Spots Global Cancer Trial Database for Comparison of Sulindac, Aspirin, and Ursodiol in Preventing Colorectal Cancer

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Trial Identification

Brief Title: Comparison of Sulindac, Aspirin, and Ursodiol in Preventing Colorectal Cancer

Official Title: Phase II Study Of Colorectal ACF Screening, Regression And Prevention In High Risk Participants

Study ID: NCT00062023

Conditions

Colorectal Cancer

Interventions

Acetylsalicylic acid (Aspirin)

Sulindac

Ursodiol

Sulindac Placebo

Study Description

Brief Summary: RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. It is not yet known whether sulindac, aspirin, or ursodiol is more effective in preventing colorectal cancer. PURPOSE: This randomized phase II trial is studying how well sulindac works compared to aspirin or ursodiol in preventing colorectal cancer.

Detailed Description: OBJECTIVES: * Determine the percentage change in colorectal aberrant crypt foci (ACF) in patients with a history of colorectal cancer or at high risk for colorectal cancer when treated with sulindac vs aspirin vs ursodiol. * Determine the safety and efficacy of these drugs, in terms of ability to cause regression of existing colorectal ACF and prevent new ACF development, in these patients. OUTLINE: This is a partially blinded, randomized, placebo-controlled study. Patients are stratified according to colorectal neoplasia (adenoma vs carcinoma). Patients are randomized to 1 of 4 treatment arms. * Arm I: Patients receive oral sulindac twice daily. * Arm II: Patients receive oral aspirin once daily. * Arm III: Patients receive oral ursodiol three times daily. * Arm IV: Patients receive oral sulindac placebo twice daily. In all arms, treatment continues for 12 months in the absence of disease progression or unacceptable toxicity. Patients undergo a colonoscopy at baseline and at the end of treatment. Patients are followed at 2 months after the end of treatment. PROJECTED ACCRUAL: A total of 172 patients (43 per treatment arm) with a history of colorectal cancer or adenomas will be accrued for this study. A total of 20 additional patients with no elevated risk of colorectal neoplasia will be accrued, but not randomized, for this study.