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RecruitingNCT07043270

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

Status
Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
35 (estimated)
Sponsor
Dartmouth-Hitchcock Medical Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGNab-paclitaxel + GemcitabineAdministered 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).

Timeline

Start date
2025-09-29
Primary completion
2028-07-01
Completion
2029-07-01
First posted
2025-06-29
Last updated
2025-10-20

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT07043270. Inclusion in this directory is not an endorsement.