KORTUC phase II
Research type
Research Study
Full title
Randomised phase II trial testing efficacy of intra-tumoural hydrogen peroxide as a radiation sensitiser in patients with locally advanced/recurrent breast cancer
IRAS ID
264012
Contact name
Navita Somaiah
Contact email
Sponsor organisation
The Institute of Cancer Research
Eudract number
2019-001709-25
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
Aim: To test a commonly available and inexpensive chemical (hydrogen peroxide) for efficacy in sensitising large cancerous lumps in the breast to a standard course of radiotherapy in patients presenting with locally advanced disease.
Background: Laboratory research and initial clinical trials in Japan suggest that 4 to 6 injections of a radiation sensitiser (‘KORTUC’) based on very dilute (0.5%) hydrogen peroxide injected into cancers under local anaesthetic twice a week during radiotherapy greatly increases the effectiveness of standard doses of radiotherapy alone. The side effects are limited to mild/moderate discomfort at the injection site for up to 24 hours reported by Japanese breast cancer patients in whom this treatment has been tested. Complete tumour shrinkage in 70/71 (98%) primary breast cancers up to 5 cm diameter have been reported by Japanese collaborators.
Design and methods: Using local anaesthetic, a trained operator uses ultrasound to guide the injection of dilute (0.5%) hydrogen peroxide solution into the tumour twice a week during 3 weeks of standard radiotherapy. The drug is suspended in a gel (1% sodium hyaluronate, licensed for treating stiff knee joints) that ensures the slow release of hydrogen peroxide into the tumour over at least 24 hours. The procedure lasts 10-15 minutes. Tiny oxygen bubbles released from the hydrogen peroxide help the operator guide the injection of drug to the tumour under the skin. We recently completed a safety study (KORTUC phase I, IRAS 203161) confirming the mildness of side effects in 12 patients treated at The Royal Marsden, and we now wish to test activity against cancer in a multicentre randomised trial in 184 patients. After written informed consent, patients participating in this second phase will have standard radiotherapy alone or the same radiotherapy plus KORTUC.
REC name
West of Scotland REC 1
REC reference
20/WS/0019
Date of REC Opinion
6 Feb 2020
REC opinion
Favourable Opinion