Breast CancerPhase 2NCT03946202
KORTUC Phase II - Intra-tumoural Radiation Sensitizer in Patients With Locally Advanced/Recurrent Breast Cancer
A Phase 2 study testing Hydrogen Peroxide in people with Breast Cancer, run by Institute of Cancer Research, United Kingdom at 10 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Hydrogen Peroxide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 16 Jun 2020to 31 Aug 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United Kingdom6 sites
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ
Beatson West of Scotland Cancer Centre
Glasgow, Scotland, G12 0YN
The Christie NHS Foundation Trust
Manchester, M20 4BX
University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, ST4 6QG
The Royal Marsden NHS Foundation Trust
Sutton, SM2 5PT
Royal Cornwall Hospitals NHS Trust
Truro, Cornwall, TR1 3LJ
India4 sites
Tata Medical Centre
Kolkata, West Bengal, 700160
Tata Memorial Centre
Mumbai
Regional Cancer Centre (RCC)
Trivandrum, Kerala, 695011
Christian Medical Centre
Vellore, Tamil Nadu, 632004
About this study
Official title: Randomised Phase II Trial Testing Efficacy of Intra-tumoural Hydrogen Peroxide as a Radiation Sensitiser in Patients With Locally Advanced/Recurrent Breast Cancer
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.
Read the detailed description
Aim: To test a slow release gel containing a commonly available and inexpensive chemical (hydrogen peroxide) for safety and activity in sensitizing large cancerous lumps in the breast or armpit to a standard 3-week course of radiotherapy in patients with locally advanced or recurrent breast cancer.
Background: Laboratory research and initial clinical trials conducted in Japan raises the possibility that a simple and inexpensive treatment based on a very dilute (0.5%) hydrogen peroxide injected into cancers under local anaesthetic greatly increases the effectiveness of standard doses of radiotherapy. The side effects appear to be limited to mild/moderate discomfort at the injection site for up to 24 hours in one-third of patients. Rapid, complete and durable tumour disappearance has been reported in 49/55 bulky breast cancers in Japanese women treated using this approach, a response that is at least 3 times the success rate of radiotherapy alone in our own patients and in a contemporary Japanese control population. The inventor, Prof Ogawa of Kochi University, has approached the investigators to lead the further clinical evaluation and commercial development, starting with the proposed early phase trials testing safety and anti-cancer activity described below.
Design and methods: After numbing the skin with local anaesthetic, a specialist doctor (radiologist) or trained radiographer will use ultrasound to guide the injection of a small volume of dilute (0.5%) hydrogen peroxide solution into the tumour twice a week during 3 weeks of standard radiotherapy. The drug is suspended in a natural gel (1% sodium hyaluronate, licensed for treating stiff knee joints) that ensures its slow release over 48 hours. The injection procedure lasts for 10-15 minutes altogether. Tiny oxygen bubbles are released from the hydrogen peroxide which help the radiologist guide the injection of drug to the proper places under the skin. We have recently completed a safety study confirming the mildness of side effects in 12 patients, and we now wish to test activity against cancer in a randomised controlled trial in 184 patients. Patients participating in Phase II will either have standard radiotherapy or the same radiotherapy plus the drug under test. Neither the patient nor the doctor will choose who has which treatment, which is allocated randomly.
Patient and public involvement: Independent Cancer Patient Voice, a patient advocate group in the field of cancer, is collaborating with the investigators on the research plan, commenting and advising on the content and clarity of the written proposal. This group plays a prominent role in promoting UK clinical research, being represented on the Trial Management Groups of several national randomised cancer clinical trials.
Dissemination: The results of this study will be presented at scientific meetings and at meetings of the patient advocate group in order to judge if the results for safety and activity are promising enough to justify taking the research further.
- Conditions
- Breast Cancer
- Being tested
- Hydrogen Peroxide
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrogen PeroxideDrug
Hydrogen Peroxide
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy + radiation sensitiser | Experimental | Patients randomised to the test group will receive standard radiotherapy for breast cancer + a radiation sensitiser Receives: Drug: Hydrogen Peroxide |
| Radiotherapy alone | No intervention | Patients randomised to the control group will receive standard radiotherapy for breast cancer alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete tumour response based on best response assessed by contrast enhanced MRI according to criteria outlined in Section 3.2.1 of the trial protocol, performed up to and including 12 months post radiotherapy
Measured: Up to and including 12 months post radiotherapy
Secondary outcomes (11)
Overall survival at 6, 12 and 24 months
Measured: 6, 12 and 24 months post radiotherapy
Loco-regional progression-free survival and distant recurrence at 6, 12 and 24 months
Measured: 12 and 24 months post radiotherapy
Proportion of patients with either complete response on MRI up to and including 12 months or pathological complete response following tumour resection before 12 months
Measured: Up to and including 12 months post radiotherapy
Proportion of patients with partial response and stable disease
Measured: 12 and 24 months post radiotherapy
Planned/unplanned tumour excision and pathological response recorded at post-RT follow-up visits
Measured: During 24-month follow up period
Adverse events (assessed by NCI CTCAE v5.0)
Measured: Up to 90 days post radiotherapy
Compliance with KORTUC injections prior to radiotherapy
Measured: During radiotherapy, an average of 3 weeks
Pain at target tumour site following KORTUC injections (10-point scale)
Measured: During radiotherapy, an average of 3 weeks
Proportion of patients withdrawing from study due to pain from intratumoural injections recorded at 2-week post-RT visit
Measured: During radiotherapy, an average of 3 weeks
Patient-reported quality of life questionnaires (EORTC QLQ-C30 and BR23)
Measured: During 24-month follow up period
Resource use and health-related quality of life (EQ-5D-5L) for health economics analysis
Measured: During 24-month follow up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start16 Jun 2020
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Institute of Cancer Research, United KingdomThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Cancer Research, United Kingdom
- Sponsor type
- University, hospital or other
- Collaborators
- Kortuc, Inc.
- Responsible party
- Sponsor
- Investigators
- Navita Somaiah, Principal investigator, The Institute of Cancer Research & The Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03946202
- Sponsor's protocol ID
- CCR5119
- Other IDs
- 2019-001709-25, 2019
- Status last verified
- Aug 2026
- First submitted
- 8 May 2019
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Phase II Trial Testing Efficacy of Intra-tumoural Hydrogen Peroxide as a Radiation Sensitiser in Patients With Locally Advanced/Recurrent Breast Cancer
- ClinicalTrials.gov ID
- NCT03946202
- Acronym / sponsor ID
- CCR5119
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Institute of Cancer Research, United KingdomUniversity, hospital or other
- Collaborators
- Kortuc, Inc.
- Study start
- 16 Jun 2020 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 10 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Aim: To test a slow release gel containing a commonly available and inexpensive chemical (hydrogen peroxide) for safety and activity in sensitizing large cancerous lumps in the breast or armpit to a standard 3-week course of radiotherapy in patients with locally advanced or recurrent breast cancer.
Background: Laboratory research and initial clinical trials conducted in Japan raises the possibility that a simple and inexpensive treatment based on a very dilute (0.5%) hydrogen peroxide injected into cancers under local anaesthetic greatly increases the effectiveness of standard doses of radiotherapy. The side effects appear to be limited to mild/moderate discomfort at the injection site for up to 24 hours in one-third of patients. Rapid, complete and durable tumour disappearance has been reported in 49/55 bulky breast cancers in Japanese women treated using this approach, a response that is at least 3 times the success rate of radiotherapy alone in our own patients and in a contemporary Japanese control population. The inventor, Prof Ogawa of Kochi University, has approached the investigators to lead the further clinical evaluation and commercial development, starting with the proposed early phase trials testing safety and anti-cancer activity described below.
Design and methods: After numbing the skin with local anaesthetic, a specialist doctor (radiologist) or trained radiographer will use ultrasound to guide the injection of a small volume of dilute (0.5%) hydrogen peroxide solution into the tumour twice a week during 3 weeks of standard radiotherapy. The drug is suspended in a natural gel (1% sodium hyaluronate, licensed for treating stiff knee joints) that ensures its slow release over 48 hours. The injection procedure lasts for 10-15 minutes altogether. Tiny oxygen bubbles are released from the hydrogen peroxide which help the radiologist guide the injection of drug to the proper places under the skin. We have recently completed a safety study confirming the mildness of side effects in 12 patients, and we now wish to test activity against cancer in a randomised controlled trial in 184 patients. Patients participating in Phase II will either have standard radiotherapy or the same radiotherapy plus the drug under test. Neither the patient nor the doctor will choose who has which treatment, which is allocated randomly.
Patient and public involvement: Independent Cancer Patient Voice, a patient advocate group in the field of cancer, is collaborating with the investigators on the research plan, commenting and advising on the content and clarity of the written proposal. This group plays a prominent role in promoting UK clinical research, being represented on the Trial Management Groups of several national randomised cancer clinical trials.
Dissemination: The results of this study will be presented at scientific meetings and at meetings of the patient advocate group in order to judge if the results for safety and activity are promising enough to justify taking the research further.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy + radiation sensitiser | Experimental | Drug: Hydrogen PeroxidePatients randomised to the test group will receive standard radiotherapy for breast cancer + a radiation sensitiser |
| Radiotherapy alone | No intervention | –Patients randomised to the control group will receive standard radiotherapy for breast cancer alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrogen PeroxideHydrogen Peroxide | Drug | Radiotherapy + radiation sensitiser |
Primary outcome
Complete tumour response based on best response assessed by contrast enhanced MRI according to criteria outlined in Section 3.2.1 of the trial protocol, performed up to and including 12 months post radiotherapy
Time frame: Up to and including 12 months post radiotherapy
11 secondary outcomes
Overall survival at 6, 12 and 24 months
Time frame: 6, 12 and 24 months post radiotherapy
Loco-regional progression-free survival and distant recurrence at 6, 12 and 24 months
Time frame: 12 and 24 months post radiotherapy
Proportion of patients with either complete response on MRI up to and including 12 months or pathological complete response following tumour resection before 12 months
Time frame: Up to and including 12 months post radiotherapy
Proportion of patients with partial response and stable disease
Time frame: 12 and 24 months post radiotherapy
Planned/unplanned tumour excision and pathological response recorded at post-RT follow-up visits
Time frame: During 24-month follow up period
Adverse events (assessed by NCI CTCAE v5.0)
Time frame: Up to 90 days post radiotherapy
Compliance with KORTUC injections prior to radiotherapy
Time frame: During radiotherapy, an average of 3 weeks
Pain at target tumour site following KORTUC injections (10-point scale)
Time frame: During radiotherapy, an average of 3 weeks
Proportion of patients withdrawing from study due to pain from intratumoural injections recorded at 2-week post-RT visit
Time frame: During radiotherapy, an average of 3 weeks
Patient-reported quality of life questionnaires (EORTC QLQ-C30 and BR23)
Time frame: During 24-month follow up period
Resource use and health-related quality of life (EQ-5D-5L) for health economics analysis
Time frame: During 24-month follow up period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Navita Somaiah principal investigator
The Institute of Cancer Research & The Royal Marsden NHS Foundation Trust
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hydrogen Peroxide in people with Breast Cancer, run by Institute of Cancer Research, United Kingdom at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United Kingdom, India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete tumour response based on best response assessed by contrast enhanced MRI according to criteria outlined in Section 3.2.1 of the trial protocol, performed up to and including 12 months post radiotherapy (time frame: Up to and including 12 months post radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.