NeoOPTIMIZE: Early Switching of mFOLFIRINOX or Gemcitabine/Nab-Paclitaxel Before Surgery for the Treatment of Resectable, Borderline Resectable, or Locally-Advanced Unresectable Pancreatic Cancer
NeoOPTIMIZE: An Open-Label, Phase II Trial to Assess the Efficacy of Adaptive Switching of FOLFIRINOX or Gemcitabine/Nab-Paclitaxel as a Neoadjuvant Strategy for Patients With Resectable and Borderline Resectable/Locally Advanced Unresectable Pancreatic Cancer
Other study identifiers
Sponsor study identifier
Secondary identifiers
REGISTRY · CTRP (Clinical Trial Reporting Program)
OTHER · OHSU Knight Cancer Institute
interventional
42
1 country
1
Study Start
May 27, 2021
Actual (reported)Primary Completion
December 8, 2024
Actual (reported)Study Completion
January 5, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Brief 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.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
- Recruitment status
- active not recruiting
- Actual enrollment (reported)
- 42 participants
- Study completion date
January 5, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
- Listed locations
- 1 countries · 1 sites
Trial Relationships
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
First Submitted
August 31, 2020
Actual (reported)First Posted
September 7, 2020
Actual (reported)Study Start
May 27, 2021
Actual (reported)Primary Completion
December 8, 2024
Actual (reported)Results Posted
January 14, 2026
Actual (reported)Study Completion
January 5, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
- Last Updated
- January 14, 2026
- Status Verified
- December 2025
- Results QC Date
- December 22, 2025
- Last Update Submitted
- December 22, 2025