ISRCTN80812769
Completed
Phase 3
A randomised phase III clinical trial investigating the effect of FRAGMin® Added to standard Therapy In patients with lung Cancer
Velindre NHS Trust (UK)0 sites2,202 target enrollmentJuly 8, 2005
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Velindre NHS Trust (UK)
- Enrollment
- 2202
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
2009 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/19807917 protocol 2016 Results article in http://www.ncbi.nlm.nih.gov/pubmed/26700124 results 2016 Results article in https://www.ncbi.nlm.nih.gov/pubmed/27439472 results
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with histopathologically or cytologically confirmed primary lung cancer of any stage or histology.
Exclusion Criteria
- •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\. Known cerebral metastases
- •4\. Haemoptysis of CTC Grade two (symptomatic haemoptysis requiring medical intervention) or above
- •5\. Known bleeding diathesis
- •6\. Known pregnancy or lactation
- •7\. Known allergy to heparin
- •8\. Platelet count lower than 100 x 10^9/l
- •9\. Renal impairment with serum creatinine greater than 150 µmol/l
- •10\. Patients who have received therapeutic anticoagulation in the last 12 months
Outcomes
Primary Outcomes
Not specified
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