Neoadjuvant Chemotherapy in Borderline Resectable and Locally Advanced Pancreatic Cancer (NORPACT-2)

University of Oslo (UIO)

Status: Active, not recruiting

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

Treatments: Drug: Folfirinox

Study type: Observational

Funder types: Other

Identifiers

NCT04423731

2017/1382/REK nord

Details and patient eligibility

About

This is a Norwegian prospective observational study that evaluates the resectability rate in patients with borderline resectable and locally advanced pancreatic cancer who received neoadjuvant chemotherapy in a population based cohort. Eligible patients are treated with neoadjuvant 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.

Enrollment: 251 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, 2015)
• Nx, M0 (UICC 8 th version, 2016)
• cytological or histological 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 pancreatectomy
• chronic neuropathy ≥ grade 2
• WHO performance score > 2
• granulocyte count < 1500 per cubic millimetre
• platelet count < 100 000 per cubic millimetre
• 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 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