目的:报告多中心POTENTIAL试验的计划基准病例结果,随机化,3期试验-评估内乳淋巴结(IMN)照射对高危乳腺癌患者的价值。
方法:向所有参与机构提供了一个基准案例的概要,他们根据方案制定了放射治疗计划。计划由质量保证小组评估,之后,这些机构重新提交了修订后的计划。有关光束布置的信息,皮肤闪光,不均匀性校正,并且在第一次和最后一次提交中评估了协议的遵守情况。
结果:分析了26个机构的计划。在第一次提交中发现了一些主要偏差。计划目标胸壁体积的剂量覆盖率的协议符合率,锁骨上窝加上腋窝,和IMN区域(PTVim)在最终提交中均有显著改善,这是96.2%vs.69.2%,100%vs.76.9%,和88.4%vs.53.8%,分别。对于OAR,心脏Dmean的依从率,左冠状动脉前降支V40Gy,同侧肺V5Gy,胃V5Gy显著改良。在第一次也是最后一次提交中,PTVimV100%的平均值为79.9%与92.7%;心脏Dmean的平均值为11.5Gyvs.9.7Gy用于大分割放射治疗,11.5Gy与11.0Gy用于常规分割放射治疗,分别。
结论:主要偏差得到纠正,修订后方案依从性显著提高,强调了规划基准案例对保证多中心试验规划质量的重要性。
OBJECTIVE: To report the planning benchmark
case results of the POTENTIAL trial-a multicenter, randomized, phase 3 trial-to evaluate the value of internal mammary nodal (IMN) irradiation for patients with high-risk breast cancer.
METHODS: All participating institutions were provided the outlines of one benchmark
case, and they generated radiation therapy plans per protocol. The plans were evaluated by a quality assurance team, after which the institutions resubmitted their revised plans. The information on beams arrangement, skin flash, inhomogeneity corrections, and protocol compliance was assessed in the first and final submission.
RESULTS: The plans from 26 institutions were analyzed. Some major deviations were found in the first submission. The protocol compliance rates of dose coverage for the planning target volume of chest wall, supraclavicular fossa plus axilla, and IMN region (PTVim) were all significantly improved in the final submission, which were 96.2% vs. 69.2%, 100% vs. 76.9%, and 88.4% vs. 53.8%, respectively. For OARs, the compliance rates of heart Dmean, left anterior descending coronary artery V40Gy, ipsilateral lung V5Gy, and stomach V5Gy were significantly improved. In the first and final submission, the mean values of PTVim V100% were 79.9% vs. 92.7%; the mean values of heart Dmean were 11.5 Gy vs. 9.7 Gy for hypofractionated radiation therapy and 11.5 Gy vs. 11.0 Gy for conventional fractionated radiation therapy, respectively.
CONCLUSIONS: The major deviations were corrected and protocol compliance was significantly improved after revision, which highlighted the importance of planning benchmark
case to guarantee the planning quality for multicenter trials.