Standard Versus Prolonged Neoadjuvant (Conversion) Chemotherapy to Prolong Survival of Patients With Borderline and Locally Advanced Pancreatic Cancer: a Phase III Randomized Controlled

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• Borderline or locally advanced pancreatic adenocarcinoma at diagnosis according to National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines, version 1.2022

• 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

• Written informed patient consent

Locations
Other Locations
Sweden
SahlgrenskaUH
RECRUITING
Gothenburg
Contact Information
Primary
Elena Rangelova, PhD
elena.rangelova@gu.se
+46 31 34 28 216
Time Frame
Start Date: 2023-10-18
Estimated Completion Date: 2033-12-31
Participants
Target number of participants: 432
Treatments
Active_comparator: Standard
8 cycles of neoadjuvant mFOLFIRINOX or 4 cycles of neoadjuvant gemcitabine-nab-paclitaxel
Experimental: Prolonged
12 cycles of neoadjuvant mFOLFIRINOX or 6 cycles of neoadjuvant gemcitabine-nab-paclitaxel
Related Therapeutic Areas
Sponsors
Collaborators: Karolinska University Hospital
Leads: Sahlgrenska University Hospital

This content was sourced from clinicaltrials.gov

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