ICON9
Research type
Research Study
Full title
An international phase III randomised study to evaluate the efficacy of maintenance therapy with olaparib and cediranib or olaparib alone in patients with relapsed platinum-sensitive ovarian cancer following a response to platinum-based chemotherapy
IRAS ID
231108
Contact name
Shibani Nicum
Contact email
Sponsor organisation
University College London
Eudract number
2017-000161-75
Clinicaltrials.gov Identifier
Duration of Study in the UK
7 years, 0 months, 1 days
Research summary
Ovarian carcinoma is the fifth commonest cause of cancer death in women in the UK. Platinum-based chemotherapy remains the cornerstone of treatment. Despite advances in treatment, about 80% of women with advanced ovarian cancer have a recurrence that is ultimately fatal. Patients who relapse >6 months after completing first-line platinum-based chemotherapy are retreated with further platinum-based chemotherapy regimens. The median survival after first relapse is about 40 months.
Two novel biological agents, cediranib targeting blood vessel growth, and olaparib targeting DNA repair processes, have individually led to an improvements in ovarian cancer control. A combination of these drugs has also demonstrated greater activity than either of them alone. The aim of the ICON9 trial is to improve progression free and overall survival by adding maintenance therapy (treatment used to slow the growth or return of cancer after initial treatment) with cediranib and olaparib in patients who have relapsed >6 months after completing platinum-based chemotherapy. We also seek to determine the effects of treatment on the quality of life, and to find cancer markers which may help identify which treatments patients are most likely to benefit from.
Patients who have responded to a minimum of 4 cycles of platinum based chemotherapy will be randomised for maintenance treatment with either olaparib and cediranib or olaparib alone.
The maintenance regimen may be continued even if the disease has worsened, as indicated by CT scan, if the clinician believes the patient is still deriving benefit. Trial treatment must be discontinued if further cancer treatment is started.
ICON9 will be undertaken internationally in approximately 70 sites. The target accrual is 618 patients. The trial is funded by Cancer Research UK and AstraZeneca. It is sponsored by University College London and coordinated by the CR UK & UCL Cancer Trials Centre.
REC name
London - Westminster Research Ethics Committee
REC reference
17/LO/1808
Date of REC Opinion
18 Dec 2017
REC opinion
Further Information Favourable Opinion