KORTUC
Research type
Research Study
Full title
Phase I ’run in’ study followed by randomised phase II trial testing intra-tumoural hydrogen peroxide as a radiation sensitizer in patients with locally advanced/recurrent breast cancer in terms of toxicity and tumour response
IRAS ID
203161
Contact name
Navita Somaiah
Contact email
Sponsor organisation
The Institute of Cancer Research
Eudract number
2016-000833-40
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
Aim: To test a commonly available and inexpensive chemical (hydrogen peroxide) for safety and activity in sensitizing large cancerous lumps in the breast to a standard course of radiotherapy in women with poorly controlled symptoms.
Background: Laboratory research and initial clinical trials in Japan suggest that 4 to 6 injections of a radiation sensitizer (‘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 48 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 wish to test this approach by confirming the mildness of side effects in 12 patients treated at The Royal Marsden, followed by a multicentre randomised trial in 84 patients to test activity against cancer. After written informed consent, patients participating in the second phase will have standard radiotherapy alone or the same radiotherapy plus KORTUC. Independent review of toxicity in the first 12 patients will be undertaken before starting the randomised trial.
REC name
London - Chelsea Research Ethics Committee
REC reference
16/LO/1566
Date of REC Opinion
23 Sep 2016
REC opinion
Favourable Opinion