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Electronic Skin Surface Brachytherapy in Treating Older Patients with Newly Diagnosed Early Stage Basal Cell or Squamous Cell Skin Cancer

Trial Status: Active

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.

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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)

Florida

Boca Raton
Boca Raton Regional Hospital
Status: ACTIVE
Contact: Michael Eugene Kasper
Phone: 561-955-4800

New Jersey

Basking Ridge
Memorial Sloan Kettering Basking Ridge
Status: ACTIVE
Contact: Christopher Andrew Barker
Phone: 212-639-8168
Middletown
Memorial Sloan Kettering Monmouth
Status: ACTIVE
Contact: Christopher Andrew Barker
Phone: 212-639-8168
Montvale
Memorial Sloan Kettering Bergen
Status: ACTIVE
Contact: Christopher Andrew Barker
Phone: 212-639-8168

New York

Commack
Memorial Sloan Kettering Commack
Status: ACTIVE
Contact: Christopher Andrew Barker
Phone: 212-639-8168
New York
Memorial Sloan Kettering Cancer Center
Status: ACTIVE
Contact: Christopher Andrew Barker
Phone: 212-639-8168
Uniondale
Memorial Sloan Kettering Nassau
Status: ACTIVE
Contact: Christopher Andrew Barker
Phone: 212-639-8168
West Harrison
Memorial Sloan Kettering Westchester
Status: ACTIVE
Contact: Christopher Andrew Barker
Phone: 212-639-8168

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 Phase Phase NA

Trial Type Treatment

Lead Organization
Memorial Sloan Kettering Cancer Center

Principal Investigator
Christopher Andrew Barker

  • Primary ID 14-001
  • Secondary IDs NCI-2014-01090
  • Clinicaltrials.gov ID NCT02131805