This pilot clinical trial studies how well electronic skin surface brachytherapy (ESSB) works in treating older patients with newly diagnosed early stage basal cell or squamous cell skin cancer. ESSB is a type of radiation therapy that uses skin surface applicators to place electronic radiation sources to treat skin cancer. Skin surface applicators are round, smooth disks that are attached to the radiation treatment machine, and give off the radiation for treatment. ESSB may allow the tumor to be treated while underlying healthy tissues are not harmed by radiation.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02131805.
PRIMARY OBJECTIVES:
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.
SECONDARY OBJECTIVES:
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.
OUTLINE:
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 PhaseNo phase specified
Trial Typetreatment
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorChristopher Andrew Barker
