Effect of Low Molecular Weight Heparin on Survival of Stage I,II or IIIA Non Small Cell Lung Cancer. A Multicenter, Open, Randomized Controlled Trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 553
- 试验地点
- 1
- 主要终点
- Overall 3-year mortality
研究概览
简要总结
Experiments suggest that low molecular weight heparin (LMWH) inhibits tumor growth and metastasis. Studies in humans suggest that LMWH is associated with a higher survival in patients with cancer related thrombosis. Two recent studies suggest that LMWH may increase the survival of patients with cancer who do not have an associated thrombosis. The purpose of the study is to assess the effect of LMWH on the overall survival of patients with localized non-small cell lung cancer after complete surgical resection.
详细描述
Phase III, prospective, multicentric, randomized, controlled, open trial in parallel groups with a blind adjudication of all end-point criteria.
Reference therapy :
Patients randomized to the control group will receive postoperative treatment according to local practice in the participating centers. However, the participating centers will have to comply with the following guidelines.
Adjuvant chemotherapy:
Adjuvant chemotherapy will be offered in all patients with stage II and stage IIIA cancers. Adjuvant chemotherapy will be platin based and include two drugs for a maximum of 4 cycles. Each center will have to select one regimen before the beginning of the study for all patients included in the study.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with completely resected non-small cell lung cancer of stage I, II, or IIIA T3N1 confirmed by histology can be included in the study Patients who had preoperative chemotherapy, those who are selected for adjuvant chemotherapy and those who are not candidates for adjuvant chemotherapy (because they have a contraindication to chemotherapy or they have a stage I cancer) are eligible for the study Written informed consent age > 18 years
排除标准
- •Previous heparin induced thrombocytopenia Allergy to tinzaparin Allergy to sulfites Renal failure with a creatinin clearance < 30 ml/min according to COCKROFT formula Prothrombin time < 50% Platelet count < 100 G/L Increased bleeding risk: ongoing hemorrhage, major bleeding within 10 days, previous intracerebral bleeding, uncontrolled hypertension (SAP > 180 mmHg or DAP > 120 mmHg) Indication for curative anticoagulant treatment on inclusion More than 6 weeks between surgery and inclusion Known pregnancy or no efficient contraception for women of childbearing age Breast feeding Previous malignant disease diagnosed within 2 years except in situ carcinoma of the uterine cervix or spinal-cellular or baso-cellular cutaneous carcinoma Inclusion in another therapeutic trial at the time of inclusion Treatment with an experimental drug within 30 days before inclusion in the study
研究组 & 干预措施
A
干预措施: Tinzaparin sodium 100 UI/Kg/OD for 12 weeks (Drug)
B
干预措施: Tinzaparin sodium 100 UI/Kg/OD for 12 weeks (Drug)
结局指标
主要结局
Overall 3-year mortality
时间窗: overall 3-years
The first included patients will be followed 9 years with no impact on the total duration of the study.
次要结局
- Symptomatic venous thromboembolic events(Overall five year survival)
- Major bleeding time(Overall five year survival)
- Disease free survival(Overall five year survival)
- Cancer related mortality(Overall five year survival)