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NCT03483038 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study of Pancreatic Adenocarcinoma, sponsored by University of Florida.
- Active
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
- 4
- Study locations
NCT03483038: Active Phase 2 study of Pancreatic Adenocarcinoma, sponsored by University of Florida.
NCT03483038 is a Phase 2 study of Pancreatic Adenocarcinoma that is active but no longer recruiting, run by University of Florida. The registered enrollment target is 45 participants, below the 99,464-participant average among 62 other Pancreatic Adenocarcinoma trials with a reported enrollment target (100% lower). The trial reports 4 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03483038, a Phase 2 study of Pancreatic Adenocarcinoma, is active but no longer recruiting, sponsored by University of Florida.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
- 4
- Study locations
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.
Primary Outcome
To determine the percentage of subjects who had post-operative complications 30 days post-surgery. Post-operative complications considered for this outcome measure included hospital readmission, death, second surgery or interventional procedure, or major complications extending hospital stay.
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 |
What the registry record for NCT03483038 still lists
NCT03483038 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 99,464-participant average among 62 other Pancreatic Adenocarcinoma trials with a reported enrollment target (100% lower).
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.
NCT03483038 reports a single indexed study location in Florida, Indiana.
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.
What interventions are being tested in trial NCT03483038?
The interventions under investigation include: FOLFOX regimen (DRUG), Liposomal Irinotecan (DRUG).
Who is sponsoring clinical trial NCT03483038?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT03483038's enrollment target sits among peer trials
45 38th of 62 higher than 24 of 62 other Pancreatic Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pancreatic Adenocarcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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