Using hydrogen peroxide to enhance radiotherapy for advanced breast cancer
Randomised Phase II Trial Testing Efficacy of Intra-tumoural Hydrogen Peroxide as a Radiation Sensitiser in Patients With Locally Advanced/Recurrent Breast Cancer
This study is testing if using a diluted hydrogen peroxide solution during radiotherapy can help people with advanced breast cancer have better treatment results.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 184 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institute of Cancer Research, United Kingdom Academic / other |
| Drugs / interventions | Pertuzumab, Denosumab, chemotherapy, radiation |
| Locations | 10 sites (Trivandrum, Kerala and 9 other locations) |
| Trial ID | NCT03946202 on ClinicalTrials.gov |
What this trial studies
This study tests the effectiveness of a dilute hydrogen peroxide solution as a radiation sensitizer for patients with locally advanced or recurrent breast cancer. Patients will receive injections of the sensitizer during a standard course of radiotherapy, with the aim of improving treatment outcomes. The approach is based on promising results from initial trials in Japan, where significant tumor shrinkage was observed. The study will assess both the safety and efficacy of this treatment method.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and over with locally advanced or recurrent breast cancer requiring radical or high-dose palliative radiotherapy.
Not a fit: Patients with tumors smaller than 30 mm or larger than 150 mm, or those who have previously received radiotherapy to the target area, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the effectiveness of radiotherapy for patients with large breast tumors.
How similar studies have performed: Initial clinical trials in Japan have shown promising results with this approach, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient age 18 years and over * Primary locally advanced breast cancer, or locally recurrent breast cancer with/without metastases (metastases, if present, should be stable or oligometastatic) * 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 from consent and for 3 months post-radiotherapy * Patient offers written informed consent Exclusion Criteria: * Prior radiotherapy to the target area * Maximum diameter of target tumour \<30 mm or \>150mm measurable by ultrasound or MR * 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
Where this trial is running
Trivandrum, Kerala and 9 other locations
- Regional Cancer Centre (RCC) — Trivandrum, Kerala, India (Recruiting)
- Christian Medical Centre — Vellore, Tamil Nadu, India (Recruiting)
- Tata Medical Centre — Kolkata, West Bengal, India (Recruiting)
- Tata Memorial Centre — Mumbai, India (Recruiting)
- Royal Cornwall Hospitals NHS Trust — Truro, Cornwall, United Kingdom (Recruiting)
- Beatson West of Scotland Cancer Centre — Glasgow, Scotland, United Kingdom (Recruiting)
- Cambridge University Hospitals NHS Foundation Trust — Cambridge, United Kingdom (Recruiting)
- The Christie NHS Foundation Trust — Manchester, United Kingdom (Recruiting)
- University Hospitals of North Midlands NHS Trust — Stoke-on-Trent, United Kingdom (Recruiting)
- The Royal Marsden NHS Foundation Trust — Sutton, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Navita Somaiah — The Institute of Cancer Research & The Royal Marsden NHS Foundation Trust
- Study coordinator: Lone Gothard
- Email: lone.gothard@icr.ac.uk
- Phone: +44(0)2086613460
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.