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Chemoradiation Versus Esophagectomy for Locally Advanced Esophageal Cancer — CELAEC  

Esophagus Cancer Clinical Trial

Official title:
A Randomized, Open-label, Multicenter Trial of the Chemoradiation Versus Standard Esophagectomy for Locally Advanced Resectable Esophageal Squamous Cell Cancer in Chinese Patients

Clinical Trial Summary

The aim of this study is to compare outcomes in Chinese patients with locally advanced resectable esophageal squamous cell cancer who have received either surgery or definitive chemoradiation (CRT) by the randomized, open-label, multicenter trial.

Clinical Trial Description

Background: More than half of global esophageal cancer cases came from China, but the report about definitive chemoradiation (CRT) compared with esophagectomy in Chinese patients with locally advanced resectable esophageal squamous cell cancer (ESCC) is limited. Aim: to compare outcomes in Chinese patients with locally advanced resectable esophageal squamous cell cancer who have received either surgery or definitive chemoradiation (CRT). Methods: 176 ESCC patients with T1bN+M0, T2-4aN0-2M0 will be randomized to CRT group or Surgery group.In the CRT group, patients will be given intensity modulation radiation therapy (IMRT) with 50Gy/25 fractions , and current chemotherapy with 5-fluorouracil (5-FU) basic regimens. In the surgery group, patients will received standard esophagectomy. 5 years follow-up for both groups patients. Primary endpoints: 2 year and 5 year Disease free survival, Overall survival Second endpoints: treatment-related adverse events; the quality of life ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02972372
Study type Interventional
Source The First Affiliated Hospital of Henan University of Science and Technology
Contact Shegan Gao, MD, PhD
Phone +86 18638859977
Email gsg112258@163.com
Status Recruiting
Phase N/A
Start date November 2016
Completion date June 2021
View Details
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