Depth of Response in Folfox-cetuximab-treated CRC patients
Research type
Research Study
Full title
Depth of Response following neoadjuvant Folfoxcetuximabtreated liver metastasis from colorectal cancer
IRAS ID
171188
Contact name
Julien Edeline
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Z6364106/2015/01/62, UCL Data Protection
Duration of Study in the UK
0 years, 5 months, 30 days
Research summary
The New EPOC study tested the addition of cetuximab to a peri-operative standard FOLFOX treatment in patients suffering from operable liver metastases from colorectal cancer. The results were disappointing as showing a detrimental effect of adding this new drug. We are currently investigating the potential causes for these results, as well as trying to define some population that could benefit from the treatment.
Cetuximab and the other anti-EGFR agent panitumumab have been associated with higher response rates. It has been also shown in the palliative setting that another approach of the definition of response, namely the depth of response, could better predict the benefit from anti-EGFR treatment, comparatively to chemotherapy alone.
Our aim in this study is thus to conduct a study of the depth of response in patients treated in the New Epoc trial.
This will require a central review of anonymised scans, which was not planned initially and is the reason of this submission to the ethics committee, and a correlation of the results of this depth of response analysis with the outcomes from the study. The process would entail identification of these scans at all sites, anonymisation of the images on electronic imaging systems such as the commonly used PACS system and electronic transfer to University College Hospitals NHS trust where the images will be reviewed. Transfer of scans on secure NHS systems is an everyday process for central review of images as part of standard clinical practice.
Moreover, heterogeneity parameters of tumours assessed by CTscans were shown to be prognostic in different malignancies. Will be test this hypothesis in the New Epoc dataset.
As all patients have finished the protocol treatment, it will not affect their actual management. No decision would be made for their future treatment and follow-up depending on this new imaging review. Furthermore, most patients will have died since the completion of the trial.REC name
London - Westminster Research Ethics Committee
REC reference
15/LO/0329
Date of REC Opinion
16 Feb 2015
REC opinion
Favourable Opinion