Different Cycles of Cisplatin-5-fluorouracil for the Chemoradiotherapy of Esophageal Squamous Cancer
- Conditions
- Stage III Esophageal Squamous Cell CarcinomaStage II Esophageal Squamous Cell Carcinoma
- Interventions
- Other: 2 cycles cisplatin-5-fluorouracilOther: 4 cycles cisplatin-5-fluorouracilRadiation: Radiotherapy
- Registration Number
- NCT02607540
- Lead Sponsor
- The First Affiliated Hospital of Henan University of Science and Technology
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 210
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Two cycles PF-radiotherapy Radiotherapy 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. Two cycles PF-radiotherapy 2 cycles cisplatin-5-fluorouracil 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. Four cycles PF-radiotherapy 4 cycles cisplatin-5-fluorouracil 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. Four cycles PF-radiotherapy Radiotherapy 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.
- Primary Outcome Measures
Name Time Method overall survival, OS 2 years
- Secondary Outcome Measures
Name Time Method disease control rate,DCR 16 weeks overall remission rate, ORR 16 weeks quality of life, Qol 16 weeks pathologic complete response rate 16 weeks progression-free survival,PFS 2 years serious adverse event,SAE 16 weeks
Trial Locations
- Locations (1)
The First Affiliated Hospital of Henan University of Science and Technology
🇨🇳Luoyang, Henan, China