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24BRO681 : Alternating Gnp and mFOLFIRINOX for BR-PDAC

  • PhasePhase 2
  • StatusRecruiting
  • Planned enrollment35 people
  • Recruiting US sites1
  • SponsorDartmouth-Hitchcock Medical Center
  • RegistryNCT07043270

Recruitment re-checked on ClinicalTrials.gov Oct 30, 2026. Public record; not medical advice.

24BRO681 : Alternating Gnp and mFOLFIRINOX for BR-PDAC: a one-minute explainerNCT070432701 min

Eligibility

Who can join

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

  • Age18 Years to no maximum
  • SexAll
  • Healthy volunteersNo

You may be able to join if

  • 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.

You cannot join if

  • 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.

The treatment

How it is intended to work

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

Cisplatin/Gemcitabine Regimen. A regimen consisting of cisplatin and gemcitabine that can be used in the treatment of biliary tract, bladder, cervical, kidney, occult primary, pancreatic, ovarian, fallopian tube, primary peritoneal, and vulvar cancers, peritoneal and pleural mesothelioma, non-small cell lung cancer (NSCLC), gestational trophoblastic neoplasia (GTN), cancer of the nasopharynx, and ampullary adenocarcinoma. NCI Drug Dictionary

Treatments listed in the registry

  • Nab-paclitaxel + Gemcitabine (Drug): Administered ion days 1, 8 and 15 of cycles 1 and 3 (28-day cycles).
  • modified FOLFIRINOX (mFOLFIRINOX) (Drug): Administered ion days 1 and 15 of cycles 2 and 4 (28-day cycles).

The study

Treatment groups

Na · Single Group · masking: None

Treatment with Gemcitabine plus Nab-Paclitaxel and mFOLFIRINOX (Experimental)

Patient has been diagnosed with borderline resectable pancreatic ductal adenocarcinoma (pancreatic cancer) and has not received systemic or radiation therapy. Treating physician has recommended neoadjuvant (pre-operative) chemotherapy and radiation, prior to surgery.

What it involves

Procedures

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

  • surgery: Part of the study plan
  • radiation: Part of the study plan

Goals

What the study measures

Main goals

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

Other goals

  • Proportion of patients who complete the study intervention
  • Proportion of patients who require dose modification
  • Proportion of patients who undergo surgery
  • Radiographic response (unconfirmed) after chemotherapy, per RECIST
  • Surgical resection rate (R0, R1 and R2 resection)
  • Pathologic response observed in the surgical specimen
  • Recurrence-free survival (RFS) in patients who undergo surgery
  • EFS (Event Free Survival) and OS (Overall Survival)
  • Trend of CA19-9

Planned enrollment: 35 (estimated).

Where

Recruiting US sites

  • Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire

Site status as of Oct 30, 2026. Check the live record before contacting a site.

Sources

Where this comes from

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Aug 5, 2026. Public record; not medical advice.

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