232
Participants
Start Date
March 31, 2012
Primary Completion Date
March 31, 2017
Study Completion Date
September 30, 2017
Maintenance:BEVACIZUMAB
"Patients will be randomly assigned to receive induction chemotherapy with the G.O.N.O. FOLFOXIRI regimen plus bevacizumab:~* BEVACIZUMAB 5 mg/kg over 30 minutes, day 1~* IRINOTECAN 165 mg/sqm IV over 1-h, day 1~* OXALIPLATIN 85 mg/sqm IV over 2-h, day 1~* L-LEUCOVORIN 200 mg/sqm IV over 2-h, day 1~* 5-FLUOROURACIL 3200 mg/sqm IV 48-h continuous infusion, starting on day 1~with cycles repeated every 2 weeks for 4 months (8 cycles), followed after 2 weeks by (if no progression occurs):~\- BEVACIZUMAB 7.5 mg/kg over 30 minutes, day 1 (every three weeks)"
Maintenance:BEVACIZUMAB+CAPECITABINE+CYCLOPHOSPHAMIDE
"Patients will be randomly assigned to receive induction chemotherapy with the G.O.N.O. FOLFOXIRI regimen plus bevacizumab:~* BEVACIZUMAB 5 mg/kg over 30 minutes, day 1~* IRINOTECAN 165 mg/sqm IV over 1-h, day 1~* OXALIPLATIN 85 mg/sqm IV over 2-h, day 1~* L-LEUCOVORIN 200 mg/sqm IV over 2-h, day 1~* 5-FLUOROURACIL 3200 mg/sqm IV 48-h continuous infusion, starting on day 1~with cycles repeated every 2 weeks for 4 months (8 cycles), followed after 2 weeks by (if no progression occurs):~* BEVACIZUMAB 7.5 mg/kg over 30 minutes, day 1 (every three weeks),~* CAPECITABINE 500 mg/tid orally, continuously,~* CYCLOPHOSPHAMIDE 50 mg/day orally, continuously."
Azienda Ospedaliera S. Croce E Carle Di Cuneo, Cuneo
E.O. Ospedali Galliera, Genova
Irccs Fondazione Centro S. Raffaele Del Monte Tabor, Milan
Istituto Ospedaliero Fondazione Poliambulanza Di Brescia, Brescia
Pres.Ospedaliero Spedali Civili Brescia, Brescia
Istituti Ospitalieri Di Cremona, Cremona
A.O. Universitaria S. Maria Della Misericordia, Udine
Irccs Istituto Oncologico Veneto (Iov), Padua
Ospedale Per Acuti Mater Salutis Di Legnago, Legnago
Ospedale S. Maria Nuova, Reggio Emilia
A.O. Universitaria Arcispedale S.Anna Di Ferrara, Ferrara
Polo Oncologico Area Vasta Nord Ovest, Pisa
Ausl 5 Di Pisa, Pontedera
Ospedale Mesericordia E Dolce, Prato
A.O. Universitaria Federico Ii Di Napoli, Napoli
Ausl Di Frosinone -, Frosinone
Oncologia AUSL 2 Lucca, Lucca
Campus Biomedico, Roma
Ospedale San Giovanni Calibita Fatebenefratelli, Roma
Ospedale San Pietro Fatebenefratelli Di Roma, Roma
Azienda Ospedaliero, Universitaria Pisana
OTHER