Actively Recruiting
KORTUC Phase II - Intra-tumoural Radiation Sensitizer in Patients With Locally Advanced/Recurrent Breast Cancer
Led by Institute of Cancer Research, United Kingdom · Updated on 2026-03-27
184
Participants Needed
10
Research Sites
419 weeks
Total Duration
On this page
Sponsors
I
Institute of Cancer Research, United Kingdom
Lead Sponsor
K
Kortuc, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
KORTUC Phase II - Intra-tumoural Radiation Sensitizer in Patients With Locally Advanced/Recurrent Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient age 18 years and over
- Primary locally advanced breast cancer, or locally recurrent breast cancer with or without metastases (metastases, if present, should be stable or oligometastatic)
- Radical or high dose palliative radiotherapy required for lifetime control of local morbidities
- Patient physically and mentally fit for radical or high dose palliative radiotherapy
- Target tumour accessible for intra-tumoural injection
- Patient suitable and compliant with MR protocol
- At least one tumour diameter between 30 mm and 150 mm measurable by ultrasound or MR imaging
- Patients with predicted life expectancy of 12 months or more
- Negative pregnancy test before start of radiotherapy in women of childbearing potential and ability or willingness to protect against pregnancy from consent and for 3 months post-radiotherapy
- Patient offers written informed consent
You will not qualify if you...
- Prior radiotherapy to the target area
- Maximum diameter of target tumour less than 30 mm or greater than 150 mm measurable by ultrasound or MR
- Anatomical location or extent of disease difficult to access for safe intra-tumoural drug injections, such as near major blood vessels or brachial plexus
- Concomitant chemotherapy or biological therapy except Herceptin, Pertuzumab, and Denosumab (all endocrine therapies and bisphosphonates allowed; other cytotoxics and biological therapies must be stopped 3 weeks prior to radiotherapy)
- Pregnancy or nursing
- Hypersensitivity to any of the KORTUC ingredients
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Trial Site Locations
Total: 10 locations
1
Regional Cancer Centre (RCC)
Trivandrum, Kerala, India, 695011
Actively Recruiting
2
Christian Medical Centre
Vellore, Tamil Nadu, India, 632004
Actively Recruiting
3
Tata Medical Centre
Kolkata, West Bengal, India, 700160
Actively Recruiting
4
Tata Memorial Centre
Mumbai, India
Actively Recruiting
5
Royal Cornwall Hospitals NHS Trust
Truro, Cornwall, United Kingdom, TR1 3LJ
Actively Recruiting
6
Beatson West of Scotland Cancer Centre
Glasgow, Scotland, United Kingdom, G12 0YN
Actively Recruiting
7
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
8
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Actively Recruiting
9
University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, United Kingdom, ST4 6QG
Actively Recruiting
10
The Royal Marsden NHS Foundation Trust
Sutton, United Kingdom, SM2 5PT
Actively Recruiting
Research Team
L
Lone Gothard
CONTACT
J
Justine Hughes
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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