The Prevention of Progression to Pancreatic Cancer Trial (The 3P-C Trial)
Status:
Recruiting
Trial end date:
2025-01-31
Target enrollment:
Participant gender:
Summary
This is a multi-center randomized double-blind placebo controlled trial of patients with
high-risk intraductal papillary mucinous neoplasms (IPMNs) of the pancreas. The primary
objective 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.
Phase:
Phase 2
Details
Lead Sponsor:
Duke University
Collaborators:
Johns Hopkins University Massachusetts General Hospital Memorial Sloan Kettering Cancer Center National Cancer Institute (NCI)