Chemotherapy With or Without Preventive Anticoagulation for Metastatic Cancer of the Pancreas
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 42
- 试验地点
- 6
- 主要终点
- Thromboembolic events
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. Anticoagulants, such as dalteparin, may help prevent blood clots from forming in patients being treated with chemotherapy. It is not yet known whether gemcitabine is more effective when given alone or together with dalteparin and/or capecitabine in treating patients with pancreatic cancer.
PURPOSE: This randomized phase III trial is studying whether dalteparin prevents blood clots in patients with pancreatic cancer receiving treatment with different combinations of gemcitabine and capecitabine.
详细描述
OBJECTIVES:
Primary
- To demonstrate that preventive anticoagulation with dalteparin reduces the number of thromboembolic events.
- To determine the number of thromboembolic events occurring with preventive anticoagulation.
Secondary
- To determine survival without thrombotic event.
- To determine progression-free and overall survival.
- To determine time to response of tumor.
- To assess tolerance of 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
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 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
chemotherapy
chemotherapy at investigator's discretion
干预措施: Chemotherapy at the investigator's discretion (Drug)
dalteparin
dalteparin: 5000 UI sub-cutaneous injection, from Day 1 to Day 28.
干预措施: daltéparine (Drug)
dalteparin
dalteparin: 5000 UI sub-cutaneous injection, from Day 1 to Day 28.
干预措施: Chemotherapy at the investigator's discretion (Drug)
结局指标
主要结局
Thromboembolic events
时间窗: during study treatment
number of thromboembolic events during anticoagulation treatment
次要结局
- Progression-free survival(at 6 months)
- Overall survival(at one year)
- Tolerance of regimens(each cycle)