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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm | Experimental | Treatment with Rhenium-SCT, Single treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rhenium-SCT | Device | Rhenium-SCT irradiation device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response (CR) with Modified Visual RECIST tool | To assess the proportion of lesions achieving complete response (CR) as per MODIFIED VISUAL RECIST criteria | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 6 months and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety as assessed by CTCAE v4.0 | Adverse events by severity and by relationship to Rhenium-SCT, including radiation dermatitis, dry skin, skin ulceration, alopecia, skin induration, hypo/hyperpigmentation, and telangiectasia. Adverse events will be coded using MedDRA and comprehensively summarised by System Organ Class (SOC) and Preferred Term (PT) overall, by severity and by relationship to Rhenium-SCT. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gerhard Dr Dahlhoff, MD | Oncobeta GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Genesis Care Health Hub at RNS | Sydney | New South Wales | 2065 | Australia | ||
| John Flynn Hospital |
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| 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. |
| 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. | 12 months and 24 months |
| 24 months |
| Tugun |
| Queensland |
| 4224 |
| Australia |
| Hollywood Private | Perth | Western Australia | 6009 | Australia |
| Klinik Ottakring | Ottakring | 1160 | Austria |
| Rostock University Hospital | Rostock | 18057 | Germany |
| Steve Beko Hospital | Pretoria | 0001 | South Africa |
| Kings College Hospital London | London | United Kingdom |