Dalteparin in Preventing Blood Clots in Patients With Lung Cancer
- Conditions
- Lung CancerThromboembolism
- Registration Number
- NCT00519805
- Lead Sponsor
- Velindre NHS Trust
- Brief Summary
RATIONALE: Anticoagulants, such as dalteparin, may help prevent blood clots from forming in patients with lung cancer. It is not yet known whether dalteparin is effective in preventing blood clots in patients with lung cancer.
PURPOSE: This randomized phase III trial is studying how well dalteparin works in preventing blood clots in patients with lung cancer.
- Detailed Description
OBJECTIVES:
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 2200
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival
- Secondary Outcome Measures
Name Time Method Venous thrombotic event-free survival Serious adverse events Metastasis-free survival Toxicity Quality of life as measured by EQ-5D Breathlessness (dyspnea) as measured by the Cancer Dyspnea Scale Anxiety and depression as measured by the Hospital Anxiety and Depression Scale Cost effectiveness Cost utility
Trial Locations
- Locations (60)
Royal Bournemouth Hospital
🇬🇧Bournemouth, England, United Kingdom
Burnley General Hospital
🇬🇧Burnley, England, United Kingdom
Nottingham City Hospital
🇬🇧Nottingham, England, United Kingdom
Doncaster Royal Infirmary
🇬🇧Doncaster, England, United Kingdom
Helen Rollason Cancer Care Centre at North Middlesex Hospital
🇬🇧London, England, United Kingdom
Wycombe General Hospital
🇬🇧High Wycombe, England, United Kingdom
Kidderminster Hospital
🇬🇧Kidderminster Worcestershire, England, United Kingdom
Whittington Hospital
🇬🇧London, England, United Kingdom
University College Hospital
🇬🇧London, England, United Kingdom
Norfolk and Norwich University Hospital
🇬🇧Norwich, England, United Kingdom
Friarage Hospital
🇬🇧North Yorkshire, England, United Kingdom
Milton Keynes General Hospital
🇬🇧Milton Keynes, England, United Kingdom
Northampton General Hospital
🇬🇧Northampton, England, United Kingdom
Scarborough General Hospital
🇬🇧Scarborough, England, United Kingdom
Royal Gwent Hospital
🇬🇧Newport Gwent, Wales, United Kingdom
Glan Clwyd Hospital
🇬🇧Rhyl, Denbighshire, Wales, United Kingdom
Newcastle Upon Tyne Hospitals NHS Trust
🇬🇧Newcastle-Upon-Tyne, England, United Kingdom
James Paget Hospital
🇬🇧Norfolk, England, United Kingdom
Mount Vernon Cancer Centre at Mount Vernon Hospital
🇬🇧Northwood, England, United Kingdom
North Tyneside Hospital
🇬🇧North Shields, England, United Kingdom
Berkshire Cancer Centre at Royal Berkshire Hospital
🇬🇧Reading, England, United Kingdom
Alexandra Healthcare NHS
🇬🇧Redditch, Worcestershire, England, United Kingdom
Yeovil District Hospital
🇬🇧Yeovil, England, United Kingdom
George Eliot Hospital
🇬🇧Nuneaton, England, United Kingdom
South Warwickshire Hospital
🇬🇧Warwick, Warwickshire, England, United Kingdom
New Cross Hospital
🇬🇧Wolverhampton, England, United Kingdom
Cancer Research Centre at Weston Park Hospital
🇬🇧Sheffield, England, United Kingdom
Llandough Hospital
🇬🇧Llandough, Wales, United Kingdom
South Tyneside District Hospital
🇬🇧South Shields, England, United Kingdom
Velindre Cancer Center at Velindre Hospital
🇬🇧Cardiff, Wales, United Kingdom
Prince Charles Hospital
🇬🇧Mid Glamorgan, Wales, United Kingdom
Stoke Mandeville Hospital
🇬🇧Aylesbury-Buckinghamshire, England, United Kingdom
Walsgrave Hospital
🇬🇧Coventry, England, United Kingdom
West Suffolk Hospital
🇬🇧Bury St. Edmunds, England, United Kingdom
Saint Bartholomew's Hospital
🇬🇧London, England, United Kingdom
Queen Elizabeth Hospital
🇬🇧Gateshead, England, United Kingdom
Russells Hall Hospital
🇬🇧Dudley, England, United Kingdom
Royal Lancaster Infirmary
🇬🇧Lancaster, England, United Kingdom
James Cook University Hospital
🇬🇧Middlesbrough, England, United Kingdom
University Hospital of North Staffordshire
🇬🇧Stoke-On-Trent, England, United Kingdom
Ysbyty Gwynedd
🇬🇧Bangor, Wales, United Kingdom
Weston General Hospital
🇬🇧Weston-super-Mare, England, United Kingdom
Furness General Hospital
🇬🇧Barrow in Furness, England, United Kingdom
Royal Blackburn Hospital
🇬🇧Blackburn, England, United Kingdom
Bristol Haematology and Oncology Centre
🇬🇧Bristol, England, United Kingdom
Queen's Hospital
🇬🇧Burton-upon-Trent, England, United Kingdom
Dorset County Hospital
🇬🇧Dorchester, England, United Kingdom
Blackpool Victoria Hospital
🇬🇧Blackpool, England, United Kingdom
Darlington Memorial
🇬🇧Darlington, England, United Kingdom
Derbyshire Royal Infirmary
🇬🇧Derby, England, United Kingdom
Whipps Cross Hospital
🇬🇧London, England, United Kingdom
UCL Cancer Institute
🇬🇧London, England, United Kingdom
Luton and Dunstable Hospital
🇬🇧Luton, England, United Kingdom
Derriford Hospital
🇬🇧Plymouth, England, United Kingdom
Rosemere Cancer Centre at Royal Preston Hospital
🇬🇧Preston, England, United Kingdom
Dorset Cancer Centre
🇬🇧Poole Dorset, England, United Kingdom
Wexham Park Hospital
🇬🇧Slough, Berkshire, England, United Kingdom
Royal Marsden - Surrey
🇬🇧Sutton, England, United Kingdom
Royal Glamorgan Hospital
🇬🇧Llantrisant, Wales, United Kingdom
Staffordshire General Hospital
🇬🇧Stafford, England, United Kingdom