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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
NCT03483038 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG FOLFOX regimen
- DRUG Liposomal Irinotecan
Study Locations (4)
Florida
- University of Florida — Gainesville
- Orlando Health UF Health Cancer Center — Orlando
- Tallahassee Memorial Health Care — Tallahassee
Indiana
- Indiana University Melvin and Bren Simon Cancer Center — Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2018-12-13 |
| Est. Completion | 2026-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03483038
The ClinicalTrials.gov registry entry for NCT03483038 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Florida, which has 1,066 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Pancreatic Adenocarcinoma appearing as the primary indexed condition, and to 2 interventions — of which FOLFOX regimen is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03483038 reports 4 study locations spanning 2 distinct geographic areas — top geographies include Florida, Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03483038 about?
NCT03483038 is a clinical study titled "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". 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 f...
What is the current status of trial NCT03483038?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2018-12-13. Estimated completion is 2026-12.
What conditions does trial NCT03483038 study?
This clinical trial studies the following conditions: Pancreatic Adenocarcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03483038?
The interventions under investigation include: FOLFOX regimen (DRUG), Liposomal Irinotecan (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03483038?
This trial is sponsored by University of Florida, which has 1,066 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03483038 being conducted?
This trial has 4 study locations across Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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