FOLFOXIRI Plus Cetuximab vs. FOLFOXIRI Plus Bevacizumab 1st-line in BRAF-mutated mCRC

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

109

Participants

Timeline

Start Date

November 25, 2016

Primary Completion Date

November 1, 2023

Study Completion Date

December 31, 2023

Conditions
Metastatic Colorectal Cancer
Interventions
DRUG

Bevacizumab

Bevacizumab 5 mg/kg BW iv over 30 to 90\* min day 1

DRUG

Irinotecan

Irinotecan 150 mg/m² iv, 30 - 90 min. day 1

DRUG

Folinic acid

Folinic acid (racemic) 400 mg/m² iv, 120 min. day 1

DRUG

Oxaliplatin

Oxaliplatin 85mg/m² day 1

DRUG

5-FU

5-FU 3000 mg/m² iv over 48 h days 1-2

DRUG

Cetuximab

Cetuximab initially 400 mg/m² with infusion rate of ≤5 mg/min., subsequently 250 mg/m² iv with infusion rate of ≤10 mg/min. days 1+8

Trial Locations (1)

81377 München

Klinikum der Universitaet Muenchen, Munich

All Listed Sponsors
lead

Ludwig-Maximilians - University of Munich

OTHER

NCT04034459 - FOLFOXIRI Plus Cetuximab vs. FOLFOXIRI Plus Bevacizumab 1st-line in BRAF-mutated mCRC | Biotech Hunter | Biotech Hunter