Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002650
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
1999-11-01
Brief Title:
High-Dose Folic Acid in Preventing Colorectal Cancer in Patients Who Have Had Polyps Surgically Removed
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
PHASE II DOUBLE-BLIND CHEMOPREVENTION TRIAL OF HIGH DOSE FOLIC ACID VERSUS PLACEBO IN PATIENTS WITH RESECTED COLORECTAL POLYPS
Status:
COMPLETED
Status Verified Date:
2023-06
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 The use of folic acid may be an effective way to prevent colorectal cancer in patients with polyps that have been surgically removed
PURPOSE Randomized phase II trial to study the effectiveness of high-dose folic acid in preventing colorectal cancer in patients who have had polyps surgically removed within 18 months of the trial
PURPOSE Randomized phase II trial to study the effectiveness of high-dose folic acid in preventing colorectal cancer in patients who have had polyps surgically removed within 18 months of the trial
Detailed Description:
OBJECTIVES I Determine whether high-dose folic acid decreases global DNA hypomethylation as well as other intermediary markers in normal-appearing colonic epithelium of patients with colonic adenomas II Determine whether a decrease in global DNA hypomethylation and other intermediary markers can be induced safely and whether these effects persist after folic acid is discontinued in these patients III Confirm pilot data that indicates patients with adenomas have widespread DNA hypomethylation of the colorectal mucosa compared to controls IV Evaluate the effect of folic acid on the clinical course and rate of recurrence of adenomatous polyps in these patients V Study a control group of patients with no history of neoplastic hyperplastic or inflammatory colorectal lesions
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to participating center and age 50-70 vs 30-49 and over 70 Patients with adenomatous polyps at least 10 mm at colonoscopy are randomized to 1 of 2 treatment arms Patients found to have no neoplastic hyperplastic or inflammatory polyps at colonoscopy are assigned to a control untreated group and complete laboratory studies and a baseline food frequency questionnaire only Arm I Patients receive folic acid daily Arm II Patients receive placebo daily Treatment continues in both arms for 1 year in the absence of unacceptable toxicity or disease progression Patients are followed at 1 year
PROJECTED ACCRUAL A total of 80 patients 30 per arm and 20 for the control group will be accrued for this study within 24 months
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to participating center and age 50-70 vs 30-49 and over 70 Patients with adenomatous polyps at least 10 mm at colonoscopy are randomized to 1 of 2 treatment arms Patients found to have no neoplastic hyperplastic or inflammatory polyps at colonoscopy are assigned to a control untreated group and complete laboratory studies and a baseline food frequency questionnaire only Arm I Patients receive folic acid daily Arm II Patients receive placebo daily Treatment continues in both arms for 1 year in the absence of unacceptable toxicity or disease progression Patients are followed at 1 year
PROJECTED ACCRUAL A total of 80 patients 30 per arm and 20 for the control group will be accrued for this study within 24 months
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 |
|---|---|---|---|
| NCI-P95-0066 | None | None | None |
| E-8292 | None | None | None |