NCT01058759终止3 期
Taxotere-Enoxaparin-(ENOXA)-Study: 1st-Line Docetaxel-Platin Chemotherapy as Single Therapy or in Combination With Enoxaparin in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, a Phase III Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Progressive free survival
研究概览
简要总结
Taxotere-Enoxaparin-(ENOXA)-Study: 1st-Line Docetaxel-Platin Chemotherapy as single therapy or in combination with Enoxaparin in patients aged older than 18 years with locally advanced or metastatic non-small cell lung cancer (stadium IIIb/IV), a phase III study. Study hypothesis: Increase of progressive free survival from 5 to 7.5 months.
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
- •Signed informed consent
- •Men and women aged 18 and older
- •Locally Advanced or Metastatic Non-small Cell Lung Cancer stage IIIB/IV without any previous therapy
- •Life expectancy at least 12 weeks
- •EOCG performance < 1
- •Appropriate renal and hepatic function
- •Appropriate Hematology
- •No bleeding events within 4 weeks prior to randomization
- •No indication for prophylactic or therapeutic anticoagulation therapy
- •Appropriate methods of contraception (both: men and women) for women of childbearing potential negative urine pregnancy test within 7 day prior to randomization
- •Capability for s.c. injection of Enoxaparin every 24 hrs
排除标准
- •History of cancer other than NSCLC
- •Known contraindication for Enoxaparin e.g. HIT,
- •Known contraindication for Docetaxel, Cisplatin, Carboplatin or co-medication
- •Participation in any other clinical trials within 30 days prior to randomization
- •Any known medical condition that does not allow therapy according to study protocol
- •Seizure disorder
研究组 & 干预措施
Arm B: Enoxaparin
Experimental
干预措施: Enoxaparin (Drug)
Arm A: No Enoxaparin
Active Comparator
干预措施: No Enoxaparin (Other)
结局指标
主要结局
Progressive free survival
时间窗: monthly
次要结局
- Overall survival(monthly)
- RECIST(monthly)
- Quality of life(every three months)
- thromboembolic complications(monthly)
- safety of long term application of Enoxaparin(monthly)
- overall toxicity(monthly)
研究者
研究点 (1)
Loading locations...
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