NCT04207944Active, not recruitingPhase 2
The Prevention of Progression to Pancreatic Cancer Trial (The 3P-C Trial)
Preventing an Incurable Disease: The Prevention of Progression to Pancreatic Cancer Trial (The 3P-C Trial)
Source: ClinicalTrials.gov · Last updated 8 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 19 Dec 2019
- Start date
- 10 Jul 2020
- Primary completion date
- 30 Jul 2026
- Lead sponsor
- Duke University
- Diseases
- Pancreatic cancer
- NCT number
- NCT04207944
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 100
- From 10 Jul 2020 to the primary completion date, 30 Jul 2026
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subject takes a systemic corticosteroid or NSAID more than 3 times per week.
- Severe adverse drug reaction to contrast agents that cannot be managed with routine premedication prior to imaging.
- History of medical procedure that would prevent an endoscopic ultrasound from being performed (such as Roux-en-Y, prior total gastrectomy).
Other illness
- 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..
- Myocardial infarction or coronary artery bypass grafting within six months of study entry.
- Diagnosis of Congestive Heart Failure.
- Diagnosis for (other) prior malignancy (except in situ and non-melanoma skin cancers) and are actively receiving antineoplastic or immuno therapy within 90 days of randomization.
Lab values
- 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.
Other
- Subject has pathologic evidence of pancreatic adenocarcinoma.
- Subject is lactating or pregnant.
Who the study is looking for
- 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 "likely", "probable" or "confirmed" 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.
Age in the registry: 21 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins University Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Duke University Medical Center Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Memorial Sloan Kettering Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.