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FOLFIRINOX for Non-Metastatic Pancreatic Cancer

This study is looking at how different types of pancreatic cancer (Pancreatic Ductal Adenocarcinoma or PDAC) respond to a chemotherapy treatment called FOLFIRINOX. FOLFIRINOX is a combination of four drugs: Oxaliplatin, Leucovorin, Irinotecan Hydrochloride, and 5-FU. This treatment is given before surgery to remove the tumor. Researchers want to see if the genetic makeup of your tumor affects how well FOLFIRINOX works. The main goal is to measure how many people show good control of their disease after 6 months of treatment, based on their tumor type. You may be able to join if you are an adult with confirmed pancreatic cancer that has not spread to other parts of your body and is potentially able to be surgically removed.

Study design
This is a single-arm study, meaning everyone receives the same treatment. It plans to enroll 45 participants.
What's involved
You would receive FOLFIRINOX chemotherapy every 14 days. You will have biopsies before treatment and after 8 cycles, and imaging scans after every 4 cycles.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for 36 months after stopping treatment or until death, whichever comes first.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03977233

Tumor Subtypes in Subjects on FOLFIRINOX With Non-Metastatic Pancreatic Cancer

Recruiting
PHASE2Ages 18–99InterventionalTreatment
UNC Lineberger Comprehensive Cancer Center
~45 participants
Updated 2026-01-13 on ClinicalTrials.gov
What's tested:OxaliplatinLeucovorinIrinotecan Hydrochloride5-FU

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Best disease control rate by Pancreatic ductal adenocarcinoma (PDAC) subtype
Measured over 6 months after start of treatment

Conditions

Pancreatic Ductal Adenocarcinoma (PDAC)
Cancer of Pancreas
Pancreatic Cancer, Adult
Pancreas Adenocarcinoma
Pancreatic Neoplasms
Pancreatic Cancer Non-resectable
Pancreatic Cancer Resectable

Explore related trials

Pancreatic Ductal Adenocarcinoma

NCT03977233

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolinastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Ashwin Somasundaram, MD · PRINCIPAL_INVESTIGATOR · University of North Carolina, Chapel Hill

Who to contact

Catherine Griffin, BS, BA
[email protected]
919-966-4432
Email the study team

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Eligibility criteria

Inclusion

Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
Histologically or cytologically confirmed adenocarcinoma of the pancreas with no evidence of distant metastatic disease.
Subject has no evidence of co-morbidities precluding the potential to undergo surgical resection of PDAC as determined by surgical investigator.
Subjects must be willing to undergo a mandatory pre- and post-treatment EUS guided core biopsy of the pancreatic mass.
Measurable or non-measurable but evaluable (as determined by Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST 1.1\]) resectable, borderline resectable or unresectable locally advanced PDAC.
Subject has adequate performance status as defined by ECOG performance status 0 or 1.
Subject has received no prior chemotherapy or chemoradiotherapy for pancreatic cancer. Subjects have not previously received surgery to remove pancreatic cancer.
Age ≥ 18 years of age.
Subject has adequate organ function at study entry.
Subject has life expectancy of at least 6 months.

Exclusion

Subject has any evidence of local recurrence or metastatic pancreatic cancer.
Other malignancies within the past 5 years except for adequately treated cervical or vulvar carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis and T1).
Subject has hypersensitivity to 5FU, oxaliplatin or other platinum agent, or irinotecan or to their excipients.
Subject has known dihydropyrimidine dehydrogenase (DPD) enzyme deficiency.
Participation in any investigational drug study within 4 weeks preceding the start of study treatment. Subjects are not permitted to participate in another investigational drug study while being treated on this protocol. Subjects participating in other clinical trials that are receiving SOC FOLFIRINOX are permitted on study.
Subject has current evidence of any condition that makes participating in this study not in the best interest of the subject, including but not limited to:
Myocardial infarction within the past 6 months
New York Heart Association (NYHA) Class III or IV heart disease
Active infection requiring IV antibiotics
Subject has a history of or suspected Gilbert's syndrome or known homozygosity for UGT1A1\*28 polymorphism (baseline testing not required).
Subject has sensory peripheral neuropathy grade ≥ 2.
Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug.
Subject is unable or unwilling to discontinue use of ketoconazole or St John's wort. Use of phenytoin, carbamazepine, phenobarbital, rifampin and rifabutin is discouraged, but not contraindicated. If subjects require phenytoin, carbamazepine or phenobarbital monitoring of drug levels is suggested during the study.
Subject is pregnant or lactating.
Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the subject before registration in the trial.

What this trial measures

  • Best disease control rate by Pancreatic ductal adenocarcinoma (PDAC) subtype6 months after start of treatment

    To evaluate the association between PDAC tumor subtype (particularly basal-like versus classical subtype) and best disease control rate (DCR) after administration of FOLFIRINOX in subjects with non-metastatic pancreatic cancer, DCR is defined as the proportion of patients with either Complete Response (CR), partial response (PR), or stable disease (SD) as determined by RECIST 1.1, Response Evaluation Criteria In Solid Tumors Criteria. CR is defined as disappearance of all target lesions; PR as a \>=30% decrease in the sum of the longest diameter of target lesions; and SD as no response or less response than Partial or Progressive.