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

Description

The purpose of this study is to test 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 test the safety, cosmetic results, and effects that ESSB has on quality of life.

Study Start Date

May 2014

Estimated Completion Date

May 2017

Interventions

  • Behavioral: Quality of life assessment
  • Radiation: Electronic Skin Surface Brachytherapy

Specialties

  • Oncology: Pharmacology/Therapy
  • Radiology: Radiotherapy (XRT)
  • Physician Assistant: Hematology/Oncology

MeSH Terms

  • Carcinoma
  • Cutaneous Basal Cell
  • Skin Surface Brachytherapy
  • Squamous Cell

Study ID

Memorial Sloan-Kettering Cancer Center -- 14-001

Status

Unknown

Trial ID

NCT02131805

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

29

Sponsor

Memorial Sloan-Kettering Cancer Center

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)
  • Low risk features (by NCCN 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)
  • Skin lesion is visible on skin imaging (reflectance confocal microscopy and ultrasonography
  • 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 5 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)

Gender

Both

Ages

60 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (5)

Study Location Distance Name Phone Email
Memorial Sloan Kettering Cancer Center Commack - Commack, New York 26.2 miles Christopher Barker MD 212-639-8168 None
Memorial Sloan Kettering West Harrison - West Harrison, New York 28.7 miles Christopher Barker MD 212-639-8168 None
Memoral Sloan Kettering Cancer Center at Phelps - Sleepy Hollow, New York 33.0 miles Christopher Barker MD 212-639-8168 None
Memorial Sloan Kettering Cancer Center - New York, New York 50.7 miles Christopher Barker MD 212-639-8168 None
Lynn Cancer Institute - Boca Raton, Florida 1,102.6 miles Michael Kasper MD None None

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