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RECRUITING
NCT06714604
PHASE3

Standard or Prolonged Neoadjuvant Chemotherapy Before Surgery for BR/LAPC

Sponsor: Sahlgrenska University Hospital

View on ClinicalTrials.gov

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

Interventions

DRUG

FOLFIRINOX or gemcitabine-nab-paclitaxel

4 months if treatment

DRUG

FOLFIRINOX or gemcitabine-nab-paclitaxel

6 months of treatment

Locations (1)

SahlgrenskaUH

Gothenburg, VGR, Sweden