Clinical Trials Logo

Clinical Trial Summary

A two-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.

The purpose of this study is to confirm the difference of 2 and 4 cycles of cisplatin plus 5-fluorouracil in the definitive chemoradiotherapy for esophagus squamous cell carcinoma. A total of 210 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.


Clinical Trial Description

We plan to recruit the patients who were pathologically confirmed with esophageal squamous cell carcinoma from the Oct 2014. The patients will be divided into two groups.Experimental group: Two cycles of cisplatin plus 5-fluorouracil concurrent radiotherapy.Control group:Four cycles of cisplatin plus 5-fluorouracil and concurrent radiotherapy.To evaluate the overall survival of the 2 group. Also observe the patient's progression-free survival, response rate, pathologic complete response rate and adverse events. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02607540
Study type Interventional
Source The First Affiliated Hospital of Henan University of Science and Technology
Contact Shegan Gao, Doctor
Phone 18638859977
Email gsg112258@163.com
Status Recruiting
Phase Phase 3
Start date October 2014
Completion date December 2020

See also
  Status Clinical Trial Phase
Recruiting NCT02628665 - Clinical Study of Time Optimizing of Endoscopic Photodynamic Therapy on Esophageal and/or Gastric Cardiac Cancer Phase 3
Recruiting NCT02603159 - Different Cycles of Capecitabine Usage in Esophageal Cancer Concurrent Chemoradiotherapy Phase 3
Recruiting NCT02604615 - The Role of Different Cycles of Chemotherapy(Capecitabine-oxaliplatin) in Esophageal Chemoradiotherapy Phase 3
Active, not recruiting NCT02025036 - Chemoradiotherapy of Capecitabine With or Without Oxaliplatin Versus Cisplatin-5-FU for Esophageal Squamous Cancer Phase 3
Completed NCT02644408 - Megestrol Acetate for the Improvement of Quality of Life in Esophageal Cancer With Chemoradiotherapy Phase 3
Recruiting NCT02812641 - Neoadjuvant CCRT With/Without Bevacizumab for Locally Advanced ESCC Phase 2
Completed NCT02459457 - A Comparison of Paclitaxel-based Three Regimens Concurrent With Radiotherapy for Patients With Local Advanced Esophageal Cancer Phase 3