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Alternating Chemotherapy for Borderline Resectable Pancreatic Cancer

This study is looking at a new way to treat borderline resectable pancreatic cancer (cancer that is close to important blood vessels and may be hard to remove with surgery). It combines two approved chemotherapy treatments: Nab-paclitaxel plus Gemcitabine (GnP) and modified FOLFIRINOX (mFOLFIRINOX). You would receive these treatments in alternating cycles. The goal is to see if this alternating approach improves how well the treatment works, makes the tumor easier to remove, and reduces the chance of the cancer coming back. The study will measure how many patients are alive and cancer-free after one year. To join, you must be at least 18 years old and have a diagnosis of borderline resectable pancreatic cancer confirmed by experts at Dartmouth Cancer Center. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 35 participants. It is testing two chemotherapy treatments given in an alternating pattern.
What's involved
You would receive Nab-paclitaxel plus Gemcitabine on days 1, 8, and 15 of cycles 1 and 3, and modified FOLFIRINOX on days 1 and 15 of cycles 2 and 4. Each cycle lasts 28 days.
Compensation
Not stated in the trial record.
Follow-up
The study will follow participants to measure one-year event-free survival, meaning they will track your health for at least one year after treatment.

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NCT07043270

24BRO681 : Alternating Gnp and mFOLFIRINOX for BR-PDAC

Recruiting
PHASE2Ages 18+InterventionalTreatment
Dartmouth-Hitchcock Medical Center
~35 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:Nab-paclitaxel + Gemcitabinemodified FOLFIRINOX (mFOLFIRINOX)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
One-year event-free survival (1y-EFS)
Measured over I year

Conditions

Pancreas Adenocarcinoma

Explore related trials

Pancreatic Carcinoma

Where it's being run

1 sites across 1 states
New Hampshire1

Who to contact

Cancer Research Nurse
[email protected]
800-639-6918
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age ≥ 18 years
Diagnosis of BR-PDAC. The resectability should be officially determined with surgical oncologists at the Dartmouth Cancer Center (DCC) GI multidisciplinary Tumor Board based on NCCN Guidelines Version 2.2024 Pancreatic Adenocarcinoma.
Patients must be able and willing to provide informed consent.
Contrast-enhanced CT scan of the chest, abdomen, and pelvis performed within 45 days before registration.
ECOG Performance Status: 0-1.
Females of childbearing potential must have a negative pregnancy test done ≤ 14 days prior to study enrollment, and must agree to use a highly effective method of contraception throughout the course of protocol therapy.

Exclusion

Any prior receipt of chemotherapy or radiation therapy for PDAC.
Known DPYD poor metabolizer genotype.
Known BRCA1/2 or PALB2 mutations. If they are found to have BRCA1/2 or PALB2 mutation after inclusion to the trial, the participant will be taken off of protocol therapy (since platinum-containing therapy is preferred for these patients).
Any confirmed second malignancy that is likely to require systemic therapy during the study period, in the opinion of the enrolling investigator.
Any of the following baseline laboratory abnormalities:
Absolute neutrophil count (ANC) \< 2,500/mm3
Platelet count \< 100,000/mm3
Hemoglobin \< 7 g/dL
Creatinine \> 1.5 x upper limit of normal (ULN)
Total bilirubin \> 1.5 x ULN
AST/ALT \> 5 x ULN
Any peripheral sensory neuropathy that meaningfully impairs performance of instrumental activities of daily living, as evaluated by the enrolling investigator.
Patients who are unable to provide informed consent.
Patients who are pregnant or breastfeeding.
Patients who are incarcerated.

What this trial measures

  • One-year event-free survival (1y-EFS)I year

    One-year EFS is defined as completing one year from enrollment without the occurrence of any of the following events: 1) disease progression per Response Evaluation Criteria in Solid Tumors (RECIST), 2) surgery with R2 resection, 3) recurrent disease following surgery, or 4) death from any cause.