The KORTUC Trial (Phase I/II trial testing intra-tumoural hydrogen peroxide as a radiation sensitizer in women with locally advanced and recurrent breast cancer in terms of toxicity and tumour response)
- Conditions
- Women with locally advanced/recurrent breast cancerTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-000833-40-GB
- Lead Sponsor
- The Institute of Cancer Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 96
•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 =40 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
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 36
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60
• 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method