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

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ClinicalTrials.gov Identifier: NCT02131805
Recruitment Status : Recruiting
First Posted : May 6, 2014
Last Update Posted : March 12, 2020
Sponsor:
Collaborator:
Lynn Cancer Institute
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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Brief Summary:
The purpose of this study is to assess 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 assess the safety, cosmetic results, the effects that ESSB has on quality of life and to correlate skin imaging with clinical response to ESSB.

Condition or disease Intervention/treatment Phase
Cutaneous Basal Cell Squamous Cell Carcinoma Radiation: Electronic Skin Surface Brachytherapy Behavioral: Quality of life assessment Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Pilot Study of Electronic Skin Surface Brachytherapy for Cutaneous Basal Cell and Squamous Cell Carcinoma
Actual Study Start Date : May 2014
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021
Arms and Interventions
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Arm Intervention/treatment
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 six outpatient visits over 2-3 weeks, on non-consecutive days. Patients will then be followed for 5 years. Reflectance confocal microscopy is optional for the participating sites.
 Radiation: Electronic Skin Surface Brachytherapy
Behavioral: Quality of life assessment


Outcome Measures
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Primary Outcome Measures :
  1. efficacy of Electronic Skin Surface Brachytherapy (ESSB) [ Time Frame: 3 years ]
    Efficacy will be measured by local control of the irradiated BCC/SCC three years after brachytherapy.

  2. assess the cosmetic outcome of ESSB [ Time Frame: 3 years ]
    Cosmetic outcome will be patient-reported and clinician-assessed after brachytherapy.


Secondary Outcome Measures :
  1. severity of adverse events [ Time Frame: 3 years ]
    (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.

  2. reported quality of life [ Time Frame: 3 years ]
    Patient reported health-related quality of life outcomes will be assessed using the Skindex-16 (Appendix A) and the Skin Cancer Index (Appendix B).


Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)

    °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 (Appendix C)
  • 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 (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 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 of protocol non-compliance (in opinion of investigator)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02131805


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

Locations
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United States, Florida
Boca Raton Regional Hospital Recruiting
Boca Raton, Florida, United States, 33486
Contact: Michael Kasper, MD         
Principal Investigator: Michael Kasper, MD         
United States, New Jersey
Memoral Sloan Kettering Basking Ridge (Consent only) Recruiting
Basking Ridge, New Jersey, United States
Contact: Christopher Barker, MD    212-639-8168      
Memorial Sloan Kettering Monmouth (Consent only) Recruiting
Middletown, New Jersey, United States, 07748
Contact: Christopher Barker, MD    212-639-8168      
Memorial Sloan Kettering Bergen (Consent only) Recruiting
Montvale, New Jersey, United States, 07645
Contact: Christopher Barker, MD    212-639-8168      
United States, New York
Memorial Sloan Kettering Commack (Consent only) Recruiting
Commack, New York, United States, 11725
Contact: Christopher Barker, MD    212-639-8168      
Memorial Sloan Kettering Westchester (All Protocol Activities) Recruiting
Harrison, New York, United States, 10604
Contact: Christopher Barker, MD    212-639-8168      
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         
Memorial Sloan Kettering Nassau (Consent only) Recruiting
Uniondale, New York, United States, 11553
Contact: Christopher Barker, MD    212-639-8168      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Lynn Cancer Institute
Investigators
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Principal Investigator: Christopher Barker, MD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02131805    
Other Study ID Numbers: 14-001
First Posted: May 6, 2014    Key Record Dates
Last Update Posted: March 12, 2020
Last Verified: March 2020
Keywords provided by Memorial Sloan Kettering Cancer Center:
skin
Brachytherapy
14-001
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell