Esophageal Cancer Clinical Trial
Official title:
Chemoprevention for Barrett's Esophagus Trial (CBET)
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the
development or recurrence of cancer. Celecoxib may be effective in preventing cancer in
patients with Barrett's esophagus.
PURPOSE: Randomized phase II trial to study the effectiveness of celecoxib in preventing
cancer in patients who have Barrett's esophagus.
OBJECTIVES:
- Determine the safety and efficacy of celecoxib for regression of Barrett's dysplasia in
patients with low or high-grade dysplasia of the esophagus.
OUTLINE: This is a randomized, parallel, double-blind, placebo-controlled, multicenter
study. Patients are stratified according to center and grade of dysplasia at baseline (low
vs high). Patients are randomized to one of two treatment arms.
- Arm I: Patients receive oral celecoxib twice daily for 48-96 weeks.
- Arm II: Patients receive oral placebo as in arm I. Treatment continues in both arms in
the absence of unacceptable toxicity or development of adenocarcinoma of the esophagus
or cancer at other sites.
Patients are followed at 12 weeks.
PROJECTED ACCRUAL: A total of 200 patients (100 per arm) will be accrued for this study.
;
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention
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