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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborator:
Lynn Cancer Institute
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT02131805
First received: May 5, 2014
Last updated: NA
Last verified: May 2014
History: No changes posted
  Purpose

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.


Condition Intervention
Cutaneous Basal Cell
Squamous Cell Carcinoma
Radiation: Electronic Skin Surface Brachytherapy
Behavioral: Quality of life assessment

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of Electronic Skin Surface Brachytherapy for Cutaneous Basal Cell and Squamous Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • efficacy of Electronic Skin Surface Brachytherapy (ESSB) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Efficacy will be measured by local control of the irradiated BCC/SCC 3 years after brachytherapy.

  • assess the cosmetic outcome of ESSB [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Cosmetic outcome will be patient-reported and clinician-assessed after brachytherapy.


Secondary Outcome Measures:
  • severity of adverse events [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    (grade 1-4 adverse events). The study will use the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for assessing toxicity related to brachytherapy.

  • reported quality of life [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Patient reported health-related quality of life outcomes will be assessed using the Skindex-16 (Appendix A) and the Skin Cancer Index (Appendix B).


Estimated Enrollment: 29
Study Start Date: May 2014
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Electronic Skin Surface Brachytherapy
The patient will undergo quality of life assessment and skin imaging (ultrasonography and reflectance confocal microscopy). Brachytherapy will be performed over 6 outpatient visits over 2-3 weeks, on non-consecutive days. Patients will then be followed for 5 years.
Radiation: Electronic Skin Surface Brachytherapy Behavioral: Quality of life assessment

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02131805

Contacts
Contact: Christopher Barker, MD 212-639-8168
Contact: Michael Zelefsky, MD 212-639-6802

Locations
United States, Florida
Lynn Cancer Institute Not yet recruiting
Boca Raton, Florida, United States, 33486
Contact: Michael Kasper, MD         
Principal Investigator: Michael Kasper, MD         
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Christopher Barker, MD    212-639-8168      
Contact: Michael Zelefsky, MD    212-639-6802      
Principal Investigator: Christopher Barker, MD         
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Lynn Cancer Institute
Investigators
Principal Investigator: Christopher Barker, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02131805     History of Changes
Other Study ID Numbers: 14-001
Study First Received: May 5, 2014
Last Updated: May 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
skin
Brachytherapy
14-001

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell

ClinicalTrials.gov processed this record on September 18, 2014