Radiation Therapy Quality Assurance Analysis of Alliance A021501: Preoperative mFOLFIRINOX or mFOLFIRINOX plus hypofractionated radiation therapy for borderline resectable adenocarcinoma of the pancreas.

Background Alliance A021501 is the first randomized trial to evaluate stereotactic body radiation therapy (SBRT) for borderline resectable pancreatic ductal adenocarcinoma (PDAC) after neoadjuvant chemotherapy. In this post hoc study, we reviewed the quality of radiation therapy (RT) delivered. Methods SBRT (6.6 Gy x 5) was intended, although hypofractionated RT (5 Gy x 5) (HIGRT) was permitted if SBRT specifications could not be met. Institutional credentialing through the National Cancer Institute-funded Imaging and Radiation Oncology Core (IROC) was required. Rigorous RT quality assurance (RT QA) was mandated, including pretreatment review by a radiation oncologist. Revisions were required for unacceptable deviations. Additionally, we performed a post hoc RT QA analysis in which contours and plans were reviewed by 3 radiation oncologists and assigned a score (1, 2, 3) based on adequacy. A score of 1 indicated no deviation, a 2 indicated minor deviation, and a 3 indicated a major deviation that could be clinically significant. Clinical outcomes were compared by treatment modality and by case score. Results Forty patients were registered to receive RT (1 planned but not treated) at 27 centers (18 academic, 9 community). Twenty-three centers were appropriately credentialed for moving lung/liver targets, while 4 were approved for static head and neck only. Thirty-two of 39 patients (82.1%) were treated with SBRT, and 7 (17.9%) with HIGRT. Five cases (13%) required revision prior to treatment. On post hoc review, 23 patients (59.0%) were noted to have suboptimal contours or plan coverage, 12 (30.8%) were scored a 2 and 11 cases (28.2%) were scored a 3. There were no apparent differences in failure patterns or surgical outcomes based on treatment technique or post hoc case score. Details related to on-treatment imaging were not recorded. Conclusion Despite rigorous QA, we encountered variability in simulation, contouring, plan coverage, and dose on trial. While clinical outcomes did not appear to be impacted, findings from this analysis serve to inform subsequent PDAC SBRT trial designs and QA requirements.