NRG/RTOG 0848是一项两步骤的随机试验，旨在评估术后化疗后（第二步）联合氟嘧啶和放射治疗（RT）对手术切除胰头腺癌患者的疗效。每位接受RT的患者都进行了实时质量保证（QA）评估。本分析旨在评估对规定轮廓和治疗计划的遵守情况，并报告需要修订的偏离类型和频率。除了基于网络的轮廓图集外，该方案还提供了逐步指导，以通过创建特定的感兴趣区域生成临床治疗容积（CTV）。规划靶体积（PTV）是CTV均匀扩展0.5厘米。两名放射治疗学研究主席中的一位独立审查了每个计划。存在不可接受的偏差的计划被退回以进行修订，并直到获得批准后再次提交。在RT计划最终获得批准后开始治疗。2014年至2018年，共有354名患者被纳入第二次随机分组。其中，160名患者接受了RT，并被纳入QA分析。对于使用3D-CRT进行计划的患者，重新提交较为常见（43%），而对于使用IMRT进行计划的患者，重新提交较少（31%）。总共，33%的患者需要至少一次重新提交治疗计划。在需要重新提交的患者中，大多数只需要一次重新提交（87%）。重新提交的最常见原因是与术前总靶体积（60.7%）和胰十二指肠吻合口（47.5%）有不可接受的偏差。结论：三分之一的患者需要重新提交以符合方案的符合性标准，这表明在评估放射治疗使用的试验中，特别是在胰腺癌中，需要继续在治疗前实施实时QA，以便更好地利用资源。严格的QA对于涉及RT的临床试验至关重要，以确保评估RT的真实影响。此外，RT QA作为一种教育过程，通过向实施放射治疗学的放射肿瘤学专家提供反馈，以促进最佳实践。版权所有 © 2023。由Elsevier公司出版。

NRG/RTOG 0848 is a two-step randomized trial to evaluate the benefit of the addition of concurrent fluoropyrimidine and radiotherapy (RT) following adjuvant chemotherapy (2nd step) for patients with resected pancreatic head adenocarcinoma. Real-time quality assurance (QA) was performed on each patient who underwent RT. This analysis aims to evaluate adherence to protocol-specified contouring and treatment planning and to report the types and frequencies of deviations requiring revisions.In addition to a web-based contouring atlas, the protocol outlined step-by-step instructions for generating the clinical treatment volume (CTV) through the creation of specific regions of interest. The planning target volume (PTV) was a uniform 0.5cm CTV expansion. One of two radiation oncology study chairs independently reviewed each plan. Plans with unacceptable deviations were returned for revision and resubmitted until approved. Treatment started after final approval of the RT plan.From 2014-2018, 354 patients were enrolled in the second randomization. Of these, 160 patients received RT and were included in the QA analysis. Resubmissions were more common for patients planned with 3D-CRT (43%) than with IMRT (31%). In total, at least one resubmission of the treatment plan was required for 33% of patients. Among patients requiring resubmission, most only needed one resubmission (87%). The most common reasons for resubmission were unacceptable deviations with respect to the pre-operative gross target volume (60.7%) and the pancreaticojejunostomy (47.5%), CONCLUSION: One-third of patients required resubmission to meet protocol compliance criteria, demonstrating the continued need for expending resources on real-time, pretreatment QA in trials evaluating the use of radiotherapy, particularly for pancreas cancer. Rigorous QA is critically important for clinical trials involving RT to ensure that the true impact of RT is assessed. Moreover, RT QA serves as an educational process through providing feedback from specialists to practicing radiation oncologists on best practices.Copyright © 2023. Published by Elsevier Inc.