A Pilot Randomised Controlled Pilot Study to Assess the Efficacy of Photodynamic Therapy vs. Radiotherapy for Superficial Skin Cancer.
A Randomised Controlled Pilot Study to Assess the Efficacy of Photodynamic Therapy vs. Radiotherapy for the Control of Basal Cell Carcinoma and Bowen's Disease.
St Vincent's Hospital, Sydney
100 participants
Oct 1, 2018
Interventional
Conditions
Summary
This study's purpose is to compare photodynamic therapy with radiation therapy (RT) for superficial skin cancer. Who is it for? You may be eligible to join this study if you have received a biopsy-proven diagnosis of superficial basal cell carcinoma or Bowen’s disease, for which you have received no previous treatment. Study Details: Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will receive photodynamic therapy, which involves the application of a topical agent to the area to be treated, and then application of a certain type of light. A red light will be placed 5-8cm away from your skin surface for approximately 9 minutes. You will receive two sets of treatment 1-4 weeks apart. Participants assigned to the other group will receive radiation therapy, which involves highly-focused radiation from outside the body onto the lesion site to destroy cancerous cells. Participants will be asked to undergo clinical assessments (including photos to assess cosmetic outcomes) and complete questionnaires before treatment and 3 months, 1 year and 2 years post-treatment. It is hoped that this research will provide insight in the efficacy and cosmetic outcomes of two different types of non-surgical intervention of skin cancer.
Eligibility
Inclusion Criteria8
- Biopsy-proven superficial BCC or Bowen’s disease.
- De novo lesions; i.e. lesions previously untreated.
- Lesion able to be treated by PDT or RT.
- Lesion originally at least 10mm in maximum dimension(this is to facilitate a single 3mm punch biopsy needed for diagnosis and for an optional translation study based on immunohistochemical staining of the diagnostic biopsy).
- 18 years or older.
- Patient is not suitable for surgery either because surgery is too great a burden, the patient is not capable of having surgery (usually due to comorbidity) or has refused surgery.
- Immunosuppressed patients to be included (HIV, Transplant, Auto immune being actively treated (i.e. with chemotherapy (CTX) or steroid dose over 7mg prednisolone equivalent daily) with stratification.
- Life expectancy of at least 2 years.
Exclusion Criteria9
- Lesions unsuitable for PDT or radiotherapy: More infiltrative skin cancers (including nodular, micronodular, infiltrative, morphoeic BCC or infiltrating SCC); Perineural invasion; Subungual lesions; Perioccular lesions unable to be treated by PDT or RT; Larger than PDT field (8x18cm); Pigmented BCC; Genital and perianal lesions
- Aged under 18 years
- Unable to attend treatment for practical reasons
- Porphyria, SLE
- Pregnancy, lactation
- Unable to have RT – e.g. Gorlins, XP.
- Photosensitive disorder to visible light spectrum
- Hypersensitivity to the Metvix cream
- Previous treatment to index lesion
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Interventions
The participant will be randomised 1:1 to Photodynamic Therapy or Radiotherapy. A Dermatologist will be responsible for the Photodynamic Therapy as part of their normal practice. Photodynamic Therapy involves the application of a topical photosensitising agent, Methyl Aminolevulinate Hydrochloride (MAL) cream, to the area to be treated. 160mg/g is applied with a 10mm margin at least 1mm thick. Occlusive and opaque dressing is then applied for 3 hours. The application of MAL makes Basal Cell Carcinoma/Bowen's Disease cells sensitive to a certain type of light. Illumination leads to the release of reactive oxygen species within the target tissue. Local anaesthesia with 1% lignocaine by injection (subcutaneous or dermal) will be offered prior to illumination. The area is illuminated with noncoherent red light at a wavelength of 630 nm for a total dose of 37 joules/cm2. The light source is placed 5-8cm away, and parallel to the skin surface. The duration of illumination is approximately 9 minutes. When the area is exposed to the light source, neoplastic cells are destroyed by either necrosis or apoptosis. Illumination is given as two 'fractions' approximately 1-4 weeks apart. This treatment is available on Medicare at St Vincent's Hospital, Sydney.
Locations(1)
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ACTRN12615001061527