EORTC Headquarters, Brussels, Belgium.
Eur J Cancer. 2012 May;48(7):1048-54. doi: 10.1016/j.ejca.2012.02.008. Epub 2012 Mar 1.
The European Organisation for Research and Treatment of Cancer (EORTC) Master Protocol for phase III radiation therapy (RT) studies was published in 1995 to define in a consistent sequence the parameters which must be addressed when designing a phase III trial 'from the rationale to the references'. This was originally implemented to assist study investigators and writing committees, and to increase homogeneity within Radiation Oncology Group (ROG) study protocols. However, RT planning, delivery, treatment verification and quality assurance (QA) have evolved significantly over the last 15 years and clinical trial protocols must reflect these developments. The goal of this update is to describe the incorporation of these developments into the EORTC-ROG protocol template. Implementation of QA procedures for advanced RT trials is also briefly described as these essential elements must also be clearly articulated. This guide may assist both investigators participating in current ROG trials and others involved in writing an advanced RT trial protocol.
欧洲癌症研究与治疗组织（EORTC）于 1995 年发布了用于 III 期放射治疗（RT）研究的主方案，以一致的顺序定义在设计 III 期试验时必须解决的参数，从原理到参考文献。这最初是为了协助研究人员和写作委员会，并增加放射肿瘤学组（ROG）研究方案的同质性。然而，在过去的 15 年中，RT 计划、交付、治疗验证和质量保证（QA）有了显著的发展，临床试验方案必须反映这些发展。本更新的目标是描述将这些发展纳入 EORTC-ROG 方案模板。还简要描述了高级 RT 试验的 QA 程序的实施，因为这些基本要素也必须明确说明。本指南可能有助于参与当前 ROG 试验的研究人员和其他参与编写高级 RT 试验方案的人员。
