Electronic Skin Surface Brachytherapy for Cutaneous Basal Cell and Squamous Cell Carcinoma
NCT ID: NCT02131805
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
36 participants
INTERVENTIONAL
2014-05-31
2025-12-23
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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. Reflectance confocal microscopy is optional for the participating sites.
Electronic Skin Surface Brachytherapy
Quality of life assessment
Interventions
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Electronic Skin Surface Brachytherapy
Quality of life assessment
Eligibility Criteria
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Inclusion Criteria
* 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 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)
60 Years
ALL
No
Sponsors
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Lynn Cancer Institute
UNKNOWN
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Christopher Barker, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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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
Countries
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Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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14-001
Identifier Type: -
Identifier Source: org_study_id