219
Participants
Start Date
July 15, 2021
Primary Completion Date
August 15, 2026
Study Completion Date
August 15, 2026
Cetuximab
"I LINE:~\- FOLFIRI + cetuximab~FOLFIRI: 200 mg L-folinic acid with 180 mg/ m² irinotecan over 1.30 h IV infusion, followed by a 400 mg/ m² IV bolus of fluorouracil followed by 2400 mg/ m² fluorouracil IV infusion over 46 h every 14 days.~Cetuximab: 400 mg/m2 initial dose (120-minute IV infusion on cycle 1 day 1), then 250 mg/m2 once weekly thereafter~II LINE:~\- FOLFOX + cetuximab~FOLFOX: 200 mg L-folinic acid given concurrently with 85 mg/ m² oxaliplatin over 2 h IV infusion, followed by a 400 mg/ m² IV bolus of fluorouracil followed by 2400 mg/ m² fluorouracil IV infusion over 46 h every 14 days.~Cetuximab: as I line~THIRD LINE:~\- Irinotecan + cetuximab~Irinotecan: 180 mg/ m² irinotecan over 1.30 h, IV infusion every 2 weeks. Cetuximab: as I line"
FOLFIRI
"I LINE:~\- FOLFIRI + cetuximab~FOLFIRI: 200 mg L-folinic acid given concurrently with 180 mg/ m² irinotecan over 1.30 h IV infusion, followed by a 400 mg/ m² IV bolus of fluorouracil followed by 2400 mg/ m² fluorouracil IV infusion over 46 h every 14 days.~Cetuximab: 400 mg/m2 initial dose (120-minute IV infusion on cycle 1 day 1), then 250 mg/m2 once weekly thereafter"
FOLFOX regimen
"II LINE:~\- FOLFOX + cetuximab~FOLFOX: 200 mg L-folinic acid given concurrently with 85 mg/ m² oxaliplatin over 2 h IV infusion, followed by a 400 mg/ m² IV bolus of fluorouracil followed by 2400 mg/ m² fluorouracil IV infusion over 46 h every 14 days.~Cetuximab: as I line"
Irinotecan
"III LINE:~\- Irinotecan + cetuximab~Irinotecan: 180 mg/ m² irinotecan over 1.30 h, IV infusion every 2 weeks. Cetuximab: as I line"
A.O.U. Ospedali Riuniti, Ancona
Ente Ecclesiastico Ospedale Generale Regionale 'F. Miulli', Acquaviva delle Fonti
IRCCS Istituto Tumori 'Giovanni Paolo II', Bari
Ospedale IRCCS 'Saverio de Bellis', Castellana Grotte
Ospedale Sacro Cuore di Gesù - FATEBENEFRATELLI, Benevento
P.O. Antonio Perrino, Brindisi
A.O.U. Cagliari - Presidio Policlinico D. Casula, Monserrato
A.R.N.A.S. Garibaldi - P.O. Garibaldi-Nesima, Catania
A.O.U. Mater Domini, Catanzaro
Fondazione IRCCS Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo
P.O. 'Vito Fazzi', Lecce
A.O. 'Pia Fondazione Cardinale G. Panico', Tricase
Istituto Europeo di Oncologia, Milan
A.O.U. Policlinico 'P. Giaccone', Palermo
Istituto Oncologico Veneto IRCCS, Padua
A.O.U. Pisana, Pisa
A.O. San Carlo, Potenza
A.U.S.L. - IRCCS di Reggio Emilia - P.O. Arcispedale S.Maria Nuova, Reggio Emilia
A.S.P. Ragusa - Ospedale Maria Paternò Arezzo, Ragusa
A.O. San Camillo-Forlanini, Roma
Fondazione Policlinico Universitario 'Agostino Gemelli' IRCCS, Roma
Ospedale San Giuseppe Moscati, Statte
A.O. Ordine Mauriziano, Torino
"A.O.U. dell'Università degli studi della Campania Luigi Vanvitelli", Napoli
Istituto Nazionale Tumori 'Fondazione G. Pascale', Napoli
University of Campania Luigi Vanvitelli
OTHER