Dalteparin in Preventing Blood Clots in Patients With Lung Cancer

August 5, 2011 updated by: Velindre NHS Trust

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • Aylesbury-Buckinghamshire, England, United Kingdom, HP21 8AL
        • Recruiting
        • Stoke Mandeville Hospital
        • Contact:
          • Nicholas Bates, MD
          • Phone Number: 44-1296-316-555
      • Barrow in Furness, England, United Kingdom, LA14 4LF
        • Recruiting
        • Furness General Hospital
        • Contact:
          • David Fyfe, MD
          • Phone Number: 44-1524-583-510
      • Blackburn, England, United Kingdom, BB2 3HH
        • Recruiting
        • Royal Blackburn Hospital
        • Contact:
          • Wiebke Appel, MD, FRCR, MRCP
          • Phone Number: 44-1772-522-792
      • Blackpool, England, United Kingdom, FY3 8NR
        • Recruiting
        • Blackpool Victoria Hospital
        • Contact:
      • Bournemouth, England, United Kingdom, BH7 7DW
        • Recruiting
        • Royal Bournemouth Hospital
      • Bristol, England, United Kingdom, BS2 8ED
        • Recruiting
        • Bristol Haematology and Oncology Centre
        • Contact:
      • Burnley, England, United Kingdom, BB10 2PQ
        • Recruiting
        • Burnley General Hospital
        • Contact:
          • Wiebke Appel, MD, FRCR, MRCP
          • Phone Number: 44-772-522-792
      • Burton-upon-Trent, England, United Kingdom, DE13 0RB
        • Recruiting
        • Queen's Hospital
        • Contact:
          • A.D. Chetiyawardana, MD
          • Phone Number: 44-283-566-333
      • Bury St. Edmunds, England, United Kingdom, IP33 2QZ
        • Recruiting
        • West Suffolk Hospital
        • Contact:
          • Contact Person
          • Phone Number: 44-1284-713-195
      • Coventry, England, United Kingdom, CV2 2DX
        • Recruiting
        • Walsgrave Hospital
        • Contact:
          • Caroline Humber, MD
          • Phone Number: 44-2476-967-478
      • Darlington, England, United Kingdom, DL3 6HX
        • Recruiting
        • Darlington Memorial
        • Contact:
          • Clive Peedell, MD
          • Phone Number: 44-1643-850-850
      • Derby, England, United Kingdom, DE1 2QY
      • Doncaster, England, United Kingdom, DN2 5LT
        • Recruiting
        • Doncaster Royal Infirmary
        • Contact:
          • Contact Person
          • Phone Number: 44-130-236-6666
      • Dorchester, England, United Kingdom, DT1 2JY
        • Recruiting
        • Dorset County Hospital
        • Contact:
          • Mike Bayne, MD
          • Phone Number: 44-1202-448-648
      • Dudley, England, United Kingdom, DY1 2HQ
        • Recruiting
        • Russells Hall Hospital
        • Contact:
          • Simon Grumett, MD
          • Phone Number: 44-384-456-111
      • Gateshead, England, United Kingdom, NE9 6SX
        • Recruiting
        • Queen Elizabeth Hospital
        • Contact:
          • Fiona McDonald, MD
          • Phone Number: 44-191-256-3567
      • High Wycombe, England, United Kingdom
        • Recruiting
        • Wycombe General Hospital
        • Contact:
          • Nicholas Bates, MD
          • Phone Number: 44-865-225-601
      • Kidderminster Worcestershire, England, United Kingdom, DY11 6RJ
        • Recruiting
        • Kidderminster Hospital
        • Contact:
          • Contact Person
          • Phone Number: 44-1562-513-093
      • Lancaster, England, United Kingdom, LA1 4RP
        • Recruiting
        • Royal Lancaster Infirmary
        • Contact:
          • David Fyfe, MD
          • Phone Number: 44-1524-583-510
      • London, England, United Kingdom, EC1A 7BE
        • Recruiting
        • Saint Bartholomew's Hospital
        • Contact:
          • Paula Wells, MD
          • Phone Number: 44-207-601-8044
      • London, England, United Kingdom, E11 1NR
        • Recruiting
        • Whipps Cross Hospital
        • Contact:
          • Paula Wells, MD
          • Phone Number: 44-20-7601-8044
      • London, England, United Kingdom, N18 1QX
        • Recruiting
        • Helen Rollason Cancer Care Centre at North Middlesex Hospital
        • Contact:
          • Contact Person
          • Phone Number: 44-20-7472-6115
      • London, England, United Kingdom, N19 5NF
        • Recruiting
        • Whittington Hospital
        • Contact:
          • Siow M. Lee, MD, PhD, FRCP
          • Phone Number: 44-20-7288-5227
      • London, England, United Kingdom, NW1 2PG
        • Recruiting
        • University College Hospital
        • Contact:
          • Siow M. Lee, MD, PhD, FRCP
          • Phone Number: 44-20-7288-5227
          • Email: sm.lee@uclh.org
      • London, England, United Kingdom, NW3 2QG
        • Recruiting
        • UCL Cancer Institute
        • Contact:
          • Contact Person
          • Phone Number: 44-20-7472-6115
      • Luton, England, United Kingdom, LU4 0DZ
        • Recruiting
        • Luton and Dunstable Hospital
        • Contact:
          • Contact Person
          • Phone Number: 44-1582-497-513
      • Middlesbrough, England, United Kingdom, TS4 3BW
        • Recruiting
        • James Cook University Hospital
        • Contact:
          • Clive Peedell, MD
          • Phone Number: 44-643-850-850
      • Milton Keynes, England, United Kingdom, MK6 5LD
        • Recruiting
        • Milton Keynes General Hospital
        • Contact:
          • Hany Eldeeb, MD
          • Phone Number: 44-1604-523-815
      • Newcastle-Upon-Tyne, England, United Kingdom, NE7 7DN
        • Recruiting
        • Newcastle Upon Tyne Hospitals NHS Trust
        • Contact:
          • Contact Person
          • Phone Number: 44-191-256-3555
      • Norfolk, England, United Kingdom, NR31 6LA
        • Recruiting
        • James Paget Hospital
        • Contact:
          • Contact Person
          • Phone Number: 44-1603-287-674
      • North Shields, England, United Kingdom, NE29 8NH
        • Recruiting
        • North Tyneside Hospital
        • Contact:
          • Contact Person
          • Phone Number: 44-191-256-3555
      • North Yorkshire, England, United Kingdom, DL6 1JG
        • Recruiting
        • Friarage Hospital
        • Contact:
          • Clive Peedell, MD
          • Phone Number: 44-643-850-850
      • Northampton, England, United Kingdom, NN1 5BD
        • Recruiting
        • Northampton General Hospital
        • Contact:
          • Contact Person
          • Phone Number: 44-1604-543-789
      • Northwood, England, United Kingdom, HA6 2RN
        • Recruiting
        • Mount Vernon Cancer Centre at Mount Vernon Hospital
        • Contact:
      • Norwich, England, United Kingdom, NR4 7UY
        • Recruiting
        • Norfolk and Norwich University Hospital
        • Contact:
      • Nottingham, England, United Kingdom, NG5 1PB
        • Recruiting
        • Nottingham City Hospital
        • Contact:
          • Contact Person
          • Phone Number: 44-115-969-1169
      • Nuneaton, England, United Kingdom, CV10 7DJ
        • Recruiting
        • George Eliot Hospital
        • Contact:
          • Mark Hocking, MD
          • Phone Number: 44-2476-967-490
      • Plymouth, England, United Kingdom, PL6 8DH
        • Recruiting
        • Derriford Hospital
        • Contact:
          • Dennis Yiannakis, MD
          • Phone Number: 44-1752-439-103
      • Poole Dorset, England, United Kingdom, BH15 2JB
        • Recruiting
        • Dorset Cancer Centre
        • Contact:
          • Virginia Laurence, MD
          • Phone Number: 44-1202-448-262
      • Preston, England, United Kingdom, PR2 9HT
        • Recruiting
        • Rosemere Cancer Centre at Royal Preston Hospital
        • Contact:
          • Geraldine Skailes, MD
          • Phone Number: 44-1772-522-913
      • Reading, England, United Kingdom, RG1 5AN
        • Recruiting
        • Berkshire Cancer Centre at Royal Berkshire Hospital
        • Contact:
          • Richard Brown, MD
          • Phone Number: 44-118-322-8343
      • Redditch, Worcestershire, England, United Kingdom, B98 7UB
        • Recruiting
        • Alexandra Healthcare NHS
        • Contact:
          • Joanna Hamilton, MD
          • Phone Number: 44-2476-967-477
      • Scarborough, England, United Kingdom, YO12 6QL
        • Recruiting
        • Scarborough General Hospital
        • Contact:
          • Contact Person
          • Phone Number: 44-1482-701-151
      • Sheffield, England, United Kingdom, S1O 2SJ
        • Recruiting
        • Cancer Research Centre at Weston Park Hospital
        • Contact:
          • Penella J. Woll, MD, PhD
          • Phone Number: 44-14-226-5235
      • Slough, Berkshire, England, United Kingdom, SL2 4HL
        • Recruiting
        • Wexham Park Hospital
        • Contact:
          • Contact Person
          • Phone Number: 44-1753-634-191
      • South Shields, England, United Kingdom, NE34 0PL
        • Recruiting
        • South Tyneside District Hospital
        • Contact:
          • Goudarz Mazdai, MD, PhD
          • Phone Number: 44-191-202-4010
      • Stafford, England, United Kingdom, ST16 3SA
        • Recruiting
        • Staffordshire General Hospital
        • Contact:
          • Caroline Brammer, MD
          • Phone Number: 44-902-695-201
      • Stoke-On-Trent, England, United Kingdom, ST4 7LN
        • Recruiting
        • University Hospital of North Staffordshire
        • Contact:
          • Contact Person
          • Phone Number: 44-1782-554-974
      • Sutton, England, United Kingdom, SM2 5PT
        • Recruiting
        • Royal Marsden - Surrey
        • Contact:
          • Contact Person
          • Phone Number: 44-20-8661-3278
      • Warwick, Warwickshire, England, United Kingdom, CV34 5BJ
        • Recruiting
        • South Warwickshire Hospital
        • Contact:
          • Caroline Humber, MD
          • Phone Number: 44-2476-967-478
      • Weston-super-Mare, England, United Kingdom, BS23 4TQ
        • Recruiting
        • Weston General Hospital
        • Contact:
          • Christopher J. Williams, DM, FRCP
          • Phone Number: 44-1934-881-136
      • Wolverhampton, England, United Kingdom, WV10 0QP
        • Recruiting
        • New Cross Hospital
        • Contact:
          • David Ferry, MD
          • Phone Number: 44-1245-516-598
      • Yeovil, England, United Kingdom, BA21 4AT
        • Recruiting
        • Yeovil District Hospital
        • Contact:
    • Wales
      • Bangor, Wales, United Kingdom, LL57 2PW
      • Cardiff, Wales, United Kingdom, CF14 2TL
        • Recruiting
        • Velindre Cancer Center at Velindre Hospital
        • Contact:
          • Fergus Macbeth, MD
          • Phone Number: 44-292-031-6232
      • Llandough, Wales, United Kingdom, CF64 2XX
        • Recruiting
        • LLandough Hospital
        • Contact:
          • Fergus Macbeth, MD
          • Phone Number: 44-29-2061-5888
      • Llantrisant, Wales, United Kingdom, CF72 8XR
        • Recruiting
        • Royal Glamorgan Hospital
        • Contact:
          • Contact Person
          • Phone Number: 44-2920-615-888
      • Mid Glamorgan, Wales, United Kingdom, CF47 9DT
        • Recruiting
        • Prince Charles Hospital
        • Contact:
          • Fergus Macbeth, MD
          • Phone Number: 44-29-2061-5888
      • Newport Gwent, Wales, United Kingdom, NP9 2UB
        • Recruiting
        • Royal Gwent Hospital
        • Contact:
          • Contact Person
          • Phone Number: 44-1633-623-623
      • Rhyl, Denbighshire, Wales, United Kingdom, LL 18 5UJ
        • Recruiting
        • Glan Clwyd Hospital
        • Contact:
          • Angel Garcia-Alonso, MD
          • Phone Number: 44-1745-583-910

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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®)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Overall survival

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Toxicity
Serious adverse events
Cost effectiveness
Venous thrombotic event-free survival
Metastasis-free survival
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 utility

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Velindre NHS Trust

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Fergus Macbeth, MD, Velindre NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2007

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 23, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 8, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CDR0000561532
  • WCTU-FRAGMATIC
  • Velindre-FRAGMATIC
  • WCTU-02
  • EU-20753
  • PFIZER-WCTU-02
  • EUDRACT-2005-002438-37
  • ISRCTN80812769

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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