NCT02025036

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

Three-arm Phase III Trial Comparing Radiotherapy With Different Chemotherapy Regimens for Esophageal Cancer

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 249 (actual)
• Sponsor: The First Affiliated Hospital of Henan University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 249 patients will be accrued from China within 2 years. The primary endpoints are grade 3-5 AEs and overall survival and the secondary endpoints include progression-free survival, response rate, pathologic complete response rate.

Detailed 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 three groups.Experimental group 1 : single drug Capecitabine and concurrent radiotherapy.Experimental group 2: Capecitabine plus oxaliplatin and concurrent radiotherapy. Control group:cisplatin plus 5-fluorouracil and concurrent radiotherapy. To evaluate the adverse events and the overall survival of the three group. Also observe the patient's progression-free survival, response rate, pathologic complete response rate.

Conditions

• Stage III Esophageal Squamous Cell Carcinoma
• Stage II Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Capecitabine(Aibin)	capecitabine(Aibin)：625mg/m2, bid d1-5; q1w, po,5 weeks in total
DRUG	Oxaliplatin(Aiheng)	Oxaliplatin(Aiheng)：65mg/m2，d1，8, 22, 29,I.V.
RADIATION	Radiotherapy	concurrent radiotherapy： 50Gy in total，2 Gy/d，5d/w，Until disease progression or unacceptable toxicity

Timeline

• Start date: 2014-10-01
• Primary completion: 2022-09-13
• Completion: 2025-04-01
• First posted: 2013-12-31
• Last updated: 2023-02-08

Locations

1 site across 1 country: China