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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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

Criteria

Inclusion Criteria:

• age 18-75years old

• Histologically proven squamous cell carcinoma of the esophagus the tumor was in T2-4N0-2M0

• The patients have not received the surgery or chemo-radiotherapy.

• Hb≥80g/L, absolute neutrophil count ≥1.5×109/L, Plt≥90×109/L,

• ALT、AST≤2.5*N,Cr≤1.5*N.

• performance status score 0-2

Exclusion Criteria:

• pregnant, lactating women

• Oxaliplatin or fluorouracil Allergy or metabolic disorders

• Radiotherapy contraindications

• History of organ transplantation

• Brain metastasis

• The peripheral nervous system disorders

• Severe infection

• Oral capecitabine who have difficulty with,such as dysphagia,The activities of digestive ulcer, Gastrointestinal bleeding

• Severe chronic diseases, such as, hepatopathy, nephropathy, respiratory disease,high blood pressure, diabetes.

• Other malignant tumor in recent 5 years.