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Active, not recruiting Phase 2

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

NCT03946202 · tracked via the Priya Life Science India tracker
Phase
Phase 2
Started
2020-06-16
Last updated
2026-09-02

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

Hydrogen Peroxide →

Hydrogen Peroxide: Hydrogen Peroxide

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patient age 18 years and over * Primary locally advanced breast cancer, or locally recurrent breast cancer with/without metastases (metastases, if present, should be stable or oligometastatic) * Radical/high dose palliative radiotherapy required for lifetime control of local morbidities * Patient physically and mentally fit for radical/high dose palliative radiotherapy * Target tumour accessible for intra-tumoural injection * Patient suitable/compliant with MR protocol * At least one tumour diameter ≥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 child bearing potential and an ability/willingness to protect against pregnancy from consent and for 3 months post-radiotherapy * Patient offers written informed consent Exclusion Criteria: * Prior radiotherapy to the target area * Maximum diameter of target tumour \<30 mm or \>150mm measurable by ultrasound or MR * Anatomical location and/or extent of disease difficult to access for safe intra-tumoural drug injections, for example by virtue of contiguous major blood vessels and/or brachial plexus * Concomitant chemotherapy or biological therapy except Herceptin, Pertuzumab and Denosumab (all endocrine therapies and bisphosphonates are allowed concomitantly; other cytotoxics and biological therapies apart from those mentioned above should be stopped 3 weeks prior to RT) * Pregnancy or nursing * Hypersensitivity to any of the KORTUC ingredients

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)

FacilityCityRegionStatus
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
Official registry record

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