Radiation Safety and Quality Assurance Division, National Cancer Center Hospital, Tokyo 104-0045, Japan.
Department of Radiation Oncology, National Cancer Center Hospital, Tokyo 104-0045, Japan; Department of Radiation Oncology, Juntendo Universitym Tokyo 113-0033, Japan.
Radiother Oncol. 2023 Jun;183:109630. doi: 10.1016/j.radonc.2023.109630. Epub 2023 Mar 18.
The Japan Clinical Oncology Group (JCOG) 1402 conducted a multicenter clinical trial of postoperative intensity-modulated radiotherapy (IMRT) for high-risk uterine cervical cancer patients. We assess effectiveness of the quality assurance (QA) program in central review through dummy runs (DRs) performed before patient enrollment and post-treatment individual case review (ICR), and clarify the pitfalls in treatment planning.
The ICRs were conducted using the same QA program as the DR for 214 plans. The deviations were compared with those demonstrated in the DRs, and the pitfalls were clarified. Fifteen face-to-face meetings were held with physicians at participating institutions to provide feedback.
Two-hundred and eighty-eight deviations and nine violations were detected in the 214 plans. The patterns of the deviations observed in the ICRs were similar to that in the DR. Frequent deviations were observed in clinical target volume (CTV) delineations, 50% in the DRs and 37% in the ICRs, respectively. In the ICRs, approximately 1.4 deviations/violations were observed per plan, which was lower than DR. Nine violations included inaccurate CTV delineation and improper PTV (planning target volume) margin, which had risks in loco-regional failures by inadequate dose coverage.
Our developed QA program commonly used in DR and ICR clarified the pitfalls in treatment plans. Although the frequent deviations in CTV delineations were observed in the ICR, the deviations decreased compared to that in the DR. More specified face-to-face meetings with participating institutions will be necessary to maintain the quality of IMRT in the clinical protocol.
日本临床肿瘤学组（JCOG）1402 进行了一项针对高危子宫颈癌患者术后强度调制放疗（IMRT）的多中心临床试验。我们通过在患者入组前和治疗后进行的模拟运行（DR）和个别病例回顾（ICR）评估中央审查质量保证（QA）计划的有效性，并阐明治疗计划中的缺陷。
对 214 个计划进行了与 DR 相同的 ICR 用 QA 程序。将偏差与 DR 中的偏差进行比较，并阐明了缺陷。与参与机构的医生举行了 15 次面对面会议，提供反馈。
在 214 个计划中发现了 288 个偏差和 9 个违规。在 ICR 中观察到的偏差模式与 DR 中的相似。CTV 勾画中经常出现偏差，DR 中为 50%，ICR 中为 37%。在 ICR 中，每个计划观察到约 1.4 个偏差/违规，低于 DR。9 个违规包括CTV 勾画不准确和 PTV（计划靶区）边界不当，由于剂量覆盖不足，存在局部区域失败的风险。
我们在 DR 和 ICR 中开发的 QA 程序普遍阐明了治疗计划中的缺陷。虽然在 ICR 中观察到 CTV 勾画的频繁偏差，但与 DR 相比，偏差有所减少。与参与机构进行更多具体的面对面会议将有助于保持临床试验方案中 IMRT 的质量。
