Use the hyperlinks, where available to access additional clinical trial information.
Evaluation of RAS mutations in cell free deoxyribonucleic acid (cfDNA) in response to cetuximab anti-epidermal growth factor receptor (EGFR) therapy in patients with metastatic colorectal cancer.
Other Non-Commercial Sponsor
Walter and Eliza Hall Institute
This aim of this study is to explore the emergence of RAS mutations as an escape mechanism in patients receiving first-line cetuximab anti-EGFR therapy in combination with FOLFOX or FOLFIRI as well as to demonstrate the general utility of cfDNA RAS mutation monitoring as compared to standard care measurements of treatment resistance and disease progression using CEA and imaging.
Who is it for?
You may be eligible to join this study if you are aged 18 years or above, and have been diagnosed with metastatic colorectal cancer.
All participants in this study will receive first line anti-EGFR antibody (cetuximab) therapy in combination with either irinotecan-based (FOLFIRI) or oxaliplatin-based (FOLFOX) chemotherapy, as chosen by their treating medical oncologist.
To examine the emergence of RAS mutations during anti-EGFR therapy, serial blood samples (30mls) will be collected from patients. The timing of emergence and genotype analysis of RAS mutations from cfDNA in patients undergoing 1st line treatment with cetuximab in combination with FOLFOX or FOLFIRI will then be examined. For all patients, disease progression will be examined by comparing RAS mutation levels to routine CEA assessment and imaging.
Patients having RAS WT tumours and receiving first-line cetuximab therapy in combination with FOLFOX or FOLFIRI will be monitored until documented tumour progression.