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A Trial of CMNa Combined With Definitive Concurrent Chemoradiotherapy for Locally Advanced ESCC

Esophageal Neoplasms Clinical Trial

Official title:
A Perspective Random Trial of Sodium Glycididazole Combined With Definitive Concurrent Chemoradiotherapy for Locally Advanced Squamous Cell Esophageal Carcinoma

Clinical Trial Summary

This is a perspective, multicenter,randomized controlled trial to evaluate the efficacy and safety of treatment with CMNa combined with concurrent chemoradiotherapy in patients with locally advanced squamous cell esophageal carcinoma . Analyses of primary objective (ORR) will be done as defined in the protocol.

Clinical Trial Description

The primary end point of this study is objective response rate.The secondary end point is OS, PFS and the safty of drug. The primary hypothesis is the CMNa will improve ORR and thus improve OS, PFS. Assuming bilateral a=0.05, statistical power of 80%.The total sample size is 104 cases. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02721563
Study type Interventional
Source Shandong Cancer Hospital and Institute
Contact
Status Completed
Phase Phase 4
Start date February 25, 2016
Completion date June 30, 2018
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