Non-melanoma Skin Cancer
Conditions
Brief summary
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.
Interventions
DEVICERhenium-SCT
Rhenium-SCT irradiation device
Sponsors
OncoBeta Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Stage I or II BCC or SCC (SCC Well to Moderately Differentiated), and clinically node negative disease 2. Confirmed Histology, and with depth of lesion noted 3. 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.) 4. Subjects able and willing to comply with the requirements of the study 5. Age \>=18 years 6. Informed Consent signed by the subject consenting to undergo the study 7. Lesions up to 8cm2 8. Lesions with a depth up to 3mm confirmed on biopsy report AND deemed appropriate clinically by treating clinician 9. 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 10. Patients who may have declined Surgery and/or fractionated Radiation Therapy
Exclusion criteria
1. Inability to personally provide written informed consent or to understand and collaborate throughout the study 2. Inability or unwillingness to comply with study requirements 3. Prior treatment with surgery or radiation therapy for their target lesion(s) 4. Depth of lesion greater than 3mm as defined by Biopsy and/or clinical assessment 5. Lupus and Scleroderma 6. Basal cell naevus syndrome, xeroderma, vitiligo and albinism 7. Prior laser at the tumour site 8. Malignant melanoma systemic therapy ongoing 9. Any ongoing treatment for malignancy, or in the last 4 weeks prior to study entry 10. A tumour affecting nerves or bony structures 11. Clinical concern of metastatic disease 12. Pregnancy and/or Lactation 13. Pathological exclusions: Perineural Invasion, Lymphovascular invasion 14. Anatomical exclusions: NMSC's of the Medial canthus, eyelid margin (upper and lower), Vermillion lip
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Response (CR) with Modified Visual RECIST tool | 12 months | To assess the proportion of lesions achieving complete response (CR) as per MODIFIED VISUAL RECIST criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SKINDEX-16 QoL Questionnaire | 6 months and 12 months | 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). |
| Comfort of Treatment short questionnaire | 14 days | 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. |
| cosmetic outcomes by Visual Analogue Scale | 12 months and 24 months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety as assessed by CTCAE v4.0 | 24 months | 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. |
Countries
Australia, Austria, Germany, South Africa, United Kingdom
Outcome results
None listed