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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02131805
Other study ID # 14-001
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 2014
Est. completion date May 2025

Study information

Verified date June 2024
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 information / eligibility

Status Active, not recruiting
Enrollment 36
Est. completion date May 2025
Est. primary completion date May 2025
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
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)

Study Design


Intervention

Radiation:
Electronic Skin Surface Brachytherapy

Behavioral:
Quality of life assessment


Locations

Country Name City State
United States Memorial Sloan Kettering Basking Ridge (Consent only) Basking Ridge New Jersey
United States Boca Raton Regional Hospital Boca Raton Florida
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 Monmouth (Consent only) Middletown New Jersey
United States Memorial Sloan Kettering Bergen (Consent only) Montvale New Jersey
United States Memorial Sloan Kettering Cancer Center New York New York
United States Memorial Sloan Kettering Nassau (Consent only) Uniondale New York

Sponsors (2)

Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center Lynn Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary assess the cosmetic outcome of ESSB Cosmetic outcome will be patient-reported and clinician-assessed after brachytherapy. 3 years
Secondary 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
Secondary 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
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