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RECRUITING
NCT03946202
PHASE2

KORTUC Phase II - Intra-tumoural Radiation Sensitizer in Patients With Locally Advanced/Recurrent Breast Cancer

Sponsor: Institute of Cancer Research, United Kingdom

View on ClinicalTrials.gov

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.

Official title: Randomised Phase II Trial Testing Efficacy of Intra-tumoural Hydrogen Peroxide as a Radiation Sensitiser in Patients With Locally Advanced/Recurrent Breast Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

184

Start Date

2020-06-16

Completion Date

2028-06-30

Last Updated

2026-03-27

Healthy Volunteers

No

Conditions

Interventions

DRUG

Hydrogen Peroxide

Hydrogen Peroxide

Locations (10)

Regional Cancer Centre (RCC)

Trivandrum, Kerala, India

Christian Medical Centre

Vellore, Tamil Nadu, India

Tata Medical Centre

Kolkata, West Bengal, India

Tata Memorial Centre

Mumbai, India

Royal Cornwall Hospitals NHS Trust

Truro, Cornwall, United Kingdom

Beatson West of Scotland Cancer Centre

Glasgow, Scotland, United Kingdom

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