Neoadjuvant Chemotherapy in Borderline Resectable and Locally Advanced Pancreatic Cancer

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    250
  • sponsor
    Oslo University Hospital
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Updated on 19 February 2024
See if I qualify
cancer
adenocarcinoma
pancreatic adenocarcinoma
folfirinox
surgical exploration
pancreatic cancer

Summary

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.

Details
Condition Pancreatectomy, Chemotherapy Effect, Borderline Resectable Pancreatic Adenocarcinoma, Locally Advanced Pancreatic Adenocarcinoma
Age 18years - 100years
Treatment FOLFIRINOX
Clinical Study IdentifierNCT04423731
SponsorOslo University Hospital
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

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
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