ARIEL
Research type
Research Study
Full title
A biomarker enrichment trial of anti-EGFR agents in patients with advanced colorectal cancer (aCRC) with wild-type RAS and right primary tumour location (right-PTL)
IRAS ID
298873
Contact name
Jenny Seligmann
Contact email
Sponsor organisation
University of Leeds
Eudract number
2021-003330-36
ISRCTN Number
ISRCTN11061442
Duration of Study in the UK
5 years, 5 months, 31 days
Research summary
For patients with advanced colorectal (bowel) cancer (aCRC) who have a gene (RAS) which is normal i.e. RAS wild-type (RAS-wt), standard first-line treatment is chemotherapy, sometimes given in combination with a type of drug called an anti-EGFR agent (cetuximab or panitumumab). However, not all RAS-wt patients benefit from anti-EGFR therapy. Anti-EGFR therapy has severe side-effects and is expensive. It should not be used for patients who will not benefit, or may even be harmed. Better selection of patients is therefore needed.\n\nWe know that patients with tumours that start in the right side of the body (right-sided) in general do not respond very well to anti-EGFR treatment. In the UK, there is no agreed standard of care for the treatment of right-sided patients, some doctors routinely use an anti-EGFR drug, but some do not. \n\nHowever, we also know that patients who have high levels of the proteins epiregulin (EREG) and/or amphiregulin (AREG) respond well to anti-EGFR treatment. EGFR therapy decisions based purely on RAS status and tumour location, risk harming some patients through over-treatment, or risk withholding potentially beneficial therapy from others.\n\nBy measuring levels of EREG and AREG, we may be able to identify patients with right-sided tumours who will benefit from anti-EGFR treatment, and also identify patients who will not benefit and may be harmed if given anti-EGFR therapy.\n\nHowever, before we can introduce this test into routine practice, we need to know that EREG and AREG levels can be measured and the results delivered to doctors quickly enough to inform treatment decisions. We also need to confirm that EGFR therapy is beneficial for patients with EREG/AREG-high, right-sided cancer. This trial aims to answer these questions. \n
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
21/YH/0237
Date of REC Opinion
22 Oct 2021
REC opinion
Favourable Opinion