NCT00519805Unknown3 期
FRAGMATIC - A Randomised Phase III Clinical Trial Investigating the Effect of FRAGMin Added to Standard Therapy In Patients With Lung Cancer
Velindre NHS Trust119 个研究点 分布在 1 个国家目标入组 2,200 人开始时间: 2007年8月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 2,200
- 试验地点
- 119
- 主要终点
- Overall survival
研究概览
简要总结
RATIONALE: Anticoagulants, such as dalteparin, may help prevent blood clots from forming in patients with lung cancer. It is not yet known whether dalteparin is effective in preventing blood clots in patients with lung cancer.
PURPOSE: This randomized phase III trial is studying how well dalteparin works in preventing blood clots in patients with lung cancer.
详细描述
OBJECTIVES:
Primary
- Determine whether the addition of dalteparin results in improved survival.
Secondary
- Determine venous thrombotic event-free survival and metastasis-free survival.
- Determine serious adverse events in patients treated with this drug.
- Determine the toxicity of this drug in these patients.
- Determine the quality of life, breathlessness, anxiety, and depression in patients treated with this drug.
- Determine the cost effectiveness and cost utility of this drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Supportive Care
- 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
- •DISEASE CHARACTERISTICS:
- •Histopathological or cytological diagnosis of primary bronchial carcinoma (small cell or non-small cell lung cancer) within the past 6 weeks
- •No other intrathoracic tumors (e.g., carcinoid tumor, mesothelioma, lymphoma, or lung metastases from another primary site)
- •No clinically apparent brain metastases
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-3
- •Platelet count ≥ 100,000/mm³
- •Serum creatinine ≤ 150 µmol/L
- •Willing and able to self-administer dalteparin by daily subcutaneous injection or have it administered by a caregiver
- •Not pregnant or nursing
- •Fertile female patients must use effective contraception (if sexually active)
- •No hemorrhagic stroke within the past 3 months
- •No known bleeding disorder
- •No hemoptysis of CTC ≥ grade 2 (i.e., symptomatic hemoptysis requiring medical intervention)
- •No central venous catheter requiring the use of thromboprophylaxis
- •No known hypersensitivity to dalteparin, heparin, or other low molecular weight heparins (e.g., history of confirmed or suspected immunologically mediated heparin-induced thrombocytopenia; acute gastroduodenal ulcer; or subacute endocarditis)
- •No prior illness likely to interfere with study treatment or comparisons
- •PRIOR CONCURRENT THERAPY:
- •No prior treatment likely to interfere with study treatment or comparisons
- •More than 12 months since prior and no concurrent therapeutic anticoagulation
- •No concurrent ketorolac (Toradol®)
排除标准
- 未提供
结局指标
主要结局
Overall survival
次要结局
- Metastasis-free survival
- Toxicity
- Quality of life as measured by EQ-5D
- Venous thrombotic event-free survival
- Serious adverse events
- Breathlessness (dyspnea) as measured by the Cancer Dyspnea Scale
- Anxiety and depression as measured by the Hospital Anxiety and Depression Scale
- Cost effectiveness
- Cost utility
研究者
研究点 (119)
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