Dalteparin in Preventing Blood Clots in Patients With Lung Cancer
NCT ID: NCT00519805
Last Updated: 2011-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
2200 participants
INTERVENTIONAL
2007-08-31
Brief Summary
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PURPOSE: This randomized phase III trial is studying how well dalteparin works in preventing blood clots in patients with lung cancer.
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Detailed Description
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Primary
* Determine whether the addition of dalteparin results in improved survival.
Secondary
* Determine venous thrombotic event-free survival and metastasis-free survival.
* Determine serious adverse events in patients treated with this drug.
* Determine the toxicity of this drug in these patients.
* Determine the quality of life, breathlessness, anxiety, and depression in patients treated with this drug.
* Determine the cost effectiveness and cost utility of this drug.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
* Arm I (control): Patients receive anticancer treatment considered appropriate by the local medical team.
* Arm II: Patients receive anticancer treatment considered appropriate by the local medical team. Beginning before the start of the first definitive anticancer treatment, patients receive dalteparin subcutaneously daily for up to 24 weeks.
Quality of life, anxiety, depression, and dyspnea are assessed at baseline, at 12 and 24 weeks, and then at 9 and 12 months.
After completion of therapy, patients are followed at 9 months, 1 year, and then every 6 months for at least 2 years.
Conditions
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Study Design
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RANDOMIZED
SUPPORTIVE_CARE
NONE
Interventions
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dalteparin
quality-of-life assessment
Eligibility Criteria
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Inclusion Criteria
* Histopathological or cytological diagnosis of primary bronchial carcinoma (small cell or non-small cell lung cancer) within the past 6 weeks
* No other intrathoracic tumors (e.g., carcinoid tumor, mesothelioma, lymphoma, or lung metastases from another primary site)
* No clinically apparent brain metastases
PATIENT CHARACTERISTICS:
* ECOG performance status 0-3
* Platelet count ≥ 100,000/mm³
* Serum creatinine ≤ 150 µmol/L
* Willing and able to self-administer dalteparin by daily subcutaneous injection or have it administered by a caregiver
* Not pregnant or nursing
* Fertile female patients must use effective contraception (if sexually active)
* No hemorrhagic stroke within the past 3 months
* No known bleeding disorder
* No hemoptysis of CTC ≥ grade 2 (i.e., symptomatic hemoptysis requiring medical intervention)
* No central venous catheter requiring the use of thromboprophylaxis
* No known hypersensitivity to dalteparin, heparin, or other low molecular weight heparins (e.g., history of confirmed or suspected immunologically mediated heparin-induced thrombocytopenia; acute gastroduodenal ulcer; or subacute endocarditis)
* No prior illness likely to interfere with study treatment or comparisons
PRIOR CONCURRENT THERAPY:
* No prior treatment likely to interfere with study treatment or comparisons
* More than 12 months since prior and no concurrent therapeutic anticoagulation
* No concurrent ketorolac (Toradol®)
18 Years
ALL
No
Sponsors
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Velindre NHS Trust
OTHER_GOV
Principal Investigators
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Fergus Macbeth, MD
Role: STUDY_CHAIR
Velindre NHS Trust
Locations
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Stoke Mandeville Hospital
Aylesbury-Buckinghamshire, England, United Kingdom
Furness General Hospital
Barrow in Furness, England, United Kingdom
Royal Blackburn Hospital
Blackburn, England, United Kingdom
Blackpool Victoria Hospital
Blackpool, England, United Kingdom
Royal Bournemouth Hospital
Bournemouth, England, United Kingdom
Bristol Haematology and Oncology Centre
Bristol, England, United Kingdom
Burnley General Hospital
Burnley, England, United Kingdom
Queen's Hospital
Burton-on-Trent, England, United Kingdom
West Suffolk Hospital
Bury St Edmunds, England, United Kingdom
Walsgrave Hospital
Coventry, England, United Kingdom
Darlington Memorial
Darlington, England, United Kingdom
Derbyshire Royal Infirmary
Derby, England, United Kingdom
Doncaster Royal Infirmary
Doncaster, England, United Kingdom
Dorset County Hospital
Dorchester, England, United Kingdom
Russells Hall Hospital
Dudley, England, United Kingdom
Queen Elizabeth Hospital
Gateshead, England, United Kingdom
Wycombe General Hospital
High Wycombe, England, United Kingdom
Kidderminster Hospital
Kidderminster Worcestershire, England, United Kingdom
Royal Lancaster Infirmary
Lancaster, England, United Kingdom
Whipps Cross Hospital
London, England, United Kingdom
Saint Bartholomew's Hospital
London, England, United Kingdom
Helen Rollason Cancer Care Centre at North Middlesex Hospital
London, England, United Kingdom
Whittington Hospital
London, England, United Kingdom
University College Hospital
London, England, United Kingdom
UCL Cancer Institute
London, England, United Kingdom
Luton and Dunstable Hospital
Luton, England, United Kingdom
James Cook University Hospital
Middlesbrough, England, United Kingdom
Milton Keynes General Hospital
Milton Keynes, England, United Kingdom
Newcastle Upon Tyne Hospitals NHS Trust
Newcastle upon Tyne, England, United Kingdom
James Paget Hospital
Norfolk, England, United Kingdom
North Tyneside Hospital
North Shields, England, United Kingdom
Friarage Hospital
North Yorks, England, United Kingdom
Northampton General Hospital
Northampton, England, United Kingdom
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, United Kingdom
Norfolk and Norwich University Hospital
Norwich, England, United Kingdom
Nottingham City Hospital
Nottingham, England, United Kingdom
George Eliot Hospital
Nuneaton, England, United Kingdom
Derriford Hospital
Plymouth, England, United Kingdom
Dorset Cancer Centre
Poole Dorset, England, United Kingdom
Rosemere Cancer Centre at Royal Preston Hospital
Preston, England, United Kingdom
Berkshire Cancer Centre at Royal Berkshire Hospital
Reading, England, United Kingdom
Alexandra Healthcare NHS
Redditch, Worcestershire, England, United Kingdom
Scarborough General Hospital
Scarborough, England, United Kingdom
Cancer Research Centre at Weston Park Hospital
Sheffield, England, United Kingdom
Wexham Park Hospital
Slough, Berkshire, England, United Kingdom
South Tyneside District Hospital
South Shields, England, United Kingdom
Staffordshire General Hospital
Stafford, England, United Kingdom
University Hospital of North Staffordshire
Stoke-on-Trent, England, United Kingdom
Royal Marsden - Surrey
Sutton, England, United Kingdom
South Warwickshire Hospital
Warwick, Warwickshire, England, United Kingdom
Weston General Hospital
Weston-super-Mare, England, United Kingdom
New Cross Hospital
Wolverhampton, England, United Kingdom
Yeovil District Hospital
Yeovil, England, United Kingdom
Ysbyty Gwynedd
Bangor, Wales, United Kingdom
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, United Kingdom
Llandough Hospital
Llandough, Wales, United Kingdom
Royal Glamorgan Hospital
Llantrisant, Wales, United Kingdom
Prince Charles Hospital
Mid Glamorgan, Wales, United Kingdom
Royal Gwent Hospital
Newport Gwent, Wales, United Kingdom
Glan Clwyd Hospital
Rhyl, Denbighshire, Wales, United Kingdom
Countries
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Facility Contacts
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Nicholas Bates, MD
Role: primary
David Fyfe, MD
Role: primary
Wiebke Appel, MD, FRCR, MRCP
Role: primary
Tom Geldart
Role: primary
Wiebke Appel, MD, FRCR, MRCP
Role: primary
A.D. Chetiyawardana, MD
Role: primary
Contact Person
Role: primary
Caroline Humber, MD
Role: primary
Clive Peedell, MD
Role: primary
Contact Person
Role: primary
Mike Bayne, MD
Role: primary
Simon Grumett, MD
Role: primary
Fiona McDonald, MD
Role: primary
Nicholas Bates, MD
Role: primary
Contact Person
Role: primary
David Fyfe, MD
Role: primary
Paula Wells, MD
Role: primary
Paula Wells, MD
Role: primary
Contact Person
Role: primary
Siow M. Lee, MD, PhD, FRCP
Role: primary
Contact Person
Role: primary
Contact Person
Role: primary
Clive Peedell, MD
Role: primary
Hany Eldeeb, MD
Role: primary
Contact Person
Role: primary
Contact Person
Role: primary
Contact Person
Role: primary
Clive Peedell, MD
Role: primary
Contact Person
Role: primary
Contact Person
Role: primary
Mark Hocking, MD
Role: primary
Dennis Yiannakis, MD
Role: primary
Virginia Laurence, MD
Role: primary
Geraldine Skailes, MD
Role: primary
Richard Brown, MD
Role: primary
Joanna Hamilton, MD
Role: primary
Contact Person
Role: primary
Penella J. Woll, MD, PhD
Role: primary
Contact Person
Role: primary
Goudarz Mazdai, MD, PhD
Role: primary
Caroline Brammer, MD
Role: primary
Contact Person
Role: primary
Contact Person
Role: primary
Caroline Humber, MD
Role: primary
Christopher J. Williams, DM, FRCP
Role: primary
David Ferry, MD
Role: primary
Fergus Macbeth, MD
Role: primary
Fergus Macbeth, MD
Role: primary
Contact Person
Role: primary
Fergus Macbeth, MD
Role: primary
Contact Person
Role: primary
Angel Garcia-Alonso, MD
Role: primary
References
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Griffiths GO, Burns S, Noble SI, Macbeth FR, Cohen D, Maughan TS. FRAGMATIC: a randomised phase III clinical trial investigating the effect of fragmin added to standard therapy in patients with lung cancer. BMC Cancer. 2009 Oct 6;9:355. doi: 10.1186/1471-2407-9-355.
Rutjes AW, Porreca E, Candeloro M, Valeriani E, Di Nisio M. Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy. Cochrane Database Syst Rev. 2020 Dec 18;12(12):CD008500. doi: 10.1002/14651858.CD008500.pub5.
Other Identifiers
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PFIZER-WCTU-02
Identifier Type: -
Identifier Source: secondary_id
WCTU-FRAGMATIC
Identifier Type: -
Identifier Source: secondary_id
Velindre-FRAGMATIC
Identifier Type: -
Identifier Source: secondary_id
WCTU-02
Identifier Type: -
Identifier Source: secondary_id
EU-20753
Identifier Type: -
Identifier Source: secondary_id
EUDRACT-2005-002438-37
Identifier Type: -
Identifier Source: secondary_id
ISRCTN80812769
Identifier Type: -
Identifier Source: secondary_id
CDR0000561532
Identifier Type: -
Identifier Source: org_study_id
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