Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-31 @ 4:36 PM
Study NCT ID:
NCT00519805
Status:
UNKNOWN
Last Update Posted:
2011-08-08
First Post:
2007-08-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dalteparin in Preventing Blood Clots in Patients With Lung Cancer
Sponsor:
Velindre NHS Trust
Organization:
Study Overview
Official Title:
FRAGMATIC - A Randomised Phase III Clinical Trial Investigating the Effect of FRAGMin Added to Standard Therapy In Patients With Lung Cancer
Status:
UNKNOWN
Status Verified Date:
2008-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: