Khalladi N, Dejean C, Bosset M, Pointreau Y, Kinj R, Racadot S, Castelli J, Huguet F, Renard S, Guihard S, Tao Y, Rouvier J M, Johnson A, Bourhis J, Xu Shan S, Thariat J
Centre François Baclesse, 3, avenue General Harris, 14076 Caen, France.
Centre Antoine Lacassagne, Nice, France.
Cancer Radiother. 2021 Dec;25(8):755-762. doi: 10.1016/j.canrad.2021.04.005. Epub 2021 Sep 23.
A Benchmark Case (BC) was performed as part of the quality assurance process of the randomized phase 2 GORTEC 2014-14 OMET study, testing the possibility of multisite stereotactic radiation therapy (SBRT) alone in oligometastatic head and neck squamous cell carcinoma (HNSCC) as an alternative to systemic treatment and SBRT.
Compliance of the investigating centers with the prescription, delineation, planning and evaluation recommendations available in the research protocol was assessed. In addition, classical dosimetric analysis was supplemented by quantitative geometric analysis using conformation indices.
Twenty centers participated in the BC analysis. Among them, four major deviations (MaD) were reported in two centers. Two (10%) centers in MaD had omitted the satellite tumor nodule and secondarily validated after revision. Their respective DICE indexes were 0.37 and 0 and use of extracranial SBRT devices suboptimal There were significant residual heterogeneities between participating centers, including those with a similar SBRT equipment, with impact of plan quality using standard indicators and geometric indices.
A priori QA using a BC conditioning the participation of the clinical investigation centers showed deviations from good SBRT practice and led to the exclusion of one out of the twenty participating centers. The majority of centers have demonstrated rigorous compliance with the research protocol. The use of quality indexes adds a complementary approach to improve assessment of plan quality.
作为随机2期GORTEC 2014 - 14 OMET研究质量保证流程的一部分，开展了一项基准病例（BC）研究，测试寡转移头颈鳞状细胞癌（HNSCC）单纯采用多中心立体定向放射治疗（SBRT）作为全身治疗和SBRT替代方案的可能性。
评估各研究中心对研究方案中处方、靶区勾画、计划制定及评估建议的依从性。此外，传统剂量学分析通过使用适形指数的定量几何分析进行补充。
20个中心参与了BC分析。其中，两个中心报告了4项主要偏差（MaD）。发生MaD的两个（10%）中心遗漏了卫星肿瘤结节，修订后进行了二次验证。它们各自的DICE指数分别为0.37和0，且颅外SBRT设备的使用欠佳。参与的中心之间存在显著的残余异质性，包括那些拥有类似SBRT设备的中心，这对使用标准指标和几何指数的计划质量产生了影响。
采用BC对临床研究中心参与情况进行前期质量保证，结果显示存在偏离良好SBRT实践的情况，并导致20个参与中心中有1个被排除。大多数中心已证明严格遵守研究方案。使用质量指标为改进计划质量评估增添了一种补充方法。
