Different Cycles of Cisplatin-5-fluorouracil for the Chemoradiotherapy of Esophageal Squamous Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Two-arm Phase III Trial Comparing Radiotherapy With Differentcycles of Cisplatin-5-fluorouracil for Esophageal Cancer

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

Intervention / Treatment
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* Other: 2 cycles cisplatin-5-fluorouracil
* Other: 4 cycles cisplatin-5-fluorouracil
* 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: Two cycles PF-radiotherapy<br>2 cycles cisplatin-5-fluorouracil: cisplatin: 75mg/m2 d1，29；5-fluorouracil：750mg/m2 CIV24h d1-4，d29-32. radiotherapy： 50Gy，2 Gy/d，5d/w. | Other: 2 cycles cisplatin-5-fluorouracil<br>* 2 cycles cisplatin-5-fluorouracil(PF 2 cycles): cisplatin: 75mg/m2 d1，29; 5-fluorouracil：750mg/m2 CIV24h d1-4，d29-32.<br>* Other names: PF 2 cycles;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: Four cycles PF-radiotherapy<br>4 cycles cisplatin-5-fluorouracil: cisplatin: 75mg/m2 d1，29, 57, 85；5-fluorouracil：750mg/m2 CIV24h d1-4，d29-32, d57-60, d85-88. radiotherapy： 50Gy，2 Gy/d，5d/w. | Other: 4 cycles cisplatin-5-fluorouracil<br>* 4 cycles cisplatin-5-fluoroura(PF 4 cycles): cilcisplatin: 75mg/m2 d1，29, 57, 85; 5-fluorouracil：750mg/m2 CIV24h d1-4，d29-32, d57-60, d85-88.<br>* Other names: PF 4 cycles;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,PFS |  | 2 years | 
| overall remission rate, ORR |  | 16 weeks | 
| serious adverse event,SAE |  | 16 weeks | 
| quality of life, Qol |  | 16 weeks | 
| pathologic complete response rate |  | 16 weeks | 
| disease control rate,DCR |  | 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, Cisplatin-5-fluorouracil