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

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.

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 Overview

• Status: Recruiting
• Conditions: Non-melanoma Skin Cancer
• Intervention / Treatment: Device: Rhenium-SCT

• Study Type: Interventional
• Enrollment (Anticipated): 210
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gerhard Dr Dahlhoff, MD; Phone Number: 08136808989; Email: gerhard.dahlhoff@oncobeta.com
• Study Contact Backup: Name: Sam Dr Vohra, PhD; Phone Number: +61450556969; Email: sam@avionmedical.com.au

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2065
      • Recruiting
      • Genesis Care Health Hub at RNS
      • Contact: Angela Prof Hong
  • Queensland
    • Tugun, Queensland, Australia, 4224
      • Recruiting
      • John Flynn Hospital
      • Contact: Sid Prof Baxi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment arm; Treatment with Rhenium-SCT, Single treatment.	Device: Rhenium-SCT; Rhenium-SCT irradiation device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Other Outcome Measures

Outcome Measure	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.	24 months

Collaborators and Investigators

• Sponsor: OncoBeta Therapeutics
• Investigators: Study Director: Gerhard Dr Dahlhoff, MD, Oncobeta GmbH

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2022
• Primary Completion (Anticipated): July 15, 2023
• Study Completion (Anticipated): May 15, 2024

Study Registration Dates

• First Submitted: October 8, 2021
• First Submitted That Met QC Criteria: November 13, 2021
• First Posted (Actual): November 26, 2021

Study Record Updates

• Last Update Posted (Actual): April 8, 2022
• Last Update Submitted That Met QC Criteria: March 30, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Skin Neoplasms
• Other Study ID Numbers: OB-RHSCT-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No