24BRO681 : Neoadjuvant Therapy With Alternating Gemcitabine Plus Nab-Paclitaxel and mFOLFIRINOX for Borderline Resectable Pancreatic Adenocarcinoma: A Phase 2 Clinical Trial
Dartmouth-Hitchcock Medical Center
Summary
The purpose of this research is to study the effects and safety of alternating neoadjuvant chemotherapy on borderline resectable pancreatic cancer.
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 mu…
Interventions
- DrugNab-paclitaxel + Gemcitabine
Administered ion days 1, 8 and 15 of cycles 1 and 3 (28-day cycles).
- Drugmodified FOLFIRINOX (mFOLFIRINOX)
Administered ion days 1 and 15 of cycles 2 and 4 (28-day cycles).
Location
- Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire