Different Cycles of Capecitabine Usage in Esophageal Cancer Concurrent Chemoradiotherapy

Study Overview
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Brief Summary
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Definitive chemoradiotherapy with cisplatin 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, Capecitabine is widely used in the chemotherapy of esophageal cancer. The purpose of this experiment was to study the different cycle on capecitabine with chemotherapy for esophageal cancer chemoradiation effect.We are prepared to within 2 years study recruited 200 patients with esophageal cancer.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
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We recruited the patients who were pathologically confirmed with esophageal squamous cell carcinoma from the Oct 2014. The the patients was divided into two groups. Group 1: Capecitabine + chemoradiation, radiation at the end of the stop using capecitabine. Group 2: Capecitabine + chemoradiation, at the end of the radiotherapy with capecitabine consolidating treatment for 5 weeks.

Conditions
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Stage III Esophageal Squamous Cell Carcinoma, Stage II Esophageal Squamous Cell Carcinoma

Intervention / Treatment
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* Drug: Capecitabine(Aibin)
* Radiation: radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 45-75years 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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Capecitabine-5 weeks-radiotherapy<br>Capecitabine 5 weeks : 625mg/m2, bid d1-5; q1w, po,5 weeks in total, radiotherapy： 50Gy ，2 Gy/d，5d/w. | Drug: Capecitabine(Aibin)<br>* Capecitabine(Aibin)：625mg/m2, bid d1-5; q1w, po,5 or 10 weeks in total<br>* Other names: Aibin;Radiation: radiotherapy<br>* Concurrent radiotherapy： 50Gy in total，2 Gy/d，5d/w，Until disease progression or unacceptable toxicity<br>* Other names: radiation therapy;|
| Active Comparator: Capecitabine-10 weeks-radiotherapy<br>Capecitabine 10 weeks : 625mg/m2, bid d1-5; q1w, po,10 weeks in total, radiotherapy： 50Gy ，2 Gy/d，5d/w. | Drug: Capecitabine(Aibin)<br>* Capecitabine(Aibin)：625mg/m2, bid d1-5; q1w, po,5 or 10 weeks in total<br>* Other names: Aibin;Radiation: radiotherapy<br>* Concurrent radiotherapy： 50Gy in total，2 Gy/d，5d/w，Until disease progression or unacceptable toxicity<br>* Other names: radiation therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival, OS |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival |  | 2 years | 
| overall remission rate, ORR |  | 16 weeks | 
| serious adverse event |  | 16 weeks | 
| quality of life, Qol |  | 16 weeks | 
| pathologic complete response rate |  | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chemoradiotherapy, Esophageal Squamous Cancer, Capecitabine