'pancreatic adenocarcinoma' 'pancreatic cancer'
Conditions
Interventions
nab-paclitaxel plus gemcitabine chemotherapy
Locally advanced
Nab-paclitaxel
Pancreatic cancer
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 64 Years
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 = 18 years • Adequate bone marrow and organ function as defined by the following laboratory values: • Absolute neutrophil count (ANC) >= 1.5 *109 / L • Hemoglobin (Hb) >= 9.0 g/dL (5.6 mmol/L) • Platelets >= 100 *109/L • Serum total bilirubin within 50 ml / min / 1.73 m2 • AST and ALT
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease control (non-progressive disease according to RECIST 1.1 criteria) after 2 cycles, confirmed after 4 cycles. | — |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity, progression-free survival, overall survival, tumor marker response, resection rate and quality of life. | — |
Countries
The Netherlands
Outcome results
None listed