A Randomized Phase III Study of Standard Treatment +/- Enoxaparin in Small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 390
- 试验地点
- 14
- 主要终点
- Significant increase of overall survival
研究概览
简要总结
The endpoint is to investigate if the addition of low molecular heparin - enoxaparin, will result in a significant increase of overall survival in patients with small cell lung cancer, receiving standard chemotherapy.
详细描述
Chemotherapy will be given in accordance with local or regional guidelines but shall include a platinum drug + any topoisomerase inhibitor. Within these limits the study will accept different local variants as long as each centre remains consistent to its declared standard chemotherapy regimen. The recommended regimen is carboplatin or cisplatin plus etoposide q3 weeks for 4 cycles but up to 6 cycles is allowed. Local dosages and dose reduction schedules will be used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •Histologically or cytologically verified SCLC, all stages
- •WHO performance status 0, 1, 2 or 3
- •Age 18 years or older
- •Intention and feasibility to treat with chemotherapy consisting of platinum + topoisomerase inhibitor.
- •Platelets >100 x109 /L
- •Signed informed consent
- •PK (prothrombin complex) INR and APTT within normal ranges.
排除标准
- •Prior systemic chemotherapy for lung cancer.
- •Concomitant anticoagulation treatment, except for ASA or clopidogrel
- •Active overt bleeding of clinical importance or at high risk (e.g. earlier observed haemorrhage in a brain metastasis, severe coagulopathy as haemophilia, severe liver dysfunction with impaired coagulation, acute peptic ulcer, and within the last 3 months suffered from intracranial haemorrhage, or surgery in the central nervous system).
- •Any other known contraindication for enoxaparine ( e.g. Hypersensitivity against enoxaparine and its derivatives).
- •Pregnancy or breast-feeding
- •Fertile women not using effective contraceptives or men who do not agree to use effective contraception during the treatment period.
- •Treatment with any other investigational agent, or participation in any other clinical trial.
研究组 & 干预措施
A
Standard chemotherapy treatment for patients with small cell lung cancer. Chemotherapy regimen contains a platinum drug and a topoisomerase inhibitor. Numbers of cycles 4-6 according to local variants.Used drugs=cisplatinum or carboplatin and e.g.etoposide.
干预措施: cisplatinum or carboplatin and e.g.etoposide. (Drug)
B
Standard chemotherapy treatment for patients with small cell lung cancer. Chemotherapy regimen contains a platinum drug and a topoisomerase inhibitor. Numbers of cycles 4-6 according to local variants. Used drugs=cisplatinum or carboplatin and e.g.etoposide. In addition to this, subjects will receive daily subcutaneous injections of enoxaparin during chemotherapy treatment.
干预措施: cisplatinum or carboplatin and e.g.etoposide+enoxaparin (Drug)
结局指标
主要结局
Significant increase of overall survival
时间窗: At follow up 1 year after treatment
次要结局
- Toxicity(During treatment)