Dalteparin in Preventing Blood Clots in Patients With Lung Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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FRAGMATIC - A Randomised Phase III Clinical Trial Investigating the Effect of FRAGMin Added to Standard Therapy In Patients With Lung Cancer

Conditions
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Lung Cancer, Thromboembolism

Intervention / Treatment
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* Drug: dalteparin
* Procedure: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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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®)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: dalteparin|nan|
|Procedure: quality-of-life assessment|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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