EUCTR2005-002438-37-GB进行中（未招募）1 期
A randomised phase III clinical trial investigating the effect of FRAGMin® Added to standard Therapy In patients with lung Cancer - FRAGMATIC
Velindre NHS Trust0 个研究点目标入组 2,202 人开始时间: 2006年11月22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
- 2,202
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
入选标准
- •1. Histopathological or cytological diagnosis of primary bronchial carcinoma (small cell or non-small cell) within the last 7 weeks.
- •2. Age 18 or over.
- •3. ECOG Performance status 0, 1, 2 or 3.
- •4. Willing and able to self-administer LMWH by daily sub-cutaneous injection or have it administered to them by a carer.
- •5. Willing and able to give informed consent.
- •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 2000
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 200
排除标准
- •1. Patients with other intrathoracic tumours (e.g. carcinoid, mesothelioma, lymphoma, lung metastases from another primary site).
- •2. Any previous illness or treatment likely to interfere with protocol treatment or comparisons.
- •3. Clinically apparent brain metastases.
- •4. Patients who have had a haemorrhagic stroke in the last 3 months
- •5. Haemoptysis of CTC Grade 2 (symptomatic haemoptysis requiring medical intervention) or above.
- •6. Known bleeding disorder.
- •7. Known pregnancy or lactation. Effective contraception is essential for all female patients (of reproductive potential) if sexually active.
- •8. Known hypersensitivity to dalteparin or other low molecular weight heparins and/or heparins (eg history of confirmed or suspected immunologically mediated heparin induced thrombocytopenia; acute gastroduodenal ulcer; subacute endocarditis)
- •9. Platelet count lower than 100 x 10 9/L.
- •10. Renal impairment with serum creatinine greater than 150 mol/L.
- •11. Patients who have received therapeutic anticoagulation in the last 12 months.
- •12. Patients taking Ketorolac (toradol) - this is a non steroidal anti-inflammatory drug (NSAID) with a well documented risk of causing increased bleeding when given with LMWH
- •13. Patients who at the time of randomisation have a central venous catheter in place and the local practice specifies the use of thromboprophylaxis
- •14. Any other active malignancy in the last 5 years, except completely treated non-melanoma skin cancer or in-situ carcinoma of cervix. Patients with previous malignancies in remission for at least 5 years can be included, provided that there is a clear MDT decision that this is a new primary.
研究者
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