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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Completed

Conditions: Squamous Cell Carcinoma; Cutaneous Basal Cell

Treatments: Behavioral: Quality of life assessment; Radiation: Electronic Skin Surface Brachytherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02131805

14-001

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

Electronic Skin Surface Brachytherapy

Experimental group

Description:

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.

Treatment:

Radiation: Electronic Skin Surface Brachytherapy

Behavioral: Quality of life assessment