Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00519805
Status:
UNKNOWN
Last Update Posted:
2011-08-08
First Post:
2007-08-21
Brief Title:
Dalteparin in Preventing Blood Clots in Patients With Lung Cancer
Sponsor:
Velindre NHS Trust
Organization:
National Cancer Institute NCI
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?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ISRCTN80812769 | None | None | None |
| WCTU-FRAGMATIC | None | None | None |
| Velindre-FRAGMATIC | None | None | None |
| WCTU-02 | None | None | None |
| EU-20753 | None | None | None |
| PFIZER-WCTU-02 | None | None | None |
| EUDRACT-2005-002438-37 | None | None | None |