Standard or Prolonged Neoadjuvant Chemotherapy Before Surgery for BR/LAPC

The goal of this multicenter randomized controlled phase III trial is to compare two durations of neoadjuvant chemotherapy (NAT) with mFOLFIRINOX or gemcitabine-nab-paclitaxel (GnP) before attempt for surgical resection in patients with borderline (BR) and locally advanced pancreatic cancer (LAPC). Patients with histologically confirmed non-metastatic BR/LAPC evaluated to potentially tolerate any of the treatment regimens and pancreatic surgery will be randomized to receive either standard duration NAT with 6 cycles mFOLFIRINOX or 4 cycles GnP or prolonged duration NAT with either 12 cycles mF

Trial Details

NCT ID
NCT06714604
Phase
PHASE3
Sponsor
Sahlgrenska University Hospital
Status
RECRUITING
Cancer Type
Pancreatic Cancer
Interventions
  • FOLFIRINOX or gemcitabine-nab-paclitaxel
Locations (sample)
  • Gothenburg, VGR, Sweden|57.70716,11.96679

Key Eligibility Criteria

  • Borderline or locally advanced pancreatic adenocarcinoma at diagnosis according to National Comprehensive Cancer Network (NCCN) Clinical Practice G…
  • Histo- or cytologically confirmed adenocarcinoma (preferably EUS-guided)
  • T1-4, Nx, M0 according to AJCC 8th edition
  • ECOG 0-1 and considered fit for the planned chemotherapy at the local hospital and surgery at the two national centers for BR/LAPC

For full eligibility, visit ClinicalTrials.gov.

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