Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00078897
Status:
TERMINATED
Last Update Posted:
2019-09-24
First Post:
2004-03-08
Brief Title:
Selenium for Prevention of Adenomatous Colorectal Polyps
Sponsor:
University of Arizona
Organization:
University of Arizona
Study Overview
Official Title:
Phase III Study of the Effects of Selenium on Adenomatous Polyp Recurrence
Status:
TERMINATED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Concluded - Terminated by PI
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 Selenium may be effective in preventing the recurrence of adenomatous colorectal polyps
PURPOSE This randomized phase III trial is studying selenium to see how well it works in preventing the recurrence of polyps in patients with adenomatous colorectal polyps
PURPOSE This randomized phase III trial is studying selenium to see how well it works in preventing the recurrence of polyps in patients with adenomatous colorectal polyps
Detailed Description:
OBJECTIVES
Primary
Compare the effects of selenium vs placebo on the recurrence of adenomatous colorectal polyps in terms of histologic type degree of dysplasia number size and location in patients with adenomatous colorectal polyps
Compare the type incidence and outcome of side effects in patients treated with these regimens
Determine patient adherence to long-term treatment with these regimens
Secondary
Determine the effects of regimen modification by baseline blood selenium level low-dose aspirin selenoprotein genetic marker polymorphisms eg GPx-1 GPx-2 and SEP15
Determine the effects of low-dose aspirin 81 mgday modification by ornithine decarboxylase promoter genotype and toxicity by slow-metabolizer genotypes of the cytochrome p450 2C9 and UT1A6 loci in these patients
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to use of low-dose 81 mgday aspirin yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral selenium once daily
Arm II Patients receive oral placebo once daily In both arms treatment continues for up to 5 years in the absence of disease progression or unacceptable toxicity
Patients undergo follow-up colonoscopy approximately 5 years after baseline colonoscopy
NOTE Some patients will continue participation for up to 7 and a half years
PROJECTED ACCRUAL A total of 1600 patients with an adenoma will be randomized to this study followed by a second group of randomization of 200 patients with at least one advanced adenoma at baseline for a substudy Total planned randomizations 1800 participants
Primary
Compare the effects of selenium vs placebo on the recurrence of adenomatous colorectal polyps in terms of histologic type degree of dysplasia number size and location in patients with adenomatous colorectal polyps
Compare the type incidence and outcome of side effects in patients treated with these regimens
Determine patient adherence to long-term treatment with these regimens
Secondary
Determine the effects of regimen modification by baseline blood selenium level low-dose aspirin selenoprotein genetic marker polymorphisms eg GPx-1 GPx-2 and SEP15
Determine the effects of low-dose aspirin 81 mgday modification by ornithine decarboxylase promoter genotype and toxicity by slow-metabolizer genotypes of the cytochrome p450 2C9 and UT1A6 loci in these patients
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to use of low-dose 81 mgday aspirin yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral selenium once daily
Arm II Patients receive oral placebo once daily In both arms treatment continues for up to 5 years in the absence of disease progression or unacceptable toxicity
Patients undergo follow-up colonoscopy approximately 5 years after baseline colonoscopy
NOTE Some patients will continue participation for up to 7 and a half years
PROJECTED ACCRUAL A total of 1600 patients with an adenoma will be randomized to this study followed by a second group of randomization of 200 patients with at least one advanced adenoma at baseline for a substudy Total planned randomizations 1800 participants
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 |
|---|---|---|---|
| P01CA041108 | NIH | None | httpsreporternihgovquickSearchP01CA041108 |
| P30CA023074 | NIH | None | None |