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Standard or Prolonged Neoadjuvant Chemotherapy Before Surgery for BR/LAPC
Sponsor: Sahlgrenska University Hospital
Summary
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.
Official title: Standard Versus Prolonged Neoadjuvant (Conversion) Chemotherapy to Prolong Survival of Patients With Borderline and Locally Advanced Pancreatic Cancer: a Phase III Randomized Controlled
Key Details
Gender
All
Age Range
18 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
432
Start Date
2023-10-18
Completion Date
2033-12-31
Last Updated
2024-12-03
Healthy Volunteers
No
Conditions
Interventions
FOLFIRINOX or gemcitabine-nab-paclitaxel
4 months if treatment
FOLFIRINOX or gemcitabine-nab-paclitaxel
6 months of treatment
Locations (1)
SahlgrenskaUH
Gothenburg, VGR, Sweden