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Standard or Prolonged Neoadjuvant Chemotherapy Before Surgery for BR/LAPC

Study acronym: ADVANTAGE
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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 mFOLFIRINOX or 6 cycles GnP before attempt for surgical resection, provided there is no evidence of disease progression. The primary objective is to compare the overall survival at 24 months after randomization of all treated patients and among the resected patients with BR/LAPC.
Trial Details
NCT Number NCT06714604
Lead Sponsor Sahlgrenska University Hospital
Collaborators: Karolinska University Hospital
Conditions
(from sponsor)		 Locally Advanced Pancreatic Adenocarcinoma, Borderline Resectable Pancreatic Carcinoma, Pancreas Cancer, Neoadjuvant Chemotherapy, Surgery, Pancreatectomy
Related terms Pancreatic Neoplasms
Enrollment 432 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov