Efficacy of Personalised Irradiation with Rhenium-Skin Cancer Therapy (SCT) for the treatment of non-melanoma skin cancer; a phase IV multi-centre, international, open label, single arm study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
210
Rhenium-SCT irradiation device
Genesis Care Health Hub at RNS
Sydney, New South Wales, Australia
John Flynn Hospital
Tugun, Queensland, Australia
Hollywood Private
Perth, Western Australia, Australia
Klinik Ottakring
Ottakring, Austria
Complete Response (CR) with Modified Visual RECIST tool
To assess the proportion of lesions achieving complete response (CR) as per MODIFIED VISUAL RECIST criteria
Time frame: 12 months
SKINDEX-16 QoL Questionnaire
The QoL questionnaire will be scored according to the author's instructions. Change from baseline in score will be calculated. Descriptive statistics will be presented for actual score and change from baseline by timepoint, overall and by tumour type (BCC/SCC).
Time frame: 6 months and 12 months
Comfort of Treatment short questionnaire
Comfort of treatment assessed using a short questionnaire completed by subjects post treatment with Rhenium-SCT. The frequency (and percentage) of subjects reporting each option for each question will be presented.
Time frame: 14 days
cosmetic outcomes by Visual Analogue Scale
Cosmetic outcome assessed by subject and Clinician, using Visual Analogue Scale. Descriptive statistics will be presented overall and by tumour type (BCC or SCC). A mixed model will be fitted with Visual Analogue Scale as the outcome variable. Tumour type and tumour stage will be included as factors. Other relevant prognostic factors assessed at Baseline will be included. From the model the adjusted mean score will be obtained and presented with 95% confidence limits. Adjusted mean score will be estimated overall and by tumour type.
Time frame: 12 months and 24 months
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Rostock University Hospital
Rostock, Germany
Steve Beko Hospital
Pretoria, South Africa
Kings College Hospital London
London, United Kingdom