A Phase III Study of Gemcitabine Plus Capecitabine (GEMCAP) Versus Gemcitabine Alone in Advanced Biliary Cancer
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 8
- 主要终点
- Overall survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether gemcitabine is more effective when given together with or without capecitabine in treating patients with biliary cancer.
PURPOSE: This randomized phase III trial is studying giving gemcitabine together with capecitabine to see how well it works compared with giving gemcitabine alone in treating patients with locally advanced, unresectable, or metastatic biliary cancer.
详细描述
OBJECTIVES:
Primary
- To compare overall survival (OS) rates in patients with locally advanced, unresectable or metastatic biliary tree cancer treated with combined gemcitabine hydrochloride and capecitabine vs. gemcitabine hydrochloride alone.
Secondary
- To compare progression-free survival (PFS) in this patient group.
- To compare response rates (complete response [CR] and partial response [PR]) in this patient group.
- To compare stable disease (SD) rates in this patient group.
- To compare rate of disease control (CR, PR and SD) in this patient group.
- To estimate and compare response duration in this patient group.
- To compare the effects of these treatments on measures of quality of life in this patient group using the EORTC QLQ-C30.
- To compare the nature, severity and frequency of toxicities between the two arms.
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
GEMCAP
Gemcitabine 1000mg/m2 IV days 1 and 8 ever 21 days; Capecitabine 650mg/m2 PO BID days 1-14 every 21 days.
干预措施: capecitabine (Drug)
GEMCAP
Gemcitabine 1000mg/m2 IV days 1 and 8 ever 21 days; Capecitabine 650mg/m2 PO BID days 1-14 every 21 days.
干预措施: gemcitabine hydrochloride (Drug)
GEMCAP
Gemcitabine 1000mg/m2 IV days 1 and 8 ever 21 days; Capecitabine 650mg/m2 PO BID days 1-14 every 21 days.
干预措施: quality-of-life assessment (Procedure)
Gemcitabine Alone
Gemcitabine 1000mg/m2 IV days 1, 8 and 15 every 28 days
干预措施: gemcitabine hydrochloride (Drug)
Gemcitabine Alone
Gemcitabine 1000mg/m2 IV days 1, 8 and 15 every 28 days
干预措施: quality-of-life assessment (Procedure)
结局指标
主要结局
Overall survival
次要结局
- Progression-free survival
- Response duration
- Rate of stable disease (SD)
- Toxicity
- Quality of Life
- Response rates (complete response [CR] and partial response [PR])
- Rate of disease control (CR, PR, and SD)