Colorectal Cancer Clinical Trial
Official title:
Chemoprevention of Duodenal Polyps in Familial Adenomatous Polyposis
RATIONALE: Exisulind may be effective in preventing the development and growth of polyps in
patients who have familial adenomatous polyposis.
PURPOSE: Randomized phase II/III trial to determine the effectiveness of exisulind in
preventing the development and growth of polyps in patients who have familial adenomatous
polyposis.
OBJECTIVES:
- Determine the ability of exisulind to inhibit growth and development of duodenal
adenomas in patients with familial adenomatous polyposis.
- Determine the effect on apoptosis in polyp vs mucosal tissue in these patients when
treated with this drug.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are
randomized to one of two treatment arms.
- Arm I: Patients receive oral exisulind 4 times daily.
- Arm II: Patients receive oral placebo 4 times daily. Treatment continues for 1 year.
PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this
study.
;
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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