34
Participants
Start Date
September 5, 2019
Primary Completion Date
May 19, 2023
Study Completion Date
September 30, 2025
Folfiri/Cetuximab
"Cetuximab 400 mg/mq intravenously (iv) with load dose of 400 mg/mq at the first cycle followed by 250 mg/mq iv weekly by iv infusion in 90 minutes. The administration of irinotecan will precede that of cetuximab and will consist on a dose of 180 mg/mq iv in 60 minutes every two weeks and it will be followed by fluorouracil (5-FU) at a dose of 400 mg/mq in slow iv bolus at half of lederfolin 200 mg/mq 2-hours infusion. At the end of the infusion of lederfolin an elastomeric pump loaded with 5-FU 2400 mg/mq in continuous 46 hours iv infusion will be applied. Only at the first administration of CT (load dose of cetuximab), irinotecan will not be administered."
RECRUITING
Istituto Nazionale dei Tumori,, Napoli
National Cancer Institute, Naples
OTHER