Dalteparin in Preventing Blood Clots in Patients With Lung Cancer

Phase 3

• Conditions: Lung Cancer; Thromboembolism

• Registration Number: NCT00519805
• Lead Sponsor: Velindre NHS Trust

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.

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-08-21
• Study First Submitted QC: 2007-08-21
• Study First Posted: 2007-08-23
• Status Verified: 2008-03
• Last Update Submitted: 2011-08-05
• Last Update Posted: 2011-08-08
• Primary Completion: 2012-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (60)

Stoke Mandeville Hospital; 🇬🇧 Aylesbury-Buckinghamshire, England, United Kingdom

Furness General Hospital; 🇬🇧 Barrow in Furness, England, United Kingdom

Royal Blackburn Hospital; 🇬🇧 Blackburn, England, United Kingdom

Blackpool Victoria Hospital; 🇬🇧 Blackpool, England, United Kingdom

Royal Bournemouth Hospital; 🇬🇧 Bournemouth, England, United Kingdom

Bristol Haematology and Oncology Centre; 🇬🇧 Bristol, England, United Kingdom

Burnley General Hospital; 🇬🇧 Burnley, England, United Kingdom

Queen's Hospital; 🇬🇧 Burton-upon-Trent, England, United Kingdom

West Suffolk Hospital; 🇬🇧 Bury St. Edmunds, England, United Kingdom

Walsgrave Hospital; 🇬🇧 Coventry, England, United Kingdom

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