Neo-adjuvant FOLF(IRIN)OX for Resectable Pancreatic Adenocarcinoma

Inclusion criteria

• Histology-proven, adenocarcinoma of the pancreas.
• Resectable adenocarcinoma (according to the NCCN classification 2014): absence of distant organ or distal lymph node metastases, absence of evidence of superior mesenteric vein (SMV) and portal vein distortion, tumour thrombus, or venous encasement, the existence of clear fat planes around the celiac axis, hepatic artery and superior mesenteric artery (SMA). Resectability is evaluated on arterial-phase and portal-phase IV contrast-enhanced multislice CT-scan of the pancreas (slice thickness: 2.5 mm), as evaluated in a multidisciplinary staff meeting including at least one radiologist and one expert surgeon.
• No prior chemotherapy.
• Age 18 years or over.
• Ability to understand and willingness to consent to formal requirements for study participation
• Provision of written informed consent prior to any study-specific screening procedures.

Exclusion criteria

• PDAC defined as "borderline", locally advanced, non-resectable or metastatic.
• Prior cancer therapy for PDAC
• Surgical or anaesthesiological contra-indications: non-controlled congestive heart failure - non-treated angina - recent myocardial infarction (in the previous year) - non-controlled arterial hypertension (SBP >160 mm or DBP > 100 mm, despite optimal drug treatment), long QT, major non-controlled infection, severe liver failure.
• Any medical, psychological or social situation that (in the investigator's opinion) could limit (i) the patient's compliance with the protocol or (ii) the ability to obtain or interpret data.
• Pregnant or breastfeeding women and women of child-bearing age not using effective means of contraception.
• History or current evidence on physical examination of central nervous system disease or peripheral neuropathy ≥ grade 1, according to according to Common Terminology Criteria for Adverse Events (CTCAE) v.4.0.
• Known hypersensitivity reaction to any of the components of study treatments.
• Pregnancy (the absence of which must be confirmed in a ß-hCG test) or breast-feeding.
• Any significant disease which, in the investigator's opinion, would exclude the patient from the study.
• Patients having been included in a clinical trial within the previous 4 weeks or participating in another trial.