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A Trial of CMNa Combined With Concurrent Chemoradiotherapy for Locally Recurrent ESCC

Esophageal Neoplasms Clinical Trial

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

Clinical Trial Summary

This is a perspective, multicenter,single arm, open study to evaluate the efficacy and safety of treatment with CMNa combined with concurrent chemoradiotherapy in patients with locally recurrent 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 safety 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 40 cases. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02721576
Study type Interventional
Source Shandong Cancer Hospital and Institute
Contact
Status Terminated
Phase Phase 4
Start date July 5, 2016
Completion date July 30, 2018
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