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BMC Cancer
Published in: BMC Cancer 1/2017

Open Access 01-12-2017 | Study protocol

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)

Authors: Han Tang, Lijie Tan, Yaxing Shen, Hao Wang, Miao Lin, Mingxiang Feng, Songtao Xu, Weigang Guo, Cheng Qian, Tianshu Liu, Zhaochong Zeng, Yingyong Hou, Zhentao Yu, Hongjing Jiang, Zhigang Li, Chun Chen, Changhong Lian, Ming Du, Hecheng Li, Deyao Xie, Jun Yin, Naiqing Zhao, Qun Wang

Published in: BMC Cancer | Issue 1/2017

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Abstract

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(cT3-4aN0-1M0).

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 (cT3-4aN0-1M0) 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.

Trial registration

NCT03001596 (December 17, 2016).
Appendix
Available only for authorised users
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Metadata
Title
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)
Authors
Han Tang
Lijie Tan
Yaxing Shen
Hao Wang
Miao Lin
Mingxiang Feng
Songtao Xu
Weigang Guo
Cheng Qian
Tianshu Liu
Zhaochong Zeng
Yingyong Hou
Zhentao Yu
Hongjing Jiang
Zhigang Li
Chun Chen
Changhong Lian
Ming Du
Hecheng Li
Deyao Xie
Jun Yin
Naiqing Zhao
Qun Wang
Publication date
01-12-2017
Publisher
BioMed Central
Published in
BMC Cancer / Issue 1/2017
Electronic ISSN: 1471-2407
DOI
https://doi.org/10.1186/s12885-017-3446-7

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