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Clinical Trial
. 2017 Jun 28;17(1):450.
doi: 10.1186/s12885-017-3446-7.

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)

Han Tang  1 , Lijie Tan  2 , Yaxing Shen  1 , Hao Wang  1 , Miao Lin  1 , Mingxiang Feng  1 , Songtao Xu  1 , Weigang Guo  1 , Cheng Qian  1 , Tianshu Liu  3 , Zhaochong Zeng  4 , Yingyong Hou  5 , Zhentao Yu  6 , Hongjing Jiang  6 , Zhigang Li  7 , Chun Chen  8 , Changhong Lian  9 , Ming Du  10 , Hecheng Li  11 , Deyao Xie  12 , Jun Yin  13 , Naiqing Zhao  14 , Qun Wang  1
Affiliations
Clinical Trial

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)

Han Tang et al. BMC Cancer. .

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).

Keywords: Esophageal esophageal squamous carcinoma; Minimally invasive esophagectomy; Neoadjuvant chemoradiation; Neoadjuvant chemotherapy.

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Conflict of interest statement

Ethics approval and consent to participate

CMISG1701 was approved by the ethics committee of the Zhongshan Hospital (B2016-177R). The other eight medical ethics committees of the participating centers also gave positive advice on the local feasibility of the trial. During the study, all modifications, extensions and updates of trial procedures should be reviewed and approved by the medical ethics committee in every participating center. The CMISG1701 trial has been registered in the ClinicalTrials.gov registry (NCT03001596). Written informed consent will be obtained from all participants before randomization.

Consent for publication

Not applicable.

Competing interests

CMISG1701 is supported by two governmental funding bodies rather than commercial organizations, so there are no competing interests. Besides, the authors declare that they also have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

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Fig. 1
Trial diagram
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