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Closed (no longer recruiting)Last updated: 24 January 2024

ctDNA-06: 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.

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 patients with Colorectal Cancer.

Cancer

Bowel Cancers Lower gastrointestinal tract

Age

People18 - 75

Phase

Not applicable

Trial Acronym

ctDNA-06

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Trial Identifiers

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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.

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

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