Electronic Skin Surface Brachytherapy for Cutaneous Basal Cell and Squamous Cell Carcinoma
Completed · Not applicable
Conditions studied: Cutaneous Basal Cell, Squamous Cell Carcinoma
In brief
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.
Key facts
- Study ID
- NCT02131805
- Run by
- Memorial Sloan Kettering Cancer Center
- People needed
- 36
- Starts
- 2014-05-01
- Expected to finish
- 2025-12-23
- Last updated by the study team
- 2025-12-30
Who can join
Age: 60 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Boca Raton Regional Hospital — Boca Raton, Florida, United States
- Memorial Sloan Kettering Basking Ridge (Consent only) — Basking Ridge, New Jersey, United States
- Memorial Sloan Kettering Monmouth (Consent only) — Middletown, New Jersey, United States
- Memorial Sloan Kettering Bergen (Consent only) — Montvale, New Jersey, United States
- Memorial Sloan Kettering Commack (Consent only) — Commack, New York, United States
- Memorial Sloan Kettering Westchester (All Protocol Activities) — Harrison, New York, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- Memorial Sloan Kettering Nassau (Consent only) — Uniondale, New York, United States
Full record on ClinicalTrials.gov
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