Electronic Skin Surface Brachytherapy for Cutaneous Basal Cell and Squamous Cell Carcinoma

Study Overview
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Brief Summary
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The purpose of this study is to assess the effectiveness of electronic skin surface brachytherapy (ESSB) for early stage basal or squamous cell carcinoma of the skin using a new device. This new device is Nucletron's Esteya Electronic Skin Surface Brachytherapy System. The investigators want to understand what effects, good and/or bad this device for delivering brachytherapy has on your skin cancer. The investigators also want to assess the safety, cosmetic results, the effects that ESSB has on quality of life and to correlate skin imaging with clinical response to ESSB.

Official Title
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A Multicenter Pilot Study of Electronic Skin Surface Brachytherapy for Cutaneous Basal Cell and Squamous Cell Carcinoma

Conditions
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Cutaneous Basal Cell, Squamous Cell Carcinoma

Intervention / Treatment
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* Radiation: Electronic Skin Surface Brachytherapy
* Behavioral: Quality of life assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women ≥ 60 years old with estimated life expectancy of ≥ 5 years Histopathologic diagnosis of basal or squamous cell carcinoma Clinical stage T1N0M0 (by AJCC 2010 criteria) °Basal cell carcinoma with morpheaform, sclerosing, mixed, infiltrative or micronodular features must be ≤1 cm Low risk pathologic features (by AJCC 2010 criteria) Eastern Cooperative Oncology Group (ECOG) performance status of 0-3 (Appendix C) Able and willing to complete the Skindex16 and Skin Cancer Index (must be able to speak English) Ability to provide informed consent Exclusion Criteria: BCC/SCC that was previously treated (ie, recurrent BCC/SCC) BCC/SCC in region adjacent to or overlapping with region of prior radiotherapy BCC/SCC on irregular surface (ie, target area not flat) BCC/SCC adjacent to or overlapping with burn or scar BCC/SCC in area prone to trauma (including, but not limited to the skin overlying the tibia, dorsum of hands and elbow) BCC/SCC in area with compromised lymphatic drainage or vascular supply BCC/SCC within 3 cm of another treated or untreated BCC/SCC Inflammatory process in target area Collagen vascular disease (lupus, scleroderma, rheumatoid arthritis) Diabetes that is poorly controlled Genetic disorder predisposing patient to skin cancers or radiation sensitivity (basal cell nevus syndrome, xeroderma pigmentosum, ataxia telangiectasia mutans) Receipt of treatment with another investigational device or drug Receipt of drug that will affect biologic response to radiation (radiosensitizer or radioprotector) High likelihood of protocol non-compliance (in opinion of investigator)

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electronic Skin Surface Brachytherapy<br>The patient will undergo quality of life assessment and skin imaging (ultrasonography and reflectance confocal microscopy). Brachytherapy will be performed over six outpatient visits over 2-3 weeks, on non-consecutive days. Patients will then be followed for 5 years. Reflectance confocal microscopy is optional for the participating sites. | Radiation: Electronic Skin Surface Brachytherapy<br> <br> Behavioral: Quality of life assessment<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy of Electronic Skin Surface Brachytherapy (ESSB) | Efficacy will be measured by local control of the irradiated BCC/SCC three years after brachytherapy. | 3 years | 
| assess the cosmetic outcome of ESSB | Cosmetic outcome will be patient-reported and clinician-assessed after brachytherapy. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| severity of adverse events | (grade 1-4 adverse events). The study will use the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for assessing toxicity related to brachytherapy. | 3 years | 
| reported quality of life | Patient reported health-related quality of life outcomes will be assessed using the Skindex-16 (Appendix A) and the Skin Cancer Index (Appendix B). | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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skin, Brachytherapy, 14-001