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A randomised phase III clinical trial investigating the effect of Fragmin® added to standard therapy In patients with lung cancer

A randomised phase III clinical trial investigating the effect of FRAGMin® Added to standard Therapy In patients with lung Cancer

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN80812769
Enrollment
2200
Registered
2005-07-08
Start date
2006-01-01
Completion date
Unknown
Last updated
2022-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung cancer Cancer Malignant neoplasm of bronchus and lung

Interventions

The trial is a multicentre randomised phase III trial. Patients are randomised to one of two groups with a 1:1 randomisation: 1. Control group: to receive anti-cancer treatment accord

Sponsors

Velindre NHS Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with histopathologically or cytologically confirmed primary lung cancer of any stage or histology.

Exclusion criteria

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 11. Patients taking Ketorolac

Design outcomes

Primary

MeasureTime frame
Overall survival

Secondary

MeasureTime frame
1. Venous thrombotic event (VTE) free survival 2. Serious Adverse Events (SAEs) 3. Metastasis-free survival 4. Toxicity 5. Quality of life 6. Levels of breathlessness 7. Anxiety and depression 8. Cost effectiveness and cost utility

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 2, 2026