Three-arm Phase III Trial Comparing Radiotherapy With Different Chemotherapy Regimens for Esophageal Cancer
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 249
- 试验地点
- 1
- 主要终点
- Grade 3/5 acute toxicities
研究概览
简要总结
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 249 patients will be accrued from China within 2 years. The primary endpoints are grade 3-5 AEs and overall survival and the secondary endpoints include progression-free survival, response rate, pathologic complete response rate.
详细描述
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 adverse events and the overall survival of the three group. Also observe the patient's progression-free survival, response rate, pathologic complete response rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Capecitabine-oxaliplatin-radiotherapy
oxaliplatin：65mg/m2，d1，8，22, 29,I.V.or d1, 8, 22, 29, 43, 50, 64, 71,I.V.plus,capecitabine: 625mg/m2, bid d1-5; q1w, po,6 weeks or 12 weeks in total.
radiotherapy： 50-50.4Gy ，1.8-2 Gy/d，5d/w.
干预措施: Capecitabine(Aibin) (Drug)
Capecitabine-oxaliplatin-radiotherapy
oxaliplatin：65mg/m2，d1，8，22, 29,I.V.or d1, 8, 22, 29, 43, 50, 64, 71,I.V.plus,capecitabine: 625mg/m2, bid d1-5; q1w, po,6 weeks or 12 weeks in total.
radiotherapy： 50-50.4Gy ，1.8-2 Gy/d，5d/w.
干预措施: Oxaliplatin(Aiheng) (Drug)
Capecitabine-oxaliplatin-radiotherapy
oxaliplatin：65mg/m2，d1，8，22, 29,I.V.or d1, 8, 22, 29, 43, 50, 64, 71,I.V.plus,capecitabine: 625mg/m2, bid d1-5; q1w, po,6 weeks or 12 weeks in total.
radiotherapy： 50-50.4Gy ，1.8-2 Gy/d，5d/w.
干预措施: Radiotherapy (Radiation)
cisplatin with 5-FU and radiotherapy
cisplatin: 75mg/m2 d1，29 or d1, 29, 57, 85, 5-Fu：750mg/m2 CIV24h d1-4，d29-32 or d1-4，d29-32, d57-60, d85-88.
radiotherapy： 50-50.4Gy ，1.8-2 Gy/d，5d/w.
干预措施: Radiotherapy (Radiation)
Capecitabine and radiotherapy
capecitabine: 625mg/m2, bid d1-5; q1w, po,6 weeks or 12 weeks in total, radiotherapy： 50-50.4Gy ，1.8-2 Gy/d，5d/w.
干预措施: Capecitabine(Aibin) (Drug)
Capecitabine and radiotherapy
capecitabine: 625mg/m2, bid d1-5; q1w, po,6 weeks or 12 weeks in total, radiotherapy： 50-50.4Gy ，1.8-2 Gy/d，5d/w.
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
Grade 3/5 acute toxicities
时间窗: 90 days
Grade 3/5 acute toxicities occurred during or within 90 days after RT
OS-2 year
时间窗: 2 years
Overall Survival rate in 2 year from Randomization
次要结局
- PFS-2 year(2 years)
- overall remission rate, ORR(16 weeks)
- quality of life, Qol(16 weeks)
- pathologic complete response rate(16 weeks)