Electronic Skin Surface Brachytherapy for Cutaneous Basal Cell and Squamous Cell Carcinoma
Last updated on April 2022Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 29
Inclusion Criteria
- Ability to provide informed consent
- Histopathologic diagnosis of basal or squamous cell carcinoma
- Able and willing to complete the Skindex16 and Skin Cancer Index (must be able to speak English)
- ...
- Ability to provide informed consent
- Histopathologic diagnosis of basal or squamous cell carcinoma
- Able and willing to complete the Skindex16 and Skin Cancer Index (must be able to speak English)
- Low risk pathologic features (by AJCC 2010 criteria)
- Men or women ≥ 60 years old with estimated life expectancy of ≥ 5 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-3 (Appendix C)
Exclusion Criteria
- BCC/SCC in area prone to trauma (including, but not limited to the skin overlying the tibia, dorsum of hands and elbow)
- High likelihood of protocol non-compliance (in opinion of investigator)
- Diabetes that is poorly controlled
- ...
- BCC/SCC in area prone to trauma (including, but not limited to the skin overlying the tibia, dorsum of hands and elbow)
- High likelihood of protocol non-compliance (in opinion of investigator)
- Diabetes that is poorly controlled
- Collagen vascular disease (lupus, scleroderma, rheumatoid arthritis)
- BCC/SCC in area with compromised lymphatic drainage or vascular supply
- BCC/SCC adjacent to or overlapping with burn or scar
- Genetic disorder predisposing patient to skin cancers or radiation sensitivity (basal cell nevus syndrome, xeroderma pigmentosum, ataxia telangiectasia mutans)
- BCC/SCC that was previously treated (ie, recurrent BCC/SCC)
- Receipt of drug that will affect biologic response to radiation (radiosensitizer or radioprotector)
- BCC/SCC on irregular surface (ie, target area not flat)
- BCC/SCC within 3 cm of another treated or untreated BCC/SCC
- Receipt of treatment with another investigational device or drug
- BCC/SCC in region adjacent to or overlapping with region of prior radiotherapy
- Inflammatory process in target area
Summary
- Conditions
- Cutaneous Basal Cell
- Squamous Cell Carcinoma
- Type
- Interventional
- Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 60 years and 125 years
- Gender
- Both males and females
Inclusion Criteria
- Ability to provide informed consent
- Histopathologic diagnosis of basal or squamous cell carcinoma
- Able and willing to complete the Skindex16 and Skin Cancer Index (must be able to speak English)
- ...
- Ability to provide informed consent
- Histopathologic diagnosis of basal or squamous cell carcinoma
- Able and willing to complete the Skindex16 and Skin Cancer Index (must be able to speak English)
- Low risk pathologic features (by AJCC 2010 criteria)
- Men or women ≥ 60 years old with estimated life expectancy of ≥ 5 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-3 (Appendix C)
Exclusion Criteria
- BCC/SCC in area prone to trauma (including, but not limited to the skin overlying the tibia, dorsum of hands and elbow)
- High likelihood of protocol non-compliance (in opinion of investigator)
- Diabetes that is poorly controlled
- ...
- BCC/SCC in area prone to trauma (including, but not limited to the skin overlying the tibia, dorsum of hands and elbow)
- High likelihood of protocol non-compliance (in opinion of investigator)
- Diabetes that is poorly controlled
- Collagen vascular disease (lupus, scleroderma, rheumatoid arthritis)
- BCC/SCC in area with compromised lymphatic drainage or vascular supply
- BCC/SCC adjacent to or overlapping with burn or scar
- Genetic disorder predisposing patient to skin cancers or radiation sensitivity (basal cell nevus syndrome, xeroderma pigmentosum, ataxia telangiectasia mutans)
- BCC/SCC that was previously treated (ie, recurrent BCC/SCC)
- Receipt of drug that will affect biologic response to radiation (radiosensitizer or radioprotector)
- BCC/SCC on irregular surface (ie, target area not flat)
- BCC/SCC within 3 cm of another treated or untreated BCC/SCC
- Receipt of treatment with another investigational device or drug
- BCC/SCC in region adjacent to or overlapping with region of prior radiotherapy
- Inflammatory process in target area
Tracking Information
- NCT #
- NCT02131805
- Collaborators
- Lynn Cancer Institute
- Investigators
- Principal Investigator: Christopher Barker, MD Memorial Sloan Kettering Cancer Center
- Christopher Barker, MD Memorial Sloan Kettering Cancer Center
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