Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00033319
Status:
UNKNOWN
Last Update Posted:
2013-09-17
First Post:
2002-04-09
Brief Title:
Aspirin andor Folic Acid in Preventing Recurrent Colorectal Polyps
Sponsor:
Queens Medical Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
UKCAP Trial A Multi-Center Double Blind Randomised Controlled Trial Of Aspirin AndOr Folate Supplementation For the Prevention Of Recurrent Colorectal Adenomas
Status:
UNKNOWN
Status Verified Date:
2002-12
Last Known Status:
ACTIVE_NOT_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 Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer The use of aspirin andor folic acid may be effective in preventing recurrent polyps in patients who have had polyps removed previously
PURPOSE Randomized clinical trial to determine the effectiveness of aspirin andor folic acid in preventing the recurrence of colorectal polyps
PURPOSE Randomized clinical trial to determine the effectiveness of aspirin andor folic acid in preventing the recurrence of colorectal polyps
Detailed Description:
OBJECTIVES
Determine whether aspirin andor folic acid prevents recurrence of colorectal adenomas in patients who have had colorectal adenomas removed
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are randomized to 1 of 4 treatment arms
Arm I Patients receive oral aspirin and oral folic acid daily
Arm II Patients receive oral aspirin and oral placebo daily
Arm III Patients receive oral placebo and oral folic acid daily
Arm IV Patients receive 2 oral placebos daily In all arms treatment continues for 3 years in the absence of unacceptable toxicity
After completion of the 3-year intervention all patients undergo a surveillance colonoscopy
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 1300 patients will be accrued for this study
Determine whether aspirin andor folic acid prevents recurrence of colorectal adenomas in patients who have had colorectal adenomas removed
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are randomized to 1 of 4 treatment arms
Arm I Patients receive oral aspirin and oral folic acid daily
Arm II Patients receive oral aspirin and oral placebo daily
Arm III Patients receive oral placebo and oral folic acid daily
Arm IV Patients receive 2 oral placebos daily In all arms treatment continues for 3 years in the absence of unacceptable toxicity
After completion of the 3-year intervention all patients undergo a surveillance colonoscopy
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 1300 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20045 | None | None | None |
| QMC-UKCAP | None | None | None |