Gemcitabine, Alone or in Combination With Cisplatin, in Patients With Advanced or Metastatic Cholangiocarcinomas and Other Biliary Tract Tumors: A Multicentre, Randomized Phase III Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 324
- 试验地点
- 25
- 主要终点
- Overall Survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, 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. It is not yet known whether gemcitabine is more effective with or without cisplatin in treating cholangiocarcinoma or biliary tract tumors.
PURPOSE: This randomized phase III trial is studying gemcitabine and cisplatin to see how well they work compared to gemcitabine alone in treating patients with unresectable locally advanced or metastatic cholangiocarcinoma or other biliary tract tumors.
详细描述
OBJECTIVES:
Primary
- Compare the overall survival of patients with unresectable locally advanced or metastatic cholangiocarcinoma or other biliary tract tumors treated with gemcitabine hydrochloride with vs without cisplatin.
Secondary
- Compare the progression-free survival of patients treated with these regimens.
- Compare the toxic effects of these regimens in these patients.
- Compare quality of life 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
- 16 Years 至 —（Child, 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
A - Gemcitabine
Gemcitabine alone
干预措施: gemcitabine hydrochloride (Drug)
B - Gemcitabine and Cisplatin
Gemcitabine and Cisplatin
干预措施: cisplatin (Drug)
B - Gemcitabine and Cisplatin
Gemcitabine and Cisplatin
干预措施: gemcitabine hydrochloride (Drug)
结局指标
主要结局
Overall Survival
时间窗: From date of randomisation till date of death or last date of follow-up (up to 5 years)
From date of randomisation till date of death or last date of follow-up (up to 5 years)
次要结局
- Progression-free survival(From date of randomisation till date of death or last date of follow-up (up to 5 years))
- Quality of life(Before and 12 weeks after completion of treatment)
- Toxicity(During treatment and follow-up)