NCT02721563

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Shandong Cancer Hospital and Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Esophageal Neoplasms

Interventions

Type	Name	Description
DRUG	Sodium Glycididazole	Sodium Glycididazole 700mg/m2.Three times a week (once every other one day),before radiation therapy, total 6 weeks.
DRUG	Placebo	Placebo:three times a week (once every other one day),before radiation therapy, total 6 weeks.

Timeline

• Start date: 2016-02-25
• Primary completion: 2018-06-10
• Completion: 2018-06-30
• First posted: 2016-03-29
• Last updated: 2019-10-11

Locations

10 sites across 1 country: China