# Preventing an Incurable Disease: The Prevention of Progression to Pancreatic Cancer Trial (The 3P-C Trial)

> **NIH NIH R01** · DUKE UNIVERSITY · 2021 · $614,787

## Abstract

PROJECT SUMMARY
Pancreatic cancer will be diagnosed in approximately 55,000 people in the U.S. in 2019. Nearly all of these
patients will die from this disease because of the late stage at diagnosis and the ineffectiveness of current
systemic therapies. The shortcomings of current diagnostic and therapeutic strategies is exemplified by the fact
that even when patients are diagnosed prior to the development of identifiable metastatic disease (<15% of
patients) and are treated with operative resection and adjuvant systemic therapy, the probability of five-year
survival is approximately 10%. There is an urgent need for novel strategies to improve patient outcomes for this
disease.
Intraductal papillary mucinous neoplasms (IPMN) of the pancreas are cystic tumors that represent the only
radiographically identifiable precursor lesion of pancreatic cancer. IPMN is a “whole-gland” process, and it is
known that patients who undergo partial pancreatectomy for IPMN have an increased risk of developing cancer
in the pancreatic remnant. Because of this, recommendations for patients who have undergone partial
pancreatectomy for non-invasive IPMN is serial radiographic and/or endoscopic surveillance of their pancreatic
remnant. Recent data from our group has shown that approximately 25% of patients will develop radiographic
signs of IPMN progression within three to four years of resection. Between our four centers (Duke University
Hospital, Johns Hopkins University Hospital, Massachusetts General Hospital, Memorial Sloan Kettering) we are
currently following over 450 patients who have undergone resection for IPMN. These patients are ideally suited
for a chemoprevention trial.
The goal of this multi-institutional research effort is to perform the first-in-human chemoprevention trial for
pancreatic adenocarcinoma. Patients who have undergone partial pancreatectomy, and have been found to
have high-risk IPMN, will be eligible for this randomized double-blind placebo controlled Phase II trial (100
patients/arm). This trial will utilize the selective COX inhibitor sulindac, which has been demonstrated to be
highly effective in preventing progression to pancreatic cancer in pre-clinical models. Clinical data from our
group and others have demonstrated a strong association between inflammation and progression in patients
with IPMN, and sulindac has been shown to decrease the size of IPMN in patients with these cystic precursor
lesions. The primary endpoint will be the rate of radiographic progression after three years. Patients will be
closely monitored, with alternating CT imaging and endoscopic ultrasound/fluid aspiration every six months.
Secondary endpoints will include: (1) assessment of the effects of this treatment on cyst fluid inflammatory
markers, and a previously developed cyst fluid biomarker panel, and (2) a novel approach to radiographic
assessment (radiomics) for early detection of progression to malignancy.

## Key facts

- **NIH application ID:** 10242845
- **Project number:** 5R01CA235677-03
- **Recipient organization:** DUKE UNIVERSITY
- **Principal Investigator:** Peter J Allen
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $614,787
- **Award type:** 5
- **Project period:** 2019-09-20 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10242845

## Citation

> US National Institutes of Health, RePORTER application 10242845, Preventing an Incurable Disease: The Prevention of Progression to Pancreatic Cancer Trial (The 3P-C Trial) (5R01CA235677-03). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10242845. Licensed CC0.

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