Actively Recruiting
Tumor Subtypes in Subjects on FOLFIRINOX With Non-Metastatic Pancreatic Cancer
Led by UNC Lineberger Comprehensive Cancer Center · Updated on 2026-01-13
45
Participants Needed
1
Research Sites
550 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a research study to evaluate how the genetic makeup of Pancreatic Ductal Adenocarcinoma (PDAC) can affect the response to FDA-approved chemotherapy treatment, FOLFIRINOX, given before surgery to remove the tumor. Certain types of PDAC tumors can be surgically resected (removed). However, not all types of PDACs are resectable, especially if they are close to important structures like blood vessels or intestines. These types of PDACs are treated with chemotherapy such as FOLFIRINOX. Research studies showed that chemotherapy after surgical resection of PDAC tumors reduced the risk of the cancer returning. Chemotherapy is used to treat PDAC that has not spread outside of the pancreas and is not resectable. FOLFIRINOX is a chemotherapy treatment that combines multiple chemotherapeutic agents, including oxaliplatin, leucovorin, irinotecan, and 5-FU. Patients receive these agents by intravenous infusion. Of these drugs, 5-FU requires you to return home with a chemotherapy pump that will deliver chemotherapy over 46 hours. This regimen has been studied in pancreatic cancer that has been removed with surgery as a method for preventing the cancer from returning. Studies showed FOLFIRINOX chemotherapy reduced the risk of cancer returning and increased patients survival. In this study, researchers want to know if FOLFIRINOX chemotherapy given before surgery will make the cancer easier to remove with surgery and increase the chances of the cancer staying away after surgery. Researchers have shown that pancreatic cancers are not all the same when you look at the DNA and RNA that is inside a pancreatic cancer cell. Depending on the expression of different genes in a cancer cell, some pancreatic cancers may respond differently to chemotherapy. In this study researchers want to know if FOLFIRINOX chemotherapy can change the genetic profile of the cancer. This will be studied by obtaining a biopsy of the cancer before the start of chemotherapy, and after 8 treatments of chemotherapy. They will also study cancer cells that will be collected from blood samples.
CONDITIONS
Official Title
Tumor Subtypes in Subjects on FOLFIRINOX With Non-Metastatic Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent and HIPAA authorization obtained
- Confirmed adenocarcinoma of the pancreas with no distant metastatic disease
- No co-morbidities preventing potential surgical resection as determined by surgical investigator
- Willingness to undergo mandatory pre- and post-treatment endoscopic ultrasound-guided core biopsies
- Measurable or evaluable resectable, borderline resectable, or unresectable locally advanced PDAC
- ECOG performance status of 0 or 1
- No prior chemotherapy, chemoradiotherapy, or surgery for pancreatic cancer
- Age 18 years or older
- Adequate organ function at study entry
- Life expectancy of at least 6 months
You will not qualify if you...
- Evidence of local recurrence or metastatic pancreatic cancer
- Other malignancies within past 5 years except treated cervical or vulvar carcinoma in situ, basal cell carcinoma, or certain superficial bladder tumors
- Hypersensitivity to 5-FU, oxaliplatin, irinotecan, platinum agents, or their excipients
- Known dihydropyrimidine dehydrogenase (DPD) deficiency
- Participation in investigational drug study within 4 weeks before treatment or concurrent investigational drug use (except SOC FOLFIRINOX trials)
- Recent myocardial infarction within 6 months or NYHA Class III or IV heart disease
- Active infection requiring IV antibiotics
- History or suspicion of Gilbert's syndrome or homozygosity for UGT1A1*28 polymorphism
- Sensory peripheral neuropathy grade ≥ 2
- Major surgery, open biopsy, or significant injury within 4 weeks before study drug
- Unable or unwilling to stop ketoconazole or St John's wort
- Pregnancy or lactation
- Psychological, familial, sociological, or geographical conditions that may hinder study compliance or follow-up
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Trial Site Locations
Total: 1 location
1
University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
Research Team
C
Catherine Griffin, BS, BA
CONTACT
B
Brian Burgess, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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