***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: INTRODUCTION The Trans-Tasman Radiation Oncology Group 03.04 ' R and omised And rogen Deprivation and Radiotherapy ' multicentre prostate cancer trial examined the optimal duration of and rogen deprivation in combination with dose-escalated radiotherapy . Rigorous quality assurance ( QA ) processes were undertaken to ensure the validity and reliability of the radiation therapy treatment plan data . METHOD QA processes included a planning benchmarking exercise and a periodic audit of target and normal tissue delineation . Central ised electronic review of digital plan data for external-beam radiotherapy was undertaken to detect protocol variations . The impact of clinical factors and feedback to su bmi tting centres during the trial on variation rates was investigated . RESULTS Twenty-three centres across Australia and New Zeal and recruited 1071 participants to the trial . Treatment plans for 754 participants receiving external-beam treatment alone  were review ed . From these , 1185 minor and 86 major variations were identified , leading to feedback to treating centres to reduce variations for subsequent patients ' treatment and plans , suggesting improvement in treatment quality through these QA programs . Participant anatomical factors ( delineated clinical target volume and rectal volume ) and treatment planning factors ( beam energy , beam definition and patient position orientation ) were found to significantly impact variation rates . The dummy run demonstrated disagreement in identification of the base of the prostate and the superior extent of the rectum . Feedback from the periodic audit led to a change of practice at five contributing centres . CONCLUSION The application of a suite of complementary QA activities allows the quality of trial data to be optimised and quantified , and can provide a catalyst for reforming treatment practice Quality assurance ( QA ) for radiation therapy  ( RT ) in clinical trials is necessary to ensure treatment is safely and effectively administered . QA assurance requires however substantial human and financial re sources , as it has become more comprehensive and labor intensive in recent RT trials . It is presumed that RT deviations decrease therapeutic effectiveness of the studied regimen . This study assesses the impact of RT protocol -deviations on patient 's outcome in prospect i ve phase II-III RT trials . PubMed , Medline and Embase identified nine prospect i ve RT trials detailing QA RT violation and patient 's outcome . Planned QA analysis was preformed retrospectively and prospect ively in eight and one studies , respectively . Non-adherence to protocol -specified RT requirements in prospect i ve trials is frequent : the observed major deviation rates range from 11.8 % to 48.0 % ( mean , 28.1 ± 17.9 % ) . QA RT deviations had a significant impact on the primary study end-point in a majority ( 62.5 % ) of studies . The number of patients accrued per center was a significant predictive factor for RT deviations in the largest series . These QA data stemming from prospect i ve clinical trials show undisputedly that non adherence to protocol -specified RT requirements is associated with reduced survival , local control and potentially increased toxicity PURPOSE In Radiation Therapy Oncology Group 9704 , as previously published , patients with resected pancreatic adenocarcinoma received continuous infusion 5-FU and concurrent radiotherapy ( 5FU-RT ) . 5FU-RT treatment was preceded and followed by r and omly assigned chemotherapy , either 5-FU or gemcitabine . This analysis explored whether failure to adhere to specified RT guidelines influenced survival and /or toxicity . METHODS AND MATERIAL S RT requirements were protocol specified . Adherence was scored as per protocol ( PP ) or less than per protocol ( < PP ) . Scoring occurred after therapy but before trial analysis and without knowledge of individual patient treatment outcomes . Scoring was done for all tumor locations and for the subset of pancreatic head location . RESULTS RT was scored for 416 patients : 216 PP and 200 < PP . For all pancreatic sites ( head , body/tail ) median survival ( MS ) for PP vs. < PP was 1.74 vs. 1.46 years ( log-rank p = 0.0077 ) . In multivariate analysis , PP vs. < PP score correlated more strongly with MS than assigned treatment arm ( p = 0.014 , p = NS , respectively ) ; for patients with pancreatic head tumors , both PP score and gemcitabine treatment correlated with improved MS ( p = 0.016 , p = 0.043 , respectively ) . For all tumor locations , PP score was associated with decreased risk of failure ( p = 0.016 ) and , for gemcitabine patients , a trend toward reduced Grade 4/5 nonhematologic toxicity ( p = 0.065 ) . CONCLUSIONS This is the first Phase III , multicenter , adjuvant protocol for pancreatic adenocarcinoma to evaluate the impact of adherence to specified RT protocol guidelines on protocol outcomes . Failure to adhere to specified RT guidelines was associated with reduced survival and , for patients receiving gemcitabine , trend toward increased nonhematologic toxicity PURPOSE Promising results in a r and omized phase II trial with the hypoxic cytotoxin tirapazamine ( TPZ ) combined with cisplatin ( CIS ) and radiation led to this phase III trial . PATIENTS AND METHODS Patients with previously untreated stage III or IV ( excluding T1 - 2N1 and M1 ) squamous cell carcinoma of the oral cavity , oropharynx , hypopharynx , or larynx were r and omly assigned to receive definitive radiotherapy ( 70 Gy in 7 weeks ) concurrently with either CIS ( 100 mg/m(2 ) ) on day 1 of weeks 1 , 4 , and 7 or CIS ( 75 mg/m(2 ) ) plus TPZ ( 290 mg/m(2)/d ) on day 1 of weeks 1 , 4 , and 7 and TPZ alone ( 160 mg/m(2)/d ) on days 1 , 3 , and 5 of weeks 2 and 3 ( TPZ/CIS ) . The primary end point was overall survival ( OS ) . The planned sample size was 850 , estimated to result in 334 deaths , which would provide 90 % power to detect a difference in 2-year survival rates of 60 % v 70 % for CIS versus TPZ/CIS , respectively ( hazard ratio = 0.69 ) . RESULTS Eight hundred sixty-one patients were accrued from 89 sites in 16 countries . In an intent-to-treat analysis , the 2-year OS rates were 65.7 % for CIS and 66.2 % for TPZ/CIS ( TPZ/CIS -- CIS : 95 % CI , -5.9 % to 6.9 % ) . There were no significant differences in failure-free survival , time to locoregional failure , or quality of life as measured by Functional Assessment of Cancer Therapy-Head and Neck . CONCLUSIONS We found no evidence that the addition of TPZ to chemoradiotherapy , in patients with advanced head and neck cancer not selected for the presence of hypoxia , improves OS INTRODUCTION A dry run of a clinical trial ( EORTC 22911 ) is presented in which 12 centres have participated . These are the centres which have contributed the largest number of patients to the trial . MATERIAL AND METHODS Each participating centre received data from a suitable patient . Investigators were asked to plan and ' treat ' the patient according to the protocol guidelines and return the data for evaluation of compliance . RESULTS The results show that compliance to the protocol guidelines was generally good . There were a few minor deviations in the dose and fractionation schedule , in the volume reduction for the booster dose and in the dose prescription point . None of these deviations will affect the outcome of the study . The most important observation is the large inter-centre variation in target volumes . CONCLUSIONS The results of this study underlines the need for a strict definition of the target volume and the adoption of the ICRU 50 recommendations in future protocol OBJECTIVE Quality assurance ( QA ) in clinical trials is essential to ensure treatment is safely and effectively delivered . As QA requirements have increased in complexity in parallel with evolution of radiation therapy ( RT ) delivery , a need to facilitate digital data exchange emerged . Our objective is to present the platform developed for the integration and st and ardization of QART activities across all EORTC trials involving RT . METHODS The following essential requirements were identified : secure and easy access without on-site software installation ; integration within the existing EORTC clinical remote data capture system ; and the ability to both customize the platform to specific studies and adapt to future needs . After retrospective testing within several clinical trials , the platform was introduced in phases to participating sites and QART study review ers . RESULTS The result ing QA platform , integrating RT analysis software installed at EORTC Headquarters , permits timely , secure , and fully digital central DICOM-RT based data review . Participating sites su bmi t data through a st and ard secure upload webpage . Supplemental information is su bmi tted in parallel through web-based forms . An internal quality check by the QART office verifies data consistency , formatting , and anonymization . QART review ers have remote access through a terminal server . Review ers evaluate su bmi ssions for protocol compliance through an online evaluation matrix . Comments are collected by the coordinating centre and institutions are informed of the results . CONCLUSIONS This web-based central review platform facilitates rapid , extensive , and prospect i ve QART review . This reduces the risk that trial outcomes are compromised through inadequate radiotherapy and facilitates correlation of results with clinical outcomes 
    Output:
    
Our findings revealed that 65 of 67 ( 97 % ) Cochrane systematic review s of radiation therapy interventions failed to consider the quality of the intervention .