24BRO681 : Neoadjuvant Therapy With Alternating Gemcitabine Plus Nab-Paclitaxel and mFOLFIRINOX for Borderline Resectable Pancreatic Adenocarcinoma: A Phase 2 Clinical Trial
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.
Arms & 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).
Outcome measures
Primary
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.
Time frame: I year
Secondary
Proportion of patients who complete the study intervention
Time frame: 1 year
Proportion of patients who require dose modification
Time frame: 1 year
Proportion of patients who undergo surgery
Time frame: 1 year
Radiographic response (unconfirmed) after chemotherapy, per RECIST
Time frame: 1 year
Surgical resection rate (R0, R1 and R2 resection)
Time frame: 1 year
Pathologic response observed in the surgical specimen
Time frame: 1 year
Recurrence-free survival (RFS) in patients who undergo surgery
Time frame: 1 year
EFS (Event Free Survival) and OS (Overall Survival)
Time frame: 1 year
Trend of CA19-9
Time frame: 1 year
Eligibility criteria
Study locations (1)
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756