings and omitting elective nodal regions may allow dose escalation by treating smaller volumes. The aim of this prospective pilot trial was to evaluate the therapeutic safety of FDG-PET-based RT treatment planning with an autocontour-derived delineation of the primary tumor. Methods and Materials: Eligible patients had Stages II-III inoperable NSCLC, and simultaneous, platinum-based radiochemotherapy was indicated. FDG-PET and computed tomography acquisitions in RT treatment planning position were coregistered. The clinical target volume (CTV) included the FDG-PET-defined primary tumor, which was autodelineated with a source-to-background algorithm, plus FDG-PET-positive lymph node stations. Limited by dose restrictions for normal tissues, prescribed total doses were in the range of 66.6 to 73.8 Gy. The primary endpoint was the rate of out-of-field isolated nodal recurrences (INR). Results: As per intent to treat, 32 patients received radiochemotherapy. In 15 of these patients, dose escalation above 66.6 Gy was achieved. No Grade 4 toxicities occurred. After a median follow-up time of 27.2 months, the estimated median survival time was 19.3 months. During the observation period, one INR was observed in 23 evaluable patients. Conclusions: FDG-PET-confined target volume definition in radiochemotherapy of NSCLC, based on a contrast-oriented source-to-background algorithm, was associated with a low risk of INR. It might provide improved tumor control because of dose escalation.

  11. Tafazzin protein expression is associated with tumorigenesis and radiation response in rectal cancer: a study of Swedish clinical trial on preoperative radiotherapy.

    Directory of Open Access Journals (Sweden)

    Surajit Pathak

    Full Text Available Tafazzin (TAZ, a transmembrane protein contributes in mitochondrial structural and functional modifications through cardiolipin remodeling. TAZ mutations are associated with several diseases, but studies on the role of TAZ protein in carcinogenesis and radiotherapy (RT response is lacking. Therefore we investigated the TAZ expression in rectal cancer, and its correlation with RT, clinicopathological and biological variables in the patients participating in a clinical trial of preoperative RT.140 rectal cancer patients were included in this study, of which 65 received RT before surgery and the rest underwent surgery alone. TAZ expression was determined by immunohistochemistry in primary cancer, distant, adjacent normal mucosa and lymph node metastasis. In-silico protein-protein interaction analysis was performed to study the predictive functional interaction of TAZ with other oncoproteins.TAZ showed stronger expression in primary cancer and lymph node metastasis compared to distant or adjacent normal mucosa in both non-RT and RT patients. Strong TAZ expression was significantly higher in stages I-III and non-mucinious cancer of non-RT patients. In RT patients, strong TAZ expression in biopsy was related to distant recurrence, independent of gender, age, stages and grade (p = 0.043, HR, 6.160, 95% CI, 1.063-35.704. In silico protein-protein interaction study demonstrated that TAZ was positively related to oncoproteins, Livin, MAC30 and FXYD-3.Strong expression of TAZ protein seems to be related to rectal cancer development and RT response, it can be a predictive biomarker of distant recurrence in patients with preoperative RT.

  12. Prospective Preference Assessment of Patients' Willingness to Participate in a Randomized Controlled Trial of Intensity-Modulated Radiotherapy Versus Proton Therapy for Localized Prostate Cancer

    Energy Technology Data Exchange (ETDEWEB)

    Shah, Anand [Department of Radiation Oncology, University of Pennsylvania, Philadelphia, PA (United States); Efstathiou, Jason A.; Paly, Jonathan J. [Department of Radiation Oncology, Massachusetts General Hospital, Boston, MA (United States); Halpern, Scott D. [Department of Medicine, University of Pennsylvania, Philadelphia, PA (United States); Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, PA (United States); Center for Bioethics, University of Pennsylvania, Philadelphia, PA (United States); Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA (United States); Bruner, Deborah W. [Winship Cancer Institute, Emory University, Atlanta, GA (United States); Christodouleas, John P. [Department of Radiation Oncology, University of Pennsylvania, Philadelphia, PA (United States); Coen, John J. [Department of Radiation Oncology, Massachusetts General Hospital, Boston, MA (United States); Deville, Curtiland; Vapiwala, Neha [Department of Radiation Oncology, University of Pennsylvania, Philadelphia, PA (United States); Shipley, William U.; Zietman, Anthony L. [Department of Radiation Oncology, Massachusetts General Hospital, Boston, MA (United States); Hahn, Stephen M. [Department of Radiation Oncology, University of Pennsylvania, Philadelphia, PA (United States); Bekelman, Justin E., E-mail: bekelman@uphs.upenn.edu [Department of Radiation Oncology, University of Pennsylvania, Philadelphia, PA (United States); Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA (United States)

    2012-05-01

    Purpose: To investigate patients' willingness to participate (WTP) in a randomized controlled trial (RCT) comparing intensity-modulated radiotherapy (IMRT) with proton beam therapy (PBT) for prostate cancer (PCa). Methods and Materials: We undertook a qualitative research study in which we prospectively enrolled patients with clinically localized PCa. We used purposive sampling to ensure a diverse sample based on age, race, travel distance, and physician. Patients participated in a semi-structured interview in which they reviewed a description of a hypothetical RCT, were asked open-ended and focused follow-up questions regarding their motivations for and concerns about enrollment, and completed a questionnaire assessing characteristics such as demographics and prior knowledge of IMRT or PBT. Patients' stated WTP was assessed using a 6-point Likert scale. Results: Forty-six eligible patients (33 white, 13 black) were enrolled from the practices of eight physicians. We identified 21 factors that impacted patients' WTP, which largely centered on five major themes: altruism/desire to compare treatments, randomization, deference to physician opinion, financial incentives, and time demands/scheduling. Most patients (27 of 46, 59%) stated they would either 'definitely' or 'probably' participate. Seventeen percent (8 of 46) stated they would 'definitely not' or 'probably not' enroll, most of whom (6 of 8) preferred PBT before their physician visit. Conclusions: A substantial proportion of patients indicated high WTP in a RCT comparing IMRT and PBT for PCa.

  13. Improved plan quality with automated radiotherapy planning for whole brain with hippocampus sparing: a comparison to the RTOG 0933 trial.

    Science.gov (United States)

    Krayenbuehl, J; Di Martino, M; Guckenberger, M; Andratschke, N

    2017-10-02

    Whole-brain radiation therapy (WBRT) with hippocampus sparing (HS) has been investigated by the radiation oncology working group (RTOG) 0933 trial for patients with multiple brain metastases. They showed a decrease of adverse neurocognitive effects with HS WBRT compared to WBRT alone. With the development of automated treatment planning system (aTPS) in the last years, a standardization of the plan quality at a high level was achieved. The goal of this study was to evaluate the feasibility of using an aTPS for the treatment of HS WBRT and see if the RTOG 0933 dose constraints could be achieved and improved. Ten consecutive patients treated with HS WBRT were enrolled in this study. 10 × 3 Gy was prescribed according to the RTOG 0933 protocol to 92% of the target volume (whole-brain excluding the hippocampus expanded by 5 mm in 3-dimensions). In contrast to RTOG 0933, the maximum allowed point dose to normal brain was significantly lowered and restricted to 36.5 Gy. All patients were planned with volumetric modulated arc therapy (VMAT) technique using four arcs. Plans were optimized using Auto-Planning (AP) (Philips Radiation Oncology Systems) with one single AP template and optimization. All the constraints from the RTOG 0933 trial were achieved. A significant improvement for the maximal dose to 2% of the brain with a reduction of 4 Gy was achieved (33.5 Gy vs. RTOG 37.5 Gy) and the minimum hippocampus dose was reduced by 10% (8.1 Gy vs. RTOG 9 Gy). A steep dose gradient around the hippocampus was achieved with a mean dose of 27.3 Gy at a distance between 0.5 cm and 1 cm from the hippocampus. The effective working time to optimize a plan was kept below 6'. Automated treatment planning for HS WBRT was able to fulfil all the recommendations from the RTOG 0933 study while significantly improving dose homogeneity and decreasing unnecessary hot spot in the normal brain. With this approach, a standardization of plan quality was achieved and the effective

  14. Double blind randomized trial of sucralfate vs. placebo during a course of radical radiotherapy for head and neck squamous carcinoma

    International Nuclear Information System (INIS)

    Carter, D.L.; Hebert, M.E.; Leopold, K.L.; Brizel, D.M.

    1997-01-01

    Purpose: To determine if sucralfate prophylaxis during a course of high dose radiation therapy (RT) for head and neck cancer decreases acute side effects including mucositis and weight loss. Methods: Ninety-eight patients receiving curative intent RT for advanced head and neck cancers participated in a single institution double blind randomized trial comparing sucralfate to placebo. Patients were stratified according to fractionation (QD or BID), use of concurrent chemotherapy (yes or no), Karnofsky performance status (KPS 5 % or > 10 % occurred more frequently in patients receiving chemotherapy (p<0.01 and p=0.05 respectively). Grade 3 mucositis was more common in patients receiving BID fractionation (p=0.04) or having a poor KPS status (continuous variable: p=0.01). Pain uncontrolled by narcotics was more common in patients who drank alcohol during therapy (p<0.01). No subset appeared to benefit from the use of sucralfate. Conclusions: Prophylactic treatment with sucralfate during high dose head and neck RT does not decrease acute treatment side effects. Other modalities should be investigated

  15. Cardiac Toxicity After Radiotherapy for Stage III Non–Small-Cell Lung Cancer: Pooled Analysis of Dose-Escalation Trials Delivering 70 to 90 Gy

    Science.gov (United States)

    Eblan, Michael J.; Deal, Allison M.; Lipner, Matthew; Zagar, Timothy M.; Wang, Yue; Mavroidis, Panayiotis; Lee, Carrie B.; Jensen, Brian C.; Rosenman, Julian G.; Socinski, Mark A.; Stinchcombe, Thomas E.; Marks, Lawrence B.

    2017-01-01

    Purpose The significance of radiotherapy (RT) –associated cardiac injury for stage III non–small-cell lung cancer (NSCLC) is unclear, but higher heart doses were associated with worse overall survival in the Radiation Therapy Oncology Group (RTOG) 0617 study. We assessed the impact of heart dose in patients treated at our institution on several prospective dose-escalation trials. Patients and Methods From 1996 to 2009, 127 patients with stage III NSCLC (Eastern Cooperative Oncology Group performance status, 0 to 1) received dose-escalated RT to 70 to 90 Gy (median, 74 Gy) in six trials. RT plans and cardiac doses were reviewed. Records were reviewed for the primary end point: symptomatic cardiac events (symptomatic pericardial effusion, acute coronary syndrome, pericarditis, significant arrhythmia, and heart failure). Cardiac risk was assessed by noting baseline coronary artery disease and calculating the WHO/International Society of Hypertension score. Competing risks analysis was used. Results In all, 112 patients were analyzed. Median follow-up for surviving patients was 8.8 years. Twenty-six patients (23%) had one or more events at a median of 26 months to first event (effusion [n = 7], myocardial infarction [n = 5], unstable angina [n = 3], pericarditis [n = 2], arrhythmia [n = 12], and heart failure [n = 1]). Heart doses (eg, heart mean dose; hazard ratio, 1.03/Gy; P = .002,), coronary artery disease (P < .001), and WHO/International Society of Hypertension score (P = .04) were associated with events on univariable analysis. Heart doses remained significant on multivariable analysis that accounted for baseline risk. Two-year competing risk–adjusted event rates for patients with heart mean dose < 10 Gy, 10 to 20 Gy, or ≥ 20 Gy were 4%, 7%, and 21%, respectively. Heart doses were not associated with overall survival. Conclusion Cardiac events were relatively common after high-dose thoracic RT and were independently associated with both heart dose and

  16. Individualized FSH dosing based on ovarian reserve testing in women starting IVF/ICSI : A multicentre trial and cost-effectiveness analysis

    NARCIS (Netherlands)

    van Tilborg, Theodora C.; Oudshoorn, Simone C.; Eijkemans, Marinus J. C.; Mochtar, Monique H.; van Golde, Ron J. T.; Hoek, Annemieke; Kuchenbecker, Walter K. H.; Fleischer, Kathrin; de Bruin, Jan Peter; Groen, Henk; van Wely, Madelon; Lambalk, Cornelis B.; Laven, Joop S. E.; Mol, Ben Willem J.; Broekmans, Frank J. M.; Torrance, Helen L.

    2017-01-01

    STUDY QUESTION: Is there a difference in live birth rate and/or cost-effectiveness between antral follicle count (AFC)-based individualized FSH dosing or standard FSH dosing in women starting IVF or ICSI treatment? SUMMARY ANSWER: In women initiating IVF/ICSI, AFC-based individualized FSH dosing

  17. Individualized FSH dosing based on ovarian reserve testing in women starting IVF/ICSI: a multicentre trial and cost-effectiveness analysis

    NARCIS (Netherlands)

    van Tilborg, Theodora C.; Oudshoorn, Simone C.; Eijkemans, Marinus J. C.; Mochtar, Monique H.; van Golde, Ron J. T.; Hoek, Annemieke; Kuchenbecker, Walter K. H.; Fleischer, Kathrin; de Bruin, Jan Peter; Groen, Henk; van Wely, Madelon; Lambalk, Cornelis B.; Laven, Joop S. E.; Mol, Ben Willem J.; Broekmans, Frank J. M.; Torrance, Helen L.

    2017-01-01

    STUDY QUESTION: Is there a difference in live birth rate and/or cost-effectiveness between antral follicle count (AFC)-based individualized FSH dosing or standard FSH dosing in women starting IVF or ICSI treatment? SUMMARY ANSWER: In women initiating IVF/ICSI, AFC-based individualized FSH dosing

  18. Effects of Home and School Computer Use on School Readiness and Cognitive Development among Head Start Children: A Randomized Controlled Pilot Trial

    Science.gov (United States)

    Li, Xiaoming; Atkins, Melissa S.; Stanton, Bonita

    2006-01-01

    Data from 122 Head Start children were analyzed to examine the impact of computer use on school readiness and psychomotor skills. Children in the experimental group were given the opportunity to work on a computer for 15-20 minutes per day with their choice of developmentally appropriate educational software, while the control group received a…

  19. Locoregional post-mastectomy radiotherapy for breast cancer: literature review

    International Nuclear Information System (INIS)

    Noel, G.; Mazeron, J.J.

    2000-01-01

    Postoperative radiotherapy is controversial after radical mastectomy. Recent clinical trials have shown an increase in survival with this irradiation and conclusions of previous meta-analyses should be reconsidered and conclusions of previous meta-analyses should be reconsidered. The results of a large number of randomized clinical trials in which women received post-mastectomy radiotherapy or not have been renewed. These trials showed a decrease in locoregional failure with the use of postoperative radiotherapy but survival advantages have not been clearly identified. A large number of randomized clinical trials compared postoperative radiotherapy alone, chemotherapy alone and the association of the two treatments. They showed that chemotherapy was less active locally than radiotherapy and that radiotherapy and chemotherapy significantly increased both disease-free and overall survival rates in the groups which received postoperative radiotherapy. These favourable results were, however, obtained with optimal radiotherapy techniques and a relative sparing of lung tissue and cardiac muscle. Many retrospective clinical analyses concluded that results obtained in locoregional failure rate were poor and that these failures led to an increase in future risks. Both radiotherapy and systemic treatment should be delivered after mastectomy, reserved for patients with a high risk of with a diameter ≥ 5 cm. However, radiotherapy could produce secondary effects, and techniques of radiotherapy should be optimal. (author)

  20. Quality Assurance of 4D-CT Scan Techniques in Multicenter Phase III Trial of Surgery Versus Stereotactic Radiotherapy (Radiosurgery or Surgery for Operable Early Stage (Stage 1A) Non-Small-Cell Lung Cancer [ROSEL] Study)

    International Nuclear Information System (INIS)

    Hurkmans, Coen W.; Lieshout, Maarten van; Schuring, Danny; Heumen, Marielle J.T. van; Cuijpers, Johan P.; Lagerwaard, Frank J.; Widder, Joachim; Heide, Uulke A. van der; Senan, Suresh

    2011-01-01

    Purpose: To determine the accuracy of four-dimensional computed tomography (4D-CT) scanning techniques in institutions participating in a Phase III trial of surgery vs. stereotactic radiotherapy (SBRT) for lung cancer. Methods and Materials: All 9 centers performed a 4D-CT scan of a motion phantom (Quasar, Modus Medical Devices) in accordance with their in-house imaging protocol for SBRT. A cylindrical cedar wood insert with plastic spheres of 15 mm (o15) and 30 mm (o30) diameter was moved in a cosine-based pattern, with an extended period in the exhale position to mimic the actual breathing motion. A range of motion of R = 15 and R = 25 mm and breathing period of T = 3 and T = 6 s were used. Positional and volumetric imaging accuracy was analyzed using Pinnacle version 8.1x at various breathing phases, including the mid-ventilation phase and maximal intensity projections of the spheres. Results: Imaging using eight CT scanners (Philips, Siemens, GE) and one positron emission tomography-CT scanner (Institution 3, Siemens) was investigated. The imaging protocols varied widely among the institutions. No strong correlation was found between the specific scan protocol parameters and the observed results. Deviations in the maximal intensity projection volumes averaged 1.9% (starting phase of the breathing cycle [o]15, R = 15), 12.3% (o15, R = 25), and -0.9% (o30, R = 15). The end-expiration volume deviations (13.4%, o15 and 2.5%, o30), were, on average, smaller than the end-inspiration deviations (20.7%, o15 and 4.5%, o30), which, in turn, were smaller than the mid-ventilation deviations (32.6%, o15 and 8.0%, o30). A slightly larger variation in the mid-ventilation origin position was observed (mean, -0.2 mm; range, -3.6-4.2) than in the maximal intensity projection origin position (mean, -0.1 mm; range, -2.5-2.5). The range of motion was generally underestimated (mean, -1.5 mm; range, -5.5-1). Conclusions: Notable differences were seen in the 4D-CT imaging protocols

  1. Effects of a Brief Early Start Denver Model (ESDM)-Based Parent Intervention on Toddlers at Risk for Autism Spectrum Disorders: A Randomized Controlled Trial

    Science.gov (United States)

    Rogers, Sally J.; Estes, Annette; Lord, Catherine; Vismara, Laurie; Winter, Jamie; Fitzpatrick, Annette; Guo, Mengye; Dawson, Geraldine

    2012-01-01

    Objective: This study was carried out to examine the efficacy of a 12-week, low-intensity (1-hour/wk of therapist contact), parent-delivered intervention for toddlers at risk for autism spectrum disorders (ASD) aged 14 to 24 months and their families. Method: A randomized controlled trial involving 98 children and families was carried out in three…

  2. A Randomized Controlled Trial of the Social Tools and Rules for Teens (START) Program: An Immersive Socialization Intervention for Adolescents with Autism Spectrum Disorder

    Science.gov (United States)

    Vernon, Ty W.; Miller, Amber R.; Ko, Jordan A.; Barrett, Amy C.; McGarry, Elizabeth S.

    2018-01-01

    Adolescents with ASD face numerous personal and contextual barriers that impede the development of social motivation and core competencies, warranting the need for targeted intervention. A randomized controlled trial was conducted with 40 adolescents to evaluate the merits of a multi-component socialization intervention that places emphasis on…

  3. Adjuvant radiotherapy for stage I endometrial cancer.

    Science.gov (United States)

    Kong, A; Johnson, N; Cornes, P; Simera, I; Collingwood, M; Williams, C; Kitchener, H

    2007-04-18

    The role of adjuvant radiotherapy (both pelvic external beam radiotherapy and vaginal intracavity brachytherapy) in stage I endometrial cancer following total abdominal hysterectomy and bilateral salpingo-oophorectomy (TAH and BSO) remains unclear. To assess the efficacy of adjuvant radiotherapy following surgery for stage I endometrial cancer. The Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, CancerLit, Physician Data Query (PDQ) of National Cancer Institute. Handsearching was also carried out where appropriate. Randomised controlled trials (RCTs) which compared adjuvant radiotherapy versus no radiotherapy following surgery for patients with stage I endometrial cancer were included. Quality of the studies was assessed and data collected using a predefined data collection form. The primary endpoint was overall survival. Secondary endpoints were locoregional recurrence, distant recurrence and endometrial cancer death. Data on quality of life (QOL) and morbidity were also collected. A meta-analysis on included trials was performed using the Cochrane Collaboration Review Manager Software 4.2. The meta-analysis was performed on four trials (1770 patients). The addition of pelvic external beam radiotherapy to surgery reduced locoregional recurrence, a relative risk (RR) of 0.28 (95% confidence interval (CI) 0.17 to 0.44, p ASTEC; Lukka) are awaited. External beam radiotherapy carries a risk of toxicity and should be avoided in stage 1 endometrial cancer patients with no high risk factors.

  4. Adjuvant radiotherapy and 5-fluorouracil after curative resection of cancer of the pancreas and periampullary region: phase III trial of the EORTC gastrointestinal tract cancer cooperative group

    NARCIS (Netherlands)

    J.H.G. Klinkenbijl (Jean); J. Wils; J. Jeekel (Hans); T. Sahmoud; R. van Pel; M.L. Couvreur; C.H. Veenhof; J.P. Arnaud; D. González González (Dionisio); L.Th. de Wit (Laurens); A. Hennipman

    1999-01-01

    textabstractOBJECTIVE: The survival benefit of adjuvant radiotherapy and 5-fluorouracil versus observation alone after surgery was investigated in patients with pancreatic head and periampullary cancers. SUMMARY BACKGROUND DATA: A previous study of adjuvant

  5. Final report of a randomized trial on altered-fractionated radiotherapy in nasopharyngeal carcinoma prematurely terminated by significant increase in neurologic complications

    International Nuclear Information System (INIS)

    Teo, Peter Man Lung; Leung, Sing Fai; Chan, Anthony Tak Cheung; Leung, Thomas Wai Tong; Choi, Peter Ho Keung; Kwan, Wing Hong; Lee, Wai Yee; Chau, Ricky Ming Chun; Yu, Peter Kau Wing; Johnson, Philip James

    2000-01-01

    Purpose: The aim of the present study was to compare the survival, local control and complications of conventional/accelerated-hyperfractionated radiotherapy and conventional radiotherapy in nonmetastatic nasopharyngeal carcinoma (NPC). Methods and Materials: From February 1993 to October 1995, 159 patients with newly diagnosed nonmetastatic (M0) NPC with N0 or 4 cm or less N1 disease (Ho's N-stage classification, 1978) were randomized to receive either conventional radiotherapy (Arm I, n = 82) or conventional/accelerated-hyperfractionated radiotherapy (Arm II, n = 77). Stratification was according to the T stage. The biologic effective dose (10 Grays) to the primary and the upper cervical lymphatics were 75.0 and 73.1 for Arm I and 84.4 and 77.2 for Arm II, respectively. Results: With comparable distribution among the T stages between the two arms, the free from local failure rate at 5 years after radiotherapy was not significantly different between the two arms (85.3%; 95% confidence interval, 77.2-93.4% for Arm I; and 88.9%; 95% confidence interval, 81.7-96.2% for Arm II). The two arms were also comparable in overall survival, relapse-free survival, and rates of distant metastasis and regional relapse. Conventional/accelerated-hyperfractionated radiotherapy was associated with significantly increased radiation-induced damage to the central nervous system (including temporal lobe, cranial nerves, optic nerve/chiasma, and brainstem/spinal cord) in Arm II. Although insignificant, radiation-induced cranial nerve(s) palsy (typically involving VIII-XII), trismus, neck soft tissue fibrosis, and hypopituiturism and hypothyroidism occurred more often in Arm II. In addition, the complications occurred at significantly shorter intervals after radiotherapy in Arm II. Conclusion: Accelerated hyperfractionation when used in conjunction with a two-dimensional radiotherapy planning technique, in this case the Ho's technique, resulted in increased radiation damage to the central

  6. A randomized trial of a cognitive-behavioral therapy and hypnosis intervention on positive and negative affect during breast cancer radiotherapy

    OpenAIRE

    Schnur, Julie B.; David, Daniel; Kangas, Maria; Green, Sheryl; Bovbjerg, Dana H.; Montgomery, Guy H.

    2009-01-01

    Breast cancer radiotherapy can be an emotionally difficult experience. Despite this, few studies have examined the effectiveness of psychological interventions to reduce negative affect, and none to date have explicitly examined interventions to improve positive affect among breast cancer radiotherapy patients. The present study examined the effectiveness of a multimodal psychotherapeutic approach, combining cognitive-behavioral therapy and hypnosis (CBTH), to reduce negative affect and incre...

  7. Therapeutic efficacy of traditional Chinese medicine, Shen-Mai San, in cancer patients undergoing chemotherapy or radiotherapy: study protocol for a randomized, double-blind, placebo-controlled trial

    Directory of Open Access Journals (Sweden)

    Lo Lun-Chien

    2012-12-01

    Full Text Available Abstract Background Cancer is one of the major health issues worldwide. An increasing number of cancer patients are offered treatment with surgery, chemotherapy and radiotherapy. Traditional Chinese medicine (TCM is one of the most common complementary therapies offered to cancer patients in Taiwan. We designed a randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy of TCM in patients with cancer. Methods/design In this study, inclusion criteria are postoperative patients with histologically confirmed cancer within 3 years who are undergoing chemotherapy or radiotherapy, more than 18 years old, have given signed informed consent, have the ability to read Chinese, and the ability for oral intake. Exclusion criteria include being pregnant, breast feeding, having completed chemotherapy or radiotherapy, brain metastasis with Eastern Cooperative Oncology Group (ECOG performance status of two to four, delusion or hallucinations, acute infection, and have received medications under other clinical trials. The patients were separated into an intervention group (Shen-Mai-San, SMS and a placebo group for four weeks using a randomized, double-blind procedure. The European Organization for Research and Treatment of Cancer (EORTC Quality of Life questionnaire (QOL-C30 was used to evaluate the quality of life. General data, hemoglobin (Hb, hematocrit (Hct, glutamic-oxalacetic transaminase (GOT, glutamic-pyruvic transaminase (GPT, blood urea nitrogen (BUN, creatinine, carcinoembryonic antigen (CEA, TCM diagnosis data and heart rate variability (HRV were also recorded. These data were collected at baseline, two weeks and four weeks after receiving medication. The patients were prescribed granules which contained therapeutic medicines or placebo. Paired-T test was used for statistical analysis. Discussion Shen-Mai-San is composed of processed Ginseng radis, Liriope spicata, and Schizandrae fructus. It was found to be effective for

  8. Radiotherapy; Strahlentherapie

    Energy Technology Data Exchange (ETDEWEB)

    Wannenmacher, M. [Heidelberg Univ., Mannheim (Germany). Abt. fuer Klinische Radiologie; Debus, J. [Univ. Heidelberg (Germany). Abt. Radioonkologie und Strahlentherapie; Wenz, F. (eds.) [Universitaetsklinikum Mannheim (Germany). Klinik fuer Strahlentherapie und Radioonkologie

    2006-07-01

    The book is focussed on the actual knowledge on the clinical radiotherapy and radio-oncology. Besides fundamental and general contributions specific organ systems are treated in detail. The book contains the following contributions: Basic principles, radiobiological fundamentals, physical background, radiation pathology, basics and technique of brachytherapy, methodology and technique of the stereotactic radiosurgery, whole-body irradiation, operative radiotherapy, hadron therapy, hpyerthermia, combined radio-chemo-therapy, biometric clinical studies, intensity modulated radiotherapy, side effects, oncological diagnostics; central nervous system and sense organs, head-neck carcinomas, breast cancer, thorax organs, esophagus carcinoma, stomach carcinoma, pancreas carcinoma, heptabiliary cancer and liver metastases, rectal carcinomas, kidney and urinary tract, prostate carcinoma, testicular carcinoma, female pelvis, lymphatic system carcinomas, soft tissue carcinoma, skin cancer, bone metastases, pediatric tumors, nonmalignant diseases, emergency in radio-oncology, supporting therapy, palliative therapy.

  9. Combined modality treatment including intraoperative radiotherapy in locally advanced and recurrent rectal cancer

    International Nuclear Information System (INIS)

    Tveit, Kjell Maque; Wiig, Johan N.; Olsen, Dag Rune; Storaas, Andreas; Poulsen, Jan Peter; Giercksky, Karl-Erik

    1997-01-01

    Background: Treatment of locally advanced and recurrent rectal cancer usually has a high local recurrence rate and poor survival. Promising results have been reported by combined external radiotherapy, extensive surgery and intraoperative radiotherapy (IORT). Methods: One hundred fifteen patients with locally advanced rectal cancers fixed to the pelvic wall or locally recurrent rectal cancers underwent preoperative external radiotherapy with 46-50 Gy. Six to 8 weeks later radical pelvic surgery was attempted, and was combined with intraoperative electron beam radiotherapy (15-20 Gy) in 66 patients. The patients were followed closely to evaluate complication rate, local and distant recurrence rate and survival. Results: Surgery with no macroscopic tumour remaining was obtained in 65% of the patients with no postoperative deaths. Pelvic infection was the major complication (21%). Although the observation time is short (3-60 months), the local recurrence rate seems low (22%) and survival seems promising (about 60% at 4 years) in patients with complete tumour resection, in contrast to patients with residual tumour (none living at 4 years). Conclusions: The combined modality treatment with preoperative external radiotherapy and extensive pelvic surgery with IORT is sufficiently promising to start a randomized trial on the clinical value of IORT as a boost treatment in the multidisciplinary approach to this disease

  10. A randomized trial of a cognitive-behavioral therapy and hypnosis intervention on positive and negative affect during breast cancer radiotherapy.

    Science.gov (United States)

    Schnur, Julie B; David, Daniel; Kangas, Maria; Green, Sheryl; Bovbjerg, Dana H; Montgomery, Guy H

    2009-04-01

    Breast cancer radiotherapy can be an emotionally difficult experience. Despite this, few studies have examined the effectiveness of psychological interventions to reduce negative affect, and none to date have explicitly examined interventions to improve positive affect among breast cancer radiotherapy patients. The present study examined the effectiveness of a multimodal psychotherapeutic approach, combining cognitive-behavioral therapy and hypnosis (CBTH), to reduce negative affect and increase positive affect in 40 women undergoing breast cancer radiotherapy. Participants were randomly assigned to receive either CBTH or standard care. Participants completed weekly self-report measures of positive and negative affect. Repeated and univariate analyses of variance revealed that the CBTH approach reduced levels of negative affect [F(1, 38)=13.49; p=.0007, omega(2)=.56], and increased levels of positive affect [F(1, 38)=9.67; p=.0035, omega(2)=.48], during the course of radiotherapy. Additionally, relative to the control group, the CBTH group demonstrated significantly more intense positive affect [F(1, 38)=7.09; p=.0113, d=.71] and significantly less intense negative affect [F(1, 38)=10.30; p=.0027, d=.90] during radiotherapy. The CBTH group also had a significantly higher frequency of days where positive affect was greater than negative affect (85% of days assessed for the CBTH group versus 43% of the Control group) [F(1, 38)=18.16; p=.0001, d=1.16]. Therefore, the CBTH intervention has the potential to improve the affective experience of women undergoing breast cancer radiotherapy.

  11. Radiotherapy apparatus

    International Nuclear Information System (INIS)

    Leung, P.M.; Webb, H.P.J.

    1985-01-01

    This invention relates to apparatus for applying intracavitary radiotherapy. In previously-known systems radioactive material is conveyed to a desired location within a patient by transporting a chain of balls pneumatically to and from an appropriately inserted applicator. According to this invention a ball chain for such a purpose comprises several radioactive balls separated by non-radioactive tracer balls of radiographically transparent material of lower density and surface hardness than the radioactive balls. The invention also extends to radiotherapy treatment apparatus comprising a storage, sorting and assembly system

  12. Analysing data from patient-reported outcome and quality of life endpoints for cancer clinical trials: a start in setting international standards.

    Science.gov (United States)

    Bottomley, Andrew; Pe, Madeline; Sloan, Jeff; Basch, Ethan; Bonnetain, Franck; Calvert, Melanie; Campbell, Alicyn; Cleeland, Charles; Cocks, Kim; Collette, Laurence; Dueck, Amylou C; Devlin, Nancy; Flechtner, Hans-Henning; Gotay, Carolyn; Greimel, Eva; Griebsch, Ingolf; Groenvold, Mogens; Hamel, Jean-Francois; King, Madeleine; Kluetz, Paul G; Koller, Michael; Malone, Daniel C; Martinelli, Francesca; Mitchell, Sandra A; Moinpour, Carol M; Musoro, Jammbe; O'Connor, Daniel; Oliver, Kathy; Piault-Louis, Elisabeth; Piccart, Martine; Pimentel, Francisco L; Quinten, Chantal; Reijneveld, Jaap C; Schürmann, Christoph; Smith, Ashley Wilder; Soltys, Katherine M; Taphoorn, Martin J B; Velikova, Galina; Coens, Corneel

    2016-11-01

    Measures of health-related quality of life (HRQOL) and other patient-reported outcomes generate important data in cancer randomised trials to assist in assessing the risks and benefits of cancer therapies and fostering patient-centred cancer care. However, the various ways these measures are analysed and interpreted make it difficult to compare results across trials, and hinders the application of research findings to inform publications, product labelling, clinical guidelines, and health policy. To address these problems, the Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL) initiative has been established. This consortium, directed by the European Organisation for Research and Treatment of Cancer (EORTC), was convened to provide recommendations on how to standardise the analysis of HRQOL and other patient-reported outcomes data in cancer randomised trials. This Personal View discusses the reasons why this project was initiated, the rationale for the planned work, and the expected benefits to cancer research, patient and provider decision making, care delivery, and policy making. Copyright © 2016 Elsevier Ltd. All rights reserved.

  13. Postoperative stereotactic radiosurgery compared with whole brain radiotherapy for resected metastatic brain disease (NCCTG N107C/CEC·3): a multicentre, randomised, controlled, phase 3 trial.

    Science.gov (United States)

    Brown, Paul D; Ballman, Karla V; Cerhan, Jane H; Anderson, S Keith; Carrero, Xiomara W; Whitton, Anthony C; Greenspoon, Jeffrey; Parney, Ian F; Laack, Nadia N I; Ashman, Jonathan B; Bahary, Jean-Paul; Hadjipanayis, Costas G; Urbanic, James J; Barker, Fred G; Farace, Elana; Khuntia, Deepak; Giannini, Caterina; Buckner, Jan C; Galanis, Evanthia; Roberge, David

    2017-08-01

    Whole brain radiotherapy (WBRT) is the standard of care to improve intracranial control following resection of brain metastasis. However, stereotactic radiosurgery (SRS) to the surgical cavity is widely used in an attempt to reduce cognitive toxicity, despite the absence of high-level comparative data substantiating efficacy in the postoperative setting. We aimed to establish the effect of SRS on survival and cognitive outcomes compared with WBRT in patients with resected brain metastasis. In this randomised, controlled, phase 3 trial, adult patients (aged 18 years or older) from 48 institutions in the USA and Canada with one resected brain metastasis and a resection cavity less than 5·0 cm in maximal extent were randomly assigned (1:1) to either postoperative SRS (12-20 Gy single fraction with dose determined by surgical cavity volume) or WBRT (30 Gy in ten daily fractions or 37·5 Gy in 15 daily fractions of 2·5 Gy; fractionation schedule predetermined for all patients at treating centre). We randomised patients using a dynamic allocation strategy with stratification factors of age, duration of extracranial disease control, number of brain metastases, histology, maximal resection cavity diameter, and treatment centre. Patients and investigators were not masked to treatment allocation. The co-primary endpoints were cognitive-deterioration-free survival and overall survival, and analyses were done by intention to treat. We report the final analysis. This trial is registered with ClinicalTrials.gov, number NCT01372774. Between Nov 10, 2011, and Nov 16, 2015, 194 patients were enrolled and randomly assigned to SRS (98 patients) or WBRT (96 patients). Median follow-up was 11·1 months (IQR 5·1-18·0). Cognitive-deterioration-free survival was longer in patients assigned to SRS (median 3·7 months [95% CI 3·45-5·06], 93 events) than in patients assigned to WBRT (median 3·0 months [2·86-3·25], 93 events; hazard ratio [HR] 0·47 [95% CI 0·35-0·63]; p<0·0001

  14. Start or STop Anticoagulants Randomised Trial (SoSTART)

    Science.gov (United States)

    2018-05-02

    Intracranial Hemorrhages; Intracranial Hemorrhage, Hypertensive; Subarachnoid Hemorrhage; Subdural Hematoma; Intraventricular Hemorrhage; Atrial Fibrillation; Atrial Flutter; Small Vessel Cerebrovascular Disease; Microhaemorrhage

  15. Screening for depression in cancer patients receiving radiotherapy: Feasibility and identification of effective tools in the NRG Oncology RTOG 0841 trial.

    Science.gov (United States)

    Wagner, Lynne I; Pugh, Stephanie L; Small, William; Kirshner, Jeffrey; Sidhu, Kulbir; Bury, Martin J; DeNittis, Albert S; Alpert, Tracy E; Tran, Binh; Bloom, Beatrice F; Mai, Julie; Yeh, Alexander; Sarma, Kalika; Becker, Mark; James, Jennifer; Bruner, Deborah Watkins

    2017-02-01

    Brief tools are needed to screen oncology outpatients for depressive symptoms. Patients starting radiotherapy for the first diagnosis of any tumor completed distress screening tools, including the 9-item Patient Health Questionnaire (PHQ-9), the 2-item Patient Health Questionnaire (PHQ-2), the National Comprehensive Cancer Network Distress Thermometer (NCCN-DT), and the Hopkins Symptom Checklist (HSCL) (25-item version). Patients exceeding validated cutoff scores and a systematic sample of patients whose screening was negative completed the Structured Clinical Interview for DSM-IV (SCID) mood disorder modules via telephone. Four hundred sixty-three patients from 35 community-based radiation oncology sites and 2 academic radiation oncology sites were recruited. Sixty-six percent of the 455 eligible patients (n = 299) were women, and the eligible patients had breast (45%), gastrointestinal (11%), lung (10%), gynecologic (6%), or other cancers (27%). Seventy-five (16.5%) exceeded screening cutoffs for depressive symptoms. Forty-two of these patients completed the SCID. Another 37 patients whose screening was negative completed the SCID. Among the 79 patients completing the SCID, 8 (10.1%) met the criteria for major depression, 2 (2.5%) met the criteria for dysthymia, and 6 (7.6%) met the criteria for an adjustment disorder. The PHQ-2 demonstrated good psychometric properties for screening for mood disorders with a cutoff score of ≥3 (receiver operating characteristic area under the curve [AUC], 0.83) and was comparable to the PHQ-9 ( > 9; AUC = 0.85). The NCCN-DT did not detect depression (AUC = 0.59). The PHQ-2 demonstrated good psychometric properties for screening for mood disorders, which were equivalent to the PHQ-9 and superior to the NCCN-DT. These findings support using the PHQ-2 to identify patients in need of further assessment for depression, which has a low prevalence but is a clinically significant comorbidity. These findings could

  16. Effects of Parent-Implemented Early Start Denver Model Intervention on Chinese Toddlers with Autism Spectrum Disorder: A Non-Randomized Controlled Trial

    OpenAIRE

    Zhou, B; Xu, Q; Li, H; Zhang, Y; Wang, Y; Rogers, SJ; Xu, X

    2018-01-01

    © 2017 International Society for Autism Research, Wiley Periodicals, Inc. To evaluate the effects of a 26-week, high-intensity, parent-implemented Early Start Denver Model (P-ESDM) intervention on developmental outcomes, severity of autism spectrum disorder (ASD), and parental stress of ASD toddlers in China. Subjects in P-ESDM group (n = 23) were recruited from 1.5- to 2.5-year-old toddlers who were screened positive in Xuhui and Minhang Districts and were diagnosed with ASD. A community (co...

  17. Individualized FSH dosing based on ovarian reserve testing in women starting IVF/ICSI: a multicentre trial and cost-effectiveness analysis

    OpenAIRE

    van Tilborg, Theodora C.; Oudshoorn, Simone C.; Eijkemans, Marinus J. C.; Mochtar, Monique H.; van Golde, Ron J. T.; Hoek, Annemieke; Kuchenbecker, Walter K. H.; Fleischer, Kathrin; de Bruin, Jan Peter; Groen, Henk; van Wely, Madelon; Lambalk, Cornelis B.; Laven, Joop S. E.; Mol, Ben Willem J.; Broekmans, Frank J. M.

    2017-01-01

    STUDY QUESTION: Is there a difference in live birth rate and/or cost-effectiveness between antral follicle count (AFC)-based individualized FSH dosing or standard FSH dosing in women starting IVF or ICSI treatment? SUMMARY ANSWER: In women initiating IVF/ICSI, AFC-based individualized FSH dosing does not improve live birth rates or reduce costs as compared to a standard FSH dose. WHAT IS KNOWN ALREADY: In IVF or ICSI, ovarian reserve testing is often used to adjust the FSH dose in order to no...

  18. Exploring Radiotherapy Targeting Strategy and Dose: A Pooled Analysis of Cooperative Group Trials of Combined Modality Therapy for Stage III Non-Small Cell Lung Cancer.

    Science.gov (United States)

    Schild, Steven E; Fan, Wen; Stinchcombe, Thomas E; Vokes, Everett E; Ramalingam, Suresh S; Bradley, Jeffrey D; Kelly, Karen; Pang, Herbert H; Wang, Xiaofei

    2018-04-21

    Concurrent chemoradiotherapy(CRT) is standard therapy for locally-advanced non-small-cell lung cancer(LA-NSCLC)patients. This study was performed to examine thoracic radiotherapy(TRT) parameters and their impact on patient survival. We collected Individual patient data(IPD) from 3600LA-NSCLC patients participating in 16 cooperative group trials of concurrent CRT. The primary TRT parameters examined included field design strategy(elective nodal irradiation(ENI) compared to involved field TRT(IF-TRT)), total dose, and biologically effective dose(BED). Hazard ratios(HRs) for overall survival were calculated with univariable and multivariable Cox models. TRT doses ranged from 60 to 74 Gy with most treatments administered once-daily. ENI was associated with poorer survival than IF-TRT(univariable HR,1.37;95%CI,1.24-1.51,pENI patients were 24 and 16 months, respectively. Patients were divided into 3 dose groups: low total dose(60 Gy), medium total dose(>60Gy-66Gy) and high total dose(>66Gy-74 Gy). With reference to the low dose group, the multivariable HR's were 1.08 for the medium dose group(95%CI=0.93-1.25) and 1.12 for the high dose group(CI=0.97-1.30).The univariate p=0.054 and multivariable p=0.17. BED was grouped as follows: low(55.5 Gy 10 ). With reference to the low BED group, the HR was 1.00(95%CI=0.85-1.18) for the medium BED group and 1.10(95%CI=0.93-1.31) for the high BED group. The univariable p=0.076 and multivariable p=0.16. For LA-NSCLC patients treated with concurrent CRT, IF-TRT was associated with significantly better survival than ENI-TRT. TRT total and BED dose levels were not significantly associated with patient survival. Future progress will require research focusing on better systemic therapy and TRT. Copyright © 2018. Published by Elsevier Inc.

  19. 20 Gy Versus 44 Gy of Supplemental External Beam Radiotherapy With Palladium-103 for Patients With Greater Risk Disease: Results of a Prospective Randomized Trial

    International Nuclear Information System (INIS)

    Merrick, Gregory S.; Wallner, Kent E.; Butler, Wayne M.; Galbreath, Robert W.; Taira, Al V.; Orio, Peter; Adamovich, Edward

    2012-01-01

    Purpose: The necessity of external beam radiotherapy (EBRT) as a supplement to prostate brachytherapy remains unknown. We report brachytherapy outcomes for patients with higher risk features randomized to substantially different supplemental EBRT regimens. Methods and Materials: Between December 1999 and June 2004, 247 patients were randomized to 20 Gy vs. 44 Gy EBRT followed by a palladium-103 boost (115 Gy vs. 90 Gy). The eligibility criteria included clinically organ-confined disease with Gleason score 7–10 and/or pretreatment prostate-specific antigen (PSA) level 10–20 ng/mL. The median follow-up period was 9.0 years. Biochemical progression-free survival (bPFS) was defined as a PSA level of ≤0.40 ng/mL after nadir. The median day 0 prescribed dose covering 90% of the target volume was 125.7%; 80 men received androgen deprivation therapy (median, 4 months). Multiple parameters were evaluated for their effect on bPFS. Results: For the entire cohort, the cause-specific survival, bPFS, and overall survival rates were 97.7%, 93.2%, and 80.8% at 8 years and 96.9%, 93.2%, and 75.4% at 10 years, respectively. The bPFS rate was 93.1% and 93.4% for the 20-Gy and 44-Gy arms, respectively (p = .994). However, no statistically significant differences were found in cause-specific survival or overall survival were identified. When stratified by PSA level of ≤10 ng/mL vs. >10 ng/mL, Gleason score, or androgen deprivation therapy, no statistically significant differences in bPFS were discerned between the two EBRT regimens. On multivariate analysis, bPFS was most closely related to the preimplant PSA and clinical stage. For patients with biochemically controlled disease, the median PSA level was <0.02 ng/mL. Conclusion: The results of the present trial strongly suggest that two markedly different supplemental EBRT regimens result in equivalent cause-specific survival, bPFS, and overall survival. It is probable that the lack of benefit for a higher supplemental EBRT

  20. The effectiveness of the Screening Inventory of Psychosocial Problems (SIPP) in cancer patients treated with radiotherapy: design of a cluster randomised controlled trial

    International Nuclear Information System (INIS)

    Braeken, Anna PBM; Lechner, Lilian; Gils, Francis CJM van; Houben, Ruud MA; Eekers, Daniëlle; Ambergen, Ton; Kempen, Gertrudis IJM

    2009-01-01

    The Screening Inventory of Psychosocial Problems (SIPP) is a short, validated self-reported questionnaire to identify psychosocial problems in Dutch cancer patients. The one-page 24-item questionnaire assesses physical complaints, psychological complaints and social and sexual problems. Very little is known about the effects of using the SIPP in consultation settings. Our study aims are to test the hypotheses that using the SIPP (a) may contribute to adequate referral to relevant psychosocial caregivers, (b) should facilitate communication between radiotherapists and cancer patients about psychosocial distress and (c) may prevent underdiagnosis of early symptoms reflecting psychosocial problems. This paper presents the design of a cluster randomised controlled trial (CRCT) evaluating the effectiveness of using the SIPP in cancer patients treated with radiotherapy. A CRCT is developed using a Solomon four-group design (two intervention and two control groups) to evaluate the effects of using the SIPP. Radiotherapists, instead of cancer patients, are randomly allocated to the experimental or control groups. Within these groups, all included cancer patients are randomised into two subgroups: with and without pre-measurement. Self-reported assessments are conducted at four times: a pre-test at baseline before the first consultation and a post-test directly following the first consultation, and three and 12 months after baseline measurement. The primary outcome measures are the number and types of referrals of cancer patients with psychosocial problems to relevant (psychosocial) caregivers. The secondary outcome measures are patients' satisfaction with the radiotherapist-patient communication, psychosocial distress and quality of life. Furthermore, a process evaluation will be carried out. Data of the effect-evaluation will be analysed according to the intention-to-treat principle and data regarding the types of referrals to health care providers and patient

  1. GETTING READY: RESULTS OF A RANDOMIZED TRIAL OF A RELATIONSHIP-FOCUSED INTERVENTION ON THE PARENT–INFANT RELATIONSHIP IN RURAL EARLY HEAD START

    Science.gov (United States)

    KNOCHE, LISA L.; SHERIDAN, SUSAN M.; CLARKE, BRANDY L.; EDWARDS, CAROLYN POPE; MARVIN, CHRISTINE A.; CLINE, KEELY D.; KUPZYK, KEVIN A.

    2014-01-01

    The purpose of this study is to investigate the effects of a relational intervention (the Getting Ready intervention) on parenting behaviors supporting the parent–infant relationship for families enrolled in Early Head Start home-based programming. Two-hundred thirty-four parents and their children participated in the randomized study, with 42% of parents reporting education of less than a high-school diploma. Brief, semistructured parent–child interaction tasks were videotaped every 4 months over a16-month intervention period. Observational codes of parent–infant relationship behaviors included quality of three parental behaviors: warmth and sensitivity, support for learning, and encouragement of autonomy; two appropriateness indicators: support for learning and guidance/directives; and one amount indicator: constructive behaviors. Parents who participated in the Getting Ready intervention demonstrated higher quality interactions with their children that included enhanced quality of warmth and sensitivity, and support for their children’s autonomy than did parents in the control group. They also were more likely to use appropriate directives with their children and more likely to demonstrate appropriate supports for their young children’s learning. Results indicate an added value of the Getting Ready intervention for Early Head Start home-based programming for families of infants and toddlers. PMID:24644374

  2. Effects of pharmacists' interventions on appropriateness of prescribing and evaluation of the instruments' (MAI, STOPP and STARTs' ability to predict hospitalization--analyses from a randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Ulrika Gillespie

    Full Text Available Appropriateness of prescribing can be assessed by various measures and screening instruments. The aims of this study were to investigate the effects of pharmacists' interventions on appropriateness of prescribing in elderly patients, and to explore the relationship between these results and hospital care utilization during a 12-month follow-up period.The study population from a previous randomized controlled study, in which the effects of a comprehensive pharmacist intervention on re-hospitalization was investigated, was used. The criteria from the instruments MAI, STOPP and START were applied retrospectively to the 368 study patients (intervention group (I n = 182, control group (C n = 186. The assessments were done on admission and at discharge to detect differences over time and between the groups. Hospital care consumption was recorded and the association between scores for appropriateness, and hospitalization was analysed.The number of Potentially Inappropriate Medicines (PIMs per patient as identified by STOPP was reduced for I but not for C (1.42 to 0.93 vs. 1.46 to 1.66 respectively, p<0.01. The number of Potential Prescription Omissions (PPOs per patient as identified by START was reduced for I but not for C (0.36 to 0.09 vs. 0.42 to 0.45 respectively, p<0.001. The summated score for MAI was reduced for I but not for C (8.5 to 5.0 and 8.7 to 10.0 respectively, p<0.001. There was a positive association between scores for MAI and STOPP and drug-related readmissions (RR 8-9% and 30-34% respectively. No association was detected between the scores of the tools and total re-visits to hospital.The interventions significantly improved the appropriateness of prescribing for patients in the intervention group as evaluated by the instruments MAI, STOPP and START. High scores in MAI and STOPP were associated with a higher number of drug-related readmissions.

  3. Phase I trial of split-dose induction docetaxel, cisplatin, and 5-fluorouracil (TPF chemotherapy followed by curative surgery combined with postoperative radiotherapy in patients with locally advanced oral and oropharyngeal squamous cell cancer (TISOC-1

    Directory of Open Access Journals (Sweden)

    Oertel Katrin

    2012-10-01

    Full Text Available Abstract Background Induction chemotherapy (ICT with docetaxel, cisplatin and fluorouracil (TPF followed by radiotherapy is an effective treatment option for unresectable locally advanced head and neck cancer. This phase I study was designed to investigate the safety and tolerability of a split-dose TPF ICT regimen prior to surgery for locally advanced resectable oral and oropharyngeal cancer. Methods Patients received TPF split on two dosages on day 1 and 8 per cycle for one or three 3-week cycles prior to surgery and postoperative radiotherapy or radiochemotherapy. Docetaxel was escalated in two dose levels, 40 mg/m2 (DL 0 and 30 mg/m2 (DL −1, plus 40 mg/m2 cisplatin and 2000 mg/m2 fluorouracil per week using a 3 +3 dose escalation algorithm. Results Eighteen patients were enrolled and were eligible for toxicity and response. A maximum tolerated dose of 30 mg/m2 docetaxel per week was reached. The most common grade 3+ adverse event was neutropenia during ICT in 10 patients. Surgery reached R0 resection in all cases. Nine patients (50% showed complete pathologic regression. Conclusions A split-dose regime of TPF prior to surgery is feasible, tolerated and merits additional investigation in a phase II study with a dose of 30 mg/m docetaxel per week. Trial registration number NCT01108042 (ClinicalTrials.gov Identifier

  4. Effects of the Healthy Start randomized intervention trial on physical activity among normal weight preschool children predisposed to overweight and obesity

    DEFF Research Database (Denmark)

    Händel, Mina Nicole; Larsen, Sofus Christian; Rohde, Jeanett Friis

    2017-01-01

    was to evaluate the effect on PA outcomes of the 15 month Healthy Start intervention that focused on changing diet, PA, sleep and stress management among normal weight but obesity-prone preschool children. Children were defined as obesity-prone if they had a birth weight > 4,000 g, mothers with a pre...... was obtained from a 7 days recording in the Children’s Physical Activity Questionnaire. Time used for sport activities were combined with outdoor playing time to achieve a proxy of total PA level of moderate to vigorous intensity. Results: Linear regression analyses revealed that at follow-up the intervention...... group spent more time on sports and outdoor activities combined per week than the control group (ITT analyses: intervention: 400 min/week; 95% confidence interval (CI): 341, 459 versus control: 321 min/week; 95% CI: 277, 366; p = 0.02), although no significant intervention effects were seen for each...

  5. Randomized controlled trial on effectiveness of ultrasonography screening for breast cancer in women aged 40-49 (J-START). Research design

    International Nuclear Information System (INIS)

    Ohuchi, Noriaki; Ishida, Takanori; Kawai, Masaaki; Narikawa, Yoko; Yamamoto, Seiichiro; Sobue, Tomotaka

    2011-01-01

    In cancer screening, it is essential to undertake effective screening with appropriate methodology, which should be supported by evidence of a reduced mortality rate. At present, mammography is the only method for breast cancer screening with such evidence. However, mammography does not achieve sufficient accuracy in breasts with high density at ages below 50. Although ultrasonography achieves better accuracy in Breast Cancer detection even in dense breasts, the effectiveness has not been verified. We have planned a randomized controlled trial to assess the effectiveness of ultrasonography in women aged 40-49, with a design to study 50,000 women with mammography and ultrasonography (intervention group), and 50,000 controls with mammography only (control group). The participants are scheduled to take second round screening with the same modality 2 years on. The primary endpoints are sensitivity and specificity, and the secondary endpoint is the rate of advanced breast cancers. (author)

  6. Randomized controlled trial of a cognitive-behavioral therapy plus hypnosis intervention to control fatigue in patients undergoing radiotherapy for breast cancer.

    Science.gov (United States)

    Montgomery, Guy H; David, Daniel; Kangas, Maria; Green, Sheryl; Sucala, Madalina; Bovbjerg, Dana H; Hallquist, Michael N; Schnur, Julie B

    2014-02-20

    The objective of this study was to test the efficacy of cognitive-behavioral therapy plus hypnosis (CBTH) to control fatigue in patients with breast cancer undergoing radiotherapy. We hypothesized that patients in the CBTH group receiving radiotherapy would have lower levels of fatigue than patients in an attention control group. Patients (n = 200) were randomly assigned to either the CBTH (n = 100; mean age, 55.59 years) or attention control (n = 100; mean age, 55.97 years) group. Fatigue was measured at four time points (baseline, end of radiotherapy, 4 weeks, and 6 months after radiotherapy). Fatigue was measured using the Functional Assessment of Chronic Illness Therapy (FACIT) -Fatigue subscale and Visual Analog Scales (VASs; Fatigue and Muscle Weakness). The CBTH group had significantly lower levels of fatigue (FACIT) at the end of radiotherapy (z, 6.73; P < .001), 4-week follow-up (z, 6.98; P < .001), and 6-month follow-up (z, 7.99; P < .001) assessments. Fatigue VAS scores were significantly lower in the CBTH group at the end of treatment (z, 5.81; P < .001) and at the 6-month follow-up (z, 4.56; P < .001), but not at the 4-week follow-up (P < .07). Muscle Weakness VAS scores were significantly lower in the CBTH group at the end of treatment (z, 9.30; P < .001) and at the 6-month follow-up (z, 3.10; P < .02), but not at the 4-week follow-up (P < .13). The results support CBTH as an evidence-based intervention to control fatigue in patients undergoing radiotherapy for breast cancer. CBTH is noninvasive, has no adverse effects, and its beneficial effects persist long after the last intervention session. CBTH seems to be a candidate for future dissemination and implementation.

  7. Intrinsic subtypes and benefit from postmastectomy radiotherapy in node-positive premenopausal breast cancer patients who received adjuvant chemotherapy - results from two independent randomized trials

    DEFF Research Database (Denmark)

    Laurberg, Tinne; Tramm, Trine; Nielsen, Torsten

    2018-01-01

    BACKGROUND: The study of the intrinsic molecular subtypes of breast cancer has revealed differences among them in terms of prognosis and response to chemotherapy and endocrine therapy. However, the ability of intrinsic subtypes to predict benefit from adjuvant radiotherapy has only been examined...... randomized to adjuvant radiotherapy or not. All patients received adjuvant chemotherapy and a subgroup of patients underwent ovarian ablation. Tumors were classified into intrinsic subtypes: Luminal A, Luminal B, HER2-enriched, Basal-like and Normal-like using the research-based PAM50 classifier. RESULTS...

  8. Sequencing of chemotherapy (CT) and radiotherapy (RT) following conservative surgery (CS) for patients with early-stage breast cancer: results of a randomized trial

    Energy Technology Data Exchange (ETDEWEB)

    Recht, A; Come, SE; Silver, B; Gelman, RS; Hayes, DF; Shulman, LN; Henderson, IC; Harris, JR

    1995-07-01

    Purpose: To determine the effects of different sequences of CT and RT following CS for pts with clinical Stage I or II breast carcinoma. Methods and Materials: From 6/84-12/92, 244 pts were randomized following CS to receive CT (4 cycles of CAMFP at 3-wk intervals) either before or after RT. Median pt age was 45 yrs (range, 20-68). 164 pts were pre-, 18 pts peri-, and 62 pts were postmenopausal. 209 pts were node-positive (61 had 4 or more positive nodes); after 6/88, 35 selected node-negative pts were also included. 45 Gy was prescribed to the entire breast, followed by a boost of 16 Gy; nodal RT was optional. The medians ( and ranges) of the surgery-radiotherapy interval (SRI) according to assigned arm were: RT-first, 36 days (14-234); CT-first, 126 days (98-185). Drug doses were based on ideal body weight. Doses (per square meter) and schedule were: methotrexate, 200 mg, d.1 and 15; leucovorin, 10 mg, q6H x 12, start d.2 and 16; 5-fluorouracil, 500 mg, d.1; cyclophosphamide, 500 mg, d.1; prednisone, 40 mg/day x 5d, start d.1; and doxorubicin, 45 mg, d.3. All except leucovorin and prednisone were given by IV bolus. Dose reductions were based on the granulocyte nadir from the previous cycle, with an attempt to reescalate doses in subsequent cycles. Tamoxifen 10 mg BID was prescribed to postmenopausal pts with ER+ tumors following both RT and CT. 4 pts were ineligible due to prior malignancies, 2 pts on the RT-first arm refused their assigned sequence and received CT first, 2 pts on the RT-first arm and 1 pt on the CT-first arm refused to start or complete CT, 1 pt on the CT-arm underwent elective mastectomy prior to starting RT, and 1 pt on each arm received nonprotocol CT. Possible prognostic factors including age, menopausal status, ERP status, nodal status, and lymphatic vessel invasion were distributed nearly uniformly between the 2 arms. There was an excess of pts with EIC-positive tumors on the RT-first arm (25%) compared to the CT-first arm (11%) (p-bar=0

  9. Sequencing of chemotherapy (CT) and radiotherapy (RT) following conservative surgery (CS) for patients with early-stage breast cancer: results of a randomized trial

    International Nuclear Information System (INIS)

    Recht, A; Come, SE; Silver, B; Gelman, RS; Hayes, DF; Shulman, LN; Henderson, IC; Harris, JR

    1995-01-01

    Purpose: To determine the effects of different sequences of CT and RT following CS for pts with clinical Stage I or II breast carcinoma. Methods and Materials: From 6/84-12/92, 244 pts were randomized following CS to receive CT (4 cycles of CAMFP at 3-wk intervals) either before or after RT. Median pt age was 45 yrs (range, 20-68). 164 pts were pre-, 18 pts peri-, and 62 pts were postmenopausal. 209 pts were node-positive (61 had 4 or more positive nodes); after 6/88, 35 selected node-negative pts were also included. 45 Gy was prescribed to the entire breast, followed by a boost of 16 Gy; nodal RT was optional. The medians ( and ranges) of the surgery-radiotherapy interval (SRI) according to assigned arm were: RT-first, 36 days (14-234); CT-first, 126 days (98-185). Drug doses were based on ideal body weight. Doses (per square meter) and schedule were: methotrexate, 200 mg, d.1 and 15; leucovorin, 10 mg, q6H x 12, start d.2 and 16; 5-fluorouracil, 500 mg, d.1; cyclophosphamide, 500 mg, d.1; prednisone, 40 mg/day x 5d, start d.1; and doxorubicin, 45 mg, d.3. All except leucovorin and prednisone were given by IV bolus. Dose reductions were based on the granulocyte nadir from the previous cycle, with an attempt to reescalate doses in subsequent cycles. Tamoxifen 10 mg BID was prescribed to postmenopausal pts with ER+ tumors following both RT and CT. 4 pts were ineligible due to prior malignancies, 2 pts on the RT-first arm refused their assigned sequence and received CT first, 2 pts on the RT-first arm and 1 pt on the CT-first arm refused to start or complete CT, 1 pt on the CT-arm underwent elective mastectomy prior to starting RT, and 1 pt on each arm received nonprotocol CT. Possible prognostic factors including age, menopausal status, ERP status, nodal status, and lymphatic vessel invasion were distributed nearly uniformly between the 2 arms. There was an excess of pts with EIC-positive tumors on the RT-first arm (25%) compared to the CT-first arm (11%) (p-bar=0

  10. Effects of Parent-Implemented Early Start Denver Model Intervention on Chinese Toddlers with Autism Spectrum Disorder: A Non-Randomized Controlled Trial.

    Science.gov (United States)

    Zhou, Bingrui; Xu, Qiong; Li, Huiping; Zhang, Ying; Wang, Yi; Rogers, Sally J; Xu, Xiu

    2018-04-01

    To evaluate the effects of a 26-week, high-intensity, parent-implemented Early Start Denver Model (P-ESDM) intervention on developmental outcomes, severity of autism spectrum disorder (ASD), and parental stress of ASD toddlers in China. Subjects in P-ESDM group (n = 23) were recruited from 1.5- to 2.5-year-old toddlers who were screened positive in Xuhui and Minhang Districts and were diagnosed with ASD. A community (comparison) group of age-matched toddlers with ASD (n = 20) was recruited from other areas. Subjects of the P-ESDM group attended 1.5-hr parent coaching per week for 26 weeks, and those in the community group received interventions available from communities. Assessments were conducted at baseline (T1) and 26 weeks later (T2). After adjusting for baseline differences between the two groups, P-ESDM group demonstrated greater improvement than the community group in general development, especially in Language domain. Neither group demonstrated significant change in ASD severity, but the P-ESDM group showed greater improvement in social affect, parent-reported social communication and symbolic play than community group did. Finally, parents in P-ESDM group experienced decreased parenting stress while those in community group showed an opposite trend, though the differences did not reach significant association with the P-ESDM intervention. Chinese toddlers with ASD receiving 26 weeks of P-ESDM via regular coaching sessions showed significant greater improvement than those receiving community interventions in multiple aspects of development including social communications. These findings add support to the importance of providing early screening, diagnosis, and immediate referral for evidence-based interventions to improve outcome of young children with ASD. Autism Res 2018, 11: 654-666. © 2017 International Society for Autism Research, Wiley Periodicals, Inc. The development of early screening and diagnosis of autism spectrum disorder (ASD) in

  11. Interstitial radiotherapy

    International Nuclear Information System (INIS)

    Scardino, P.T.; Bretas, F.

    1987-01-01

    The authors now have 20 years of experience with modern techniques of brachytherapy. The large number of patients treated in medical centers around the world and the widespread use of this type of radiotherapy have provided us with substantial information about the indications and contraindications, advantages and disadvantages, pitfalls and complications, as well as the results of these techniques. Although the focus of this review is the experience at Baylor using the combined technique of gold seed implantation plus external beam irradiation, the alternative forms of brachytherapy will be described and compared. The authors' intention is to provide the busy clinician with a succinct and informative review indicating the status of modern interstitial radiotherapy and describing day-to-day approach and results

  12. Differentiation of irradiation and cetuximab induced skin reactions in patients with locally advanced head and neck cancer undergoing radioimmunotherapy: the HICARE protocol (Head and neck cancer: ImmunoChemo and Radiotherapy with Erbitux) – a multicenter phase IV trial

    International Nuclear Information System (INIS)

    Habl, G; Potthoff, K; Haefner, MF; Abdollahi, A; Hassel, JC; Boller, E; Indorf, M; Debus, J

    2013-01-01

    In order to improve the clinical outcome of patients with locally advanced squamous cell carcinoma of the head and neck (LASCCHN) not being capable to receive platinum-based chemoradiation, radiotherapy can be intensified by addition of cetuximab, a monoclonal antibody that blocks the epidermal growth factor receptor (EGFR). The radioimmunotherapy with cetuximab is a feasible treatment option showing a favourable toxicity profile. The most frequent side effect of radiotherapy is radiation dermatitis, the most common side effect of treatment with cetuximab is acneiform rash. Incidence and severity of these frequent, often overlapping and sometimes limiting skin reactions, however, are not well explored. A clinical and molecular differentiation between radiogenic skin reactions and skin reactions caused by cetuximab which may correlate with outcome, have never been described before. The HICARE study is a national, multicenter, prospective phase IV study exploring the different types of skin reactions that occur in patients with LASCCHN undergoing radioimmun(chemo)therapy with the EGFR inhibitor cetuximab. 500 patients with LASCCHN will be enrolled in 40 participating sites in Germany. Primary endpoint is the rate of radiation dermatitis NCI CTCAE grade 3 and 4 (v. 4.02). Radioimmunotherapy will be applied according to SmPC, i.e. cetuximab will be administered as loading dose and then weekly during the radiotherapy. Irradiation will be applied as intensity-modulated radiation therapy (IMRT) or 3D-dimensional radiation therapy. The HICARE trial is expected to be one of the largest trials ever conducted in head and neck cancer patients. The goal of the HICARE trial is to differentiate skin reactions caused by radiation from those caused by the monoclonal antibody cetuximab, to evaluate the incidence and severity of these skin reactions and to correlate them with outcome parameters. Besides, the translational research program will help to identify and confirm novel

  13. Palliative Radiotherapy

    International Nuclear Information System (INIS)

    Salinas, J.

    2003-01-01

    Palliative care does not attempt to prolong survival but to the achieve the highest quality of life both for the patient and their family covering their physical, psychological, social and spiritual needs. Radiotherapy (RT), one of the most important therapeutic modalities, has a great significance in palliative medicine for cancer since it attempts to reduce as much as possible the acute reaction associated with the treatment for the patient. (Author)

  14. Using rewards-based incentives to increase purchase of fruit and vegetables in lower-income households: design and start-up of a randomized trial.

    Science.gov (United States)

    Phipps, Etienne J; Wallace, Samantha L; Stites, Shana D; Uplinger, Nadine; Brook Singletary, S; Hunt, Lacy; Axelrod, Saul; Glanz, Karen; Braitman, Leonard E

    2013-05-01

    To report the design and baseline results of a rewards-based incentive to promote purchase of fruit and vegetables by lower-income households. A four-phase randomized trial with wait-listed controls. In a pilot study, despite inadequate study coupon use, purchases of fresh fruit (but not vegetables) increased, but with little maintenance. In the present study, credits on the study store gift card replace paper coupons and a tapering phase is added. The primary outcome is the number of servings of fresh and frozen fruit and vegetables purchased per week. A large full-service supermarket located in a predominantly minority community in Philadelphia, Pennsylvania, USA. Fifty-eight households, with at least one child living in the home. During the baseline period, households purchased an average of 3·7 servings of fresh vegetables and an average of less than 1 serving of frozen vegetables per week. Households purchased an average of 1·9 servings of fresh fruit per week, with little to no frozen fruit purchases. Overall, the range of fresh and frozen produce purchased during this pre-intervention period was limited. At baseline, produce purchases were small and of limited variety. The study will contribute to understanding the impact of financial incentives on increasing the purchases of healthier foods by lower-income populations.

  15. Factors associated with acute and late dysphagia in the DAHANCA 6 & 7 randomized trial with accelerated radiotherapy for head and neck cancer

    DEFF Research Database (Denmark)

    Mortensen, Hanna R; Overgaard, Jens; Jensen, Kenneth

    2013-01-01

    Dysphagia is a common and debilitating side effect in head and neck radiotherapy (RT). Prognostic factors are numerous and their interrelationship not well understood. The aim of this study was to establish a multivariate prognostic model for acute and late dysphagia after RT, based on information...

  16. FAZA PET/CT hypoxia imaging in patients with squamous cell carcinoma of the head and neck treated with radiotherapy: Results from the DAHANCA 24 trial

    DEFF Research Database (Denmark)

    Mortensen, Lise Saksø; Johansen, Jørgen; Kallehauge, Jesper Folsted

    2012-01-01

    Hypoxia is a cause of resistance to radiotherapy, especially in patients with head and neck squamous cell carcinoma (HNSCC). The purpose of this study was to evaluate (18)F-fluoroazomycin arabinoside (FAZA) positron emission tomography (PET)/computed tomography (CT) hypoxia imaging as a prognostic...

  17. Impact of short-term preoperative radiotherapy on health-related quality of life and sexual functioning in primary rectal cancer : Report of a multicenter randomized trial

    NARCIS (Netherlands)

    Marijnen, CAM; van de Velde, CJH; Putter, H; van den Brink, M; Maas, CP; Martijn, H; Rutten, HJ; Wiggers, T; Kranenbarg, EK; Leer, JWH; Stiggelbout, AM

    2005-01-01

    Background Few prospective studies have been performed about the impact of preoperative radiotherapy (PRT) or total mesorectal excision (TME) on health-related quality of life (HRQL) and sexual functioning in patients with resectable rectal cancer. This report describes the HRQL and sexual

  18. Impact of short-term preoperative radiotherapy on health-related quality of life and sexual functioning in primary rectal cancer: report of a multicenter randomized trial.

    NARCIS (Netherlands)

    Marijnen, C.A.; Velde, C.J. van de; Putter, H.; Brink, M.; Maas, C.P.; Martijn, H.; Rutten, H.J.; Wiggers, T.; Kranenbarg, E.K.; Leer, J.W.H.; Stiggelbout, A.M.

    2005-01-01

    BACKGROUND: Few prospective studies have been performed about the impact of preoperative radiotherapy (PRT) or total mesorectal excision (TME) on health-related quality of life (HRQL) and sexual functioning in patients with resectable rectal cancer. This report describes the HRQL and sexual

  19. Efficacy of Traditional Chinese Medicine in Treatment and Prophylaxis of Radiation-Induced Oral Mucositis in Patients Receiving Radiotherapy: A Randomized Controlled Trial.

    Science.gov (United States)

    Wang, Cong; Wang, Peiguo; Ouyang, Huaqiang; Wang, Jing; Sun, Lining; Li, Yanwei; Liu, Dongying; Jiang, Zhansheng; Wang, Bin; Pan, Zhanyu

    2018-06-01

    To estimate the efficacy of traditional Chinese medicine (Chining decoction, CHIN) for radiation-induced oral mucositis in patients with head and neck cancer. From May 2014 to December 2015, 70 consecutive patients were randomly assigned to receive CHIN (treatment group) or recombinant human epidermal growth factor (rhEGF) spray (control group) at a 1:1 ratio. CHIN was administered to treatment group from the first day of radiotherapy until the completion of radiotherapy. Simultaneously, the rhEGF spray was administered to control group on the oral mucosa of irradiated area. The clinical benefit was determined by gradation of mucositis (Common Terminology Criteria for Adverse Events v4.0), oral pain, and xerostomia (visual analysis scale) for each week during radiotherapy. Body mass index was evaluated before and after radiotherapy. Patients in the treatment group had prominent remission of oral pain and grade of mucositis on each observing point compared with those in control group ( P .05). CHIN presented an obvious advantage in preventing radiation-induced oral mucositis compared with rhEGF spray.

  20. Stereotactic ablative radiotherapy versus lobectomy for operable stage I non-small-cell lung cancer : a pooled analysis of two randomised trials

    NARCIS (Netherlands)

    Chang, Joe Y.; Senan, Suresh; Paul, Marinus A.; Mehran, Reza J.; Louie, Alexander V.; Balter, Peter; Groen, Harry; McRae, Stephen E.; Widder, Joachim; Feng, Lei; van den Borne, Ben E. E. M.; Munsell, Mark F.; Hurkmans, Coen; Berry, Donald A.; van Werkhoven, Erik; Kresl, John J.; Dingemans, Anne-Marie; Dawood, Omar; Haasbeek, Cornelis J. A.; Carpenter, Larry S.; De Jaeger, Katrien; Komaki, Ritsuko; Slotman, Ben J.; Smit, Egbert F.; Roth, Jack A.

    Background The standard of care for operable, stage I, non-small-cell lung cancer (NSCLC) is lobectomy with mediastinal lymph node dissection or sampling. Stereotactic ablative radiotherapy (SABR) for inoperable stage I NSCLC has shown promising results, but two independent, randomised, phase 3

  1. Effect of magnesium oxide on interfraction prostate motion and rectal filling in prostate cancer radiotherapy. Analysis of a randomized clinical trial

    International Nuclear Information System (INIS)

    Harder, Annemarie M. den; Kotte, Alexis N.T.J.; Vulpen, Marco van; Lips, Irene M.; Gils, Carla H. van

    2014-01-01

    To investigate whether magnesium oxide reduces the interfraction motion of the prostate and the amount of rectal filling and rectal gas, which influences prostate position during radiotherapy for prostate cancer. From December 2008 to February 2010, 92 prostate cancer patients scheduled for intensity-modulated radiotherapy (77 Gy in 35 fractions) using fiducial marker-based position verification were randomly assigned to receive magnesium oxide (500 mg twice a day) or placebo during radiotherapy. In a previous study, we investigated the effect on intrafraction motion and did not find a difference between the treatment arms. Here, we compared the interfraction prostate motion between the two treatment arms as well as the amount of rectal filling and rectal air pockets using pretreatment planning computed tomography and magnetic resonance imaging scans. There was no statistically significant difference between the treatment arms in translation and rotation of the prostate between treatment fractions, except for the rotation around the cranial caudal axis. However, the difference was less than 1 and therefore considered not clinically relevant. There was no significant difference in the amount of rectal filling and rectal air pockets between the treatment arms. Magnesium oxide is not effective in reducing the interfraction prostate motion or the amount of rectal filling and rectal gas during external-beam radiotherapy. Therefore, magnesium oxide is not recommended in clinical practice for these purposes. (orig.) [de

  2. Acute side effects and complications after short-term preoperative radiotherapy combined with total mesorectal excision in primary rectal cancer: report of a multicenter randomized trial.

    NARCIS (Netherlands)

    Marijnen, C.A.; Kapiteijn, E.; Veld, C.J.H. van de; Martijn, H.; Steup, W.H.; Wiggers, T.; Meershoek-Klein Kranenbarg, E.; Leer, J.W.H.

    2002-01-01

    PURPOSE: Total mesorectal excision (TME) surgery in the treatment of rectal cancer has been shown to result in a reduction in the number of local recurrences in retrospective studies. Reports on improved local control after preoperative, hypofractionated radiotherapy (RT) have led to the

  3. Acute side effects and complications after short-term preoperative radiotherapy combined with total mesorectal excision in primary rectal cancer : Report of a multicenter randomized trial

    NARCIS (Netherlands)

    Marijnen, CAM; Kapiteijn, E; van de Velde, CJH; Martijn, H; Steup, WH; Wiggers, T; Kranenbarg, EK; Leer, JWH

    2002-01-01

    Purpose: Total mesorectal excision (TME) surgery in the treatment of rectal cancer has been shown to result in a reduction in the number of local recurrences in retrospective studies. Reports on improved local control after preoperative, hypofractionated radiotherapy (RT) have led to the

  4. Dexamethasone for the prevention of a pain flare after palliative radiotherapy for painful bone metastases : a multicenter double-blind placebo-controlled randomized trial

    NARCIS (Netherlands)

    Westhoff, Paulien G.; de Graeff, Alexander; Geerling, Jenske I.; Reyners, Anna K. L.; van der Linden, Yvette M.

    2014-01-01

    Background: Radiotherapy has a good effect in palliation of painful bone metastases, with a pain response rate of more than 60%. However, shortly after treatment, in approximately 40% of patients a temporary pain flare occurs, which is defined as a two-point increase of the worst pain score on an

  5. Estimating the Risks of Breast Cancer Radiotherapy

    DEFF Research Database (Denmark)

    Taylor, Carolyn; Correa, Candace; Duane, Frances K

    2017-01-01

    Purpose Radiotherapy reduces the absolute risk of breast cancer mortality by a few percentage points in suitable women but can cause a second cancer or heart disease decades later. We estimated the absolute long-term risks of modern breast cancer radiotherapy. Methods First, a systematic literature...... review was performed of lung and heart doses in breast cancer regimens published during 2010 to 2015. Second, individual patient data meta-analyses of 40,781 women randomly assigned to breast cancer radiotherapy versus no radiotherapy in 75 trials yielded rate ratios (RRs) for second primary cancers...... and cause-specific mortality and excess RRs (ERRs) per Gy for incident lung cancer and cardiac mortality. Smoking status was unavailable. Third, the lung or heart ERRs per Gy in the trials and the 2010 to 2015 doses were combined and applied to current smoker and nonsmoker lung cancer and cardiac mortality...

  6. Sector resection with and without radiotherapy in early breast cancer

    International Nuclear Information System (INIS)

    Holmberg, L.

    1989-01-01

    In 1982 a prospective, multicentre randomized trial of breast preserving surgery for invasive histopathological stage I breast cancer was started in the Uppsala-Oerebro health care region in Sweden. After identical preoperative investigation and surgical treatment, patients are randomly allocated to receive postoperative radiation with 54 Gy to the remaining breast for five weeks, or to serve as controls. The primary aim of the trial is to determine whether a standardized surgical technique aiming at local tumour radicality can reduce the rate of local recurrence to an acceptable level without postoperative radiotherapy. In December 1987 a second trial was initiated, with an almost identical design but including women with tumours mammographically 21-30 mm in diameter and with histopathologically negative nodes. The first trial is near the termination of patient accrual. Studies of the cosmetic result and of the psychosocial adjustment after breast conserving therapy as compared with mastectomy have been coupled to the trials. Among 263 patients who answered a questionnaire, 96.5% found the new appearance of the treated breast good or acceptable. The psychosocial adjustment was assessed in semi-structured interviews 4 and 13 months postoperatively in 99 women, 37 of whom underwent breast conserving surgery and the remainder modified radical mastectomy. There was a consistent but statistically non-significant tendency for the conservatively treated women to adjust better. Overall 5% of the women in the conservatively treated group and 22% of the mastectomized women are still suffering substantial psychosocial disturbance after 13 months. (orig.)

  7. Prospective Trial of High-Dose Reirradiation Using Daily Image Guidance With Intensity-Modulated Radiotherapy for Recurrent and Second Primary Head-and-Neck Cancer

    International Nuclear Information System (INIS)

    Chen, Allen M.; Farwell, D. Gregory; Luu, Quang; Cheng, Suzan; Donald, Paul J.; Purdy, James A.

    2011-01-01

    Purpose: To report a single-institutional experience using intensity-modulated radiotherapy with daily image-guided radiotherapy for the reirradiation of recurrent and second cancers of the head and neck. Methods and Materials: Twenty-one consecutive patients were prospectively treated with intensity-modulated radiotherapy from February 2006 to March 2009 to a median dose of 66 Gy (range, 60-70 Gy). None of these patients received concurrent chemotherapy. Daily helical megavoltage CT scans were obtained before each fraction as part of an image-guided radiotherapy registration protocol for patient alignment. Results: The 1- and 2-year estimates of in-field control were 72% and 65%, respectively. A total of 651 daily megavoltage CT scans were obtained. The mean systematic shift to account for interfraction motion was 1.38 ± 1.25 mm, 1.79 ± 1.45 mm, and 1.98 ± 1.75 mm for the medial-lateral, superior-inferior, and anterior-posterior directions, respectively. Pretreatment shifts of >3 mm occurred in 19% of setups in the medial-lateral, 27% in the superior-inferior, and 33% in the anterior-posterior directions, respectively. There were no treatment-related fatalities or hospitalizations. Complications included skin desquamation, odynophagia, otitis externa, keratitis, naso-lacrimal duct stenosis, and brachial plexopathy. Conclusions: Intensity-modulated radiotherapy with daily image guidance results in effective disease control with relatively low morbidity and should be considered for selected patients with recurrent and second primary cancers of the head and neck.

  8. A comparison of mean parotid gland dose with measures of parotid gland function after radiotherapy for head-and-neck cancer: Implications for future trials

    International Nuclear Information System (INIS)

    Roesink, Judith M.; Schipper, Maria; Busschers, Wim; Raaijmakers, Cornelis P.J.; Terhaard, Chris H.J.

    2005-01-01

    Purpose: To determine the most adequate parameter to measure the consequences of reducing the parotid gland dose. Methods and Materials: One hundred eight patients treated with radiotherapy for various malignancies of the head and neck were prospectively evaluated using three methods. Parotid gland function was objectively determined by measuring stimulated parotid flow using Lashley cups and scintigraphy. To assess xerostomi