RecruitingPhase 2NCT03946202

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

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


Sponsor

Institute of Cancer Research, United Kingdom

Enrollment

184 participants

Start Date

Jun 16, 2020

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a hydrogen peroxide-based injection given directly into locally advanced or recurrent breast tumors to make them more sensitive to radiation therapy. The goal is to boost how well radiation works against tumors that are difficult to treat surgically, reducing the chance they grow back in the same area. **You may be eligible if...** - You are 18 years or older - You have locally advanced breast cancer (primary) or breast cancer that has come back locally, with or without stable spread to other sites - Your cancer requires high-dose radiation for long-term local control - You are in good enough health to receive radiation therapy **You may NOT be eligible if...** - Your cancer has spread widely and is progressing quickly - You have had prior radiation to the same breast area at doses that would not allow further treatment - You have serious medical conditions that make radiation or injection unsafe - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHydrogen 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

View Full Details on ClinicalTrials.gov

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NCT03946202


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