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

Primary Purpose

Cutaneous Basal Cell, Squamous Cell Carcinoma

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electronic Skin Surface Brachytherapy
Quality of life assessment
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cutaneous Basal Cell focused on measuring skin, Brachytherapy, 14-001

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Boca Raton Regional Hospital
  • Memorial Sloan Kettering Basking Ridge (Consent only)
  • Memorial Sloan Kettering Monmouth (Consent only)
  • Memorial Sloan Kettering Bergen (Consent only)
  • Memorial Sloan Kettering Commack (Consent only)
  • Memorial Sloan Kettering Westchester (All Protocol Activities)
  • Memorial Sloan Kettering Cancer Center
  • Memorial Sloan Kettering Nassau (Consent only)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Electronic Skin Surface Brachytherapy

Arm Description

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.

Outcomes

Primary Outcome Measures

efficacy of Electronic Skin Surface Brachytherapy (ESSB)
Efficacy will be measured by local control of the irradiated BCC/SCC three years after brachytherapy.
assess the cosmetic outcome of ESSB
Cosmetic outcome will be patient-reported and clinician-assessed after brachytherapy.

Secondary Outcome Measures

severity of adverse events
(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
Patient reported health-related quality of life outcomes will be assessed using the Skindex-16 (Appendix A) and the Skin Cancer Index (Appendix B).

Full Information

First Posted
May 5, 2014
Last Updated
September 19, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Lynn Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02131805
Brief Title
Electronic Skin Surface Brachytherapy for Cutaneous Basal Cell and Squamous Cell Carcinoma
Official Title
A Multicenter Pilot Study of Electronic Skin Surface Brachytherapy for Cutaneous Basal Cell and Squamous Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 2014 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Lynn Cancer Institute

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous Basal Cell, Squamous Cell Carcinoma
Keywords
skin, Brachytherapy, 14-001

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electronic Skin Surface Brachytherapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Electronic Skin Surface Brachytherapy
Intervention Type
Behavioral
Intervention Name(s)
Quality of life assessment
Primary Outcome Measure Information:
Title
efficacy of Electronic Skin Surface Brachytherapy (ESSB)
Description
Efficacy will be measured by local control of the irradiated BCC/SCC three years after brachytherapy.
Time Frame
3 years
Title
assess the cosmetic outcome of ESSB
Description
Cosmetic outcome will be patient-reported and clinician-assessed after brachytherapy.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
severity of adverse events
Description
(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.
Time Frame
3 years
Title
reported quality of life
Description
Patient reported health-related quality of life outcomes will be assessed using the Skindex-16 (Appendix A) and the Skin Cancer Index (Appendix B).
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Barker, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boca Raton Regional Hospital
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Memorial Sloan Kettering Basking Ridge (Consent only)
City
Basking Ridge
State/Province
New Jersey
Country
United States
Facility Name
Memorial Sloan Kettering Monmouth (Consent only)
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Facility Name
Memorial Sloan Kettering Bergen (Consent only)
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Facility Name
Memorial Sloan Kettering Commack (Consent only)
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memorial Sloan Kettering Westchester (All Protocol Activities)
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Memorial Sloan Kettering Nassau (Consent only)
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center

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

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