A New Clinical Pathway for Personalized Management of Borderline Resectable and Locally Advanced Pancreatic Cancer

RecruitingOBSERVATIONAL
Enrollment

400

Participants

Timeline

Start Date

December 3, 2024

Primary Completion Date

December 31, 2028

Study Completion Date

December 31, 2028

Conditions
Locally Advanced Pancreatic CancerBorderline Resectable Pancreatic CancerPancreatectomyChemotherapy Effect
Interventions
DRUG

Chemotherapy

The choice of chemotherapy regimen follows national guidelines, preferably mFOLFIRINOX or gemcitabine-nab-paclitaxel.

DIAGNOSTIC_TEST

Radiology

PET/CT is optional. PET/CT will be offered as a part of the diagnostic work up at baseline and one additional scan after a minimum of two months of chemotherapy.

PROCEDURE

Pancreatectomy

Surgery is scheduled within 4 weeks after the last neoadjuvant infusion. Resection will be performed as a standard or pylorus-preserving pancreatoduodenectomy (PD), distal pancreatectomy (DP) with splenectomy, or total pancreatectomy (TP) with splenectomy, and with or without venous or arterial resection and reconstruction.

PROCEDURE

Endoscopy

Endoscopic ultrasound fine-needle biopsy to establish the diagnosis with histopathology and to obtain an adequate sample for molecular pathology (KRAS status (mutation or wild type), microsatellite instability (MSI)).

Trial Locations (5)

4068

NOT_YET_RECRUITING

Stavanger University Hospital, Stavanger

5021

NOT_YET_RECRUITING

Haukeland University Hospital, Bergen

7006

NOT_YET_RECRUITING

St. Olavs Hospital, Trondheim University Hospital, Trondheim

9038

NOT_YET_RECRUITING

University Hospital of North Norway, Tromsø

0424

RECRUITING

Oslo University Hospital, Oslo

All Listed Sponsors
collaborator

University Hospital of North Norway

OTHER

collaborator

Haukeland University Hospital

OTHER

collaborator

Helse Stavanger HF

OTHER_GOV

collaborator

St.Olavs Hospital, Trondheim University Hospital, Norway

UNKNOWN

lead

Oslo University Hospital

OTHER