A nationwide open-label multi-center prospective cohort study of nab-paclitaxel plus gemcitabine in patients with locally advanced pancreatic cancer
- Conditions
- 'pancreatic adenocarcinoma' 'pancreatic cancer'10017991
- Registration Number
- NL-OMON46852
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Trial ended prematurely
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
• 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 <270° or occlusion)
• ECOG (WHO) performance status 0-2
• Age >= 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 <= 1.5 x ULN (upper limit of normal); or total bilirubin < 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert*s syndrome.
• Creatinine clearance > 50 ml / min / 1.73 m2
• AST and ALT < 2.5 ULN
• 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Disease control (non-progressive disease according to RECIST 1.1 criteria)<br /><br>after 2 cycles, confirmed after 4 cycles.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Toxicity, progression-free survival, overall survival, tumor marker response,<br /><br>resection rate and quality of life. </p><br>