24BRO681 : Alternating Gnp and mFOLFIRINOX for BR-PDAC

24BRO681 : Neoadjuvant Therapy With Alternating Gemcitabine Plus Nab-Paclitaxel and mFOLFIRINOX for Borderline Resectable Pancreatic Adenocarcinoma: A Phase 2 Clinical Trial

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

Study Overview

• Status: Recruiting
• Conditions: Pancreas Adenocarcinoma
• Intervention / Treatment: Drug: Nab-paclitaxel + Gemcitabine; Drug: modified FOLFIRINOX (mFOLFIRINOX)

Detailed Description

Modified FOLFIRINOX (mFOLFIRINOX) and gemcitabine plus nab-paclitaxel (GnP) are two of the preferred chemotherapy treatments at this time. The U.S. Food and Drug Administration (FDA) has approved each of these treatments for patients with borderline resectable pancreatic cancer. This study will alternate these two neoadjuvant chemotherapy treatments (GnP and mFOLFIRINOX). The study doctors hope that alternating these treatments may improve the treatment response, improve tumor removal (also called "resectability"), and lower the risk of cancer coming back.

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Cancer Research Nurse; Phone Number: 800-639-6918; Email: cancer.research.nurse@hitchcock.org

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Recruiting
      • Dartmouth-Hitchcock Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Nab-paclitaxel + Gemcitabine; Administered ion days 1, 8 and 15 of cycles 1 and 3 (28-day cycles).; Drug: modified FOLFIRINOX (mFOLFIRINOX); Administered ion days 1 and 15 of cycles 2 and 4 (28-day cycles).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
One-year event-free survival (1y-EFS)	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.	I year

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients who complete the study intervention	1 year
Proportion of patients who require dose modification	1 year
Proportion of patients who undergo surgery	1 year
Radiographic response (unconfirmed) after chemotherapy, per RECIST	1 year
Surgical resection rate (R0, R1 and R2 resection)	1 year
Pathologic response observed in the surgical specimen	1 year
Recurrence-free survival (RFS) in patients who undergo surgery	1 year
Trend of CA19-9	1 year
EFS (Event Free Survival) and OS (Overall Survival)	1 year

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2029

Study Registration Dates

• First Submitted: June 12, 2025
• First Submitted That Met QC Criteria: June 20, 2025
• First Posted (Actual): June 29, 2025

Study Record Updates

• Last Update Posted (Estimated): October 20, 2025
• Last Update Submitted That Met QC Criteria: October 16, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Gemcitabine; Pancreatic Cancer; mFOLFIRINOX; Nab-Paclitaxel; BR-PDAC; Neoadjuvant alternating chemotherapy; Resectable Pancreatic cancer
• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Gemcitabine; 130-nm albumin-bound paclitaxel
• Other Study ID Numbers: STUDY02002681; 24BRO681 (Other Identifier: DHMC); NCI-2022-08163 (Other Identifier: National Cancer Institute)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No