KORTUC: Intra-tumoural Hydrogen Peroxide as a Radiation Sensitizer in Patients With Locally Advanced/Recurrent Breast Cancer in Terms of Toxicity and Tumour Response

• Status: Completed
• Trial end date: 2020-11-12
• Target enrollment: 0
• Participant gender: All

Summary

This is a study aimed at testing a commonly available and inexpensive chemical (hydrogen peroxide) for safety and activity in sensitising large cancerous lumps in the breast to a standard course of radiotherapy in women with poorly controlled symptoms. 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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Cancer Research, United Kingdom; Royal Marsden NHS Foundation Trust
• Collaborator: Kortuc Inc.
• Treatments: Hydrogen Peroxide

Criteria

Inclusion Criteria:

• Age over 18 years

• Primary locally advanced breast cancer, or locally recurrent breast cancer with/without metastases

• 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

• At least one tumour diameter ≥30 mm measurable by ultrasound or magnetic resonance imaging

• Patient available for minimum 3 months follow up post-treatment prior to any surgical resection

• Negative pregnancy test within 7 days of starting radiotherapy in women of child bearing potential and an ability/willingness to protect against pregnancy for 3 months post- radiotherapy

• Patient offers written informed consent

Exclusion Criteria:

• Prior radiotherapy to the target area

• Anatomical location &/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