drugset / Trial / NCT02351219

FOLFOXIRI as Primary Treatment for Locally Advanced Pancreatic Cancer

NCT02351219 ↗

Phase 2 Completed 50 enrolled Azienda Ospedaliero, Universitaria Pisana
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2012-12
Primary completion
2014-12
Completion
2014-12

Drugs

EvaluationDrugModalityDoseRoute
Subject FOLFOXIRI Unknown — —