Electronic Skin Surface Brachytherapy in Treating Older Patients with Newly Diagnosed Early Stage Basal Cell or Squamous Cell Skin Cancer
- Estimated life expectancy of >= 5 years
- Histopathologic diagnosis of basal or squamous cell carcinoma
- Clinical stage T1N0M0 (by American Joint Committee on Cancer [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
- Able and willing to complete the Skindex16 and Skin Cancer Index (must be able to speak English)
- Ability to provide informed consent
- BCC/SCC that was previously treated (i.e., recurrent BCC/SCC)
- BCC/SCC in region adjacent to or overlapping with region of prior radiotherapy
- BCC/SCC on irregular surface (i.e., 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 or protocol non-compliance (in opinion of investigator)
I. To assess the efficacy of ESSB in patients with early stage basal cell carcinoma (BCC)/squamous cell carcinoma (SCC).
II. To assess the cosmetic outcome of ESSB in patients with early stage BCC/SCC.
I. To assess the safety of ESSB as measured by the rate and severity of adverse events (grade 1-4 adverse events, using Common Terminology Criteria for Adverse Events version 4.0 [CTCAE v4.0]).
II. To evaluate the patient reported quality of life following ESSB in patients with early stage BCC/SCC.
III. To correlate skin imaging with clinical response to ESSB.
Patients undergo 6 fractions of ESSB over 30 minutes on non-consecutive days within 2-3 weeks.
After completion of study treatment, patients are followed up at 2 and 6 weeks, 3, 6 and 12 months, and then annually for up to 5 years.
Trial Phase Phase NA
Trial Type Treatment
Memorial Sloan Kettering Cancer Center
Christopher Andrew Barker
- Primary ID 14-001
- Secondary IDs NCI-2014-01090
- Clinicaltrials.gov ID NCT02131805