NCT00642239

A Clinical Trial of a Radiation Sensitizer in Radiochemotherapy for Thoracic Esophageal Squamous Carcinoma

A Double-Blind, Placebo-Controlled, Randomized Clinical Trial of Sodium Glycididazole in Concurrent Radiochemotherapy for the Treatment of Thoracic Esophageal Squamous Carcinoma

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Shandong Luye Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This multicentered clinical trial is going to find out the radio-sensitization action of sodium glycididazole in radiochemotherapy for esophageal cancer.

Detailed description

Esophageal cancer is one of the most frequent causes of cancer death in the world. The most common type of esophageal cancer is squamous cell carcinoma (SCC) in China. Although concurrent radiochemotherapy is recommended as the standard treatment for advanced esophageal carcinoma, the local failure still reaches up to 44%-54%. Sodium Glycididazole(CMNa) is a radiosensitive drug for hypoxic tumor cells. Clinical trials showed that CMNa can improve local control rate and survival rate of esophageal cancer. This study is going to confirm the efficacy and safety of CMNa in concurrent radiochemotherapy of radiotherapy and 5-FU+DDP for esophageal squamous carcinoma.

Conditions

• Esophageal Carcinoma

Interventions

Type	Name	Description
DRUG	placebo	placebo in 100 mL 0.9% NaCl intravenous drip in 30 minutes,then begin radiotherapy in 60 minutes.duration of treatment is 6 weeks.
DRUG	Sodium Glycididazole	Sodium Glycididazole 700mg/m2 in 100 mL 0.9% NaCl intravenous drip in 30 minutes,then begin radiotherapy in 60 minutes.duration of treatment is 6 weeks.

Timeline

• Start date: 2008-04-01
• Primary completion: 2008-12-01
• Completion: 2009-12-01
• First posted: 2008-03-25
• Last updated: 2008-05-14

Locations

4 sites across 1 country: China