CORAL: Cancer of the OvaRy Abiraterone triaL
Research type
Research Study
Full title
A prospective, multi-centre, open label, non-randomised two stage phase II clinical trial evaluating the efficacy of abiraterone in patients with epithelial ovarian (including fallopian tube and primary peritoneal) cancer.
IRAS ID
119739
Contact name
Susana Banerjee
Contact email
Sponsor organisation
Royal Marsden NHS Foundation Trust
Eudract number
2013-000293-29
ISRCTN Number
ISRCTN63407050
Duration of Study in the UK
2 years, 11 months, 29 days
Research summary
There are over 6,900 diagnoses of ovarian cancer per year in the UK and more than 4,300 deaths from the disease. The majority of women are diagnosed with advanced disease. The CORAL study investigates whether a drug called abiraterone might help women with advanced ovarian cancer that has come back within a year of last treatment. We also want to investigate who will be helped the most by abiraterone treatment by collecting samples and looking at the way cancer reacts to the drug. Abiraterone has already been found to be very effective in the treatment of patients with prostate cancer and is also now being used in women participating in breast cancer trials.
Abiraterone is a tablet and patients will need to take four tablets together, once a day. They will continue to take abiraterone as long as it is helping to prevent their cancer from getting worse and will have regular check-ups at the hospital to see how they are getting on.
An important part of CORAL is also to look at biological samples donated by participants. This is to see if there is anything that will predict who abiraterone treatment will work best for. At the moment, little is known about who should receive which treatment in this sort of cancer. Participants will be asked to donate blood samples three times during the study. We will also collect samples of their cancer (tumour tissue) before they start treatment and then again during and/or after they finish treatment.
The main aim of CORAL is to find out how well patients have responded to abiraterone 12 weeks after joining the trial.
REC name
London - Westminster Research Ethics Committee
REC reference
13/LO/1599
Date of REC Opinion
7 Nov 2013
REC opinion
Favourable Opinion