Actively Recruiting
Impact of Tumor and Stromal Subtypes on Efficacy of Neoadjuvant FOLFIRINOX in Subjects With Non-Metastatic Pancreatic Cancer
Led by UNC Lineberger Comprehensive Cancer Center · Updated on 2026-01-13
45
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how the genetic makeup of pancreatic ductal adenocarcinoma (PDAC), a type of pancreatic cancer, affects the response to the chemotherapy treatment FOLFIRINOX given before surgery. This research focuses on patients with PDAC that can be surgically removed or is locally advanced but not spread to distant sites. The study aims to understand if pre-surgery FOLFIRINOX improves the ability to remove tumors and reduces cancer recurrence by examining changes in tumor genetics before and after treatment. Participants will receive FOLFIRINOX chemotherapy every two weeks as outpatients for up to 12 cycles (24 weeks) or until disease progression or unacceptable side effects. After 8 cycles, imaging will assess if surgery is possible; if so, surgery occurs followed by 4 more cycles of chemotherapy. The drugs include oxaliplatin, leucovorin, irinotecan, and 5-FU, with 5-FU delivered partly by a continuous infusion pump over 46 hours. Biopsies and blood samples will be collected before treatment and after 8 cycles to study molecular changes in tumor and stromal subtypes. During the study, participants undergo regular imaging every 8 weeks to monitor tumor response and resectability. Researchers will evaluate response rates, resectability, survival, adverse events, and changes in tumor subtype over up to 3 years of follow-up. Participants must have adequate organ function and performance status and will be monitored for safety and treatment effects throughout the study and follow-up period.
CONDITIONS
Brief Title
Tumor Subtypes in Subjects on FOLFIRINOX With Non-Metastatic Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must provide written informed consent and authorization for health information release.
- Diagnosis of pancreatic adenocarcinoma confirmed by tissue analysis with no distant metastasis.
- No health problems preventing possible surgical tumor removal.
- Willingness to undergo pre- and post-chemotherapy pancreas biopsies.
- Tumor is resectable, borderline resectable, or locally advanced unresectable PDAC.
- Performance status must be 0 or 1 on the ECOG scale.
- No prior chemotherapy, chemoradiotherapy, or surgery for pancreatic cancer.
- Age 18 years or older.
- Adequate organ function at study start.
- Life expectancy of at least 6 months.
You will not qualify if you...
- Evidence of local recurrence or metastatic pancreatic cancer.
- Other cancers in the past 5 years except certain treated skin or cervical cancers.
- Allergic reaction to 5FU, oxaliplatin, irinotecan, or related agents.
- Known deficiency of the enzyme DPD.
- Participation in another investigational drug study within 4 weeks before starting treatment.
- Serious health conditions like recent heart attack, severe heart failure, or active infection needing IV antibiotics.
- History or suspicion of Gilbert's syndrome or certain genetic polymorphisms.
- Peripheral neuropathy grade 2 or higher.
- Major surgery or significant injury within 4 weeks before starting treatment.
- Inability or unwillingness to stop using ketoconazole or St John's wort.
- Pregnancy or breastfeeding.
- Conditions that may interfere with study compliance or follow-up.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 24 weeks or until discontinuation
Participants receive FOLFIRINOX chemotherapy as an outpatient every 14 days, for up to 12 cycles (24 weeks), or until disease progression, unacceptable toxicity, withdrawal, or death. Surgery may be performed after 8 cycles if scans show resectable disease, with remaining chemotherapy cycles given after surgery.
Every 2 weeks during treatment
Duration - Up to 36 months
Participants are followed for up to 36 months after treatment ends or until death, to monitor long-term outcomes and adverse events.
Visits scheduled periodically during follow-up
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
B
Brian Burgess, BS
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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