MedTrace Logo

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

NCT04539808 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-01-14

Study results available
· View outcomes & findings →

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.

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

Interventions

DRUG

Capecitabine

Given PO

DRUG

Fluorouracil

Given IV

DRUG

Irinotecan Hydrochloride

Given IV

DRUG

Leucovorin Calcium

Given IV

DRUG

Losartan Potassium

Given PO

DRUG

Oxaliplatin

Given IV

RADIATION

Radiation Therapy

Undergo short-course or long-course RT

PROCEDURE

Resection

Undergo surgical resection

PROCEDURE

Diagnostic Imaging

Undergo diagnostic imaging

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

DRUG

Gemcitabine

Given IV

DRUG

Nab paclitaxel

Given IV

Sponsors & Collaborators

  • Oregon Health and Science University

    collaborator OTHER

  • OHSU Knight Cancer Institute

    lead OTHER

Principal Investigators

  • Charles D Lopez · OHSU Knight Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-27
Primary Completion
2024-12-08
Completion
2027-01-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04539808 on ClinicalTrials.gov