Completed

Modified FOLFIRINOX for Gemcitabine-Refractory Pancreatic Cancer: Improved Safety and Efficacy

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Study Aim

This phase 2 study aims to evaluate the true response rate of a modified FOLFIRINOX treatment in individuals with pancreatic cancer that has not responded to gemcitabine.

What is being tested

modified FOLFIRINOX regimen

Drug
Who is being recruted

From 19 to 75 Years
+18 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: August 2015
See protocol details

Summary

Principal SponsorYonsei University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 28, 2015

Actual date on which the first participant was enrolled.

Pancreatic cancer is a serious condition, being the fourth leading cause of death in the Western world. Usually, surgery is the only treatment that offers a significant survival advantage, but unfortunately, only a small number of patients (10-20%) have operable cancer at the time of diagnosis. Gemcitabine has been the standard treatment for advanced pancreatic cancer, but it hasn't significantly improved the prognosis. A treatment called FOLFIRINOX has shown to extend survival compared to gemcitabine, but it comes with increased side effects. However, a modified FOLFIRINOX regimen has demonstrated a better safety profile in certain studies. This research aims to investigate the effectiveness and safety of this modified FOLFIRINOX treatment in patients with pancreatic cancer who didn't respond well to initial gemcitabine-based chemotherapy. During this phase II, multi-center study, participants with pancreatic cancer who have progressed despite gemcitabine-based first line chemotherapy will receive the modified FOLFIRINOX treatment. This treatment includes specific doses of oxaliplatin and irinotecan. The main goal of the study is to measure the 'true response rate', which helps to understand how many patients respond positively to the treatment. The study also monitors the safety of this treatment regimen for these patients.

Official TitleModified FOLFIRINOX for Gemcitabine Refractory Pancreatic Cancer: A Phase II Multicenter Trial
NCT02440958
Principal SponsorYonsei University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 19 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

10 inclusion criteria required to participate
Pathologically confirmed pancreatic ductal adenocarcinoma (metastatic or locally advanced stage)

Refractory or progress to Gemcitabine based 1st line chemotherapy

Older than 19 years old and younger than 75 years old

Life expectancy> 3 months

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8 exclusion criteria prevent from participating
Pathologically confirmed another type of pancreatic cancer (except ductal adenocarcinoma)

Metastatic adenocarcinoma of originating at other organs

Evidence with CNS metastasis

Active infection

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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CompletedNo study centers
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