Radiation therapy quality assurance analysis of alliance A021501: Preoperative mFOLFIRINOX or mFOLFIRINOX plus hypofractionated radiation therapy for borderline resectable adenocarcinoma of the pancreas Journal Article
| Authors: | Tchelebi, L. T.; Segovia, D.; Smith, K.; Shi, Q.; Fitzgerald, T. J.; Chuong, M. D.; Zemla, T. J.; O'Reilly, E. M.; Meyerhardt, J. A.; Koay, E. J.; Lowenstein, J.; Shergill, A.; Katz, M. H. G.; Herman, J. M. |
| Article Title: | Radiation therapy quality assurance analysis of alliance A021501: Preoperative mFOLFIRINOX or mFOLFIRINOX plus hypofractionated radiation therapy for borderline resectable adenocarcinoma of the pancreas |
| Abstract: | Purpose: 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 and Materials: SBRT (6.6 Gy × 5) was intended but hypofractionated RT (5 Gy × 5) 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, or 3) based on adequacy. A score of 1 indicated no deviation, 2 indicated minor deviation, and 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 and 9 community). Twenty-three centers were appropriately credentialed for moving lung/liver targets and 4 for static head and neck only. Thirty-two of 39 patients (82.1%) were treated with SBRT and 7 (17.9%) with hypofractionated RT. Five cases (13%) required revision before 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 (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. Conclusions: Despite rigorous QA, we encountered variability in simulation, contouring, plan coverage, and dose on trial. Although clinical outcomes did not appear to have been affected, findings from this analysis serve to inform subsequent PDAC SBRT trial designs and QA requirements. © 2024 Elsevier Inc. |
| Keywords: | adult; clinical article; controlled study; aged; treatment failure; intensity modulated radiation therapy; fluorouracil; treatment planning; neoadjuvant therapy; pancreatic neoplasms; chemotherapy; antineoplastic agent; adenocarcinoma; quality control; randomized controlled trial; antineoplastic combined chemotherapy protocols; radiotherapy; carcinoma, pancreatic ductal; pathology; oncology; irinotecan; simulation; health care quality; liver; quality assurance; quality assurance, health care; folinic acid; pancreas tumor; radiosurgery; scoring system; lung; surgery; neck; radiotherapy planning, computer-assisted; neoadjuvant chemotherapy; oxaliplatin; stereotactic body radiation therapy; randomized trial; leucovorin; national health organization; radiation oncologists; hypofractionated; gross tumor volume; head; clinical outcome; pancreatic ductal carcinoma; preoperative radiotherapy; national cancer institute; image guided radiotherapy; protocol compliance; preoperative chemotherapy; organ; ductal adenocarcinomas; planning target volume; hypofractionated radiotherapy; methods and materials; humans; human; male; female; article; radiotherapy planning system; radiation oncologist; folfirinox; neoadjuvant chemotherapies; adenocarcinoma of the pancreas; radiation dose hypofractionation |
| Journal Title: | International Journal of Radiation Oncology, Biology, Physics |
| Volume: | 120 |
| Issue: | 1 |
| ISSN: | 0360-3016 |
| Publisher: | Elsevier Inc. |
| Date Published: | 2024-09-01 |
| Start Page: | 111 |
| End Page: | 119 |
| Language: | English |
| DOI: | 10.1016/j.ijrobp.2024.03.013 |
| PUBMED: | 38492812 |
| PROVIDER: | scopus |
| PMCID: | PMC11329353 |
| DOI/URL: | |
| Notes: | Article -- Source: Scopus |
