KORTUC: Intra-tumoural Hydrogen Peroxide as a Radiation Sensitizer in Patients With Locally Advanced/Recurrent Breast Cancer in Terms of Toxicity and Tumour Response

NCT02757651 | Completed Phase 1 DMC

• 1 other identifier: CCR4502
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Phase I: Patient reported maximum intra-tumoural pain intensity over duration of treatment

  During radiotherapy

• Phase II: Tumour response 3 months post-radiotherapy according to RECIST 1.1 criteria

  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

  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

  During radiotherapy & 3 and 24 months post radiotherapy

• Phase I: Tumour response 3 months post- radiotherapy according to RECIST 1.1 criteria

  3 months post radiotherapy

• Phase II: Local progression-free survival at 24 months

  24 months post radiotherapy

Study Arms (2)

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

Drug: Hydrogen Peroxide

Radiotherapy alone

NO INTERVENTION

Patients randomised to the control group in phase II will receive standard radiotherapy for breast cancer alone.

Interventions

Hydrogen Peroxide DRUG

Hydrogen Peroxide

Radiotherapy + radiation sensitizer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Cancer Research, United Kingdom: lead
• Kortuc, Inc.: collaborator

Study Sites (1)

The Royal Marsden NHS Foundation Trust

London, SW3 6JJ, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Hydrogen Peroxide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Peroxides; Oxides; Anions; Ions; Electrolytes; Inorganic Chemicals; Reactive Oxygen Species; Free Radicals; Oxygen Compounds; Organic Chemicals

Study Officials

• Navita Somaiah

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2016
• First Posted: May 2, 2016
• Study Start: January 19, 2017
• Primary Completion: November 12, 2020
• Study Completion: November 12, 2020
• Last Updated: November 27, 2020

Record last verified: 2020-11

Locations

GB (1)