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

被引：3

作者：

Fan, Chengcheng ^{[1
]}

Wang, Xu ^{[1
,2
]}

Zheng, Xiaoli ^{[1
,2
]}

Sun, Yanan ^{[1
,2
]}

Ye, Ke ^{[1
,2
]}

Jiang, Yue ^{[1
,2
]}

Liu, Xiao ^{[1
,2
]}

Xu, Wencai ^{[1
,2
]}

Liu, Yang ^{[1
,2
]}

Yang, Yuanyuan ^{[1
,2
]}

Liu, Jinsong ^{[1
,2
]}

Jiang, Qiong ^{[1
,2
]}

He, Chunyu ^{[1
,2
]}

Wu, Xiaoyuan ^{[1
,2
]}

Nie, Xin ^{[1
,2
]}

Zhang, Jingwei ^{[1
,2
]}

Tan, Bo ^{[1
,2
]}

Wang, Wen ^{[1
,2
]}

Zhang, Yougai ^{[1
,2
]}

Feng, Zhuo ^{[1
,2
]}

Yang, Chengliang ^{[1
,2
]}

Lu, Yufei ^{[1
,2
]}

Liu, Hailong ^{[1
,2
]}

Chen, Xijuan ^{[1
,2
]}

Xu, Jing ^{[1
,2
]}

Liu, Fang ^{[1
,2
]}

Zheng, Xuefeng ^{[1
,2
]}

Wang, Jianhua ^{[1
,2
]}

Wu, Shang ^{[3
,4
]}

Chen, Guofu ^{[3
,4
]}

Zhang, Yaowen ^{[2
,5
]}

Jin, Linzhi ^{[2
,5
]}

Ge, Hong ^{[1
,2
]}

机构：

[1] Zhengzhou Univ, Affiliated Canc Hosp, Zhengzhou 450008, Peoples R China

[2] Henan Canc Hosp, Zhengzhou 450008, Peoples R China

[3] Zhengzhou Univ, Xinyang Hosp, Xinyang 464000, Peoples R China

[4] Xinyang Cent Hosp, Xinyang 464000, Peoples R China

[5] Anyang Canc Hosp, Anyang 455000, Peoples R China

来源：

BMC CANCER | 2024年 / 24卷 / 01期

关键词：

Esophageal squamous cell carcinoma; Consolidation chemotherapy; Definitive concurrent chemoradiotherapy; INTENSITY-MODULATED RADIOTHERAPY; CANCER; CISPLATIN; CAPECITABINE; CHEMORADIATION; PACLITAXEL; SURGERY;

D O I：

10.1186/s12885-024-12002-5

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

BackgroundDefinitive 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.MethodsThis 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.DiscussionThis study aid in further understanding the effects of consolidation chemotherapy after dCCRT in patients with locally advanced, inoperable ESCC.Trial registrationChiCTR1800017646.

引用

页数：8

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