Electronic Skin Surface Brachytherapy for Cutaneous Basal Cell and Squamous Cell Carcinoma
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.
Cutaneous Basal Cell
Squamous Cell Carcinoma
Radiation: Electronic Skin Surface Brachytherapy
Behavioral: Quality of life assessment
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study of Electronic Skin Surface Brachytherapy for Cutaneous Basal Cell and Squamous Cell Carcinoma|
- efficacy of Electronic Skin Surface Brachytherapy (ESSB) [ Time Frame: 3 years ] [ Designated as safety issue: No ]Efficacy will be measured by local control of the irradiated BCC/SCC three years after brachytherapy.
- assess the cosmetic outcome of ESSB [ Time Frame: 3 years ] [ Designated as safety issue: No ]Cosmetic outcome will be patient-reported and clinician-assessed after brachytherapy.
- severity of adverse events [ Time Frame: 3 years ] [ Designated as safety issue: Yes ](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 [ Time Frame: 3 years ] [ Designated as safety issue: No ]Patient reported health-related quality of life outcomes will be assessed using the Skindex-16 (Appendix A) and the Skin Cancer Index (Appendix B).
|Study Start Date:||May 2014|
|Estimated Primary Completion Date:||May 2017 (Final data collection date for primary outcome measure)|
Experimental: 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.
|Radiation: Electronic Skin Surface Brachytherapy Behavioral: Quality of life assessment|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02131805
|Contact: Christopher Barker, MD||212-639-8168|
|Contact: Michael Zelefsky, MD||212-639-6802|
|United States, Florida|
|Lynn Cancer Institute||Not yet recruiting|
|Boca Raton, Florida, United States, 33486|
|Contact: Michael Kasper, MD|
|Principal Investigator: Michael Kasper, MD|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Christopher Barker, MD 212-639-8168|
|Contact: Michael Zelefsky, MD 212-639-6802|
|Principal Investigator: Christopher Barker, MD|
|Principal Investigator:||Christopher Barker, MD||Memorial Sloan Kettering Cancer Center|