Phase II Trial for The Prevention of Progression to Pancreatic Cancer Trial (The 3P-C Trial): Preventing an Incurable Disease
Summary
The purpose of this phase II, multi-center, randomized, double-blind placebo controlled trial of patients with high-risk intraductal papillary mucinous neoplasms (IPMNs) of the pancreas is to evaluate the effect of sulindac on the presence or absence of progression of IPMN after 3 years of treatment. Patients without contraindications will be considered to be eligible and will be required to have a cross-sectional imaging study of the pancreas (pancreas protocol CT or CT angiogram of the pancreas) within 3 months of study entry to document residual IPMNs and to rule out any evidence of pancreatic cancer. Patients will be randomized to receive either sulindac (200 mg p.o. BID) plus standard radiographic and endoscopic surveillance or placebo plus standard radiographic and endoscopic surveillance. Randomization will be stratified by (1) whether the patient had high-grade dysplasia identified in the initial resection specimen (resected patients only) and (2) whether the patient is taking metformin at the time of randomization.
General Information
NCT#: NCT04207944
Study ID: Pro00103684
Trial Phase: Phase II
Trial Sponsor: National Cancer Institute (NCI), Johns Hopkins University, Massachusetts General Hospital, Duke University, Memorial Sloan Kettering
Therapies Used in This Trial: Sulindac
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