Randomized Phase II-III Study of Chemoradiation With Fluorouracil and Cisplatin Versus Chemotherapy (Gemcitabine/Oxaliplatin) in Non Resectable But Non Metastatic Cancer of the Biliary Tract
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 20
- 主要终点
- Progression rate at 3 months
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, cisplatin, oxaliplatin, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether giving fluorouracil and cisplatin together with radiation therapy is more effective than giving gemcitabine together with oxaliplatin in treating nonmetastatic biliary tract cancer.
PURPOSE: This randomized phase II/III trial is studying fluorouracil, cisplatin, and radiation therapy to see how well they work compared to gemcitabine and oxaliplatin in treating patients with nonmetastatic biliary tract cancer that cannot be removed by surgery.
详细描述
OBJECTIVES:
Primary
- Compare the 3-month progression rate in patients with unresectable, nonmetastatic cancer of the biliary tract treated with fluorouracil, cisplatin, and radiotherapy vs gemcitabine hydrochloride and oxaliplatin. (phase II)
- Compare the overall survival of patients treated with these regimens. (phase III)
Secondary
- Compare toxicities of these regimens in these patients. (phase II)
- Compare the quality of life at initial drainage (phase II) and overall (phase III) of patients treated with these regimens.
- Compare the biliary complication rate in patients treated with these regimens.
- Compare the duration of hospitalization of patients treated with these regimens.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Radio-chimiothérapie
Radio-chimiothérapie
干预措施: cisplatin (Drug)
GEMOX
GEMOX
干预措施: gemcitabine hydrochloride (Drug)
GEMOX
GEMOX
干预措施: oxaliplatin (Drug)
结局指标
主要结局
Progression rate at 3 months
时间窗: 2012
Overall survival
时间窗: 2012
次要结局
- Toxicity(2012)
- Biliary complication rate(2012)