Introduction Advances in RT planning enhance the need for uniform quality oversight on clinical trials. NRG GY-17 was a randomized trial of the anti PD-L1 antibody, atezolizumab, before and concurrent (Arm A) or concurrent with CRT (Arm B). We describe the prospectively collected pre-treatment RT quality and workflow.
Methods 40 patients were consented; 36 patients with locally advanced, LN+ cervical cancer were randomized. IMRT contouring guidelines and dose specifics were outlined in the protocol with deviations specified as per protocol and major. Each site had to pass a rigorous IMRT credentialing process. Sites were required to submit a pre-treatment IMRT plan for physician expert contour target and organ at risk review in a rapid pre-treatment manner. The expert physician then scored the contours and plan as per protocol or as a major deviation. For major deviations the sites were required to revise and resubmit the plans which were then re-reviewed prior to protocol start.
Results The median follow-up time was 20 months. 37 participants had central review of the pre-treatment EBRT plan. 13 plans (35%) were scored as a major deviation requiring revision: 11 due to contours (5 bowel and 6 LN) and 2 due to incorrect expansion/dose. The major deviation plans were resubmitted and passed; 2 required revisions for a total of 3 plans.
Conclusion/Implications Our data indicate that 35% of the submitted advanced technology IMRT plans required revision and resubmission in order to meet per protocol standards. Pre- treatment plan review is an important quality measure for cervical cancer clinical trials.
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