Is pre-trial quality assurance necessary? Experiences of the CONVERT Phase III randomized trial for good performance status patients with limited-stage small-cell lung cancer.

OBJECTIVE: This study is an analysis of the pre-trial quality assurance (QA) exercises submitted by clinicians from radiotherapy (RT) centres across Europe and Canada to qualify for participation in the CONVERT trial.
METHODS: QA exercises submitted by 64 clinicians at 64 RT centres were included in this analysis. The exercises included the completion of a trial-specific questionnaire and submission of a treatment plan, for both trial arms, for a patient fitting the eligibility criteria of the trial. This article describes the QA programme set up for the CONVERT trial and identifies deviations from the trial protocol. Patient eligibility, disease and critical structure outlining and treatment planning technique were assessed.
RESULTS: Results from QA trial-specific questionnaires received between February 2008 and September 2011, returned as part of the QA exercise, indicated that the majority of centres (70.3%) were using 6-MV photons and type B treatment planning system algorithms (57.8%). 90.6% of clinicians assessed submitted data for patients who fitted the eligibility criteria for the trial. There were inconsistencies in outlining of gross tumour volume (GTV) and organs at risk, mainly heart and oesophagus, and in the use of margins around the GTV.
CONCLUSION: Such a QA programme helps to ensure that centres conform to trial protocol and should reduce inconsistencies in RT planning that may confound the results of the CONVERT trial. ADVANCES IN KNOWLEDGE: Few studies reporting pre-trial QA have been published to date. This article outlines the importance of such a QA programme in the context of multicentre Phase III studies.