Nordic Pancreatic Cancer Trial (NorPACT) - 1

• Status: Active, not recruiting
• Trial end date: 2026-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluate the additional effect of adding chemotherapy prior to resection of a pancreatic head malignancy. The patients will be randomized into two groups; surgery first (control group) and neoadjuvant chemotherapy (intervention). Primary endpoint is overall survival after resection

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oslo University Hospital
• Collaborators: Haukeland University Hospital; Helse Stavanger HF; St. Olavs Hospital; University Hospital of North Norway
• Treatments: Capecitabine; Fluorouracil; Gemcitabine; Irinotecan; Oxaliplatin

Criteria

Inclusion Criteria:

• Resectable adenocarcinoma of the pancreatic head

• T1-3, Nx, M0 (UICC 7th version, 2010)

• Cytologic or histologic confirmation of adenocarcinoma

• Age > 18 year and considered fit for major surgery

• Written informed consent

• Considered able to receive the study specific chemotherapy

Exclusion Criteria:

• Co-morbidity precluding pancreaticoduodenectomy

• Chronic neuropathy ≥ grade 2

• WHO performance score > 2 • Granulocyte count < 1500 per cubic millimetre

• Platelet count < 100 000 per cubic millimeter

• Serum creatinine > 1.5 UNL (upper limit normal range)

• Albumin < 2,5 g/dl

• Female patients in child bearing age not using adequate contraception, pregnant or lactating women • Mental or organic disorders which could interfere with informed consent or treatments

• Other malignancy within the past 5 years, except non-melanomatous skin or non-invasive cervical cancer

• Percutaneous tumor biopsy

• Any reason why, in the opinion of the investigator, the patient should not participate

• Pregnancy

• Breastfeeding