The Prevention of Progression to Pancreatic Cancer Trial (The 3P-C Trial)
IPMN, IPMN, Pancreatic
About this trial
This is an interventional prevention trial for IPMN
Eligibility Criteria
Inclusion Criteria:
- Subject is a man or woman between the ages of 21 and 85 (inclusive) years.
Subject has high-risk IPMN as defined below.
- Patient (previously resected) has undergone partial pancreatectomy for non-invasive IPMN AND has new or residual cyst(s) > 1 cm and/or Patient (not previously resected) has a radiographic lesion of the pancreas consistent with IPMN as documented by:
Cyst fluid CEA > 192 ng/ml OR presence of GNAS or RNF 43 mutation noted in cyst fluid OR MRI imaging confirmation of communication with main pancreatic duct AND at least one of the following worrisome features:
- Cyst > 2.5 cm
- Thickened/enhancing cyst walls
- Main pancreatic duct > 5mm
- Abrupt change in caliber of pancreatic duct with distal atrophy
- Subjects has ECOG of 0-2
- Subject is medically fit to undergo EUS.
- Female subjects who are of childbearing potential or are capable of becoming pregnant must be willing to use appropriate methods of contraception for the length of the study.
- Subject is able to provide written informed consent.
Exclusion Criteria:
- Subject has pathologic evidence of pancreatic adenocarcinoma.
- Subject takes a systemic NSAID or corticosteroid 3 or more times per week.
- Subject has a known history of or currently existing allergy to NSAIDs, aspirin induced asthma, gastric ulcers, non-iatrogenic intestinal perforation, or gastrointestinal bleeding from NSAID usage for which intervention was required..
- Subject has an ongoing history of renal insufficiency (eGFR <50 mL/minute/1.73 m2), cardiovascular disease, gastrointestinal disorder, or any other condition that serves as a contraindication to the use of sulindac in the opinion of the treating investigator.
- Myocardial infarction or coronary artery bypass grafting within six months of study entry.
- Diagnosis of Congestive Heart Failure.
- Severe adverse drug reaction to iodinated contrast agents that cannot be managed with routine premedication prior to imaging.
- Diagnosis for (other) prior malignancy (except in situ and non-melanoma skin cancers) within the previous 3 years and actively receiving antineoplastic or immuno therapy within 90 days of randomization.
- History of medical procedure that would prevent an endoscopic ultrasound from being performed (such as Roux-en-Y, prior total gastrectomy).
- Subject is lactating or pregnant.
Sites / Locations
- Johns Hopkins UniversityRecruiting
- Massachusetts General HospitalRecruiting
- Memorial Sloan KetteringRecruiting
- Duke University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Sulindac
Placebo
Patients will be randomized to receive standard radiographic/endoscopic surveillance plus sulindac. The sulindac starting dose is 200 mg by mouth 2x daily. Patients will continue drug for 3 years during follow-up.
Patients will be randomized to receive standard radiographic/endoscopic surveillance plus placebo. Patients will continue placebo for 3 years during follow-up.