24BRO681 : Alternating Gnp and mFOLFIRINOX for BR-PDAC

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDartmouth-Hitchcock Medical Center

About this trial

The purpose of this research is to study the effects and safety of alternating neoadjuvant chemotherapy on borderline resectable pancreatic cancer.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Nab-paclitaxel + Gemcitabine
  • modified FOLFIRINOX (mFOLFIRINOX)

Treatment groups

35 Participants
are divided into 1 treatment group