Chemoprevention for Barrett's Esophagus Trial (CBET)
- 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
Arlene A. Forastiere, MD
Sidney Kimmel Comprehensive Cancer Center
United States: Federal Government
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|Jonsson Comprehensive Cancer Center, UCLA||Los Angeles, California 90095-1781|
|Ireland Cancer Center||Cleveland, Ohio 44106-5065|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|
|Veterans Affairs Medical Center - Tucson||Tucson, Arizona 85723|
|Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)||Hines, Illinois 60141|
|Herbert Irving Comprehensive Cancer Center||New York, New York 10032|
|Veterans Affairs Medical Center - Portland||Portland, Oregon 97207|