Randomised phase II trial testing efficacy of intra-tumoural hydrogen peroxide as a radiation sensitiser in patients with locally advanced or recurrent breast cancer - KORTUC Phase II

The Institute of Cancer Research0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年7月22日

试验速览

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•Patient age 18 years and over.
•Primary locally advanced breast cancer, or locally recurrent breast cancer with/without metastases
•Radical/high dose palliative RT required for lifetime control of local morbidities.
•Patient physically and mentally fit for radical/high dose palliative RT.
•Target tumour accessible for intra-tumoural injection.
•Patient suitable/compliant with MRI protocol
•At least one tumour diameter =30mm and =150mm measurable by ultrasound, MRI, CT or PET-CT
•Patients with predicted life expectancy of 12 months or more.
•Negative pregnancy test before start of RT in women of child bearing potential and an ability/ willingness to protect against pregnancy from consent and for 3 months post-RT.
•Documented informed consent obtained.

•Prior RT to the target area.
•Maximum diameter of target tumour 150mm measurable by ultrasound, MRI, CT or PET-CT.
•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.

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