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

  • STATUS
    Recruiting
  • End date
    May 15, 2024
  • participants needed
    210
  • sponsor
    OncoBeta Therapeutics
Updated on 20 April 2022

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.

Details
Condition Non-melanoma Skin Cancer
Treatment Rhenium-SCT
Clinical Study IdentifierNCT05135052
SponsorOncoBeta Therapeutics
Last Modified on20 April 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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