About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Chemotherapy
- Radiology
- Pancreatectomy
- Endoscopy
Treatment groups
Sponsors and collaborators
Oslo University Hospital
Lead sponsor
University Hospital of North Norway
Collaborator
Haukeland University Hospital
Collaborator
Helse Stavanger HF
Collaborator
St. Olavs Hospital
Collaborator