Conditions: Neoplasm Metastasis Colorectal Cancer
Keywords: FOLFOX-4 Cetuximab First-line mCRC EGFR positive metastatic CRC
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 344
Healthy volunteers: no

Brief summary:
This is an open label, randomized, controlled, multicenter phase II study comparing 5-FU/FA + oxaliplatin (FOLFOX-4) + cetuximab versus 5-FU/FA + oxaliplatin as first-line treatment for epidermal growth factor receptor (EGFR)-expressing mCRC.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Cetuximab intervention 2: Oxaliplatin
Intervention descriptions: intervention 1: Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin folinic acid (FA) will be administered (at a dose of 200 mg/m\^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-Fluorouracil (5-FU) (as a bolus of 400 mg/m\^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m\^2/day infused over 22-hour, on day 1 and day 2, every two weeks).

Until progression or unacceptable toxicity develops intervention 2: Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m\^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m\^2/day IV over 2-4 minutes followed by 600 mg/m\^2/day infused over 22-hour, on day 1 and day 2, every two weeks).

Until progression or unacceptable toxicity develops

Protocol document: