$0.00
Shopping Cart
Facebook-f Instagram
DONATE
Donate

Clinical Trial Record

Return to Clinical Trials

24BRO681 : Alternating Gnp and mFOLFIRINOX for BR-PDAC

2025-09-01

2028-07-01

2029-07-01

35

Study Overview

24BRO681 : Alternating Gnp and mFOLFIRINOX for BR-PDAC

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

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.

  • Pancreas Adenocarcinoma
  • DRUG: Nab-paclitaxel + Gemcitabine
  • DRUG: modified FOLFIRINOX (mFOLFIRINOX)
  • STUDY02002681
  • 24BRO681 (OTHER Identifier) (OTHER: DHMC)
  • NCI-2022-08163 (OTHER Identifier) (OTHER: National Cancer Institute)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2025-06-12  

N/A  

2025-07-18  

2025-06-20  

N/A  

2025-07-23  

2025-06-29  

N/A  

2025-05  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/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

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).
Primary Outcome MeasuresMeasure DescriptionTime 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 MeasuresMeasure DescriptionTime Frame
Proportion of patients who complete the study intervention1 year
Proportion of patients who require dose modification1 year
Proportion of patients who undergo surgery1 year
Radiographic response (unconfirmed) after chemotherapy, per RECIST1 year
Surgical resection rate (R0, R1 and R2 resection)1 year
Pathologic response observed in the surgical specimen1 year
Recurrence-free survival (RFS) in patients who undergo surgery1 year
EFS (Event Free Survival) and OS (Overall Survival)1 year
Trend of CA19-91 year

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Cancer Research Nurse

Phone Number: 800-639-6918

Email: cancer.research.nurse@hitchcock.org

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

NPCF Pop up

Make-A-Will Month

Snag 6508be92
Learn More
Donate Now Online
Other Ways to Donate