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Recruiting NCT07043270

24BRO681 : Alternating Gnp and mFOLFIRINOX for BR-PDAC

Phase II Interventional Pancreas Adenocarcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nab-paclitaxel + Gemcitabine, modified FOLFIRINOX (mFOLFIRINOX).
Who it may be relevant to
Registry conditions: Pancreas Adenocarcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

24BRO681 : Neoadjuvant Therapy With Alternating Gemcitabine Plus Nab-Paclitaxel and mFOLFIRINOX for Borderline Resectable Pancreatic Adenocarcinoma: A Phase 2 Clinical Trial

Overview

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.

Interventions

  • 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 measures

  • One-year event-free survival (1y-EFS) [Time frame: I year]
Secondary outcome measures (9)
  • 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

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Dartmouth-Hitchcock Medical Center — Lebanon

Identifiers

NCT: NCT07043270 · STUDY02002681 · 24BRO681 · NCI-2022-08163

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗