Randomised phase II trial testing efficacy of intra-tumoural hydrogen peroxide as a radiation sensitiser in patients with locally advanced/recurrent breast cancer.
Disease site: Breast cancer
Treatment modality: Radiotherapy +/- Radiation sensitiser
Status: Open to recruitment
KORTUC phase II is a multi-centre, non-blinded, randomised trial with two groups comparing radiotherapy plus/minus a novel radiation sensitiser (intra-tumoural injections of hydrogen peroxide), in patients with primary or recurrent locally advanced breast cancer requiring high dose radiotherapy for lifetime control of moderate or severe morbidities.
This is a multi-centre trial involving 6 centres in the UK (The Royal Marsden NHS Foundation Trust, Beatson Oncology Centre, Cambridge University Hospitals NHS Foundation Trust, The Christie NHS Foundation Trust, Royal Cornwall NHS Trust, University Hospitals of North Midlands NHS Trust) and 2 centres in India; Tata Medical Centre, Kolkata and Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow. 184 patients will be recruited over a 3-year period. Patients will receive radiotherapy alone or radiotherapy + KORTUC and will be followed up for a period of 2 years.
Chief Investigator: Dr Navita Somaiah, Team Leader, Translational Breast Radiobiology, The Institute of Cancer Research and Honorary Consultant Clinical Oncologist, The Royal Marsden NHS Foundation Trust
ICR-CTSU Scientific Lead: Professor Judith Bliss
ICR-CTSU Trial Statistician: Fay Cafferty
Trial management contact: [email protected]
ISRCTN: Not applicable
Sponsor: The Institute of Cancer Research
Funding: Kortuc Inc., Japan (Main Trial) and CRUK Convergence Science Centre, UK (Translational Imaging Sub-studies).
Further information including recruitment progress is available from the ClinicalTrials.gov portfolio.
A lay summary in plain English is available from Cancer Research UK.
Publications and presentations
Nimalasena, S., et al., Intratumoral Hydrogen Peroxide With Radiation Therapy in Locally Advanced Breast Cancer: Results From a Phase 1 Clinical Trial. Int J Radiat Oncol Biol Phys, 2020.
Navita Somaiah. KORTUC phase I trial testing hydrogen peroxide as a novel radiation sensitiser in patients with locally advanced/recurrent breast cancer. Oral presentation at the 16th International Crongress of Radiation Research (ICRR) in Manchester, UK 25-29 August 2019.
Samantha Nimalasena: ESTRO Presentation: Tumour reoxygenation by intratumoural hydrogen peroxide: a mechanism for enhanced radiosensitivity. An oral presentation of pre-clinical results–demonstrating tissue reoxygenation following KORTUC injections –a novel way to overcome tumour hypoxia.
Megan Morris: ESTRO Poster: Super-resolution Ultrasound and MRI for Monitoring Breast Tumour Response to Radiotherapy.