Two-arm Phase III Trial Comparing Radiotherapy With Differentcycles of Cisplatin-5-fluorouracil for Esophageal Cancer
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- overall survival, OS
研究概览
简要总结
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.
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 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.
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
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
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.
结局指标
主要结局
overall survival, OS
时间窗: 2 years
次要结局
- 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)
- disease control rate,DCR(16 weeks)