Clinical Trial

NeoOPTIMIZE: Early Switching of mFOLFIRINOX or Gemcitabine/Nab-Paclitaxel Before Surgery for the Treatment of Resectable, Borderline Resectable, or Locally-Advanced Unresectable Pancreatic Cancer

Active, Not Recruiting Phase 2
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Summary
This phase II trial evaluates whether early switching from modified fluorouracil/irinotecan/leucovorin/oxaliplatin (mFOLFIRINOX) chemotherapy regimen to a combination of gemcitabine and nab-paclitaxel (GA) before surgery is effective in treating patients with pancreatic cancer that can be surgically removed (resectable or borderline resectable), or that has spread to nearby tissue or lymph nodes and cannot be removed by surgery (locally-advanced unresectable). Chemotherapy drugs, such as fluorouracil, irinotecan, leucovorin, oxaliplatin, gemcitabine, and nab-paclitaxel work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The study will also evaluate the drug losartan in combination with mFOLFIRINOX or GA.
Protocol Amendment History 14 amendments
This ClinicalTrials.gov record has been amended 14 times since 2020-08-31; most recent amendment 2025-12-22.
Status change: Recruiting → Active, Not Recruiting 2025-01-02
Status change: Not Yet Recruiting → Recruiting 2021-05-20
Trial Details
NCT Number NCT04539808
Lead Sponsor OHSU Knight Cancer Institute
Collaborators: Oregon Health and Science University
Conditions Pancreatic Adenocarcinoma, Stage 0 Pancreatic Cancer American Joint Committee on Cancer v8, Stage I Pancreatic Cancer American Joint Committee on Cancer v8, Stage III Pancreatic Cancer American Joint Committee on Cancer v8, Stage IV Pancreatic Cancer American Joint Committee on Cancer v8
Enrollment 42 participants
Start Date 2021-05-27
Primary Completion 2024-12-08 (estimated)
Study Completion 2027-01-05 (estimated)
Updated on ClinicalTrials.gov 2026-01-14