Technical quality assurance during the TROG 03.04 RADAR prostate radiotherapy trial: Are the results reflected in observed toxicity rates?. Issue 1 (1st August 2014)

• Record Type: Journal Article
• Authors: 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
• Is Part Of: Journal of medical imaging and radiation oncology. Volume 59:Issue 1(2015:Feb.)
• Page Start: 99
• Page End: 108
• Publication Date: 2014-08-01
• Subjects: Radiology, Medical -- Periodicals; Radiology, Medical -- Australasia -- Periodicals; 616.0757
• DOI: 10.1111/1754-9485.12212
• Languages: English
• ISSNs: 1754-9477

Abstract

<abstract abstract-type="main"> <title>Abstract</title> <sec id="jmiro12212-sec-0001" sec-type="section"> <title>Introduction</title> <p>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.</p> </sec> <sec id="jmiro12212-sec-0002" sec-type="section"> <title>Methods</title> <p>Using QA records from the TROG 03.04 RADAR trial, the impact of variations on gastrointestinal (GI) and genito‐urinary (GU) toxicities was investigated.</p> </sec> <sec id="jmiro12212-sec-0003" sec-type="section"> <title>Results</title> <p>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 Level 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.</p> </sec> <sec id="jmiro12212-sec-0004" sec-type="section"> <title>Conclusions</title> <p>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.</p> </sec> </abstract>