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.

Not Applicable

Active, not recruiting

• Conditions: Patients with histologically confirmed metastatic colorectal cancer.; Cancer - Bowel - Back passage (rectum) or large bowel (colon)

• Registration Number: ACTRN12615000770561
• Lead Sponsor: The Walter and Eliza Hall Institute of Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-24
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

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 Criteria

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

Study & Design

• Study Type: Observational
• Study Design: Not specified