RecruitingNCT06944587

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

A New Clinical Pathway for Personalized Management of Borderline Resectable and Locally Advanced Pancreatic Cancer - Norwegian Pancreatic Cancer Trial-3 (NORPACT 3)

Sponsor

Oslo University Hospital

Enrollment

400 participants

Start Date

Dec 3, 2024

Study Type

OBSERVATIONAL

Conditions

Chemotherapy Effect Locally Advanced Pancreatic Cancer Pancreatectomy Borderline Resectable Pancreatic Cancer

Summary

NORPACT-3 is a nationwide, Norwegian single arm prospective study that evaluates the resectability rates and survival in patients with borderline resectable and locally advanced pancreatic cancer who received primary chemotherapy. Eligible patients are treated with primary chemotherapy possibly followed by surgical exploration and resection. All Norwegian centres performing pancreatic surgery have agreed to collaborate in this trial. The assignment of the medical intervention is not at the discretion of the investigator, but follow the national Norwegian guidelines regarding diagnostic work up, oncological and surgical treatment and follow up. The primary aim is a national resection rate of 50% in BRPC and 15% in LAPC in patients initiating primary chemotherapy, with adequate overall survival and morbidity/mortality (after resection median overall survival of 24 months, 1 year survival 80%, and 5 year survival \>20% + 90 day postoperative mortality ≤5%, 90-day postoperative major morbidity (Clavien Dindo grade 3) ≤40%).

Eligibility

Min Age: 18 Years

Inclusion Criteria6

Borderline resectable or locally advanced adenocarcinoma of the pancreas (NCCN, version 2, 2021) (Appendix 3)
Nx, M0 (UICC 8th version, 2016)
Cytological or histological confirmation of adenocarcinoma
Age \>18 year
Considered able to receive primary chemotherapy and possible surgery
Written informed consent

Exclusion Criteria5

Co-morbidity or performance status precluding primary chemotherapy
Co-morbidity or performance status precluding pancreatectomy
Female patients in child-bearing age not using adequate contraception, pregnant or lactating women
Mental or physical disorders that could interfere with treatment of with the provision of informed consent
Any reason why, in the opinion of the investigator, the patient should not participate

Interventions

DRUGChemotherapy

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

DIAGNOSTIC_TESTRadiology

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.

PROCEDUREPancreatectomy

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.

PROCEDUREEndoscopy

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)).