Dalteparin in Preventing Blood Clots in Patients With Lung Cancer
Recruitment status was Recruiting
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.
Procedure: quality-of-life assessment
|Study Design:||Allocation: Randomized
Masking: 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|
- 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
|Study Start Date:||August 2007|
|Estimated Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
- 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.
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|Study Chair:||Fergus Macbeth, MD||Velindre NHS Trust|