Locally advanced pancreatic cancer, pancreatic cancer, pancreascarcinoom, lokaal irresectabel pancreascarcinoom
Conditions
Interventions
chemotherapy treatment with nab-paclitaxel plus gemcitabine
Sponsors
Academic Medical Center Amsterdam
Eligibility
Inclusion criteria
Inclusion criteria: • Written informed consent according to ICH/GCP, and national/local regulations prior to any screening procedures. • Histological or cytological confirmed diagnosis of pancreatic ductal adenocarcinoma. • Locally advanced pancreatic cancer according to DPCG criteria (SMA, celiac axis or CHA contact >90° or SMV-PV contact 50 ml / min / 1.73 m2 • AST and ALT < 2.5 ULN
Exclusion criteria
Exclusion criteria: • ECOG (WHO) performance status ≥ 3 • Distant metastases on abdominal or thoracic CT scan. • Previous surgical, local ablative, chemotherapy or radiotherapy for pancreatic cancer except for a surgical exploration with no options for resection. • Pregnancy • Patients who in the investigators’ opinion may be unwilling, unable or unlikely to comply with requirements of the study protocol • Patients who are not willing to avoid consumption of seville oranges, grapefruit or grapefruit juice grapefruit hybrids, pommelos and exotic citrus fruits during the entire study and preferably 7 days before the first dose of study medications, due to potential CYP3A4 interaction with the study medications. • Patient is currently being treated with drugs known to be strong inhibitors or inducers of CYP3A4 or CYP2C8, which cannot be discontinued or switched to a different medication 7 days prior to starting study treatment and for the duration of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| disease controle rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity, progression-free survival, overall survival, tumor marker response, resection rate and quality of life. | — |
Contacts
Public ContactLilly Brada
UMCU/AMC
Outcome results
None listed