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

Squamous Cell Carcinoma Clinical Trial

Official title:

A Multicenter Pilot Study of Electronic Skin Surface Brachytherapy for Cutaneous Basal Cell and Squamous Cell Carcinoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02131805
• Other study ID #: 14-001
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Cutaneous Basal Cell
• Squamous Cell Carcinoma

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

External Links

•   Memorial Sloan Kettering Cancer Center