Overview

Study in mCRC Patients RAS/BRAF wt Tissue and RAS Mutated LIquid BIopsy to Compare FOLFIRI Plus CetuxiMAb or BevacizumaB

Status:
Recruiting
Trial end date:
2024-04-29
Target enrollment:
Participant gender:
Summary
This study is a prospective, randomized phase III, to evaluate if in patients with mCRC RAS/BRAF wild type on tumor tissue and RAS mutations on liquid biopsy, treating in first line with antibody anti-VEGF (bevacizumab) plus chemotherapy (FOLFIRI) is superior in terms of PFS compared to standard treatment with antibody anti-EGFR (cetuximab) plus FOLFIRI, and then in patients RAS/BRAF wild type on tumor tissue who develop RAS mutations on liquid biopsy after the beginning of the first line treatment with cetuximab plus FOLFIRI, in the absence of a clinical or radiological progression disease, to anticipate a change of treatment with bevacizumab plus FOLFIRI further impacts on the PFS.
Phase:
Phase 3
Details
Lead Sponsor:
Azienda Unità Sanitaria Locale Reggio Emilia
Collaborators:
Istituto Di Ricerche Farmacologiche Mario Negri
Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
Treatments:
Bevacizumab
Calcium
Cetuximab
Fluorouracil
Irinotecan
Leucovorin
Levoleucovorin