Celecoxib to Prevent Colorectal Cancer in Patients Who Have Undergone Surgery to Remove Polyps
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|ClinicalTrials.gov Identifier: NCT00005094|
Recruitment Status : Completed
First Posted : November 5, 2003
Last Update Posted : April 12, 2013
|Condition or disease||Intervention/treatment||Phase|
|Colon Cancer Rectal Cancer||Drug: celecoxib Other: placebo||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1170 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Prevention of Sporadic Colorectal Adenomas With Celecoxib|
|Study Start Date :||March 2000|
|Actual Primary Completion Date :||April 2006|
Experimental: Arm I (celecoxib)
Patients receive celecoxib twice a day for 3 years.
Placebo Comparator: Arm II (placebo)
Patients receive placebo twice a day for 3 years.
Other Name: PLCB
- Percentage of subjects with newly detected adenomas, and will be estimated using the life table method for each treatment group [ Time Frame: Year 3 (cumulative for year one and year three) ]Will be estimated using the life table method for each treatment group and compared using a life-table extension of the Mantel-Haenszel statistics with stratification for aspirin use. Additional analysis will be performed for the primary endpoint to adjust for the baseline prognostic factors and colon cancer/adenoma risk factors using, for example, proportional hazard model or logistic model.
- Percentage of patients with adenomas, aspirin use at baseline, and covariates [ Time Frame: Year 5 ]This will be derived by treatment group (celecoxib 400 mg bid, celecoxib 200 mg bid, or placebo) and low-dose aspirin use at baseline and in relationship to the patient's adenoma history at the year 3 colonoscopy. Of particular interest is whether the conditional rate of adenomas at year 5 differs by treatment group and strata with control for potential differences in these groups by adenoma history at year 3 colonoscopy, age, sex, family history of colorectal cancer, smoking, concomitant use of NSAID's, total time on study drug, and other covariates.
- The number of adenomas identified per patient [ Time Frame: Year 1 ]Will be compared between the Celecoxib treated arm and the Placebo treated arm using nonparametric analogs of the t-test (Wilcoxon rank sum or similar statistics). Poisson regression will also be used to assess whether the number of adenomas detected at surveillance colonoscopy differs between the celecoxib and placebo groups.
- The number of adenomas identified per patient [ Time Frame: Year 3 ]Will be compared between the Celecoxib treated arm and the Placebo treated arm using nonparametric analogs of the t-test (Wilcoxon rank sum or similar statistics). Poisson regression will also be used to assess whether the number of adenomas detected at surveillance colonoscopy differs between the celecoxib and placebo groups.
- The highest histopathologic grade, largest size, and polyp burden (sum of the polyp diameters) of the colorectal adenomas [ Time Frame: Up to 3 years ]Will be analyzed using ordinal categorical data analysis methods.
- The number of advanced adenomas (adenoma of size 1.0 cm or larger, any villous histology, high grade dysplasia, or invasive cancer) detected at surveillance [ Time Frame: Up to 3 years ]
- Adenoma findings at year 1 colonoscopy as predictors of adenoma findings at year 3 colonoscopy [ Time Frame: Year 3 ]The findings of the Year 1 surveillance colonoscopy will also be evaluated as whether they can be used in future studies as a surrogate endpoint for the primary outcomeof the cumulative percentage of patients with newly detected adenomas at either the year one and/or at the Year 3 colonoscopy surveillance.
- Adverse events will be coded using the MedRA dictionary [ Time Frame: Up to 3 months post-treatment ]The safety analyses will consist of displays of the distribution by treatment group and adverse event category of the numbers of subjects reporting at least one episode of a specific adverse event (incidence table) and the severity and attribution to study drug of each episode reported (severity and attribution table). The proportion of subjects withdrawn due to adverse events will also be summarized.
- Mean number of adenomas detected at year 5, as well as the distribution of number of adenomas, and the adenoma burden based on the sum of the adenoma diameters at year 5 [ Time Frame: Year 5 ]
- Adverse events coded using the MedRA dictionary [ Time Frame: Up to 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005094
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Monica Bertagnolli||Brigham and Women's Hospital|