The Prevention of Progression to Pancreatic Cancer Trial (The 3P-C Trial)
Estimated Enrollment: 200 participants
Actual Study Start Date: July 10, 2020
Estimated Primary Completion Date: January 31, 2025
Estimated Study Completion Date: January 31, 2025
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.
A Window-of-Opportunity Trial Using Neoadjuvant Hepatic Artery Chemotherapy for Patients With Localized Pancreas Cancer
Estimated Enrollment: 40 participants
Estimated Study Start Date: April 1, 2023
Estimated Primary Completion Date: April 30, 2025
Estimated Study Completion Date: June 30, 2028
This is a window-of-opportunity study which will evaluate the safety and feasibility of single-dose neoadjuvant hepatic artery (HA) chemotherapy (FUDR/oxaliplatin) in patients with localized pancreatic ductal adenocarcinoma (PDAC) eligible for surgical resection and systemic chemotherapy.
Current standard-of-care therapy for patients with localized PDAC includes surgical resection and six months of systemic chemotherapy. Because the sequence of these treatments (surgery and chemotherapy) is not well established, we will include both patients planned to undergo surgery before chemotherapy, as well as patients planned to receive systemic chemotherapy before surgery. This will allow us to test the safety and feasibility of adding single-dose neoadjuvant HA chemotherapy prior to surgery across the real-world treatment strategies employed in typical clinical practice. Moreover, the window-of-opportunity design is intended to make sure that all patients receive HA chemotherapy in addition to standard-of-care surgery and systemic chemotherapy, so as not to withhold the treatment approach currently associated with best outcomes.
The primary endpoint is safety and feasibility, and patients will be followed for 30 days after resection of their primary tumors to assess these outcomes. Following the short-term follow-up period, patients move to long-term follow-up, which will occur every three months after resection of the primary tumor, for a period of up to three years. Long-term secondary endpoints include disease free survival (DFS), liver metastasis-free survival (LMFS), and overall survival (OS).
The purpose of this study is to evaluate the efficacy and safety of adjuvant autogene cevumeran plus atezolizumab and modified leucovorin, 5-fluorouracil (5-FU), irinotecan, and oxaliplatin (mFOLFIRINOX) versus mFOLFIRINOX alone in participants with resected pancreatic ductal adenocarcinoma (PDAC) who have not received prior systemic anti-cancer treatment for PDAC and have no evidence of disease after surgery.
A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected Pancreatic Ductal Adenocarcinoma (IMCODE003)
Site PI: Daniel Nussbaum, M.D.
Estimated Enrollment: 260 participants
Estimated Study Start Date: Oct 5, 2023
Estimated Primary Completion Date: May 22, 2029
Estimated Study Completion Date: May 22, 2029