100
Participants
Start Date
July 10, 2020
Primary Completion Date
July 30, 2026
Study Completion Date
October 31, 2026
Sulindac 400 MG
Patients will be randomized to receive standard radiographic/endoscopic surveillance plus sulindac. The sulindac starting dose is 200 mg by mouth 2x daily. Randomization will be performed at Duke and stratified by (1) the presence of high-grade dysplasia on the operative pathologic report and (2) the use of metformin at the time of enrollment. Patients will be provided the study drugs by a Duke, MSK, MGH, or JHH pharmacist. Patients will continue drug/placebo for 3 years during follow-up.
Placebo
Patients will be randomized to receive standard radiographic/endoscopic surveillance plus sulindac. The sulindac starting dose is 200 mg by mouth 2x daily. Randomization will be performed at Duke and stratified by (1) the presence of high-grade dysplasia on the operative pathologic report and (2) the use of metformin at the time of enrollment. Patients will be provided the study drugs by a Duke, MSK, MGH, or JHH pharmacist. Patients will continue drug/placebo for 3 years during follow-up.
Memorial Sloan Kettering, New York
Johns Hopkins University, Baltimore
Duke University Medical Center, Durham
Massachusetts General Hospital, Boston
Lead Sponsor
Johns Hopkins University
OTHER
Massachusetts General Hospital
OTHER
Memorial Sloan Kettering Cancer Center
OTHER
National Cancer Institute (NCI)
NIH
Duke University
OTHER