Validatie van predictieve biomarkers voor FOLFIRINOX respons in patiënten met pancreascarcinoom
- Conditions
- Pancreatic cancer
- Registration Number
- NL-OMON21925
- Lead Sponsor
- Erasmus University Medical Center, department of Surgery
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 240
• Age = 18 years.
• Diagnosed with (borderline) resectable, locally advanced or metastatic PDAC.
• Treatment with FOLFIRINOX chemotherapy, including neoadjuvant therapy in the investigational group ór treatment with gemcitabine (with nab-paclitaxel) in the control group.
• Written informed consent (either for PANCAKE in case of locally advanced PDAC and metastasized PDAC or for the PREOPANC-3 trial in case of (borderline) resectable PDAC).
• Combined treatment with other chemotherapeutics then FOLFIRINOX.
• Previous treatment with FOLFIRINOX chemotherapy.
• Pregnancy.
• Serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Differences in circulating tumor DNA, microRNAs, SNPs, and cytokines between patients with disease control and patients with progressive disease during FOLFIRINOX treatment and sensitivity and specificity of these biomarkers.
- Secondary Outcome Measures
Name Time Method