The (cost)effectiveness of neoadjuvant FOLFIRINOX versus neoadjuvant gemcitabine based chemoradiotherapy and adjuvant gemcitabine for (borderline) resectable pancreatic cancer.
- Conditions
- (borderline) resectable pancreatic cancerpancreatic cancer1001567410017991
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 368
• Histologically or cytologically confirmed pancreatic cancer (i.e. pancreatic
ductal adenocarcinoma)
• (Borderline) resectable tumor without metastatic disease
• WHO performance status 0 or 1
• Ability to undergo surgery, chemoradiotherapy and chemotherapy
• Leucocytes (WBC) >= 3.0 X 109/l (should be assesed within 4 weeks prior to
randomization)
• Platelets >= 100X 109 /l (should be assesed within 4 weeks prior to
randomization)
• Hemoglobin >= 6 mmol/l (should be assesed within 4 weeks prior to
randomization)
• Renal function: E-GFR >= 50 ml/min (should be assesed within 4 weeks prior to
randomization)
• Age >= 18 years
• Written informed consent
• Prior radiotherapy, chemotherapy, or resection for pancreatic cancer.
• Prior radiotherapy or chemotherapy precluding chemoradiotherapy or FOLFIRINOX.
• Previous malignancy (excluding non-melanoma skin cancer, pancreatic
neuroendocrine tumor (pNET) <2cm, and gastrointestinal stromal tumor (GIST)
<2cm), unless no evidence of disease and diagnosed more than 3 years before
diagnosis of pancreatic cancer, or with a life expectancy of more than 5 years
from date of inclusion.
• 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
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method