Dalteparin in Preventing Blood Clots in Patients With Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00519805|
Recruitment Status : Unknown
Verified March 2008 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : August 23, 2007
Last Update Posted : August 8, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer Thromboembolism||Drug: dalteparin Procedure: quality-of-life assessment||Phase 3|
- Determine whether the addition of dalteparin results in improved survival.
- 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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2200 participants|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||FRAGMATIC - A Randomised Phase III Clinical Trial Investigating the Effect of FRAGMin Added to Standard Therapy In Patients With Lung Cancer|
|Study Start Date :||August 2007|
|Estimated Primary Completion Date :||August 2012|
- Overall survival
- Venous thrombotic event-free survival
- Serious adverse events
- 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 effectiveness
- Cost utility
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00519805
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|Study Chair:||Fergus Macbeth, MD||Velindre NHS Trust|