FOLFOXIRI as Primary Treatment for Locally Advanced Pancreatic Cancer

Phase II Study of FOLFOXIRI as Primary Treatment for Stage III Unresectable Locally Advanced Pancreatic Cancer

The study is conducted as a monocentric prospective phase II trial. Patients with unresectable stage III locally advanced pancreatic cancer (defined for extended encasement of superior mesenteric artery/celiac axis/hepatic artery or for combined venous and arterial involvement or for unreconstructible venous encasement), ECOG PS 0-1 and age 18-75 are eligible.

After multidisciplinary evaluation of resectability, treatment with FOLFOXIRI is provided for a maximum of 12 cycles with multidisciplinary evaluation of disease status every 4 cycle.

In case of tumors have deemed resectable surgery is considered. In case tumors remain unresectable, radiotherapy is evaluated after the end of chemotherapy.

Primary objective of the study is the rate of patients who become resectable and undergo radical surgical resection after chemotherapy.

Secondary objectives are: response rate, progression-free survival, overall survival, toxicity.

Inclusion Criteria:

• Stage III unresectable pancreatic cancer defined for:

  • extended encasement of superior mesenteric artery or celiac axis/hepatic artery
  • both arterial and venous (portal vein/superior mesenteric vein) encasement
  • unreconstructible vessel encasement

• ECOG Performance Status 0-1

• Age 18-75

• Adequate liver, renal and bone marrow function

Exclusion Criteria:

• Evidence of distant metastases
• Cardiovascular diseases
• Contraindications to studied drugs