Status:
ACTIVE_NOT_RECRUITING
Neoadjuvant Chemotherapy in Borderline Resectable and Locally Advanced Pancreatic Cancer (NORPACT-2)
Lead Sponsor:
Oslo University Hospital
Conditions:
Locally Advanced Pancreatic Adenocarcinoma
Chemotherapy Effect
Eligibility:
All Genders
18+ years
Brief 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 chemoth...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
251 Patients enrolled
Trial Details
Trial ID
NCT04423731
Start Date
January 1 2018
End Date
December 31 2025
Last Update
November 20 2024
Active Locations (1)
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1
Oslo University Hospital
Oslo, Norway, 0268