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

Brief summary public domain (ClinicalTrials.gov)

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%).

Intervention public domain (ClinicalTrials.gov)

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

Intervention public domain (ClinicalTrials.gov)

Diagnostic_Test: Radiology. 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.

Intervention public domain (ClinicalTrials.gov)

Procedure: Pancreatectomy. 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.

Intervention public domain (ClinicalTrials.gov)

Procedure: Endoscopy. 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)).

Primary outcome public domain (ClinicalTrials.gov)

Resection rate (of the pancreatic tumour). Resection rate: National target of 50% in BRPC and 15% in LAPC in patients initiating primary chemotherapy. Time frame: From November 2024-December 2027.

Secondary outcome public domain (ClinicalTrials.gov)

Overall survival. Time frame: From November 2024-December 2027.

Secondary outcome public domain (ClinicalTrials.gov)

Mortality after surgical resection. Time frame: From November 2024-December 2027.

Secondary outcome public domain (ClinicalTrials.gov)

Morbidity after surgical resection. Time frame: From November 2024-December 2027.

Secondary outcome public domain (ClinicalTrials.gov)

Number of patients evaluated at national MDT undergoing resection. Time frame: From November 2024-December 2027.

Secondary outcome public domain (ClinicalTrials.gov)

Adverse events. Time frame: From November 2023-December 2027.

Secondary outcome public domain (ClinicalTrials.gov)

R0 resection rate. Time frame: From November 2023-December 2027.

Eligibility public domain (ClinicalTrials.gov)

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

Enrollment public domain (ClinicalTrials.gov)

Enrollment: 400 participants (estimated).