Overview

Chemoradiotherapy of Capecitabine With or Without Oxaliplatin Versus Cisplatin-5-FU for Esophageal Squamous Cancer

Status:
Active, not recruiting

Trial end date:
2022-04-25

Target enrollment:

Participant gender:

Summary

A three-arm Phase III trial was started in Oct. 2014. Definitive chemoradiotherapy with cisplatin plus 5-fluorouracil is the standard in Western countries in esophagus cancer. But in China because of its toxic reaction, most of patients stop the halfway. Because low toxicity, the chemotherapy regimen of capecitabine with or without oxaliplatin are widely used in clinical. The purpose of this study is to confirm the difference of Capecitabine plus with or without oxaliplatin over cisplatin plus 5-fluorouracil with definitive chemoradiotherapy for esophagus squamous cell carcinoma. A total of 630 patients will be accrued from China within 2 years. The primary endpoint is overall survival and the secondary endpoints include progression-free survival, response rate, pathologic complete response rate and adverse events.

Phase:

Phase 3

Details

Lead Sponsor:

The First Affiliated Hospital of Henan University of Science and Technology

Collaborators:

Anyang Cancer Hospital
Henan Oncology Hospital
Luoyang Central Hospital
Military 150 Hospital
Nanyang Central Hospital
Sanmenxia Central Hospital
The First Affiliated Hospital of Xinyang Medical College

Treatments:

Capecitabine
Cisplatin
Oxaliplatin