Basal Cell Carcinoma Clinical Trial
Official title:
A Phase 2 Double-blind Placebo Randomized Controlled Trial of 30% Topical Application of Hydrogen Peroxide as Neoadjuvant Treatment of Non-melanoma Skin Cancers Prior to Definitive Surgery or Radiation
Previous work suggests that topical treatment with 33% hydrogen peroxide can reduce lesion size and, in about half of patients, can cause complete pathologic response. For patients with reduction in lesions size, the required size of the surgical excision or radiation field will be similarly decreased, thus potentially limiting associated morbidity and better cosmetic outcomes. Additionally, patients that experience a complete pathological response will be able to avoid additional treatment with either surgery or radiation. This will benefit both patients as well as helping to decreased use of health care resources. For the current study we will be using 30% hydrogen peroxide as it is commercially available. If this study shows positive results, it could lead to significant benefit on both a patient and systems level. Locally, our cancer Centre treats approximately 700 new patients per year who fit into the study criteria and could potentially benefit from this novel neoadjuvant treatment that is fairly inexpensive.
Status | Recruiting |
Enrollment | 51 |
Est. completion date | December 2023 |
Est. primary completion date | August 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Pathologically confirmed measurable basal cell carcinoma (BCC) or well to moderately differentiated squamous cell carcinoma (SCC) - Age 18 years or older - Able to provide informed consent Exclusion Criteria: - Lesion with indistinct borders - Any evidence of metastatic disease - Poor performance status (Eastern Cooperative Oncology Group > 1) with life expectancy of less than 2 years - Gorlins syndrome, a genetic predisposition to multiple skin cancers where surveillance and early intervention is of paramount importance - Any recurrent cancer after surgery or radiation - Very extensive carcinoma that cannot be readily removed by surgery or treated by radiation using orthovoltage or electron beam - History of cutaneous photosensitization, porphyria or photodimerization as their tolerance to hydrogen peroxide application is unpredictable - Previous application of 5-Fluorouracil cream to the lesion within the last 8 weeks - Any immune-compromised patients where skin cancers can be very aggressive - Patients who are unwilling to return for 1-year follow-up assessment - Poorly differentiated SCC |
Country | Name | City | State |
---|---|---|---|
Canada | London Regional Cancer Program | London | Ontario |
Lead Sponsor | Collaborator |
---|---|
Lawson Health Research Institute |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in lesion size | Reduction in lesion size, measured in square centimeter, 4 weeks after the last application of hydrogen peroxide. | 4 weeks after the last application of hydrogen peroxide | |
Secondary | Proportion of Patients with complete response | Proportion of patients with complete response not requiring surgery or radiation. | At study completion, an approximate of 1 year | |
Secondary | Proportion of patients requiring definitive surgery | Proportion of patients requiring definitive surgery or radiation who achieve complete clinical response, but not complete pathological response following hydrogen peroxide treatment. | At study completion, an approximate of 1 year | |
Secondary | Size of surgically removed skin | Reduction in the size of the skin, measured in square centimeter, that needs to be surgically removed before and after hydrogen peroxide treatment for patients selecting surgery | At study completion, an approximate of 1 year | |
Secondary | Change in the size of the radiation field | Reduction in the size of the radiation field, measured in square centimeter, before and after hydrogen peroxide treatment for patients selecting radiation. | At study completion, an approximate of 1 year | |
Secondary | Local Control | Clinical local control at one year after randomization. | At study completion, an approximate of 1 year | |
Secondary | Adverse Events | Adverse events associated with hydrogen peroxide treatment, assessed using standardized questionnaire one week after each application. Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe, Grade 4: Life-threatening or disabling, Grade 5: Death. | At baseline, week 1, week 2, week 3, and also at 4 weeks after last hydrogen peroxide application. Adverse events will also be assessed at 3, 6, 9 and 12 months after the baseline visit. |
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