Different Cycles of Capecitabine Usage in Esophageal Cancer Concurrent Chemoradiotherapy
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- overall survival, OS
研究概览
简要总结
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.
详细描述
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.
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.
研究组 & 干预措施
Capecitabine-5 weeks-radiotherapy
Capecitabine 5 weeks : 625mg/m2, bid d1-5; q1w, po,5 weeks in total, radiotherapy： 50Gy ，2 Gy/d，5d/w.
干预措施: Capecitabine(Aibin) (Drug)
Capecitabine-5 weeks-radiotherapy
Capecitabine 5 weeks : 625mg/m2, bid d1-5; q1w, po,5 weeks in total, radiotherapy： 50Gy ，2 Gy/d，5d/w.
干预措施: radiotherapy (Radiation)
Capecitabine-10 weeks-radiotherapy
Capecitabine 10 weeks : 625mg/m2, bid d1-5; q1w, po,10 weeks in total, radiotherapy： 50Gy ，2 Gy/d，5d/w.
干预措施: Capecitabine(Aibin) (Drug)
Capecitabine-10 weeks-radiotherapy
Capecitabine 10 weeks : 625mg/m2, bid d1-5; q1w, po,10 weeks in total, radiotherapy： 50Gy ，2 Gy/d，5d/w.
干预措施: radiotherapy (Radiation)
结局指标
主要结局
overall survival, OS
时间窗: 2 years
次要结局
- quality of life, Qol(16 weeks)
- serious adverse event(16 weeks)
- pathologic complete response rate(16 weeks)
- progression-free survival(2 years)
- overall remission rate, ORR(16 weeks)