Department of Medical Physics, Velindre Cancer Centre, Cardiff, CF14 2TL, UK.
National Radiotherapy Trials QA (RTTQA) Group, Velindre Cancer Centre, Cardiff, CF14 2TL, UK.
Radiat Oncol. 2017 Nov 15;12(1):179. doi: 10.1186/s13014-017-0916-7.
SCOPE 1 was the first UK based multi-centre trial involving radiotherapy of the oesophagus. A comprehensive radiotherapy trials quality assurance programme was launched with two main aims: 1. To assist centres, where needed, to adapt their radiotherapy techniques in order to achieve protocol compliance and thereby enable their participation in the trial. 2. To support the trial's clinical outcomes by ensuring the consistent planning and delivery of radiotherapy across all participating centres.
A detailed information package was provided and centres were required to complete a benchmark case in which the delineated target volumes and organs at risk, dose distribution and completion of a plan assessment form were assessed prior to recruiting patients into the trial. Upon recruiting, the quality assurance (QA) programme continued to monitor the outlining and planning of radiotherapy treatments. Completion of a questionnaire was requested in order to gather information about each centre's equipment and techniques relating to their trial participation and to assess the impact of the trial nationally on standard practice for radiotherapy of the oesophagus. During the trial, advice was available for individual planning issues, and was circulated amongst the SCOPE 1 community in response to common areas of concern using bulletins.
36 centres were supported through QA processes to enable their participation in SCOPE1. We discuss the issues which have arisen throughout this process and present details of the benchmark case solutions, centre questionnaires and on-trial protocol compliance. The range of submitted benchmark case GTV volumes was 29.8-67.8cm; and PTV volumes 221.9-513.3 cm. For the dose distributions associated with these volumes, the percentage volume of the lungs receiving 20Gy (V20Gy) ranged from 20.4 to 33.5%. Similarly, heart V40Gy ranged from 16.1 to 33.0%. Incidence of incorrect outlining of OAR volumes increased from 50% of centres at benchmark case, to 64% on trial. Sixty-five percent of centres, who returned the trial questionnaire, stated that their standard practice had changed as a result of their participation in the SCOPE1 trial.
The SCOPE 1 QA programme outcomes lend support to the trial's clinical conclusions. The range of patient planning outcomes for the benchmark case indicated, at the outset of the trial, the significant degree of variation present in UK oesophageal radiotherapy planning outcomes, despite the presence of a protocol. This supports the case for increasingly detailed definition of practice by means of consensus protocols, training and peer review. The incidence of minor inconsistencies of technique highlights the potential for improved QA systems and the need for sufficient resource for this to be addressed within future trials. As indicated in questionnaire responses, the QA exercise as a whole has contributed to greater consistency of oesophageal radiotherapy in the UK via the adoption into standard practice of elements of the protocol.
The SCOPE1 trial is an International Standard Randomized Controlled Trial, ISRCTN47718479 .
SCOPE1 是英国首例涉及食管放射治疗的多中心试验。启动了一项全面的放射治疗试验质量保证计划，主要有两个目标：1. 协助有需要的中心调整放射治疗技术，以达到协议要求，从而使其能够参与试验。2. 通过确保所有参与中心的放射治疗计划和实施的一致性，支持试验的临床结果。
提供了详细的信息包，要求中心完成基准案例，在该案例中，在招募患者参加试验之前，评估勾画的靶区和危及器官、剂量分布以及完成计划评估表。在招募之后，质量保证（QA）计划继续监测放射治疗的勾画和计划。要求完成一份调查问卷，以收集与每个中心参与试验相关的设备和技术的信息，并评估该试验对全国食管放射治疗标准实践的影响。在试验过程中，为个别计划问题提供了建议，并通过公告在 SCOPE1 社区中进行了交流，以解决共同关注的问题。
通过 QA 流程支持了 36 个中心参与 SCOPE1。我们讨论了整个过程中出现的问题，并介绍了基准案例解决方案、中心调查问卷和试验期间协议遵守情况的详细信息。提交的基准案例 GTV 体积范围为 29.8-67.8cm；PTV 体积为 221.9-513.3cm。对于与这些体积相关的剂量分布，肺部接受 20Gy（V20Gy）的体积百分比范围为 20.4%至 33.5%。同样，心脏 V40Gy 范围为 16.1%至 33.0%。不正确勾画 OAR 体积的发生率从基准案例时的 50%中心增加到试验时的 64%。返回试验问卷的 65%中心表示，他们的标准实践因参与 SCOPE1 试验而发生了变化。
SCOPE1 QA 计划的结果支持了试验的临床结论。基准案例的患者计划结果范围表明，尽管存在协议，但英国食管放射治疗计划结果存在很大程度的差异。这支持了通过共识协议、培训和同行评审来更详细地定义实践的情况。技术上的轻微不一致性表明需要改进 QA 系统，并需要在未来的试验中投入足够的资源来解决这一问题。正如问卷回答所表明的，整个 QA 工作通过采用协议中的要素，促进了英国食管放射治疗的更大一致性。
SCOPE1 试验是一项国际标准随机对照试验，ISRCTN47718479。
