KORTUC Phase II - Intra-tumoural Radiation Sensitizer in Patients With Locally Advanced/Recurrent Breast Cancer
Condition(s) studied
Study summary
This is a study aimed at testing 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 with locally advanced or recurrent breast cancer. 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.
Eligibility
Primary outcome measure(s)
- Complete tumour response based on best response assessed by contrast enhanced MRI according to criteria outlined in Section 3.2.1 of the trial protocol, performed up to and including 12 months post radiotherapy — Up to and including 12 months post radiotherapy
Trial sites (10)
| Facility | City | Region | Status |
|---|---|---|---|
| Regional Cancer Centre (RCC) | Trivandrum | Kerala | |
| Christian Medical Centre | Vellore | Tamil Nadu | |
| Tata Medical Centre | Kolkata | West Bengal | |
| Tata Memorial Centre | Mumbai | India | |
| Royal Cornwall Hospitals NHS Trust | Truro | Cornwall | |
| Beatson West of Scotland Cancer Centre | Glasgow | Scotland | |
| Cambridge University Hospitals NHS Foundation Trust | Cambridge | United Kingdom | |
| The Christie NHS Foundation Trust | Manchester | United Kingdom | |
| University Hospitals of North Midlands NHS Trust | Stoke-on-Trent | United Kingdom | |
| The Royal Marsden NHS Foundation Trust | Sutton | United Kingdom |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03946202 on ClinicalTrials.gov ↗ ← All trials in India