ACTOv
Research type
Research Study
Full title
A multicentre phase II randomised controlled trial to evaluate the efficacy of Adaptive Therapy (AT) with carboplatin, based on changes in CA125, in patients with relapsed platinum-sensitive high grade serous or high grade endometrioid ovarian cancer
IRAS ID
1003954
Contact name
Ka Man Mak
Contact email
Sponsor organisation
University College London
Eudract number
2021-003412-40
Clinicaltrials.gov Identifier
Research summary
We are conducting the ACTOv trial in 9 sites in the UK to find out whether a new way of giving chemotherapy doses called ‘adaptive therapy’ (AT), can work better than standard dose chemotherapy and improve treatment in women with advanced stage ovarian cancer that has come back (recurrent). To be eligible, women must have been previously treated with chemotherapy and need treatment again with carboplatin chemotherapy.
With standard dose chemotherapy, drug sensitive cancer cells are killed, leaving resistant cells behind and so most patients eventually die with drug-resistant cancer. It is known that drug-resistant cells usually grow more slowly than their drug-sensitive counterparts. AT will prescribe periods without drug to allow faster-growing sensitive cells to take over the tumour, thereby re-sensitising the cancer to the next round of treatment. In this trial, the proposed adaptive therapy is to either increase or decrease the dose of carboplatin, according to changes in CA125 in each individual patient. CA125 is a chemical that is released by some cancer cells and measured by a blood test which is already used routinely to monitor ovarian cancer growth and response to treatment.
The women who consent to take part are put into one of the following treatment groups by computer: 1) control group to receive usual standard of care 6 courses of chemotherapy or 2) AT group to receive 12 courses of chemotherapy. Each woman will be followed up for 12 months after receiving their last treatment. Translational research including mandatory blood samples and optional tumour samples forms part of the trial.
The proposed AT could transform cancer care: patients could receive less drug, less often, and live longer with fewer treatment-related side effects.
The target accrual is 80 patients from 9 hospitals in the UK. The trial is funded by Barts Charity and Anticancer Fund, sponsored by University College London and coordinated by the CR UK & UCL Cancer Trials Centre.REC name
London - Dulwich Research Ethics Committee
REC reference
22/LO/0543
Date of REC Opinion
23 Aug 2022
REC opinion
Further Information Favourable Opinion