Lung Cancer, Thromboembolism
Conditions
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
Brief 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. 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.
Interventions
DRUGdalteparin
PROCEDUREquality-of-life assessment
Sponsors
Velindre NHS Trust
Study design
Allocation
RANDOMIZED
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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®)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Serious adverse events | — |
| Metastasis-free survival | — |
| Toxicity | — |
| Quality of life as measured by EQ-5D | — |
| Venous thrombotic event-free survival | — |
| Anxiety and depression as measured by the Hospital Anxiety and Depression Scale | — |
| Cost effectiveness | — |
| Cost utility | — |
| Breathlessness (dyspnea) as measured by the Cancer Dyspnea Scale | — |
Countries
United Kingdom
Outcome results
None listed