Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-26 @ 12:03 AM
Study NCT ID:
NCT00005094
Status:
COMPLETED
Last Update Posted:
2013-04-12
First Post:
2000-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Celecoxib to Prevent Colorectal Cancer in Patients Who Have Undergone Surgery to Remove Polyps
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
Prevention of Sporadic Colorectal Adenomas With Celecoxib
Status:
COMPLETED
Status Verified Date:
2013-04
Last Known Status:
None
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:
Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. The use of celecoxib has been approved for use in reducing the number of adenomatous colorectal polyps in familial adenomatous polyposis (FAP). It is not known whether there is a clinical benefit from a reduction in the number of colorectal polyps in FAP patients. The use of celecoxib may be an effective way to prevent the development of sporadic adenomatous polyps, precursors of colorectal cancer. This randomized phase III trial is studying celecoxib to see how well it works compared to a placebo in preventing the development of adenomatous colorectal polyps in patients who have had at least one polyp removed.
Detailed Description:
PRIMARY OBJECTIVES:
I. Determine the safety and efficacy of celecoxib in reducing the occurrence of new sporadic adenomatous polyps (SAP) in the colon and rectum in patients who have undergone polypectomy for previous SAP.
OUTLINE: This is a randomized, double blind, placebo controlled study. Patients are entered on one of two treatment arms.
Arm I: Patients receive celecoxib twice a day for 3 years.
Arm II: Patients receive placebo twice a day for 3 years.
Patients are evaluated for adenomatous colorectal polyps at 1 and 3 years.
PROJECTED ACCRUAL: Over 1000 patients will be accrued for this study.
I. Determine the safety and efficacy of celecoxib in reducing the occurrence of new sporadic adenomatous polyps (SAP) in the colon and rectum in patients who have undergone polypectomy for previous SAP.
OUTLINE: This is a randomized, double blind, placebo controlled study. Patients are entered on one of two treatment arms.
Arm I: Patients receive celecoxib twice a day for 3 years.
Arm II: Patients receive placebo twice a day for 3 years.
Patients are evaluated for adenomatous colorectal polyps at 1 and 3 years.
PROJECTED ACCRUAL: Over 1000 patients will be accrued for this study.
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?: