Department of Clinical Oncology, Weston Park Hospital, Sheffield, UK.
Cancer Research UK Clinical Trials Unit, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.
BMJ Open. 2019 Jan 29;9(1):e019903. doi: 10.1136/bmjopen-2017-019903.
Lung cancer is the most common cause of cancer mortality in the UK, and non-small-cell lung cancer (NSCLC) accounts for approximately 85% of all lung cancers. Most patients present with inoperable disease; therefore, radiotherapy plays a major role in treatment. However, the majority of patients are not suitable for the gold standard treatment (concurrent chemoradiotherapy) due to performance status and comorbidities. Novel strategies integrating radiotherapy advances and radiobiological knowledge need to be evaluated in patients treated with sequential chemoradiotherapy. Four separate dose escalation accelerated radiotherapy schedules have been completed in UK (CHART-ED, IDEAL-CRT, I-START and Isotoxic IMRT). This study will compare these schedules with a UK standard sequential chemoradiotherapy schedule of 55 Gy in 20 fractions over 4 weeks. As it would be impossible to test all schedules in a phase III study, the aim is to use a combined randomised phase II screening/'pick the winner' approach to identify the best schedule to take into a randomised phase III study against conventionally fractionated radiotherapy.
Suitable patients will have histologically/cytologically confirmed, stage III NSCLC and are able to undergo chemoradiotherapy treatment. The study will recruit 360 patients; 120 on the standard arm and 60 on each experimental arm. Patients will complete 2-4 cycles of platinum-based chemotherapy before being randomised to one of the radiotherapy schedules. The primary endpoint is progression-free survival, with overall survival, time to local-regional failure, toxicity and cost-effectiveness as secondary objectives.
The study has received ethical approval (research ethics committee (REC) reference: 16/WS/0165) from the West of Scotland REC 1. The trial is conducted in accordance with the Declaration of Helsinki and Good Clinical Practice. Trial results will be published in a peer-reviewed journal and presented internationally.
ISRCTN47674500.
肺癌是英国癌症死亡的最常见原因，非小细胞肺癌（NSCLC）约占所有肺癌的 85%。大多数患者表现为不可手术的疾病；因此，放射治疗在治疗中起着重要作用。然而，由于身体状况和合并症，大多数患者不适合黄金标准治疗（同期放化疗）。需要在接受序贯放化疗的患者中评估整合放射治疗进展和放射生物学知识的新策略。英国已经完成了四项单独的剂量递增加速放射治疗方案（CHART-ED、IDEAL-CRT、I-START 和等剂量调强放疗）。本研究将比较这些方案与英国标准的序贯放化疗方案（55 Gy，20 个分次，4 周完成）。由于不可能在 III 期研究中测试所有方案，因此本研究的目的是使用联合随机 II 期筛选/选择最佳方案的方法，以确定最佳方案进入随机 III 期研究，与常规分割放疗进行比较。
适合的患者将具有组织学/细胞学证实的 III 期 NSCLC，能够接受放化疗治疗。该研究将招募 360 名患者；标准组 120 名，实验组每组 60 名。患者将在接受随机分组至其中一种放射治疗方案之前完成 2-4 个周期的铂类为基础的化疗。主要终点是无进展生存期，次要终点是总生存期、局部区域失败时间、毒性和成本效益。
该研究已获得西苏格兰 REC 1 的伦理批准（研究伦理委员会（REC）参考号：16/WS/0165）。该试验符合赫尔辛基宣言和良好临床实践。试验结果将在同行评议的期刊上发表，并在国际上进行报告。
ISRCTN47674500。
