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| Name | Class |
|---|---|
| Lynn Cancer Institute | UNKNOWN |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electronic Skin Surface Brachytherapy | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electronic Skin Surface Brachytherapy | Radiation |
| ||
| Quality of life assessment |
| 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 |
| 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 |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Barker, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boca Raton Regional Hospital | Boca Raton | Florida | 33486 | United States | ||
| Memorial Sloan Kettering Basking Ridge (Consent only) |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| Behavioral |
|
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 |
| Basking Ridge |
| New Jersey |
| United States |
| Memorial Sloan Kettering Monmouth (Consent only) | Middletown | New Jersey | 07748 | United States |
| Memorial Sloan Kettering Bergen (Consent only) | Montvale | New Jersey | 07645 | United States |
| Memorial Sloan Kettering Commack (Consent only) | Commack | New York | 11725 | United States |
| Memorial Sloan Kettering Westchester (All Protocol Activities) | Harrison | New York | 10604 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Memorial Sloan Kettering Nassau (Consent only) | Uniondale | New York | 11553 | United States |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
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