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

The Institute of Cancer Research0 个研究点目标入组 184 人开始时间: 2020年1月14日最近更新: 2020年3月23日

适应症

试验速览

暂无简介。

•Patient age 18 years and over
•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
•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 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 64
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 120

•Prior radiotherapy to the target area
•Maximum diameter of target tumour <30 mm or >150mm measurable by ultrasound or MRI
•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

发起方