24BRO681 : Alternating Gnp and mFOLFIRINOX for BR-PDAC

Not Applicable

Not yet recruiting

• Conditions: Pancreas Adenocarcinoma
• Interventions: Drug: Nab-paclitaxel + Gemcitabine; Drug: modified FOLFIRINOX (mFOLFIRINOX)

• Registration Number: NCT07043270
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

Brief Summary

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

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 Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-06-12
• Study First Submitted QC: 2025-06-20
• Study First Posted: 2025-06-29
• Last Update Submitted: 2025-07-18
• Last Update Posted: 2025-07-23
• Study Start: 2025-09-01
• Primary Completion: 2028-07-01
• Study Completion: 2029-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 35

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment with Gemcitabine plus Nab-Paclitaxel and mFOLFIRINOX	Nab-paclitaxel + Gemcitabine	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.
Treatment with Gemcitabine plus Nab-Paclitaxel and mFOLFIRINOX	modified FOLFIRINOX (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.
Treatment with Gemcitabine plus Nab-Paclitaxel and mFOLFIRINOX	modified FOLFIRINOX (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.
Treatment with Gemcitabine plus Nab-Paclitaxel and mFOLFIRINOX	Nab-paclitaxel + Gemcitabine	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.

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Surgical resection rate (R0, R1 and R2 resection)	1 year
Pathologic response observed in the surgical specimen	1 year
EFS (Event Free Survival) and OS (Overall Survival)	1 year
Trend of CA19-9	1 year
Proportion of patients who complete the study intervention	1 year
Recurrence-free survival (RFS) in patients who undergo surgery	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

Trial Locations

Locations (1)

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States