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%).
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
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
Nationwide, population based cohort from a universal health care system
Cohort
Prospective
Chemotherapy
DrugThe choice of chemotherapy regimen follows national guidelines, preferably mFOLFIRINOX or gemcitabine-nab-paclitaxel.
Radiology
Diagnostic testPET/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.
Pancreatectomy
Procedure/SurgerySurgery 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.
Endoscopy
Procedure/SurgeryEndoscopic 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)).
Resection rate (of the pancreatic tumour)
Resection rate: National target of 50% in BRPC and 15% in LAPC in patients initiating primary chemotherapy.
Overall survival
After resection, median overall survival of 24 months, 1 year survival 80%, and 5 year survival \>20%.
Mortality after surgical resection
90-day postoperative mortality ≤5%
Morbidity after surgical resection
90-day postoperative major morbidity (Clavien-Dindo ≥ grade3) of ≤40%
Number of patients evaluated at national MDT undergoing resection
PET CT
* Extrapancreatic disease detected at baseline PET-CT * Correlation of PET-CT findings with histopathological tumor regression grading * Correlation of PET-CT findings with CA19-9 dynamics * Prognostic value of metabolic tumor response in resected patients
Molecular profiling (KRAS mutation status, MSI) at time of diagnosis
* Number of patients with KRAS mutations, KRAS wild type, or MSI tumors * Number of patients undergoing additional genetic profiling and/or targeted therapy in accordance with the national guidelines protocols or ongoing trials.
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Oslo University Hospital
Lead sponsor
University Hospital of North Norway
Collaborator
Haukeland University Hospital
Collaborator
Helse Stavanger HF
Collaborator
St. Olavs Hospital
Collaborator
