Consolidation chemotherapy after definitive concurrent chemoradiotherapy in patients with inoperable esophageal squamous cell carcinoma: a multicenter non-inferiority phase III randomized clinical trial

期刊论文
出版模式：

开放获取
发表日期：

2024年3月7日

查看全文

Chengcheng Fan,
Xu Wang,
Xiaoli Zheng,
Yanan Sun,
Ke Ye,
Yue Jiang,
Xiao Liu,
Wencai Xu,
Yang Liu,
Yuanyuan Yang,
Jinsong Liu,
Qiong Jiang,
Chunyu He,
Xiaoyuan Wu,
Xin Nie,
Jingwei Zhang,
Bo Tan,
Wen Wang,
Yougai Zhang,
Zhuo Feng,
Chengliang Yang,
Yufei Lu,
Hailong Liu,
Xijuan Chen,
Jing Xu,
Fang Liu,
Xuefeng Zheng,
Jianhua Wang,
Shang Wu,
Guofu Chen,
Yaowen Zhang,
Linzhi Jin,
Hong Ge

摘要

Background

Definitive concurrent chemoradiotherapy (dCCRT) is the gold standard for the treatment of locally advanced esophageal squamous cell carcinoma (ESCC). However, the potential benefits of consolidation chemotherapy after dCCRT in patients with esophageal cancer remain debatable. Prospective randomized controlled trials comparing the outcomes of dCCRT with or without consolidation chemotherapy in patients with ESCC are lacking. In this study, we aim to generate evidence regarding consolidation chemotherapy efficacy in patients with locally advanced, inoperable ESCC.

Methods

This is a multicenter, prospective, open-label, phase-III randomized controlled trial comparing non-inferiority of dCCRT alone to consolidation chemotherapy following dCCRT. In total, 600 patients will be enrolled and randomly assigned in a 1:1 ratio to receive either consolidation chemotherapy after dCCRT (Arm A) or dCCRT alone (Arm B). Overall survival will be the primary endpoint, whereas progression-free survival, locoregional progression-free survival, distant metastasis-free survival, and treatment-related toxicity will be the secondary endpoints.

Discussion

This study aid in further understanding the effects of consolidation chemotherapy after dCCRT in patients with locally advanced, inoperable ESCC.

Trial registration

ChiCTR1800017646.