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放射治疗临床试验中危险器官勾画:全球协调组共识指南。

Organ at risk delineation for radiation therapy clinical trials: Global Harmonization Group consensus guidelines.

机构信息

National Radiotherapy Trials Quality Assurance (RTTQA) Group, Mount Vernon Cancer Centre, United Kingdom.

European Organisation for Research and Treatment of Cancer (EORTC) Headquarters, Brussels, Belgium; Quality and Excellence in Radiotherapy and Imaging for Children and Adolescents with Cancer across Europe in Clinical Trials (QUARTET) Project, SIOP Europe, Brussels, Belgium.

出版信息

Radiother Oncol. 2020 Sep;150:30-39. doi: 10.1016/j.radonc.2020.05.038. Epub 2020 Jun 3.

Abstract

BACKGROUND AND PURPOSE

The Global Quality Assurance of Radiation Therapy Clinical Trials Harmonization Group (GHG) is a collaborative group of Radiation Therapy Quality Assurance (RTQA) Groups harmonizing and improving RTQA for multi-institutional clinical trials. The objective of the GHG OAR Working Group was to unify OAR contouring guidance across RTQA groups by compiling a single reference list of OARs in line with AAPM TG 263 and ASTRO, together with peer-reviewed, anatomically defined contouring guidance for integration into clinical trial protocols independent of the radiation therapy delivery technique.

MATERIALS AND METHODS

The GHG OAR Working Group comprised of 22 multi-professional members from 6 international RTQA Groups and affiliated organizations conducted the work in 3 stages: (1) Clinical trial documentation review and identification of structures of interest (2) Review of existing contouring guidance and survey of proposed OAR contouring guidance (3) Review of survey feedback with recommendations for contouring guidance with standardized OAR nomenclature.

RESULTS

157 clinical trials were examined; 222 OAR structures were identified. Duplicates, non-anatomical, non-specific, structures with more specific alternative nomenclature, and structures identified by one RTQA group were excluded leaving 58 structures of interest. 6 OAR descriptions were accepted with no amendments, 41 required minor amendments, 6 major amendments, 20 developed as a result of feedback, and 5 structures excluded in response to feedback. The final GHG consensus guidance includes 73 OARs with peer-reviewed descriptions (Appendix A).

CONCLUSION

We provide OAR descriptions with standardized nomenclature for use in clinical trials. A more uniform dataset supports the delivery of clinically relevant and valid conclusions from clinical trials.

摘要

背景与目的

全球放疗临床试验质量保证协调组(GHG)是一个由放疗质量保证(RTQA)小组组成的协作组,旨在协调和改进多机构临床试验的 RTQA。GHG 危及器官工作组成立的目的是通过编译一份符合 AAPM TG 263 和 ASTRO 的 OAR 参考列表,以及经过同行评审的、解剖定义的轮廓指导,来统一 RTQA 小组之间的 OAR 轮廓指导,将其纳入与放疗技术无关的临床试验方案中。

材料与方法

由来自 6 个国际 RTQA 小组和附属组织的 22 名多专业成员组成的 GHG 危及器官工作组分三个阶段开展工作:(1)临床试验文件审查和感兴趣结构的识别;(2)现有轮廓指导的审查和拟议 OAR 轮廓指导的调查;(3)对调查反馈的审查,并提出具有标准化 OAR 命名的轮廓指导建议。

结果

共检查了 157 项临床试验,确定了 222 个 OAR 结构。排除了重复、非解剖、非特定、具有更具体替代命名的结构、以及仅由一个 RTQA 小组识别的结构,留下 58 个感兴趣的结构。有 6 个 OAR 描述被接受,无需修订;41 个需要进行小的修订;6 个需要进行大的修订;20 个是根据反馈意见制定的;5 个因反馈而被排除。最终的 GHG 共识指导包括 73 个具有同行评审描述的 OAR(附录 A)。

结论

我们提供了具有标准化命名的 OAR 描述,用于临床试验。更统一的数据集支持从临床试验中得出具有临床意义和有效的结论。

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