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

Not Applicable

Active, not recruiting

Interventions: Radiation: Electronic Skin Surface Brachytherapy
Behavioral: Quality of life assessment

Brief Summary: 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.

Recruitment & Eligibility

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)

Arm && Interventions

Group	Intervention	Description
Electronic Skin Surface Brachytherapy	Electronic Skin Surface Brachytherapy	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.
Electronic Skin Surface Brachytherapy	Quality of life assessment	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
severity of adverse events	3 years	(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.
reported quality of life	3 years	Patient reported health-related quality of life outcomes will be assessed using the Skindex-16 (Appendix A) and the Skin Cancer Index (Appendix B).

Locations (8): Memorial Sloan Kettering Commack (Consent only)
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Commack, New York, United States
Memorial Sloan Kettering Westchester (All Protocol Activities)
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Harrison, New York, United States
Boca Raton Regional Hospital
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Boca Raton, Florida, United States
Memorial Sloan Kettering Monmouth (Consent only)
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Middletown, New Jersey, United States
Memorial Sloan Kettering Nassau (Consent only)
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Uniondale, New York, United States
Memorial Sloan Kettering Bergen (Consent only)
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Montvale, New Jersey, United States
Memorial Sloan Kettering Basking Ridge (Consent only)
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Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Cancer Center
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New York, New York, United States