NCT03946202 KORTUC Phase II - Intra-tumoural Radiation Sensitizer in Patients With Locally Advanced/Recurrent Breast Cancer
| NCT ID | NCT03946202 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Institute of Cancer Research, United Kingdom |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 184 participants |
| Start Date | 2020-06-16 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 184 participants in total. It began in 2020-06-16 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a study aimed at testing a commonly available and inexpensive chemical (hydrogen peroxide) for efficacy in sensitising large cancerous lumps in the breast to a standard course of radiotherapy in patients with locally advanced or recurrent breast cancer. Laboratory research and initial clinical trials in Japan suggest that 4 to 6 injections of a radiation sensitiser ('KORTUC') based on very dilute (0.5%) hydrogen peroxide injected into cancers under local anaesthetic twice a week during radiotherapy greatly increases the effectiveness of standard doses of radiotherapy alone. The side effects are limited to mild/moderate discomfort at the injection site for up to 24 hours reported by Japanese breast cancer patients in whom this treatment has been tested. Complete tumour shrinkage in 70/71 (98%) primary breast cancers up to 5 cm diameter have been reported by Japanese collaborators.
Eligibility 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
Contact & Investigator
Navita Somaiah
PRINCIPAL INVESTIGATOR
The Institute of Cancer Research & The Royal Marsden NHS Foundation Trust
Frequently Asked Questions
Who can join the NCT03946202 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03946202 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT03946202 currently recruiting?
Yes, NCT03946202 is actively recruiting participants. Contact the research team at lone.gothard@icr.ac.uk for enrollment information.
Where is the NCT03946202 trial being conducted?
This trial is being conducted at Trivandrum, India, Vellore, India, Kolkata, India, Mumbai, India and 6 additional locations.
Who is sponsoring the NCT03946202 clinical trial?
NCT03946202 is sponsored by Institute of Cancer Research, United Kingdom. The principal investigator is Navita Somaiah at The Institute of Cancer Research & The Royal Marsden NHS Foundation Trust. The trial plans to enroll 184 participants.
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