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.

Male<br/>OnlyGender Male
Only

RecruitingStatus Recruiting

Treatment<br/>TrialTypeTreatment
Trial

UnknownPhase Unknown

18-75Age 18-75

Bowel<br/>CancersCancer LocationBowel
Cancers

Treatment | Bowel (colorectum)Colon,Colorectum,Rectum

Trial Overview Read MoreRead more

This trial is treating patients with Colorectal Cancer.

This is a systemic therapy trial.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

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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.

Other Non-Commercial Sponsor

Walter and Eliza Hall Institute

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.

Recruiting Hospitals Read MoreRead more

Warrnambool Hospital
Warrnambool
Sandra Robinson
sjrobinson@swh.net.au
03 5562 9056

Western Health - Sunshine Hospital
St Albans
Ms Heike Raunow
Heike.Raunow@wh.org.au
03 8395 9167

Not Recruiting Hospitals Read MoreRead more

Closed

Barwon Health, University Hospital Geelong
Geelong
Dr Lea-Anne Harrison
leaanne.harrison@barwonhealth.org.au
03 42 15 2758

Completed

Box Hill Hospital Medical Oncology
Box Hill
Yvonne Chan
yvonne.chan@monash.edu
03 9895 3203

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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