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

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

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

Conditions2

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