Colorectal Cancer Clinical Trial
Official title:
Phase II Study Of Colorectal ACF Screening, Regression And Prevention In High Risk Participants
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
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