CMISG1701: a multicenter prospective randomized phase III clinical trial comparing neoadjuvant chemoradiotherapy to neoadjuvant chemotherapy followed by minimally invasive esophagectomy in patients with locally advanced resectable esophageal squamous cell carcinoma (cT3-4aN0-1M0) (NCT03001596)

被引：27

作者：

Tang, Han ^{[1
]}

Tan, Lijie ^{[1
]}

Shen, Yaxing ^{[1
]}

Wang, Hao ^{[1
]}

Lin, Miao ^{[1
]}

Feng, Mingxiang ^{[1
]}

Xu, Songtao ^{[1
]}

Guo, Weigang ^{[1
]}

Qian, Cheng ^{[1
]}

Liu, Tianshu ^{[2
]}

Zeng, Zhaochong ^{[3
]}

Hou, Yingyong ^{[4
]}

Yu, Zhentao ^{[5
]}

Jiang, Hongjing ^{[5
]}

Li, Zhigang ^{[6
]}

Chen, Chun ^{[7
]}

Lian, Changhong ^{[8
]}

Du, Ming ^{[9
]}

Li, Hecheng ^{[10
]}

Xie, Deyao ^{[11
]}

Yin, Jun ^{[12
]}

Zhao, Naiqing ^{[13
]}

Wang, Qun ^{[1
]}

机构：

[1] Fudan Univ, Zhongshan Hosp, Dept Thorac Surg, 180 Fenglin Rd, Shanghai 200032, Peoples R China

[2] Fudan Univ, Zhongshan Hosp, Dept Med Oncol, Shanghai 200032, Peoples R China

[3] Fudan Univ, Zhongshan Hosp, Dept Radiotherapy, Shanghai 200032, Peoples R China

[4] Fudan Univ, Zhongshan Hosp, Dept Pathol, Shanghai 200032, Peoples R China

[5] Tianjin Med Univ, Canc Inst & Hosp, Key Lab Canc Prevent & Therapy Tianjin City, Dept Esophageal Canc, Tianjin 300060, Peoples R China

[6] Shanghai Jiao Tong Univ, Shanghai Chest Hosp, Dept Thorac Surg, Shanghai 200032, Peoples R China

[7] Fujian Med Univ, Fujian Union Hosp, Dept Thorac Surg, Fuzhou 350001, Fujian, Peoples R China

[8] Changzhi Med Coll, Heping Hosp, Dept Gen Surg, Changzhi 046000, Shanxi, Peoples R China

[9] Chongqing Med Univ, Affiliated Hosp 1, Dept Cardiothorac Surg, Chongqing 400016, Peoples R China

[10] Shanghai Jiao Tong Univ, Sch Med, Ruijin Hosp, Dept Thorac Surg, Shanghai 200025, Peoples R China

[11] Wenzhou Med Univ, Affiliated Hosp 1, Dept Cardiothorac Surg, Wenzhou 325035, Zhejiang, Peoples R China

[12] Jiangsu Univ, Affiliated Peoples Hosp, Dept Cardiothorac Surg, Zhenjiang 212002, Jiangsu, Peoples R China

[13] Fudan Univ, Sch Publ Hlth, Dept Biostat, Shanghai 200032, Peoples R China

来源：

BMC CANCER | 2017年 / 17卷

关键词：

Esophageal esophageal squamous carcinoma; Neoadjuvant chemoradiation; Neoadjuvant chemotherapy; Minimally invasive esophagectomy; CANCER; OUTCOMES; SURGERY; SURVIVAL;

D O I：

10.1186/s12885-017-3446-7

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Background: Neoadjuvant chemoradiation is not recommended as an approach for treatment of esophageal squamous cell carcinoma due to its significant postoperative mortality. However, it is assumed the combination of neoadjuvant chemoradiation with minimally invasive esophagectomy (MIE) may reduce postoperative mortality, which can revive preoperative chemoradiation. No randomized controlled studies comparing neoadjuvant chemoradiation plus MIE with neoadjuvant chemotherapy plus MIE have been performed so far. The present trial is initiated to obtain valid information whether neoadjuvant chemoradiation plus MIE yields better survival without worse postoperative morbidity and mortality in the treatment of locally advanced resectable esophageal squamous cell carcinoma(cT(3-4a)N(0-1)M(0)). Methods/design: CMISG1701 is a multicenter, prospective, randomized, phase III clinical trial, investigating the safety and efficacy of neoadjuvant chemoradiation plus MIE compared with neoadjuvant chemotherapy plus MIE. Patients with locally advanced resectable esophageal squamous cell carcinoma (cT(3-4a)N(0-1)M(0)) are eligible for the study. A total of 264 patients are randomly assigned to neoadjuvant chemoradiation (arm A) or neoadjuvant chemotherapy (arm B) with a 1:1 allocation ratio. The primary outcome is overall survival assessed with a minimum follow-up of 36 months. Secondary outcomes are progression-free survival, recurrence-free survival, postoperative pathologic stage, treatment-related complications, postoperative mortality as well as quality of life. Discussion: The objective of this trial is to identify the superior protocol with regard to patient survival, treatment morbidity/mortality and quality of life between neoadjuvant chemoradiation plus MIE and neoadjuvant chemotherapy plus MIE.

引用

页数：8

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