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.
Provision of written informed consent;
Male or female > 18 years of age;
Histologically confirmed diagnosis of colorectal adenocarcinoma RAS/BRAF wild type (analysed either on primary and/or related metastasis);
Initially unresectable metastatic colorectal cancer not previously treated with chemotherapy for metastatic disease;
Previous chemotherapy treatment, with the exception of patient treated in adjuvant setting completed at least 6 months before the randomization;
Any contraindication to the use of Cetuximab, Bevacizumab, Irinotecan, 5FU or folinic acid;
Radiotherapy to any site within 4 weeks before the randomization;
Serious, non-healing wound, ulcer, or bone fracture;
Azienda USL Reggio Emilia - IRCCS
Lead sponsor
Istituto Di Ricerche Farmacologiche Mario Negri
Collaborator
Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
Collaborator