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ISRCTN
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ISRCTN80812769
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ClinicalTrials.gov identifier
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NCT00519805
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Public title
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A randomised phase III clinical trial investigating the effect of FRAGMin® Added to standard Therapy In patients with lung Cancer
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Scientific title
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Acronym
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FRAGMATIC
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Serial number at source
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2005-002438-37
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Study hypothesis
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To assess the effect of adding six months of daily dalteparin (Fragmin) to standard treatment for patients with lung cancer.
Please note, as of 15/02/2011 the anticipated end date for this trial has been updated from 31/12/2010 to 31/10/2011.
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Lay summary
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http://www.cancerhelp.org.uk/trials/a-trial-to-find-out-if-dalteparin-can-improve-treatment-for-lung-cancer
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Ethics approval
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MREC for Wales on 08/08/2006 (ref: 06/MRE09/29)
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Lung Cancer
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Participants - inclusion criteria
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Patients with histopathologically or cytologically confirmed primary lung cancer of any stage or histology.
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Participants - exclusion criteria
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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
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Anticipated start date
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01/01/2006
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Anticipated end date
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31/10/2011
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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2200
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Interventions
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The trial is a multicentre randomised phase III trial. Patients are randomised to one of two groups with a 1:1 randomisation:
Control group: to receive anti-cancer treatment according to local practice
Intervention group: to receive anti-cancer treatment according to local practice plus once daily sub-cutaneous dalteparin (fragmin) for six months at a thromboprophylactic dose
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Primary outcome measure(s)
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Overall survival
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Secondary outcome measure(s)
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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
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Sources of funding
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Cancer Research UK (CRUK) and Pfizer
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Trial website
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Publications
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2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19807917
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Contact name
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Dr
Fergus
Macbeth
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Address
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NICE,
Holborn,
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City/town
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London
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Zip/Postcode
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WC1V 6NA
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Country
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United Kingdom
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Sponsor
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Velindre NHS Trust (UK)
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Address
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Unit 2, Charnwood Court
Parc Nantgarw
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City/town
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Cardiff
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Zip/Postcode
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CF15 7QW
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Country
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United Kingdom
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Date applied
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24/05/2005
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Last edited
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02/08/2011
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Date ISRCTN assigned
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08/07/2005
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