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Brief Title: FOLFOXIRI Plus Panitumumab In Kras and Braf Wild-Type Metastatic Colorectal Cancer
Official Title: Phase II Trial of FOLFOXIRI Plus Panitumumab as First-Line Treatment for Kras and Braf Wild-Type Metastatic Colorectal Cancer
Study ID: NCT01358812
Brief Summary: The GONO-FOLFOXIRI regimen demonstrated higher activity and efficacy compared to FOLFIRI in a phase III trial. Panitumumab with oxaliplatin- or irinotecan-based doublets is feasible and associated with improved activity in KRAS codon 12-13 wild-type patients. BRAF and other RAS rare mutations have been suggested as additional potential biomarkers for anti-EGFR agents in metastatic colo-rectal cancer. The present study aims to demonstrate the feasibility and the activity of the first-line combination of the GONO-FOLFOXIRI regimen and Panitumumab in molecularly selected metastatic colo-rectal cancer patients.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
P.O. Zona Aretina - Ospedale S. Donato Di Arezzo, Arezzo, , Italy
Istituto Nazionale Per La Ricerca Sul Cancro, Genova, , Italy
IRCCS Ospedale San Raffaele, Milano, , Italy
Asl Olbia - Uo Oncologia Ospedale San Giovanni Di Dio, Olbia, , Italy
Istituto Oncologico Veneto (IOV), Padova, , Italy
Polo Oncologico Area Vasta Nord-Ovest, Pisa, , Italy
Universita' Campus Bio-Medico Di Roma, Roma, , Italy
Asl Di Sassari - Ospedale S.S. Annunziata -U.O. Oncologia Medica, Sassari, , Italy
Ausl 7 Di Siena, Siena, , Italy
A.O. Universitaria S.Maria Della Misericordia Di Udine, Udine, , Italy
Name: Alfredo Falcone, MD
Affiliation: Polo Oncologico Area Vasta Nord-Ovest
Role: PRINCIPAL_INVESTIGATOR