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JCOG2004: Randomized Phase II Study of Bevacizumab plus FOLFIRI versus Ramucirumab plus FOLFIRI versus Aflibercept plus FOLFIRI for Metastatic Colorectal Cancer after failure of First-line chemotherapy with Fluoropyrimidine and Oxaliplatin to Explore Predictive Biomarker

ABSTRACT: Interventions: Arm A: Bevacizumab+FOLFIRI (1) BEV 5 mg/kg iv (over 10 minutes) day 1 (2) l-LV 200 mg/m2 iv (2hr) day 1 (3) IRI 150 mg/m2 iv (90min) day 1 (4) 5-FU 400 mg/m2 bolus day 1 (5) 5-FU 2,400 mg/m2/46h continuous iv day 1-3 Arm B: Ramucirumab+FOLFIRI (1) RAM 8 mg/kg iv (1hr) day 1 (2) l-LV 200 mg/m2 iv (2hr) day 1 (3) IRI 150 mg/m2 iv (90min) day 1 (4) 5-FU 400 mg/m2 bolus day 1 (5) 5-FU 2,400 mg/m2/46h continuous iv day 1-3 Arm C: Aflibercept+FOLFIRI (1) AFL 4 mg/kg iv (1hr) day 1 (2) l-LV 200 mg/m2 iv (2hr) day 1 (3) IRI 150 mg/m2 iv (90min) day 1 (4) 5-FU 400 mg/m2 bolus day 1 (5) 5-FU 2,400 mg/m2/46h continuous iv day 1-3 Primary outcome(s): Progression-free survival Study Design: randomized controlled trial, open(masking not used), active control, parallel assignment, treatment purpose

DISEASE(S): Metastatic Colorectal Cancer

PROVIDER: 2739106 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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