International Trials Management Section, Clinical Research Support Office, National Cancer Center Hospital, Japan.
Medical Department, EORTC Headquarters, Belgium.
Jpn J Clin Oncol. 2019 Dec 18;49(11):1055-1060. doi: 10.1093/jjco/hyz112.
A randomized phase III trial commenced in Japan in February 2018. Definitive chemoradiotherapy (CRT) with cisplatin plus 5-fluorouracil is the current standard treatment for locally advanced unresectable esophageal carcinoma. The purpose of this study is to confirm the superiority of induction chemotherapy with docetaxel plus cisplatin and 5-fluorouracil (DCF) followed by conversion surgery or definitive CRT over definitive CRT alone for overall survival (OS) in patients with locally advanced unresectable squamous-cell carcinoma of thoracic esophagus. A total of 230 patients will be accrued from 47 Japanese institutions over 4.5 years. The primary endpoint is OS, and the secondary endpoints are progression-free survival, complete response rate of CRT, response rate of DCF, adverse events of DCF and CRT, late adverse events and surgical complications. This trial has been registered at the Japan Registry of Clinical Trials as jRCTs031180181.
一项随机 III 期临床试验于 2018 年 2 月在日本启动。顺铂联合 5-氟尿嘧啶的确定性放化疗（CRT）是目前局部晚期不可切除食管癌的标准治疗方法。本研究旨在确认多西他赛联合顺铂和 5-氟尿嘧啶（DCF）诱导化疗后行转化手术或确定性 CRT 与单纯确定性 CRT 相比，在局部晚期不可切除的胸段食管鳞状细胞癌患者中的总生存期（OS）方面的优越性。该研究将在 4.5 年内从 47 家日本机构共招募 230 名患者。主要终点为 OS，次要终点为无进展生存期、CRT 的完全缓解率、DCF 的缓解率、DCF 和 CRT 的不良事件、晚期不良事件和手术并发症。该试验已在日本临床试验注册中心（jRCTs031180181）注册。
