Study of 5-Fluorouracil/Leucovorin/Oxaliplatin (FOLFOX) + Bevacizumab Versus 5-Fluorouracil/Leucovorin/Oxaliplatin/Irinotecan (FOLFOXIRI) + Bevacizumab as First Line Treatment of Patients With Metastatic Colorectal Cancer Not Previously Treated and With Three or More Circulating Tumoral Cells

PHASE3CompletedINTERVENTIONAL
Enrollment

350

Participants

Timeline

Start Date

July 31, 2012

Primary Completion Date

November 30, 2018

Study Completion Date

November 30, 2018

Conditions
Metastatic Colorectal Cancer
Interventions
DRUG

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)."

DRUG

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)."

Trial Locations (1)

28046

Spanish Cooperative Group for Digestive Tumour Therapy, Madrid

All Listed Sponsors
collaborator

Roche Pharma AG

INDUSTRY

lead

Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)

OTHER

NCT01640405 - Study of 5-Fluorouracil/Leucovorin/Oxaliplatin (FOLFOX) + Bevacizumab Versus 5-Fluorouracil/Leucovorin/Oxaliplatin/Irinotecan (FOLFOXIRI) + Bevacizumab as First Line Treatment of Patients With Metastatic Colorectal Cancer Not Previously Treated and With Three or More Circulating Tumoral Cells | Biotech Hunter | Biotech Hunter