The KORTUC phase II Trial (Phase II trial testing efficacy of intra-tumoural hydrogen peroxide as a radiation sensitiser in patients with locally advanced and recurrent breast cancer)

Phase 1

• Conditions: Patients with locally advanced/recurrent breast cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-001709-25-GB
• Lead Sponsor: The Institute of Cancer Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-14
• Last Update Posted: 23 March 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 184

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified