350
Participants
Start Date
July 31, 2012
Primary Completion Date
November 30, 2018
Study Completion Date
November 30, 2018
modified FOLFOX6 + bevacizumab
"* Bevacizumab 5 mg/kg iv, day 1, followed by~* Oxaliplatin 85 mg/m2 iv administered over a period of 2 hours, day 1, followed by~* 5- Fluorouracil (FU)/Leucovorin (LV), day 1 and 2, as follow:~ * LV 400 mg/m2 iv administered over a period of 2 hours, followed by~ * 5-FU 400 mg/m2 iv bolus, followed by~ * 5-FU 2.400 mg/m2 over 46 h continuous infusion. This treatment will start on day 1 and will be repeated every 2 weeks (1 cycle)."
FOLFOXIRI + Bevacizumab
"* Bevacizumab 5 mg/kg iv, followed by~* Irinotecan 165 mg/m2 iv administered over a period of 30-90 minutes, followed by~* Oxaliplatin 85 mg/m2 iv administered over a period of 2 hours, followed by~* LV 400 mg/m2 iv administered over a period of 2 hours, followed by~* 5-FU 3,200 mg/m2 for 48 h continuous infusion. This treatment will start on day 1 and will be repeated every 2 weeks (1 cycle)."
Spanish Cooperative Group for Digestive Tumour Therapy, Madrid
Roche Pharma AG
INDUSTRY
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
OTHER