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2025-09-01
2028-07-01
2029-07-01
35
NCT07043270
Dartmouth-Hitchcock Medical Center
Dartmouth-Hitchcock Medical Center
INTERVENTIONAL
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.
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 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
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 | DRUG: Nab-paclitaxel + Gemcitabine
DRUG: modified FOLFIRINOX (mFOLFIRINOX)
|
| Primary Outcome Measures | 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 | Measure Description | 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 | |
| EFS (Event Free Survival) and OS (Overall Survival) | 1 year | |
| Trend of CA19-9 | 1 year |
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 |
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:
This is where you will find people and organizations involved with this study.
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
