Oncobeta EPIC-SKIN (OB-RHSCT-101)
Efficacy of Personalised Irradiation with Rhenium-SCT Skin Cancer Therapy (SCT) for the treatment of non-melanoma skin cancer; a phase IV, multi-centre, international, open label, single arm study
- Stage I or II BCC or SCC (SCC Well to Moderately Differentiated), and clinically node negative disease
- Confirmed Histology, and with depth of lesion noted
- Subjects with up to 3 lesions suitable to enter the study (subjects with more than 3 lesions are not excluded from the study, however 3 target lesions are determined for study evaluation only.)
- Lesions up to 8cm2
- Patients who may have declined Surgery and/or fractionated Radiation Therapy
- Lesions with a depth up to 3mm confirmed on biopsy report AND deemed appropriate clinically by treating clinician
- Subjects who are not deemed suitable for surgery, for example due to tumour location, performance status or other comorbidities as deemed relevant by the treating clinician
The EPIC Skin study is based on the proven effect of the ß-emitter rhenium-188 in the treatment of basal cell (BCC) and squamous cell carcinomas (SCC). The Aim of the study is to further evaluate the efficacy of Rhenium-SCT® as well as important Patient Reported Outcome Measures such as quality of life, treatment comfort and cosmetic outcomes.
The study will enrol a minimum number of 175 adult patients in a number of countries with a confirmed histologically of stage I or II non-melanoma skin cancer to participate for 12 months, with a follow up period to 24 months.