Trial purpose
Cancer treatment
Tumor type
Lower gastrointestinal tract
Age
18 - 75
Clinical summary
Summary
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. Study details 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.
Conditions
This trial is treating people with Colorectal Cancer
Eligibility
Inclusion
1. Subjects with histologically confirmed metastatic colorectal cancer
2. Systemic treatment will comprise (first line anti-EGFR antibody (cetuximab) therapy in combination with either irinotecan-based (FOLFIRI) or oxaliplatin-based (FOLFOX) chemotherapy
3. A representative tumour sample is available for molecular testing
4. Has measurable metastatic lesion(s), as defined by RECIST version 1.1.
5. ECOG performance status 0-2
Exclusion
1. History of another primary cancer within the last 3 years, with the exception of non-melanomatous skin cancer and carcinoma in situ of the cervix
2. Prior treatment with an anti-EGFR antibody
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ANZCTR *. View further details about this trial on the registry via the links below:
Trial sponsor
Walter and Eliza Hall Institute
Scientific Title
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.
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