At a glance
ClinicalIndex Comparison Record- ✓History of ≥1 surgically resected adenomatous polyp of the colon measuring ≥3 mm within the past 5 years
- ✓Screening colonoscopy performed within the past 6 months with all polyps removed, pathologically examined, and archived
- ✓ECOG performance status 0-1
- ✓Normal pure tone audiometry evaluation
- ✕Prior surgical resection removing >40 cm of the colon
- ✕Personal or family history of familial polyposis or hereditary non-polyposis colon cancer
- ✕History of inflammatory bowel disease
- ✕Gastric or duodenal ulcers within the past 12 months (unless adequately treated >24 months ago)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III Randomized, Double-Blind, Placebo-Controlled Clinical Trial of the Combination of DFMO and Sulindac to Decrease the Rate of Recurrence of Adenomatous Polyps in the Colon
In Brief
A Phase 3 clinical trial evaluating placebo, eflornithine, and 2 other interventions for Precancerous Condition. Completed, enrolled 375 participants across 1 site.
Detailed Summary
This randomized phase III trial is studying eflornithine and sulindac to see how well they work compared to a placebo in preventing colorectal cancer in patients with colon polyps. Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of eflornithine and sulindac may prevent colorectal cancer. It is not yet known whether eflornithine and sulindac are more effective than a placebo in preventing colorectal cancer
Study Details
Timeline
Interventions
Given orally
Given orally
Given orally
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