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

No treatment groups listed

Locations

5
Haukeland University Hospital5021, BergenNorway, Norway
Stavanger University Hospital4068, StavangerNorway, Norway
University Hospital of North Norway9038, TromsøNorway, Norway
St. Olavs Hospital, Trondheim University Hospital7006, TrondheimNorway, Norway

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