The Feasibility of Quality Assurance in the TOPGEAR International Phase 3 Clinical Trial of Neoadjuvant Chemoradiation Therapy for Gastric Cancer (an Intergroup Trial of the AGITG/TROG/NHMRC CTC/EORTC/CCTG)
- Author(s)
- Lukovic, J; Moore, AJ; Lee, MT; Willis, D; Ahmed, S; Akra, M; Hortobagyi, E; Kron, T; Lim Joon, D; Liu, A; Ryan, J; Thomas, M; Wall, K; Ward, I; Wiltshire, KL; O'Callaghan, CJ; Wong, RKS; Ringash, JG; Haustermans, K; Leong, T;
- Details
- Publication Year 2023-12-01,Volume 117,Issue #5,Page 1096-1106
- Journal Title
- International Journal of Radiation Oncology, Biology, Physics
- Publication Type
- Research article
- Abstract
- PURPOSE: The TOPGEAR phase 3 trial hypothesized that adding preoperative chemoradiation therapy (CRT) to perioperative chemotherapy will improve survival in patients with gastric cancer. Owing to the complexity of gastric irradiation, a comprehensive radiation therapy quality assurance (RTQA) program was implemented. Our objective is to describe the RTQA methods and outcomes. METHODS AND MATERIALS: RTQA was undertaken in real time before treatment for the first 5 patients randomized to CRT from each center. Once acceptable quality was achieved, RTQA was completed for one-third of subsequent cases. RTQA consisted of evaluating (1) clinical target volume and organ-at-risk contouring and (2) radiation therapy planning parameters. Protocol violations between high- (20+ patients enrolled) and low-volume centers were compared using the Fisher exact test. RESULTS: TOPGEAR enrolled 574 patients, of whom 286 were randomized to receive preoperative CRT and 203 (71%) were included for RTQA. Of these, 67 (33%) and 136 (67%) patients were from high- and low-volume centers, respectively. The initial RTQA pass rate was 72%. In total, 28% of cases required resubmission. In total, 200 of 203 cases (99%) passed RTQA before treatment. Cases from low-volume centers required resubmission more often (44/136 [33%] vs 13/67 [18%]; P = .078). There was no change in the proportion of cases requiring resubmission over time. Most cases requiring resubmission had multiple protocol violations. At least 1 aspect of the clinical target volume had to be adjusted in all cases. Inadequate coverage of the duodenum was most common (53% major violation, 25% minor violation). For the remaining cases, the resubmission process was triggered secondary to poor contour/plan quality. CONCLUSIONS: In a large multicenter trial, RTQA is feasible and effective in achieving high-quality treatment plans. Ongoing education should be performed to ensure consistent quality during the entire study period.
- Keywords
- Humans; *Stomach Neoplasms/therapy; Neoadjuvant Therapy; Feasibility Studies; Quality Assurance, Health Care; Chemoradiotherapy
- Department(s)
- Physical Sciences; Radiation Oncology
- Publisher's Version
- https://doi.org/10.1016/j.ijrobp.2023.06.011
- Terms of Use/Rights Notice
- Refer to copyright notice on published article.
Creation Date: 2024-01-19 03:10:20
Last Modified: 2024-07-09 05:55:59