Spots Global Cancer Trial Database for Aspirin in Preventing Disease Recurrence in Patients With Barrett Esophagus After Successful Elimination by Radiofrequency Ablation
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Trial Identification
Brief Title: Aspirin in Preventing Disease Recurrence in Patients With Barrett Esophagus After Successful Elimination by Radiofrequency Ablation
Official Title: Effect of Aspirin on Biomarkers of Barrett's Esophagus After Successful Eradication of Barrett's Esophagus With Radiofrequency Ablation
Study ID: NCT02521285
Conditions
Study Description
Brief Summary: This randomized phase II trial studies the safety of and how well aspirin works in preventing Barrett's esophagus from returning after it has been successfully eliminated by radiofrequency ablation. Studying samples of tissue from patients with Barrett's esophagus for the levels of a specific protein that is linked to developing Barrett's esophagus may help doctors learn whether aspirin can prevent it from returning after it has been successfully treated.
Detailed Description: PRIMARY OBJECTIVES: I. To conduct a randomized, double blind, placebo-controlled phase II chemoprevention trial, investigating whether supplementation with aspirin 325 mg/day for 12 months is safe and reduces the expression of CDX2 messenger ribonucleic acid (mRNA) (a biomarker which has been associated with the risk of developing Barrett's esophagus \[BE\]) in comparison to placebo after successful radiofrequency ablation (RFA). SECONDARY OBJECTIVES: I. To assess safety at 12 months. II. To assess differences in the expression of CDX2 at 18 months, activation status of NF-kB by assessing levels of total and phosphorylated (phospho)-p65 and cytoplasmic to nuclear translocation of phospho-p65 which is likely to be affected by aspirin. III. To assess the prostanoid marker, prostaglandin E2, and prostaglandin synthases, which are known to respond to aspirin and to correlation with clinicopathological factors in the esophageal cancer. IV. To assess differences in the expression of proinflammatory cytokines known to induce activation of NFkB, i.e., TNFalpha, IL-1beta, IL-6, IL-10, IL-17A, IL-23 will be measured. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM A: Patients receive aspirin orally (PO) once daily (QD) for 12 months. ARM B: Patients receive placebo PO QD for 12 months. After completion of study treatment, patients are followed up at 1, 3, 6, 9, 12, and 18 months.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, United States
UCHealth University of Colorado Hospital, Aurora, Colorado, United States
Northwestern University, Chicago, Illinois, United States
Mayo Clinic in Rochester, Rochester, Minnesota, United States
Kansas City Veterans Affairs Medical Center, Kansas City, Missouri, United States
UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States
University of Pennsylvania/Abramson Cancer Center, Philadelphia, Pennsylvania, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center, Houston, Texas, United States
M D Anderson Cancer Center, Houston, Texas, United States
Saint Michael's Hospital, Toronto, Ontario, Canada
Contact Details
Name: Robert S Bresalier
Affiliation: M.D. Anderson Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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