Geneva University Hospital, Switzerland.
Radiother Oncol. 2011 Jul;100(1):150-6. doi: 10.1016/j.radonc.2011.05.073. Epub 2011 Jun 29.
The European Organization for the Research and Treatment of Cancer (EORTC) is a pan-European structure charged with improving cancer treatment through the testing of new therapeutic strategies in phases I-III clinical studies. Properly conducted trials in radiation oncology are required to demonstrate superiority of a new treatment over the current standard. The Radiation Oncology Group (ROG) has initiated a complex quality assurance (QA) program to ensure safe and effective treatment delivery. Most modern trials are multicenter and multidisciplinary, further increasing the importance of early, strict and consistent QA in radiotherapy (RT). QART measures confirm whether a site possesses minimum staff and equipment for participation. Dummy runs, reviews of patient treatment plans and complex dosimetry checks verify the ability of an institution to comply with the protocol. Data required for evaluation are increasingly exchanged digitally, allowing detailed plan reconstruction, evaluation of target volume delineation and recalculation of dose-volume parameters for comparison against predefined standards. The five tiers of QA implemented in EORTC trials are reviewed, along with past, current and future QART initiatives. As substantial human and financial resources are increasingly invested in QART, the importance of cost-benefit analysis of QA and its impact on clinical outcome cannot be overstated.
欧洲癌症研究与治疗组织（EORTC）是一个泛欧结构，负责通过在 I-III 期临床试验中测试新的治疗策略来改善癌症治疗。为了证明新的治疗方法优于当前的标准，需要进行适当的放射肿瘤学试验。放射肿瘤学组（ROG）已经启动了一个复杂的质量保证（QA）计划，以确保安全有效的治疗。大多数现代试验是多中心和多学科的，这进一步增加了早期、严格和一致的放射治疗（RT）QA 的重要性。QART 测量结果确认一个机构是否具备参与试验的最低人员和设备。模拟运行、患者治疗计划的审查以及复杂的剂量学检查验证了机构是否有能力遵守协议。越来越多的评价数据以数字方式交换，允许对目标体积勾画和剂量体积参数进行详细的计划重建、评估和重新计算，以与预设标准进行比较。本文回顾了 EORTC 试验中实施的五个层次的 QA，以及过去、现在和未来的 QART 计划。由于大量的人力和财力投入到 QART 中，QA 的成本效益分析及其对临床结果的影响怎么强调都不为过。
