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

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 months later Jun 30, 2028 → Aug 31, 2028
See other at-risk trials from Institute of Cancer Research, United Kingdom

Record History

See every version on ClinicalTrials.gov ↗

  1. Enrollment closed, study ongoing
    • Primary and study completion pushed from Jun 30, 2028 to Aug 31, 2028
    • Site details revised at 10 of 10 sites
    v16
  2. Primary completion date: Apr 30, 2027 to Jun 30, 2028
    • Study sites: 9 to 10
    • Study completion date: Apr 30, 2028 to Jun 30, 2028
    v15
  3. Primary completion date: Nov 30, 2027 to Apr 30, 2027
    • Study completion date: Nov 30, 2027 to Apr 30, 2028
    v14
  4. Primary and study completion dates: Dec 31, 2026 to Nov 30, 2027
    • Study sites: 8 to 9
    v13
  5. Study sites revised (8)v12
Show 10 earlier versionsHide 10 earlier versions
  1. Primary endpoint revised
    • Eligibility criteria revised
    • Secondary endpoints: 6 to 11
    • Site contacts updated at 2 of 8 sites
    v11
  2. Study sites: 6 to 8v10
  3. Primary and study completion dates: Jun 16, 2025 to Dec 31, 2026
    • Eligibility criteria expanded, about 8 words
    v9
  4. Study sites: 4 to 6v8
  5. Study sites: 1 to 4v7
  6. Trial status: Not Yet Recruiting to Recruitingv6 Show 4 more changesShow less
    • Primary completion date: Mar 1, 2024 to Jun 16, 2025
    • Start date changed from estimate of Mar 1, 2020 to Jun 16, 2020
    • Study sites: 0 to 1
    • Study completion date: Mar 1, 2025 to Jun 16, 2025
  7. Enrollment target: 144 to 184v5
  8. Start date: Nov 1, 2019 to Mar 1, 2020
    • Primary completion date: Nov 1, 2023 to Mar 1, 2024
    • Study completion date: Nov 1, 2024 to Mar 1, 2025
    v4
  9. Start date: Sep 1, 2019 to Nov 1, 2019
    • Primary completion date: Sep 1, 2023 to Nov 1, 2023
    • Study completion date: Sep 1, 2024 to Nov 1, 2024
    • Eligibility criteria expanded, about 14 words
    v3
  10. Collaborators expanded, about 2 wordsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT03946202
Lead Sponsor Institute of Cancer Research, United Kingdom
Collaborators: Kortuc, Inc.
Conditions
(from sponsor)		 Breast Cancer
Related terms Breast Neoplasms
Enrollment 184 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov