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

Recruiting Phase 3 Interventional Study
Colorectal Cancer Metastatic Colorectal Cancer RAS Mutation
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
280 (estimated)
Sponsor
Azienda USL Reggio Emilia - IRCCS · Government
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Provision of written informed consent; 2. Male or female \> 18 years of age; 3. Histologically confirmed diagnosis of colorectal adenocarcinoma RAS/BRAF wild type (analysed either on primary and/or related metastasis); 4. Initially unresectable metastatic colorectal cancer no…
Contacts

Carmine Pinto, MD

052295181

carmine.pinto@ausl.re.it

CONTACT

Angela Damato, MD

052296858

angela.damato@ausl.re.it

CONTACT