121
Participants
Start Date
November 1, 2017
Primary Completion Date
July 31, 2024
Study Completion Date
December 31, 2024
Capecitabine
"750 mg/sqm/bid, day 2 to 15; if toxicities grade ≥2 do not occur, pts may subsequently receive capecitabine 1000 mg/sqm/bid, day 2 to 15 starting the second cycle based on investigator's choice.~To be repeated every 3 weeks (21 days), for a maximum of 8 cycles.~If no progression occurs, pts will receive maintenance capecitabine (starting at the same dose used at the last cycle of the induction treatment) plus bevacizumab every 3 weeks (21 days), until disease progression, unacceptable toxicity or patient's refusal."
Oxaliplatin
100 mg/sqm iv over 2 hours, day 1 To be repeated every 3 weeks (21 days), for a maximum of 8 cycles.
Bevacizumab
"7.5 mg/kg iv over 90 minutes, day 1; if the first infusion is tolerated, then subsequent infusions may be administered in 30 minutes.~If no progression occurs, pts will receive maintenance capecitabine (starting at the same dose used at the last cycle of the induction treatment) plus bevacizumab every 3 weeks (21 days), until disease progression, unacceptable toxicity or patient's refusal. To be repeated every 3 weeks (21 days), for a maximum of 8 cycles."
Istituto Oncologico Veneto IRCCS, Padua
Istituto Oncologico Veneto IRCCS
OTHER