Ignite Creation Date:
2024-05-05 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005878
Status:
COMPLETED
Last Update Posted:
2016-10-13
First Post:
2000-06-02
Brief Title:
Celecoxib to Prevent Cancer in Patients With Barretts Esophagus
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
Chemoprevention for Barretts Esophagus Trial CBET
Status:
COMPLETED
Status Verified Date:
2016-10
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:
RATIONALE Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer Celecoxib may be effective in preventing cancer in patients with Barretts esophagus
PURPOSE Randomized phase II trial to study the effectiveness of celecoxib in preventing cancer in patients who have Barretts esophagus
PURPOSE Randomized phase II trial to study the effectiveness of celecoxib in preventing cancer in patients who have Barretts esophagus
Detailed Description:
OBJECTIVES
Determine the safety and efficacy of celecoxib for regression of Barretts dysplasia in patients with low or high-grade dysplasia of the esophagus
OUTLINE This is a randomized parallel double-blind placebo-controlled multicenter study Patients are stratified according to center and grade of dysplasia at baseline low vs high Patients are randomized to one of two treatment arms
Arm I Patients receive oral celecoxib twice daily for 48-96 weeks
Arm II Patients receive oral placebo as in arm I Treatment continues in both arms in the absence of unacceptable toxicity or development of adenocarcinoma of the esophagus or cancer at other sites
Patients are followed at 12 weeks
PROJECTED ACCRUAL A total of 200 patients 100 per arm will be accrued for this study
Determine the safety and efficacy of celecoxib for regression of Barretts dysplasia in patients with low or high-grade dysplasia of the esophagus
OUTLINE This is a randomized parallel double-blind placebo-controlled multicenter study Patients are stratified according to center and grade of dysplasia at baseline low vs high Patients are randomized to one of two treatment arms
Arm I Patients receive oral celecoxib twice daily for 48-96 weeks
Arm II Patients receive oral placebo as in arm I Treatment continues in both arms in the absence of unacceptable toxicity or development of adenocarcinoma of the esophagus or cancer at other sites
Patients are followed at 12 weeks
PROJECTED ACCRUAL A total of 200 patients 100 per arm 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 |
|---|---|---|---|
| P30CA006973 | NIH | None | None |
| JHOC-J9932 | None | None | None |
| JHOC-99061108 | None | None | None |
| NCI-P00-0145 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA006973 |