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RecruitingInterventionalPhase 2

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

NCT ID: NCT07043270Sponsor: Dartmouth-Hitchcock Medical CenterLast updated: 2025-10-20

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

Sex: AllAge: 18 Years and olderHealthy 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 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.

Study locations (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756

Recruiting
24BRO681 : Alternating Gnp and mFOLFIRINOX for BR-PDAC | Cancerify