180
Participants
Start Date
January 31, 2015
Primary Completion Date
July 15, 2019
Study Completion Date
February 4, 2020
Aflibercept
Administered I.V. at doses of 4 mg/Kg on Day 1 every 14 days. It will be supplied to sites by Sponsor as 4 ml vials at a concentration of 25 mg/ml
5-Fluoruracil
Once every 14 days. Day 1: 400 mg/m2 I.V. bolus and a 46 h infusion of 5-FU 2400 mg/m2
Oxaliplatin
Once every 14 days. Day 1: 85 mg/m2 I.V. infusion in 250-500 mL, over two hours, followed by 5-FU
Leucovorin
Once every 14 days. Day 1: 200 mg/m2 I.V., over two hours, followed by 5-FU
Pivotal S.L.
INDUSTRY
Grupo Espanol Multidisciplinario del Cancer Digestivo
OTHER