A Randomized Phase III Trial Comparing Folfirinox to Gemcitabine in Locally Advanced Pancreatic Carcinoma

Inclusion Criteria

• •1. Histologically or cytologically confirmed adenocarcinoma of the pancreas
• •2. Proven unresectability after multidisciplinary discussion involving radiologist and a surgeon
• •3. Locally advanced (i.e.: no metastasis or suspicion of metastasis) and unresectable tumors: for example mesenteric or portal vein involvement, or \> 180° encasement of the superior mesenteric artery, or celiac abutment (NCCN 2012 criteria)
• •4. Measurable tumor lesions with longest diameter ≥ 20 mm using conventional techniques or ≥ 10 mm with spiral CT scan according RECIST 1.1
• •5. WHO Performance status (PS) 0-1
• •6. Age ≥18 years
• •7. Patient with organ function as follows:
• •* Absolute neutrophil count (ANC) ≥ 1.5 x 10⁹/L
• •* Hemoglobin ≥ 10 g/dL
• •* Platelets (PTL) ≥ 75 x 10⁹/L
• •* Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN)
• •* Bilirubin ≤ 1.5 x ULN
• •* Creatinine ≤ 2 x ULN
• •* Albumin \> 0.75 x lower limit of normal (LLN)
• •* Urea ≤ 2 x ULN
• •8. Adequate vital functions
• •9. Patient of child-bearing potential (for female patient: study entry after a menstrual period and a negative pregnancy test) must agree to use medically acceptable methods of contraception during the study and for 4 months after the last intake of study treatment for women and for 6 months after for men.
• •10. Patient information and signed informed consent form
• •11. Public or private health insurance coverage
• •12. Uracilemia \< 16 ng/ml