Clinical trial NCT05135052: Rhenium-Skin Cancer Therapy (SCT) for the Treatment of Non-Melanoma Skin Cancer.
Official title: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Non-melanoma Skin Cancer
Lead sponsor: OncoBeta International GmbH
Sponsor class: INDUSTRY
First posted: 2021-11-26
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Complete Response (CR) with Modified Visual RECIST tool
timeFrame: 12 months
Secondary outcomes:
measure: SKINDEX-16 QoL Questionnaire
timeFrame: 6 months and 12 months
measure: Comfort of Treatment short questionnaire
timeFrame: 14 days
measure: cosmetic outcomes by Visual Analogue Scale
timeFrame: 12 months and 24 months
Other outcomes:
measure: Safety as assessed by CTCAE v4.0
timeFrame: 24 months
Locations:
city: Sydney
country: Australia
facility: Genesis Care Health Hub at RNS
state: New South Wales
city: Tugun
country: Australia
facility: John Flynn Hospital
state: Queensland
city: Perth
country: Australia
facility: Hollywood Private
state: Western Australia
city: Ottakring
country: Austria
facility: Klinik Ottakring
city: Rostock
country: Germany
facility: Rostock University Hospital
city: Pretoria
country: South Africa
facility: Steve Beko Hospital
city: London
country: United Kingdom
facility: Kings College Hospital London
Study officials:
affiliation: Oncobeta GmbH
name: Gerhard Dr Dahlhoff, MD
role: STUDY_DIRECTOR
References: