The Prevention of Progression to Pancreatic Cancer Trial (The 3P-C Trial)

Study 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 up to 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 by CT scan or MRI 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.

Primary Outcome

Patients will be determined to have progressed if they have: 1. New cystic lesion(s) of the pancreas \>1 cm in diameter (or initial lesion(s) \<5 mm that are now \>1cm), 2. Doubling of the diameter of any preexisting cyst initially measuring ≥5 mm 3. Increase in diameter of the main pancreatic duct by \>3mm 4. Pancreatic resection 5. The development of pancreatic adenocarcinoma

Conditions Studied

Interventions

• OTHER Placebo
• DRUG Sulindac 400 MG

Study Locations (4)