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.
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.
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DOI：
10.1136/bmjopen-2015-009849
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发表时间：
2016-01-20
期刊：
影响因子：
2.9
通讯作者：
Blackhall F
中科院分区：
文献类型：
--
作者：
Faivre-Finn C;Falk S;Ashcroft L;Bewley M;Lorigan P;Wilson E;Groom N;Snee M;Fournel P;Cardenal F;Bezjak A;Blackhall F
同步每日一次与每日两次放射治疗(CONVERT)是唯一在欧洲和加拿大开放的多中心、国际、随机、第三阶段试验，旨在优化有限阶段小细胞肺癌(LS-SCLC)的放化疗(RT)。继每天一次与每天两次(BD)同步放化疗的Turrisi试验之后，确实需要一项新的III期试验，使用现代适形RT技术并研究更高的每日一次放射剂量。这项试验有可能为表现良好的LS-SCLC患者定义一种新的标准化疗-放疗方案。2008年至2013年期间，从8个国家的74个中心招募了447名经组织学或细胞学诊断为小细胞肺癌的患者。从第1周期的第22天开始，患者被随机分为两组，一组接受每日两次放疗(45 Gy30次，共3 周)，另一组每日一次放疗(66 Gy33次，每日一次，共6.5 周)，均从第1周期的第22天开始。这项研究的主要终点是总体存活率，次要终点包括局部无进展存活率、无转移存活率、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RT剂量强度。该试验获得了NRES西北-大曼彻斯特中心委员会的伦理批准(07/H1008/229)。有一个试验指导委员会，包括独立成员和独立的数据监测委员会。研究结果将发表在同行评议的期刊上，并在国际会议上公布。结果出炉前。
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. 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. 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. ISRCTN91927162; Pre-results.