Modified FOLFIRINOX for Gemcitabine-Refractory Pancreatic Cancer: Improved Safety and Efficacy
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.
modified FOLFIRINOX regimen
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.50 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives