KORTUC Phase II - Intra-tumoural Radiation Sensitizer in Patients With Locally Advanced/Recurrent Breast Cancer
Recruiting · NCT03946202 · Interventional (participants receive a specific treatment) · Lead sponsor: Institute of Cancer Research, United Kingdom
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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
Where it is running
10 locations listed.
- Cambridge University Hospitals NHS Foundation Trust - Cambridge, United Kingdom
- The Christie NHS Foundation Trust - Manchester, United Kingdom
- Tata Memorial Centre - Mumbai, India
- University Hospitals of North Midlands NHS Trust - Stoke-on-Trent, United Kingdom
- The Royal Marsden NHS Foundation Trust - Sutton, United Kingdom
- Royal Cornwall Hospitals NHS Trust - Truro, Cornwall, United Kingdom
- Regional Cancer Centre (RCC) - Trivandrum, Kerala, India
- Beatson West of Scotland Cancer Centre - Glasgow, Scotland, United Kingdom
- Christian Medical Centre - Vellore, Tamil Nadu, India
- Tata Medical Centre - Kolkata, West Bengal, India