Breast Cancer Clinical Trial
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
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.
Status | Recruiting |
Enrollment | 184 |
Est. completion date | November 30, 2027 |
Est. primary completion date | November 30, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 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 |
Country | Name | City | State |
---|---|---|---|
India | Tata Medical Centre | Kolkata | West Bengal |
India | Regional Cancer Centre (RCC) | Trivandrum | Kerala |
India | Christian Medical Centre | Vellore | Tamil Nadu |
United Kingdom | Cambridge University Hospitals NHS Foundation Trust | Cambridge | |
United Kingdom | Beatson West of Scotland Cancer Centre | Glasgow | Scotland |
United Kingdom | The Christie NHS Foundation Trust | Manchester | |
United Kingdom | University Hospitals of North Midlands NHS Trust | Stoke-on-Trent | |
United Kingdom | The Royal Marsden NHS Foundation Trust | Sutton | |
United Kingdom | Royal Cornwall Hospitals NHS Trust | Truro | Cornwall |
Lead Sponsor | Collaborator |
---|---|
Institute of Cancer Research, United Kingdom | Kortuc, Inc. |
India, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Overall survival at 6, 12 and 24 months | 6, 12 and 24 months post radiotherapy | ||
Secondary | Loco-regional progression-free survival and distant recurrence at 6, 12 and 24 months | 12 and 24 months post radiotherapy | ||
Secondary | 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 | ||
Secondary | Proportion of patients with partial response and stable disease | 12 and 24 months post radiotherapy | ||
Secondary | Planned/unplanned tumour excision and pathological response recorded at post-RT follow-up visits | During 24-month follow up period | ||
Secondary | Adverse events (assessed by NCI CTCAE v5.0) | Up to 90 days post radiotherapy | ||
Secondary | Compliance with KORTUC injections prior to radiotherapy | During radiotherapy, an average of 3 weeks | ||
Secondary | Pain at target tumour site following KORTUC injections (10-point scale) | During radiotherapy, an average of 3 weeks | ||
Secondary | Proportion of patients withdrawing from study due to pain from intratumoural injections recorded at 2-week post-RT visit | During radiotherapy, an average of 3 weeks | ||
Secondary | Patient-reported quality of life questionnaires (EORTC QLQ-C30 and BR23) | During 24-month follow up period | ||
Secondary | Resource use and health-related quality of life (EQ-5D-5L) for health economics analysis | During 24-month follow up period |
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