Spots Global Cancer Trial Database for Dalteparin in Preventing Blood Clots in Patients With Lung Cancer

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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