NCT03946202

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
184

participants targeted

Target at P75+ for phase_2 breast-cancer

Timeline
26mo left

Started Jun 2020

Longer than P75 for phase_2 breast-cancer

Geographic Reach
2 countries

10 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Jun 2020Jun 2028

First Submitted

Initial submission to the registry

May 8, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 10, 2019

Completed
1.1 years until next milestone

Study Start

First participant enrolled

June 16, 2020

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

March 27, 2026

Status Verified

February 1, 2026

Enrollment Period

8 years

First QC Date

May 8, 2019

Last Update Submit

March 23, 2026

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

    Up to and including 12 months post radiotherapy

Secondary Outcomes (11)

  • Overall survival at 6, 12 and 24 months

    6, 12 and 24 months post radiotherapy

  • Loco-regional progression-free survival and distant recurrence at 6, 12 and 24 months

    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

    Up to and including 12 months post radiotherapy

  • Proportion of patients with partial response and stable disease

    12 and 24 months post radiotherapy

  • Planned/unplanned tumour excision and pathological response recorded at post-RT follow-up visits

    During 24-month follow up period

  • +6 more secondary outcomes

Study Arms (2)

Radiotherapy + radiation sensitiser

EXPERIMENTAL

Patients randomised to the test group will receive standard radiotherapy for breast cancer + a radiation sensitiser

Drug: Hydrogen Peroxide

Radiotherapy alone

NO INTERVENTION

Patients randomised to the control group will receive standard radiotherapy for breast cancer alone

Interventions

Hydrogen PeroxideDRUG

Hydrogen Peroxide

Radiotherapy + radiation sensitiser

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Regional Cancer Centre (RCC)

Trivandrum, Kerala, 695011, India

RECRUITING

Christian Medical Centre

Vellore, Tamil Nadu, 632004, India

RECRUITING

Tata Medical Centre

Kolkata, West Bengal, 700160, India

RECRUITING

Tata Memorial Centre

Mumbai, India

RECRUITING

Royal Cornwall Hospitals NHS Trust

Truro, Cornwall, TR1 3LJ, United Kingdom

RECRUITING

Beatson West of Scotland Cancer Centre

Glasgow, Scotland, G12 0YN, United Kingdom

RECRUITING

Cambridge University Hospitals NHS Foundation Trust

Cambridge, CB2 0QQ, United Kingdom

RECRUITING

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

RECRUITING

University Hospitals of North Midlands NHS Trust

Stoke-on-Trent, ST4 6QG, United Kingdom

RECRUITING

The Royal Marsden NHS Foundation Trust

Sutton, SM2 5PT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Hydrogen Peroxide

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

PeroxidesOxidesAnionsIonsElectrolytesInorganic ChemicalsReactive Oxygen SpeciesFree RadicalsOxygen CompoundsOrganic Chemicals

Study Officials

  • Navita Somaiah

    The Institute of Cancer Research & The Royal Marsden NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lone Gothard

CONTACT

+44(0)2086613460lone.gothard@icr.ac.uk

Justine Hughes

CONTACT

+44(0)2086613273justine.hughes@icr.ac.uk

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2019

First Posted

May 10, 2019

Study Start

June 16, 2020

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2028

Last Updated

March 27, 2026

Record last verified: 2026-02

Locations

IN(4)GB(6)