Recruiting
Phase 2

Chemotherapy

Sponsor:

Dartmouth-Hitchcock Medical Center

Code:

NCT07043270

Conditions

Pancreas Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Nab-paclitaxel + Gemcitabine

modified FOLFIRINOX (mFOLFIRINOX)

Study Details

Brief summary:

The purpose of this research is to study the effects and safety of alternating neoadjuvant chemotherapy on borderline resectable pancreatic cancer.

Conditions

Pancreas Adenocarcinoma

Study ID

NCT07043270

Start date

Sep 29, 2025

Status verified date

Jun, 2026

Completion date

Jul 1, 2029

Anticipated

Primary completion date

Jul 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

35 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment with Gemcitabine plus Nab-Paclitaxel and mFOLFIRINOX

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.

Interventions

Nab-paclitaxel + Gemcitabine

Administered ion days 1, 8 and 15 of cycles 1 and 3 (28-day cycles).

modified FOLFIRINOX (mFOLFIRINOX)

Administered ion days 1 and 15 of cycles 2 and 4 (28-day cycles).

Primary outcome measure

  • One-year event-free survival (1y-EFS) [ Time Frame: I year ]

Central Contacts and Locations

Central contacts

Cancer Research Nurse

800-639-6918cancer.research.nurse@hitchcock.org

Locations

Dartmouth-Hitchcock Medical Center

Recruiting

Lebanon, New Hampshire, United States, 03756

More Information

Sponsor

Dartmouth-Hitchcock Medical Center

Last update posted

Aug 6, 2026

Last verified

Jun, 2026

Keywords

  • mFOLFIRINOX
  • Gemcitabine
  • Nab-Paclitaxel
  • Neoadjuvant alternating chemotherapy
  • Resectable Pancreatic cancer
  • BR-PDAC
  • Pancreatic Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dartmouth-Hitchcock Medical Center on 2026-08-06.