Lung CancerPhase 3NCT00519805
Dalteparin in Preventing Blood Clots in Patients With Lung Cancer
A Phase 3 study testing dalteparin and quality-of-life assessment in people with Lung Cancer and Thromboembolism, run by Velindre NHS Trust at 60 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Thromboembolism
- What is being tested?
- dalteparin and quality-of-life assessment
- Type of treatment
- Surgery or procedure
- How many people
- 2,200 participants
- Where
- 60 sitesUnited Kingdom
- Study dates
- Aug 2007to Aug 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- 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®)
Trial locations and contacts
60 sites in 1 country.
60 sites in 1 country
United Kingdom60 sites, 60 recruiting
- Recruiting
Stoke Mandeville Hospital
Aylesbury-Buckinghamshire, England, HP21 8AL
Nicholas Bates, MD, 44-1296-316-555
- Recruiting
Ysbyty Gwynedd
Bangor, Wales, LL57 2PW
Nick Stuart, MD, 44-1248-384-150, nick.stuart@nww-tr.wales.nus.uk
- Recruiting
Furness General Hospital
Barrow in Furness, England, LA14 4LF
David Fyfe, MD, 44-1524-583-510
- Recruiting
Royal Blackburn Hospital
Blackburn, England, BB2 3HH
Wiebke Appel, MD, FRCR, MRCP, 44-1772-522-792
- Recruiting
Blackpool Victoria Hospital
Blackpool, England, FY3 8NR
Andrew C. Hindley, MD, 44-177-252-2908, andrew.hindley@lthtr.nhs.uk
- Recruiting
Royal Bournemouth Hospital
Bournemouth, England, BH7 7DW
Tom Geldart, 44-1202-726-088
- Recruiting
Bristol Haematology and Oncology Centre
Bristol, England, BS2 8ED
Stephen J. Falk, MD, 44-1935-384-559, stephen.falk@ubht.nhs.uk
- Recruiting
Burnley General Hospital
Burnley, England, BB10 2PQ
Wiebke Appel, MD, FRCR, MRCP, 44-772-522-792
- Recruiting
Queen's Hospital
Burton-on-Trent, England, DE13 0RB
A.D. Chetiyawardana, MD, 44-283-566-333
- Recruiting
West Suffolk Hospital
Bury St Edmunds, England, IP33 2QZ
Contact Person, 44-1284-713-195
- Recruiting
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, CF14 2TL
Fergus Macbeth, MD, 44-292-031-6232
- Recruiting
Walsgrave Hospital
Coventry, England, CV2 2DX
Caroline Humber, MD, 44-2476-967-478
- Recruiting
Darlington Memorial
Darlington, England, DL3 6HX
Clive Peedell, MD, 44-1643-850-850
- Recruiting
Derbyshire Royal Infirmary
Derby, England, DE1 2QY
Muthu Kumar, MD, 44-1332-347-141 ext. 2437, muthu.kumar@derbyhospitals.nhs.uk
- Recruiting
Doncaster Royal Infirmary
Doncaster, England, DN2 5LT
Contact Person, 44-130-236-6666
- Recruiting
Dorset County Hospital
Dorchester, England, DT1 2JY
Mike Bayne, MD, 44-1202-448-648
- Recruiting
Russells Hall Hospital
Dudley, England, DY1 2HQ
Simon Grumett, MD, 44-384-456-111
- Recruiting
Queen Elizabeth Hospital
Gateshead, England, NE9 6SX
Fiona McDonald, MD, 44-191-256-3567
- Recruiting
Wycombe General Hospital
High Wycombe, England
Nicholas Bates, MD, 44-865-225-601
- Recruiting
Kidderminster Hospital
Kidderminster Worcestershire, England, DY11 6RJ
Contact Person, 44-1562-513-093
- Recruiting
Royal Lancaster Infirmary
Lancaster, England, LA1 4RP
David Fyfe, MD, 44-1524-583-510
- Recruiting
Llandough Hospital
Llandough, Wales, CF64 2XX
Fergus Macbeth, MD, 44-29-2061-5888
- Recruiting
Royal Glamorgan Hospital
Llantrisant, Wales, CF72 8XR
Contact Person, 44-2920-615-888
- Recruiting
Whipps Cross Hospital
London, England, E11 1NR
Paula Wells, MD, 44-20-7601-8044
- Recruiting
Saint Bartholomew's Hospital
London, England, EC1A 7BE
Paula Wells, MD, 44-207-601-8044
- Recruiting
Helen Rollason Cancer Care Centre at North Middlesex Hospital
London, England, N18 1QX
Contact Person, 44-20-7472-6115
- Recruiting
Whittington Hospital
London, England, N19 5NF
Siow M. Lee, MD, PhD, FRCP, 44-20-7288-5227
- Recruiting
University College Hospital
London, England, NW1 2PG
Siow M. Lee, MD, PhD, FRCP, 44-20-7288-5227, sm.lee@uclh.org
- Recruiting
UCL Cancer Institute
London, England, NW3 2QG
Contact Person, 44-20-7472-6115
- Recruiting
Luton and Dunstable Hospital
Luton, England, LU4 0DZ
Contact Person, 44-1582-497-513
- Recruiting
Prince Charles Hospital
Mid Glamorgan, Wales, CF47 9DT
Fergus Macbeth, MD, 44-29-2061-5888
- Recruiting
James Cook University Hospital
Middlesbrough, England, TS4 3BW
Clive Peedell, MD, 44-643-850-850
- Recruiting
Milton Keynes General Hospital
Milton Keynes, England, MK6 5LD
Hany Eldeeb, MD, 44-1604-523-815
- Recruiting
Newcastle Upon Tyne Hospitals NHS Trust
Newcastle upon Tyne, England, NE7 7DN
Contact Person, 44-191-256-3555
- Recruiting
Royal Gwent Hospital
Newport Gwent, Wales, NP9 2UB
Contact Person, 44-1633-623-623
- Recruiting
James Paget Hospital
Norfolk, England, NR31 6LA
Contact Person, 44-1603-287-674
- Recruiting
North Tyneside Hospital
North Shields, England, NE29 8NH
Contact Person, 44-191-256-3555
- Recruiting
Friarage Hospital
North Yorks, England, DL6 1JG
Clive Peedell, MD, 44-643-850-850
- Recruiting
Northampton General Hospital
Northampton, England, NN1 5BD
Contact Person, 44-1604-543-789
- Recruiting
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, HA6 2RN
Jeanette Dickson, MD, 44-923-844-551, jeanette.dickson@nhs.net
- Recruiting
Norfolk and Norwich University Hospital
Norwich, England, NR4 7UY
Tom W. Roques, MD, 44-603-287-671, tom.roques@nnuh.nhs.uk
- Recruiting
Nottingham City Hospital
Nottingham, England, NG5 1PB
Contact Person, 44-115-969-1169
- Recruiting
George Eliot Hospital
Nuneaton, England, CV10 7DJ
Mark Hocking, MD, 44-2476-967-490
- Recruiting
Derriford Hospital
Plymouth, England, PL6 8DH
Dennis Yiannakis, MD, 44-1752-439-103
- Recruiting
Dorset Cancer Centre
Poole Dorset, England, BH15 2JB
Virginia Laurence, MD, 44-1202-448-262
- Recruiting
Rosemere Cancer Centre at Royal Preston Hospital
Preston, England, PR2 9HT
Geraldine Skailes, MD, 44-1772-522-913
- Recruiting
Berkshire Cancer Centre at Royal Berkshire Hospital
Reading, England, RG1 5AN
Richard Brown, MD, 44-118-322-8343
- Recruiting
Alexandra Healthcare NHS
Redditch, Worcestershire, England, B98 7UB
Joanna Hamilton, MD, 44-2476-967-477
- Recruiting
Glan Clwyd Hospital
Rhyl, Denbighshire, Wales, LL 18 5UJ
Angel Garcia-Alonso, MD, 44-1745-583-910
- Recruiting
Scarborough General Hospital
Scarborough, England, YO12 6QL
Contact Person, 44-1482-701-151
- Recruiting
Cancer Research Centre at Weston Park Hospital
Sheffield, England, S1O 2SJ
Penella J. Woll, MD, PhD, 44-14-226-5235
- Recruiting
Wexham Park Hospital
Slough, Berkshire, England, SL2 4HL
Contact Person, 44-1753-634-191
- Recruiting
South Tyneside District Hospital
South Shields, England, NE34 0PL
Goudarz Mazdai, MD, PhD, 44-191-202-4010
- Recruiting
Staffordshire General Hospital
Stafford, England, ST16 3SA
Caroline Brammer, MD, 44-902-695-201
- Recruiting
University Hospital of North Staffordshire
Stoke-on-Trent, England, ST4 7LN
Contact Person, 44-1782-554-974
- Recruiting
Royal Marsden - Surrey
Sutton, England, SM2 5PT
Contact Person, 44-20-8661-3278
- Recruiting
South Warwickshire Hospital
Warwick, Warwickshire, England, CV34 5BJ
Caroline Humber, MD, 44-2476-967-478
- Recruiting
Weston General Hospital
Weston-super-Mare, England, BS23 4TQ
Christopher J. Williams, DM, FRCP, 44-1934-881-136
- Recruiting
New Cross Hospital
Wolverhampton, England, WV10 0QP
David Ferry, MD, 44-1245-516-598
- Recruiting
Yeovil District Hospital
Yeovil, England, BA21 4AT
Stephen J. Falk, MD, 44-932-384-559, stephen.falk@swest.uhs.uk
About this study
Official title: FRAGMATIC - A Randomised Phase III Clinical Trial Investigating the Effect of FRAGMin Added to Standard Therapy In Patients With Lung Cancer
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.
Read the 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.
- Conditions
- Lung Cancer, Thromboembolism
- Being tested
- dalteparin, quality-of-life assessment
- Keywords
- thromboembolism, extensive stage small cell lung cancer, limited stage small cell lung cancer, stage IV non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage I non-small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Thromboembolism, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dalteparinDrug
quality-of-life assessmentProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Secondary outcomes (9)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Masking
- None (open label)
- Enrolment
- 2,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Velindre NHS Trust
- Sponsor type
- Other government
- Investigators
- Fergus Macbeth, MD, Study chair, Velindre NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00519805
- Sponsor's protocol ID
- CDR0000561532
- Other IDs
- WCTU-FRAGMATIC, Velindre-FRAGMATIC, WCTU-02, EU-20753, PFIZER-WCTU-02, EUDRACT-2005-002438-37, ISRCTN80812769
- Status last verified
- Mar 2008
- First submitted
- 21 Aug 2007
- Last updated
- 8 Aug 2011
- Results posted
- No
Publications
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.
PubMed 19807917Rutjes 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.
PubMed 33337539
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FRAGMATIC - A Randomised Phase III Clinical Trial Investigating the Effect of FRAGMin Added to Standard Therapy In Patients With Lung Cancer
- ClinicalTrials.gov ID
- NCT00519805
- Acronym / sponsor ID
- CDR0000561532
- Conditions
- Lung Cancer, Thromboembolism
- Keywords
- thromboembolism, extensive stage small cell lung cancer, limited stage small cell lung cancer, stage IV non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage I non-small cell lung cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,200 participants (estimated)
- Lead sponsor
- Velindre NHS TrustOther government
- Study start
- Aug 2007
- Primary completion
- Aug 2012 (estimated)
- First posted
- 23 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dalteparin | Drug | – |
| quality-of-life assessment | Procedure or surgery | – |
Primary outcome
Overall survival
9 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2011.
- Results publication: PubMed 19807917Griffiths 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.
- Derived from this study: PubMed 33337539Rutjes 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fergus Macbeth, MD study chair
Velindre NHS Trust
60 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing dalteparin and quality-of-life assessment in people with Lung Cancer and Thromboembolism, run by Velindre NHS Trust at 60 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00519805, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2011.