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Active, not recruiting Phase 2 Interventional Results available

A Study of the Safety and Activity of Liposomal Irinotecan in Combination With the 5-FU and Oxaliplatin in the Preoperative Treatment of Pancreatic Adenocarcinoma

ClinicalTrials.gov ID: NCT03483038

Public ClinicalTrials.gov record NCT03483038. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 3, 2026, 6:01 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase II, Open-label Pilot Study Evaluating the Safety and Activity of Liposomal Irinotecan in Combination With 5-FU and Oxaliplatin in Preoperative Treatment of Pancreatic Adenocarcinoma (NEO-Nal- IRI Study)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a phase II, single arm, non-randomized, open label study of liposomal irinotecan with FOLFOX in the neoadjuvant setting in patients with resectable or borderline resectable, previously untreated pancreatic adenocarcinoma. The primary objective of this study is to investigate the safety and feasibility of this treatment regimen in this patient population.

Study identification

NCT ID
NCT03483038
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 2
Lead sponsor
University of Florida
Other
Enrollment
45 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 99 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 12, 2018
Primary completion
Sep 15, 2023
Completion
Nov 30, 2026
Last update posted
Feb 26, 2026

2018 – 2026

United States locations

U.S. sites
4
U.S. states
2
U.S. cities
4
Facility City State ZIP Site status
University of Florida Gainesville Florida 32608
Orlando Health UF Health Cancer Center Orlando Florida 32806
Tallahassee Memorial Health Care Tallahassee Florida 32308
Indiana University Melvin and Bren Simon Cancer Center Indianapolis Indiana 46202

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03483038, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 26, 2026 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03483038 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →