Prevention of Venous and Arterial Thromboembolism, in Cancer Patients Undergoing Chemotherapy, With a Low Molecular Weight Heparin (Nadroparin Calcium). A Randomized, Placebo-controlled, Double-blind, Multicenter Phase III Study.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,166
- 试验地点
- 25
- 主要终点
- Cumulative incidence of symptomatic venous and arterial thromboembolism, in patients with metastatic or locally advanced solid tumors undergoing chemotherapy
研究概览
简要总结
In this phase III, multicenter study, 1200 patients with lung, breast, gastrointestinal (stomach, colon-rectum, pancreas), ovarian or head and neck cancer undergoing chemotherapy will be randomly assigned (at the beginning of cytotoxic therapy) in a 2:1 ratio and in double-blind conditions to a treatment with subcutaneous low molecular weight heparin (nadroparin calcium, one injection/day) or placebo for the overall duration of chemotherapy or up to a maximum of 4 months (+/- 10 days).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（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
saline solution
Pre-filled syringes of 0.4 ml, 1 subcutaneous injection/day (every 24 hours).
干预措施: saline solution (placebo) (Drug)
nadroparin calcium
Nadroparin calcium; Pre-filled syringes of 0.4 ml (3.800 anti-Xa IU), 1 subcutaneous injection/day (every 24 hours).
干预措施: Nadroparin calcium (Drug)
结局指标
主要结局
Cumulative incidence of symptomatic venous and arterial thromboembolism, in patients with metastatic or locally advanced solid tumors undergoing chemotherapy
时间窗: Events occurring during the four months of treatment plus 10 days
次要结局
- Survival, at the end of study treatment(Events occurring during the four months of treatment plus 10 days)
- Response to chemotherapy(Events occurring during the four months of treatment plus 10 days)
- For patients with central venous catheters (CVC), complications of possible thrombotic origin, such as malfunction or requirement of CVC removal(Events occurring during the four months of treatment plus 10 days)
- Superficial thrombophlebitis of lower limbs(Events occurring during the four months of treatment plus 10 days)
- Asymptomatic thromboembolic events diagnosed during tests performed for other purposes(Events occurring during the four months of treatment plus 10 days)
- Safety (major bleeding, minor bleeding, other adverse events)(Events occurring during the four months of treatment plus 48 hours)