Modulation of the FOLFIRI-based standard 1st-line therapy with cetuximab, controlled by monitoring the RAS mutation load by liquid biopsy in RAS-mutated mCRC patients

Interventions: Group 1: FOLFIRI or mFOLFIRI (q14d) + cetuximab (q7d):
o Irinotecan 180 mg/m² iv, 30 - 90 min, day 1
o Folinic acid (racemic) 400 mg/m² iv, 120 min, day 1
o [5-FU 400 mg/m² bolus, day 1]
o 5-FU 2400 mg/m² iv over 46 h, day 1-2
o Cetuximab initially 400 mg/m² as a 120 min infusion (= 5 mg/min); subsequently 250 mg/m² iv as a 60 min infusion (= 10 mg/min), day 1 + 8
One cycle consists of 14 days
Group 2: FOLFIRI (q14d):
o Irinotecan 180 mg/m² iv, 30 - 90 min, day 1
o Folinic acid (racemic) 400 mg/m² iv, 120 min, day 1
o Fluorouracil (5-FU) 400 mg/m² bolus, day 1
o 5-FU 2400 mg/m² iv over 46 h, day 1-2
OR
modified FOLFIRI (mFOLFIRI) (q14d):
o Irinotecan 180 mg/m² iv, 30 - 90 min, day 1
o Folinic acid (racemic) 400 mg/m² iv, 120 min, day 1
o 5-FU 2400 mg/m² iv over 46 h, day 1-2
Primary outcome(s): The primary objective is to evaluate efficacy in terms of progression free survival (PFS) from the date of randomization in the study according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria in experimental and control arms.
Study Design: Allocation: Randomized controlled study; Masking: Open (masking not used); Control: active; Assignment: parallel; Study design purpose: treatment