NCT01396668已完成2 期
Phase Ⅱ Trial of Fixed Dose Rate Gemcitabine and Cisplatin Chemotherapy Followed by Chemoradiation With Capecitabine in Patients With Locally Advanced Pancreatic Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 4
- 主要终点
- Time to progression
研究概览
简要总结
This is a phase Ⅱ trial of fixed dose rate gemcitabine and cisplatin chemotherapy followed by chemoradiation with capecitabine in patients with locally advanced pancreatic cancer.
详细描述
The main purpose of this study is to evaluate the efficacy and safety of fixed dose rate gemcitabine and cisplatin chemotherapy followed by chemoradiation with capecitabine in patients with locally advanced pancreatic cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •unresectable locally advanced pancreatic cancer
- •no distant metastasis
- •histologically confirmed adenocarcinoma of pancreas
- •18-75 of age
- •ECOG performance status 0-2
- •normal marrow function :
- •WBC at least 3,000/mm3 OR Absolute neutrophil count at least 1,500/mm3
- •Platelet count at least 100,000/mm3
- •normal liver function :
- •-Bilirubin no greater than 2.0 mg/dL AST less than 3 times upper limit of normal (ULN)
- •normal renal function :
- •-Creatinine no greater than 1.5 times ULN
- •signed informed consent
排除标准
- 未提供
结局指标
主要结局
Time to progression
时间窗: 12 months
次要结局
- safety(12 months)
- 1 year survival rate(1 year)
- response rate(1 year)
- overall survival(1 year)
- clinical benefit rate(1 year)
研究者
研究点 (4)
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