Rhenium-Skin Cancer Therapy (SCT) for the Treatment of Non-Melanoma Skin Cancer.

Non-melanoma Skin Cancer Clinical Trial

— EPIC-Skin  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05135052
• Other study ID #: OB-RHSCT-101
• Status: Recruiting
• Phase: N/A
• Start date: January 17, 2022
• Est. completion date: May 15, 2024

Study information

• Verified date: March 2022
• Source: OncoBeta International GmbH
• Contact: Gerhard Dr Dahlhoff, MD
• Phone: 08136808989
• Email: gerhard.dahlhoff[@]oncobeta.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: May 15, 2024
• Est. primary completion date: July 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Non-melanoma Skin Cancer
• Skin Neoplasms

Intervention

Device:
• Rhenium-SCT
Rhenium-SCT irradiation device

Locations

Country	Name	City	State
Australia	Genesis Care Health Hub at RNS	Sydney	New South Wales
Australia	John Flynn Hospital	Tugun	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
OncoBeta Therapeutics

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	24 months
Primary	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
Secondary	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
Secondary	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
Secondary	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