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

University of Oslo (UIO)

Status: Enrolling

Conditions: Chemotherapy Effect; Locally Advanced Pancreatic Cancer; Borderline Resectable Pancreatic Cancer; Pancreatectomy

Treatments: Diagnostic Test: Radiology; Procedure: Pancreatectomy; Procedure: Endoscopy; Drug: Chemotherapy

Study type: Observational

Funder types: Other

Identifiers

NCT06944587

2023010 (Other Grant/Funding Number)

279530-2023 (Other Grant/Funding Number)

REK sør-øst D 733339

Details and patient eligibility

About

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%).

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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