Breast CancerPhase 1/2NCT02757651
KORTUC: Intra-tumoural Hydrogen Peroxide as a Radiation Sensitizer in Patients With Locally Advanced/Recurrent Breast Cancer in Terms of Toxicity and Tumour Response
A Phase 1/2 study testing Hydrogen Peroxide in people with Breast Cancer, run by Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.
Trial summary
This is a study aimed at testing a commonly available and inexpensive chemical (hydrogen peroxide) for safety and activity in sensitising large cancerous lumps in the breast to a standard course of radiotherapy in women with poorly controlled symptoms. 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
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Jan 2017to 12 Nov 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- Age over 18 years
- 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
- At least one tumour diameter ≥30 mm measurable by ultrasound or magnetic resonance imaging
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- Patient available for minimum 3 months follow up post-treatment prior to any surgical resection
- Negative pregnancy test within 7 days of starting 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
Who cannot join
- Prior radiotherapy to the target area
- Anatomical location \&/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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Royal Marsden NHS Foundation Trust
London, SW3 6JJ
About this study
Official title: Phase I 'Run in' Study Followed by Randomised Phase II Trial Testing Intra-tumoural Hydrogen Peroxide as a Radiation Sensitizer in Women With Locally Advanced/Recurrent Breast Cancer in Terms of Toxicity and Tumour Response
This is a study aimed at testing a commonly available and inexpensive chemical (hydrogen peroxide) for safety and activity in sensitising large cancerous lumps in the breast to a standard course of radiotherapy in women with poorly controlled symptoms. 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
PLEASE NOTE: Phase II of this protocol will now be conducted under protocol CCR5119/IRAS 264012 (NCT03946202)
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 women with poorly controlled symptoms.
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. The investigators want to test this approach, starting with a careful study of side effects in 12 patients (pilot study) followed by a randomised trial in 84 patients to test activity against cancer (Phase II). 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. Review of the Pilot study data by an independent committee of experts will be completed before starting the phase II (efficacy) study.
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 sensitizer | Experimental | Patients in phase I and patients randomised to the test group in phase II will receive standard radiotherapy for breast cancer + a radiation sensitizer Receives: Drug: Hydrogen Peroxide |
| Radiotherapy alone | No intervention | Patients randomised to the control group in phase II 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.
Phase I: Patient reported maximum intra-tumoural pain intensity over duration of treatment
Measured: During radiotherapy
Phase II: Tumour response 3 months post-radiotherapy according to RECIST 1.1 criteria
Measured: 3 months months post radiotherapy
Secondary outcomes (4)
Phase I: Proportion of patients with severe pain at any time before and up to 24 hours after any of the KORTUC injections. Server Sever pain is defined as scoring a max grade ≥5 above baseline
Measured: During radiotherapy and 3 months post radiotherapy
Phase II: Proportion of patients with severe pain at any time before and up to 24 hours after any of the KORTUC injections. Server pain is defined as scoring a max grade ≥5 above baseline Frequency and duration of pain score ≥1 at each time point
Measured: During radiotherapy & 3 and 24 months post radiotherapy
Phase I: Tumour response 3 months post- radiotherapy according to RECIST 1.1 criteria
Measured: 3 months post radiotherapy
Phase II: Local progression-free survival at 24 months
Measured: 24 months post radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study start19 Jan 2017
- Primary completion12 Nov 2020
- Study completion12 Nov 2020
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
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 and The Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02757651
- Sponsor's protocol ID
- CCR4502
- Status last verified
- Nov 2020
- First submitted
- 27 Apr 2016
- Last updated
- 27 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I 'Run in' Study Followed by Randomised Phase II Trial Testing Intra-tumoural Hydrogen Peroxide as a Radiation Sensitizer in Women With Locally Advanced/Recurrent Breast Cancer in Terms of Toxicity and Tumour Response
- ClinicalTrials.gov ID
- NCT02757651
- Acronym / sponsor ID
- CCR4502
- Conditions
- Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Institute of Cancer Research, United KingdomUniversity, hospital or other
- Collaborators
- Kortuc, Inc.
- Study start
- 19 Jan 2017 (actual)
- Primary completion
- 12 Nov 2020 (actual)
- Study completion
- 12 Nov 2020 (actual)
- First posted
- 2 May 2016 (estimated)
- 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 safety and activity in sensitising large cancerous lumps in the breast to a standard course of radiotherapy in women with poorly controlled symptoms. 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
PLEASE NOTE: Phase II of this protocol will now be conducted under protocol CCR5119/IRAS 264012 (NCT03946202)
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 women with poorly controlled symptoms.
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. The investigators want to test this approach, starting with a careful study of side effects in 12 patients (pilot study) followed by a randomised trial in 84 patients to test activity against cancer (Phase II). 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. Review of the Pilot study data by an independent committee of experts will be completed before starting the phase II (efficacy) study.
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
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy + radiation sensitizer | Experimental | Drug: Hydrogen PeroxidePatients in phase I and patients randomised to the test group in phase II will receive standard radiotherapy for breast cancer + a radiation sensitizer |
| Radiotherapy alone | No intervention | –Patients randomised to the control group in phase II 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 (9 listed)
- Age over 18 years
- 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
Key exclusion criteria (2 listed)
- Prior radiotherapy to the target area
- Anatomical location \&/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
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 sensitizer |
Primary outcome
Phase I: Patient reported maximum intra-tumoural pain intensity over duration of treatment
Time frame: During radiotherapy
Phase II: Tumour response 3 months post-radiotherapy according to RECIST 1.1 criteria
Time frame: 3 months months post radiotherapy
4 secondary outcomes
Phase I: Proportion of patients with severe pain at any time before and up to 24 hours after any of the KORTUC injections. Server Sever pain is defined as scoring a max grade ≥5 above baseline
Time frame: During radiotherapy and 3 months post radiotherapy
Phase II: Proportion of patients with severe pain at any time before and up to 24 hours after any of the KORTUC injections. Server pain is defined as scoring a max grade ≥5 above baseline Frequency and duration of pain score ≥1 at each time point
Time frame: During radiotherapy & 3 and 24 months post radiotherapy
Phase I: Tumour response 3 months post- radiotherapy according to RECIST 1.1 criteria
Time frame: 3 months post radiotherapy
Phase II: Local progression-free survival at 24 months
Time frame: 24 months post radiotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2020.
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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 and The Royal Marsden NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Hydrogen Peroxide in people with Breast Cancer, run by Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.
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 9 inclusion and 2 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: finished, as of the sponsor's last update on 27 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Phase I: Patient reported maximum intra-tumoural pain intensity over duration of treatment (time frame: During radiotherapy). The study lists 2 primary outcomes in all. 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 27 Nov 2020.