Mirabella Eclano

Researchers are evaluating the effects of continuing cetuximab treatment beyond first-line progression in adults with metastatic colorectal cancer whose tumors have specific genetic characteristics, including RAS and BRAF wild-type status. This Phase 3 trial aims to compare chemotherapy combined with cetuximab against chemotherapy combined with bevacizumab to see if cetuximab continuation improves tumor response, progression-free survival, overall survival, and safety. The study builds on earlier trials suggesting potential benefits of cetuximab continuation in this patient group. Participants will receive a standard chemotherapy regimen, either FOLFOX or FOLFIRI, combined with either cetuximab or bevacizumab every two weeks. Cetuximab is administered as an intravenous infusion of 500 mg/m² every 14 days, while bevacizumab is given at 5 mg/kg every 14 days. Treatment continues until disease progression, unacceptable side effects, or withdrawal of consent. Tumor response will be regularly assessed using imaging scans according to RECIST criteria. Throughout the study, patients will undergo regular CT or MRI scans, laboratory tests, and clinical evaluations to monitor disease status and safety. Biological samples such as tumor tissue, blood, and stool will be collected for research on treatment resistance and the gut microbiome. The primary outcome is the overall response rate measured from randomization until progression, death, or study completion, with assessments continuing up to 48 months. Approximately 360 patients will participate across sites in Italy and Spain.