To test effect of hydrogen peroxide on radiation sensitivity in breast cancer patients
- Conditions
- Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
- Registration Number
- CTRI/2022/02/040331
- Lead Sponsor
- The Institute of Cancer Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To test efficacy <br/ ><br>Timepoint: Complete tumour response based on best response assessed by contrast enhanced MRI, according to criteria <br/ ><br>outlined in protocol, performed up to and including 12 months post-RT.
- Secondary Outcome Measures
Name Time Method To further characterise efficacy & safetyTimepoint: Overall survival at 6,12&24 months <br/ ><br>Loco-regional recurrence,local progression-free survival & distant recurrence at 6, 12 & 24 months <br/ ><br>Proportion of patients with either complete response on MRI up to & including 12 months or pathological complete response following tumour resection before 12 months. <br/ ><br>Proportion of patients with partial response & stable <br/ ><br>disease <br/ ><br>Planned/unplanned tumour excision & pathological <br/ ><br>response <br/ ><br>Adverse events <br/ ><br>Compliance with KORTUC administration