Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00087256
Status:
TERMINATED
Last Update Posted:
2013-01-07
First Post:
2004-07-08
Brief Title:
Celecoxib in Preventing Polyps in Patients Who Have Undergone Surgery for Stage I Colon Cancer
Sponsor:
NSABP Foundation Inc
Organization:
NSABP Foundation Inc
Study Overview
Official Title:
Celecoxib Polyp Prevention Trial in Participants With Resected Stage I Colon Cancer
Status:
TERMINATED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
For scientific logistic and administrative reasons
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 of cancer It is not yet known whether celecoxib is effective in preventing polyps in patients with colon cancer
PURPOSE Randomized phase III trial to study the effectiveness of celecoxib in preventing the development of polyps in patients who have undergone surgery for stage I colon cancer
PURPOSE Randomized phase III trial to study the effectiveness of celecoxib in preventing the development of polyps in patients who have undergone surgery for stage I colon cancer
Detailed Description:
OBJECTIVES
Primary
Compare celecoxib vs placebo in terms of decreasing the incidence of adenomatous polyps of the colon and rectum in patients with resected stage I adenocarcinoma of the colon
Secondary
Compare disease-free survival of patients treated with these regimens
Compare the effect of these regimens on self-reported symptoms and health-related quality of life of these patients
Compare the quality of life of patients treated with these regimens
Compare the benefits of celecoxib in patients with primary tumors or polyps that express cyclo-oxygenase-2 COX-2 with those that do not express COX-2
Compare the expression of signaling targets such as serinethreonine AKT extracellular signal-regulated kinase 2 ERK2 and endoplasmic reticulum Ca2- ATPases in the index tumor and polyps
Determine the toxicity and safety of celecoxib in these patients
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to gender tumor stage T1 vs T2 age 49 vs 50 to 59 vs 60 years and current aspirin use yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral celecoxib twice daily for 3 years
Arm II Patients receive oral placebo twice daily for 3 years In both arms treatment continues in the absence of unacceptable toxicity or the diagnosis of invasive colon cancer carcinoma in situ of the colon or rectum or a non-colon primary cancer
Quality of life is assessed at baseline and then at 6 12 24 36 and 42 months
Patients are followed at 6 months and at 2 years
PROJECTED ACCRUAL A total of 1200 patients 600 per treatment arm will be accrued for this study within 25 years
Primary
Compare celecoxib vs placebo in terms of decreasing the incidence of adenomatous polyps of the colon and rectum in patients with resected stage I adenocarcinoma of the colon
Secondary
Compare disease-free survival of patients treated with these regimens
Compare the effect of these regimens on self-reported symptoms and health-related quality of life of these patients
Compare the quality of life of patients treated with these regimens
Compare the benefits of celecoxib in patients with primary tumors or polyps that express cyclo-oxygenase-2 COX-2 with those that do not express COX-2
Compare the expression of signaling targets such as serinethreonine AKT extracellular signal-regulated kinase 2 ERK2 and endoplasmic reticulum Ca2- ATPases in the index tumor and polyps
Determine the toxicity and safety of celecoxib in these patients
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to gender tumor stage T1 vs T2 age 49 vs 50 to 59 vs 60 years and current aspirin use yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral celecoxib twice daily for 3 years
Arm II Patients receive oral placebo twice daily for 3 years In both arms treatment continues in the absence of unacceptable toxicity or the diagnosis of invasive colon cancer carcinoma in situ of the colon or rectum or a non-colon primary cancer
Quality of life is assessed at baseline and then at 6 12 24 36 and 42 months
Patients are followed at 6 months and at 2 years
PROJECTED ACCRUAL A total of 1200 patients 600 per treatment arm will be accrued for this study within 25 years
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 |
|---|---|---|---|
| NSABP-P-3 | None | None | None |