Servagi-Vernat Stéphanie, Créhange Gilles, Bonnetain Franck, Mertens Cécile, Brain Etienne, Bosset Jean François
Department of radiotherapy, Institut de Cancérologie Jean Godinot, F-51100, Reims, France.
Departmentof radiotherapy, Centre Georges François Leclerc, F-21000, Dijon, France.
BMC Cancer. 2017 Jul 13;17(1):483. doi: 10.1186/s12885-017-3465-4.
The management of elderly patients with cancer is a therapeutic challenge and a public health problem. Definitive chemoradiotherapy (CRT) is an accepted standard treatment for patients with locally advanced esophageal cancer who cannot undergo surgery. However, there are few reports regarding tolerance to CRT in elderly patients. We previously reported results for CRT in patients aged ≥75 years. Following this first phase II trial, we propose to conduct a phase I/II study to evaluate the combination of carboplatin and paclitaxel, with concurrent RT in unresectable esophageal cancer patients aged 75 years or older.
METHODS/DESIGN: This prospective multicenter phase I/II study will include esophageal cancer in patients aged 75 years or older. Study procedures will consist to determinate the tolerated dose of chemotherapy (Carboplatin, paclitaxel) and of radiotherapy (41.4-45 and 50.4 Gy) in the phase I. Efficacy will be assessed using a co-primary endpoint encompassing health related quality of life and the progression-free survival in the phase II with the dose recommended of CRT in the phase I. This geriatric evaluation was defined by the French geriatric oncology group (GERICO).
This trial has been designed to assess the tolerated dose of CRT in selected patient aged 75 years or older.
Clinicaltrials.gov ID: NCT02735057 . Registered on 18 March 2016.
老年癌症患者的管理是一项治疗挑战，也是一个公共卫生问题。根治性放化疗（CRT）是无法接受手术的局部晚期食管癌患者公认的标准治疗方法。然而，关于老年患者对CRT耐受性的报道很少。我们之前报道了≥75岁患者CRT的结果。在这项一期试验之后，我们提议开展一项I/II期研究，以评估卡铂和紫杉醇联合同步放疗在75岁及以上不可切除食管癌患者中的疗效。
方法/设计：这项前瞻性多中心I/II期研究将纳入75岁及以上的食管癌患者。研究程序将在I期确定化疗（卡铂、紫杉醇）和放疗（41.4 - 45和50.4 Gy）的耐受剂量。在II期，将使用包括健康相关生活质量和无进展生存期的共同主要终点来评估疗效，采用I期推荐的CRT剂量。这种老年评估由法国老年肿瘤学组（GERICO）定义。
本试验旨在评估75岁及以上选定患者对CRT的耐受剂量。
Clinicaltrials.gov标识符：NCT02735057。于2016年3月18日注册。
