Purdy James A
Department of Radiation Oncology, University of California, Davis, School of Medicine, Sacramento, CA 95816, USA.
Int J Radiat Oncol Biol Phys. 2008;71(1 Suppl):S66-70. doi: 10.1016/j.ijrobp.2007.07.2393.
The National Cancer Institute-sponsored Advanced Technology Quality Assurance (QA) Consortium, which consisted of the Image-Guided Therapy QA Center, Radiation Therapy Oncology Group, Radiological Physics Center, Quality Assurance Review Center, and Resource Center for Emerging Technologies, has pioneered the development of an infrastructure and QA method for advanced technology clinical trials that requires volumetric digital data submission of a protocol patient's treatment plan and verification data. In particular, the Image-Guided Therapy QA Center has nearly 15 years experience in facilitating QA review for Radiation Therapy Oncology Group advanced technology clinical trials. This QA process includes (1) a data integrity review for completeness of protocol required elements, the format of data, and possible data corruption, and recalculation of dose-volume histograms; (2) a review of compliance with target volume and organ-at-risk contours by study chairs; and (3) a review of dose prescription and dose heterogeneity compliance by the Radiation Therapy Oncology Group Headquarters Dosimetry Group or the Radiological Physics Center dosimetrists (for brachytherapy protocols). This report reviews the lessons learned and the QA challenges presented by the use of advanced treatment modalities in clinical trials requiring volumetric digital data submission.
由美国国立癌症研究所资助的先进技术质量保证（QA）联盟，由图像引导治疗QA中心、放射治疗肿瘤学组、放射物理中心、质量保证审查中心和新兴技术资源中心组成，率先为先进技术临床试验开发了一种基础设施和QA方法，该方法要求提交方案患者治疗计划的体积数字数据和验证数据。特别是，图像引导治疗QA中心在促进放射治疗肿瘤学组先进技术临床试验的QA审查方面拥有近15年的经验。这个QA过程包括：（1）对方案要求要素的完整性、数据格式和可能的数据损坏进行数据完整性审查，并重新计算剂量体积直方图；（2）由研究负责人审查与靶区体积和危及器官轮廓的一致性；（3）由放射治疗肿瘤学组总部剂量测定组或放射物理中心剂量测定师（针对近距离放射治疗方案）审查剂量处方和剂量异质性的合规性。本报告回顾了在需要提交体积数字数据的临床试验中使用先进治疗方式所吸取的经验教训和QA挑战。
