Int J Radiat Oncol Biol Phys. 2023 Aug 18:S0360-3016(23)07781-7. doi: 10.1016/j.ijrobp.2023.08.014. Online ahead of print.
ABSTRACT
PURPOSE: NRG/RTOG 0848 is a two-step randomized trial to evaluate the benefit of the addition of concurrent fluoropyrimidine and radiotherapy (RT) following adjuvant chemotherapy (2nd step) for patients with resected pancreatic head adenocarcinoma. Real-time quality assurance (QA) was performed on each patient who underwent RT. This analysis aims to evaluate adherence to protocol-specified contouring and treatment planning and to report the types and frequencies of deviations requiring revisions.
METHODS AND MATERIALS: In addition to a web-based contouring atlas, the protocol outlined step-by-step instructions for generating the clinical treatment volume (CTV) through the creation of specific regions of interest. The planning target volume (PTV) was a uniform 0.5cm CTV expansion. One of two radiation oncology study chairs independently reviewed each plan. Plans with unacceptable deviations were returned for revision and resubmitted until approved. Treatment started after final approval of the RT plan.
RESULTS: From 2014-2018, 354 patients were enrolled in the second randomization. Of these, 160 patients received RT and were included in the QA analysis. Resubmissions were more common for patients planned with 3D-CRT (43%) than with IMRT (31%). In total, at least one resubmission of the treatment plan was required for 33% of patients. Among patients requiring resubmission, most only needed one resubmission (87%). The most common reasons for resubmission were unacceptable deviations with respect to the pre-operative gross target volume (60.7%) and the pancreaticojejunostomy (47.5%), CONCLUSION: One-third of patients required resubmission to meet protocol compliance criteria, demonstrating the continued need for expending resources on real-time, pretreatment QA in trials evaluating the use of radiotherapy, particularly for pancreas cancer. Rigorous QA is critically important for clinical trials involving RT to ensure that the true impact of RT is assessed. Moreover, RT QA serves as an educational process through providing feedback from specialists to practicing radiation oncologists on best practices.
PMID:37598723 | DOI:10.1016/j.ijrobp.2023.08.014
