AusCOR
Research type
Research Study
Full title
A Phase II Trial of Aflibercept Monotherapy With Early Dynamic Contrast Enhanced Ultrasound Monitoring in Chemorefractory Metastatic Colorectal Cancer
IRAS ID
134944
Contact name
David Propper
Contact email
Sponsor organisation
Barts Health NHS Trust
Eudract number
2014-002003-25
Duration of Study in the UK
2 years, 11 months, 31 days
Research summary
This study investigates a new way of monitoring metastatic colorectal cancer in patients who are no longer benefitting from standard chemotherapy.
The purpose of this study is to assess how useful an advanced type of ultrasound scan called Dynamic Contrast Enhanced Ultrasound (DCE-US) is in detecting the early response to aflibercept.
We want to find out whether performing this test enables us to identify patients who will benefit from the drug at a very early stage of treatment - after 2 weeks. Typically it takes 2 months to find out whether a drug works for a patient using the normal CT scan method. This would save patients who are not benefitting from receiving unnecessary treatment and enable identification of patients who will benefit at a very early stage.
DCE-US is an ultrasound test. It is simple way of looking at blood flow in tumours. The aim in the study is to see if aflibercept reduces blood flow in the tumour and if so, does this reduction in blood flow means that the drug is improving the survival of patients.
Aflibercept is a type of chemotherapy and works by inhibiting the growth of new blood vessels within tumours. The treatment is given by an injection into the veins (IV) every two weeks. In clinical trials, aflibercept was well tolerated and of potential benefit and may be effective in limiting the growth of new blood vessels within tumours. It is now licensed in the United States as a treatment of colon cancer in combination with irinotecan and 5-FU chemotherapy.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
16/EM/0096
Date of REC Opinion
6 Apr 2016
REC opinion
Further Information Favourable Opinion