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Chemoradiotherapy of Capecitabine With or Without Oxaliplatin Versus Cisplatin-5-FU for Esophageal Squamous Cancer
Conditions
Stage III Esophageal Squamous Cell Carcinoma - Stage II Esophageal Squamous Cell Carcinoma
Conditions: official terms
Carcinoma - Carcinoma, Squamous Cell - Esophageal Neoplasms
Conditions: Keywords
Chemoradiotherapy， Esophageal Squamous Cancer
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Intervention
Name: Capecitabine(Aibin)
Type: Drug
Name: Oxaliplatin(Aiheng)
Type: Drug
Name: Radiotherapy
Type: Radiation
Overall Status
Recruiting
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 chemoradiotherapy as preoperative therapy for squamous cell carcinoma of esophagus. A total of 495 patients will be accrued from China within 3 years. The primary endpoint is overall survival and the secondary endpoints include progression-free survival, response rate, pathologic complete response rate and adverse events.
. The purpose of this study is to confirm the difference of Capecitabine plus with or without oxaliplatin over cisplatin plus 5-fluorouracil with chemoradiotherapy as preoperative therapy for squamous cell carcinoma of esophagus. A total of 495 patients will be accrued from China within 3 years. The primary endpoint is overall survival and the secondary endpoints include progression-free survival, response rate, pathologic complete response rate and adverse events.
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 overall survival of the three group.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 45 Years
Gender: Both
Criteria: Inclusion Criteria:
- age 45-75years old
- Histologically proven squamous cell carcinoma of the esophagus
- the tumor was in T2-4N0-1M0
- 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.
- age 45-75years old
- Histologically proven squamous cell carcinoma of the esophagus
- the tumor was in T2-4N0-1M0
- 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.
Location
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
Status: Recruiting
Contact: shegan gao, doctor - 0379 64811906 - gsg112258@sohu.com
Start Date
October 2014
Completion Date
December 2022
Sponsors
The First Affiliated Hospital of Henan University of Science and Technology
Source
The First Affiliated Hospital of Henan University of Science and Technology
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page