EUCTR2007-006033-14-SE进行中（未招募）1 期
A randomized phase III study of standard treatment +/- enoxaparin in small cell lung cancer. - RASTE
niversity Hospital Lund, Thoracic Oncology Unit, Dept of Respiratory Medicine0 个研究点目标入组 390 人开始时间: 2008年2月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 390
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Histologically or cytologically verified small cell lung cancer, all stages
- •WHO Performance Status 0-3
- •Age 18 years or older
- •Intention and feasibility to treat with chemotherapy consisting of a platinum and a topoisomeras inhibitor
- •Platelets over 100 x 10 9/L
- •PK (prothrombine komplex) INR and APTT within normal ranges
- •Signed informed concent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 290
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
- •Any other known contraindication for enoxaparine (eg. hypersensitivity against enoxaparine and its derivates
- •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
研究者
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