CONVERT试验方案——同步每日一次与每日两次放疗：一项针对局限期小细胞肺癌（LS-SCLC）且体能状态良好患者的同步放化疗国际双臂随机对照试验，比较每日两次与每日一次放疗方案
Protocol for the CONVERT trial-Concurrent ONce-daily VErsus twice-daily RadioTherapy: an international 2-arm randomised controlled trial of concurrent chemoradiotherapy comparing twice-daily and once-daily radiotherapy schedules in patients with limited stage small cell lung cancer (LS-SCLC) and good performance status.
作者信息
Faivre-Finn Corinne, Falk Sally, Ashcroft Linda, Bewley Michelle, Lorigan Paul, Wilson Elena, Groom Nicki, Snee Michael, Fournel Pierre, Cardenal Felipe, Bezjak Andrea, Blackhall Fiona
机构信息
Manchester Academic Health Science Centre, Institute of Cancer Sciences, Manchester Cancer Research Centre (MCRC), The University of Manchester, Manchester, UK Radiotherapy Related Research, The Christie NHS Foundation Trust, Manchester, UK.
Manchester Academic Health Science Centre Trials Coordination Unit (MAHSC-CTU), The Christie NHS Foundation Trust, Manchester, UK.
出版信息
BMJ Open. 2016 Jan 20;6(1):e009849. doi: 10.1136/bmjopen-2015-009849.
INTRODUCTION
Concurrent ONce-daily VErsus twice-daily RadioTherapy (CONVERT) is the only multicentre, international, randomised, phase III trial open in Europe and Canada looking at optimisation of chemoradiotherapy (RT) in limited stage small cell lung cancer (LS-SCLC). Following on from the Turrisi trial of once-daily versus twice-daily (BD) concurrent chemoradiotherapy, there is a real need for a new phase III trial using modern conformal RT techniques and investigating higher once-daily radiation dose. This trial has the potential to define a new standard chemo-RT regimen for patients with LS-SCLC and good performance status.
METHODS AND ANALYSIS
447 patients with histologically or cytologically proven diagnosis of SCLC were recruited from 74 centres in eight countries between 2008 and 2013. Patients were randomised to receive either concurrent twice-daily RT(45 Gy in 30 twice-daily fractions over 3 weeks) or concurrent once-daily RT(66 Gy in 33 once-daily fractions over 6.5 weeks) both starting on day 22 of cycle 1. Patients are followed up until death. The primary end point of the study is overall survival and secondary end points include local progression-free survival, metastasis-free survival, acute and late toxicity based on the Common Terminology Criteria for Adverse Events V.3.0, chemotherapy and RTdose intensity.
ETHICS AND DISSEMINATION
The trial received ethical approval from NRES Committee North West-Greater Manchester Central (07/H1008/229). There is a trial steering committee, including independent members and an independent data monitoring committee. Results will be published in a peer-reviewed journal and presented at international conferences.
TRIAL REGISTRATION NUMBER
ISRCTN91927162; Pre-results.
简介
同步每日一次与每日两次放疗对比研究（CONVERT）是欧洲和加拿大开展的唯一一项多中心、国际性、随机、III期试验，旨在优化局限期小细胞肺癌（LS-SCLC）的放化疗。继图里西关于每日一次与每日两次（BD）同步放化疗的试验之后，确实需要开展一项新的III期试验，采用现代适形放疗技术并研究更高的每日一次放疗剂量。该试验有可能为LS-SCLC且体能状态良好的患者确定一种新的标准放化疗方案。
方法与分析
2008年至2013年期间，从八个国家的74个中心招募了447例经组织学或细胞学确诊为SCLC的患者。患者被随机分配接受同步每日两次放疗（3周内分30次给予45 Gy，每日两次）或同步每日一次放疗（6.5周内分33次给予66 Gy，每日一次），均从第1周期的第22天开始。对患者进行随访直至死亡。研究的主要终点是总生存期，次要终点包括局部无进展生存期、无转移生存期、基于不良事件通用术语标准V.3.0的急性和晚期毒性、化疗和放疗剂量强度。
伦理与传播
该试验获得了西北-大曼彻斯特中部国家研究伦理服务委员会（07/H1008/229）的伦理批准。有一个试验指导委员会，包括独立成员和一个独立的数据监测委员会。结果将在同行评审期刊上发表，并在国际会议上公布。
试验注册号
ISRCTN91927162；预结果。
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