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Technical quality assurance during the TROG 03.04 RADAR prostate radiotherapy trial: Are the results reflected in observed toxicity rates?
Author(s) -
Ebert Martin A,
Bulsara Max,
Haworth Annette,
Kearvell Rachel,
Richardson Sharon,
Kennedy Angel,
Spry Nigel A,
Bydder Sean A,
Joseph David J,
Denham James W
Publication year - 2015
Publication title -
journal of medical imaging and radiation oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.31
H-Index - 43
eISSN - 1754-9485
pISSN - 1754-9477
DOI - 10.1111/1754-9485.12212
Subject(s) - medicine , toxicity , context (archaeology) , quality assurance , clinical trial , protocol (science) , prostate cancer , pathology , cancer , paleontology , external quality assessment , alternative medicine , biology
Multicentre radiotherapy clinical trials can incorporate quality assurance ( QA ) procedures for ensuring consistent application of the trial protocol in the planning, delivery and reporting of participant treatments. Subsequently detected variations from trial protocol have previously been shown to reduce treatment efficacy, although little has been shown for toxicity rates. The purpose of this study was to investigate the association of QA measures and protocol variations on toxicity incidence in the context of a prostate radiotherapy trial. Methods Using QA records from the TROG 03.04 RADAR trial, the impact of variations on gastrointestinal ( GI ) and genito‐urinary ( GU ) toxicities was investigated. Results Protocol variation rates were lower than reported in previous studies, and showed little correlation with GI toxicity outcomes. Variations classified as ‘major’ showed a non‐significant trend for increased toxicity relative to those classified as ‘minor’. Results from a L evel III phantom‐based dosimetry study showed some correlation with GI toxicity, whereas ranking on a set‐up accuracy study did not impact on toxicity. Toxicity in general increased with the number of participants accrued per centre, at odds with previous reports relating to disease progression, with a potential link to increases in low–mid‐range rectal doses in the cohort from higher‐accruing centres. No QA ‐related variables correlated with GU toxicities. Conclusions Besides non‐significant trends, minimal association was observed between QA variables and toxicity rates for the RADAR trial. The intention of the trial's QA programme was to reduce treatment variations and minimise toxicity in the context of a relevantly advanced treatment approach.