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NCT Number: NCT05135052

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Non-Melanoma Skin Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Genesis Care Health Hub at RNS, Sydney, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.)
  • Subjects able and willing to comply with the requirements of the study
  • Age >=18 years
  • Informed Consent signed by the subject consenting to undergo the study
  • Lesions up to 8cm2
  • 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
  • Patients who may have declined Surgery and/or fractionated Radiation Therapy

Exclusion criteria

  • Inability to personally provide written informed consent or to understand and collaborate throughout the study
  • Inability or unwillingness to comply with study requirements
  • Prior treatment with surgery or radiation therapy for their target lesion(s)
  • Depth of lesion greater than 3mm as defined by Biopsy and/or clinical assessment
  • Lupus and Scleroderma
  • Basal cell naevus syndrome, xeroderma, vitiligo and albinism
  • Prior laser at the tumour site
  • Malignant melanoma systemic therapy ongoing
  • Any ongoing treatment for malignancy, or in the last 4 weeks prior to study entry
  • A tumour affecting nerves or bony structures
  • Clinical concern of metastatic disease
  • Pregnancy and/or Lactation
  • Pathological exclusions: Perineural Invasion, Lymphovascular invasion
  • Anatomical exclusions: NMSC's of the Medial canthus, eyelid margin (upper and lower), Vermillion lip

Treatment and study plan

Rhenium-SCT

Device

Rhenium-SCT irradiation device

Primary outcomes

  1. Complete Response (CR) with Modified Visual RECIST tool

    Time frame: 12 months

    To assess the proportion of lesions achieving complete response (CR) as per MODIFIED VISUAL RECIST criteria

Secondary outcomes

  1. SKINDEX-16 QoL Questionnaire

    Time frame: 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).

  2. Comfort of Treatment short questionnaire

    Time frame: 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.

  3. cosmetic outcomes by Visual Analogue Scale

    Time frame: 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 outcomes

  1. Safety as assessed by CTCAE v4.0

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

OncoBeta Therapeutics

Industry

Registry information

Official study 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.

Acronym: EPIC-Skin

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Nov 26, 2021
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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