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KORTUC Phase II - Intra-tumoural Radiation Sensitizer in Patients With Locally Advanced/Recurrent Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03946202
Recruitment Status : Recruiting
First Posted : May 10, 2019
Last Update Posted : June 24, 2020
Sponsor:
Collaborator:
Kortuc Inc.
Information provided by (Responsible Party):
Institute of Cancer Research, United Kingdom

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Hydrogen Peroxide Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 184 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 16, 2020
Estimated Primary Completion Date : June 16, 2025
Estimated Study Completion Date : June 16, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Radiotherapy + radiation sensitiser
Patients randomised to the test group will receive standard radiotherapy for breast cancer + a radiation sensitiser
Drug: Hydrogen Peroxide
Hydrogen Peroxide

No Intervention: Radiotherapy alone
Patients randomised to the control group will receive standard radiotherapy for breast cancer alone



Primary Outcome Measures :
  1. Complete tumour response 12 months post-radiotherapy assessed by MR [ Time Frame: 12 months post radiotherapy ]

Secondary Outcome Measures :
  1. 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 ]
  2. Patients achieving pathological complete response following tumour resection prior to the 12-month MR assessment will be included in a sensitivity analysis of the primary endpoint [ Time Frame: During 24-month follow up period ]
  3. Proportion of patients with partial response and stable disease [ Time Frame: 12 and 24 months post radiotherapy ]
  4. Planned/unplanned tumour excision and pathological response recorded at post-RT follow-up visits [ Time Frame: During 24-month follow up period ]
  5. Local progression-free survival at 12 and 24 months [ Time Frame: 12 and 24 months post radiotherapy ]
  6. Overall survival at 12 and 24 months [ Time Frame: 12 and 24 months post radiotherapy ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient age 18 years and over
  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03946202


Contacts
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Contact: Lone Gothard +44(0)2086613460 lone.gothard@icr.ac.uk
Contact: Claire Lucy +44(0)2086613273 claire.lucy@icr.ac.uk

Locations
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United Kingdom
The Royal Marsden NHS Foundation Trust Recruiting
Sutton, United Kingdom, SM2 5PT
Contact: Lone Gothard    02086613460    lone.gothard@icr.ac.uk   
Contact: Claire Lucy    02086613273    claire.lucy@icr.ac.uk   
Principal Investigator: Navita Dr Somaiah         
Sub-Investigator: Anna Dr Kirby         
Sub-Investigator: Imogen Dr Locke         
Sub-Investigator: Ross Dr Gillian         
Sponsors and Collaborators
Institute of Cancer Research, United Kingdom
Kortuc Inc.
Investigators
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Principal Investigator: Navita Somaiah The Institute of Cancer Research & The Royal Marsden NHS Foundation Trust
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Responsible Party: Institute of Cancer Research, United Kingdom
ClinicalTrials.gov Identifier: NCT03946202    
Other Study ID Numbers: CCR5119
2019-001709-25 ( EudraCT Number )
First Posted: May 10, 2019    Key Record Dates
Last Update Posted: June 24, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Hydrogen Peroxide
Anti-Infective Agents, Local
Anti-Infective Agents