Canadian Cancer Trials Group Bulletins


Canadian Cancer Trials Group CO.17 Continues to Impact Practice Standards

The US Food and Drug Administration (FDA) has approved a genetic test to help physicians determine which patients with metastatic colorectal cancer are likely to benefit from the drug cetuximab (Erbitux).

FDA approval of the test was based on a retrospective analysis of biopsy samples from patients participating in Canadian Cancer Trials Group CO.17 (A Phase III Randomized Study of Cetuximab [Erbitux TM, C225] and Best Supportive Care versus Best Supportive Care in Patients with Pretreated Metastatic Epidermal Growth Factor Receptor (EGFR) - Positive Colorectal Carcinoma). The trial results showed that patients whose tumours lack KRAS mutations (also known as KRAS wild-type tumours) had an overall survival of 8.6 months with the addition of cetuximab compared with 5.0 months with best supportive care alone. For patients whose tumours had KRAS mutations, adding cetuximab did not significantly affect survival. Results of the the trial supported the original approval of cetuximab and were published in the New England Journal of Medicine in 2007 (

The therascreen KRAS RGQ PCR Kit can detect seven mutations in the KRAS gene in DNA extracted from a patient's tumour.

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The Canadian Cancer Trials Group is very pleased that the results of Canadian Cancer Trials Group CO.17 continue to have an impact on practice standards around the world.