Pancreatic cancer
Conditions
Interventions
- FOLFIRINOX
a combination of oxaliplatin, leucovorin, irinotecan and
fluorouracil every 2 weeks
or
- Gemcitabine + nab paclitaxel weekly for 3 weeks, every 4 weeks
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Signed, written Institutional Review Board/Ethics Committee-approved Informed Consent Form (ICF). 2. Patients with histologically/cytological confirmed diagnosis of metastatic pancreatic ductal adenocarcinoma. 3. Measurable disease on computed tomography (CT) scan per RECIST version 1.1 criteria. 4. Eastern Cooperative Oncology Group Performance Status of 0-1. 5. Life expectancy >= 3 months. 6. Age >= 18 years. 7. No symptoms related to advanced disease.
Exclusion criteria
Exclusion criteria: 1. Known central nervous system involvement or brain metastases. 2. New York Heart Association Class III or IV cardiac disease or myocardial infarction within the past 12 months. 3. Any other disease, active, uncontrolled bacterial, viral or fungal infection requiring systemic therapy, metabolic dysfunction, physical examination finding or clinical laboratory finding that leads to reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, that may affect the interpretation of the results, or that may render the subject at high risk for treatment complications. 4. Inability to comply with study and follow-up procedures as judged by the Investigator. 5. Women currently pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality Adjusted Survival. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to disease progression after randomization. Adverse events according to NCI CTC version 5.0. | — |
Countries
Netherlands
Outcome results
None listed