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Clinical Trials/ISRCTN80812769
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

Registry
who.int
Start Date
July 8, 2005
End Date
October 31, 2011
Last Updated
3 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Velindre NHS Trust (UK)

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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