Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
29

Inclusion Criteria

Histopathologic diagnosis of basal or squamous cell carcinoma
Low risk pathologic features (by AJCC 2010 criteria)
Men or women ≥ 60 years old with estimated life expectancy of ≥ 5 years
...
Histopathologic diagnosis of basal or squamous cell carcinoma
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)
Ability to provide informed consent
Able and willing to complete the Skindex16 and Skin Cancer Index (must be able to speak English)

Exclusion Criteria

BCC/SCC in area prone to trauma (including, but not limited to the skin overlying the tibia, dorsum of hands and elbow)
Collagen vascular disease (lupus, scleroderma, rheumatoid arthritis)
BCC/SCC that was previously treated (ie, recurrent BCC/SCC)
...
BCC/SCC in area prone to trauma (including, but not limited to the skin overlying the tibia, dorsum of hands and elbow)
Collagen vascular disease (lupus, scleroderma, rheumatoid arthritis)
BCC/SCC that was previously treated (ie, recurrent BCC/SCC)
BCC/SCC on irregular surface (ie, target area not flat)
Genetic disorder predisposing patient to skin cancers or radiation sensitivity (basal cell nevus syndrome, xeroderma pigmentosum, ataxia telangiectasia mutans)
High likelihood of protocol non-compliance (in opinion of investigator)
Diabetes that is poorly controlled
Receipt of drug that will affect biologic response to radiation (radiosensitizer or radioprotector)
BCC/SCC within 3 cm of another treated or untreated BCC/SCC
BCC/SCC in region adjacent to or overlapping with region of prior radiotherapy
Receipt of treatment with another investigational device or drug
Inflammatory process in target area
BCC/SCC adjacent to or overlapping with burn or scar
BCC/SCC in area with compromised lymphatic drainage or vascular supply

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

Histopathologic diagnosis of basal or squamous cell carcinoma
Low risk pathologic features (by AJCC 2010 criteria)
Men or women ≥ 60 years old with estimated life expectancy of ≥ 5 years
...
Histopathologic diagnosis of basal or squamous cell carcinoma
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)
Ability to provide informed consent
Able and willing to complete the Skindex16 and Skin Cancer Index (must be able to speak English)

Exclusion Criteria

BCC/SCC in area prone to trauma (including, but not limited to the skin overlying the tibia, dorsum of hands and elbow)
Collagen vascular disease (lupus, scleroderma, rheumatoid arthritis)
BCC/SCC that was previously treated (ie, recurrent BCC/SCC)
...
BCC/SCC in area prone to trauma (including, but not limited to the skin overlying the tibia, dorsum of hands and elbow)
Collagen vascular disease (lupus, scleroderma, rheumatoid arthritis)
BCC/SCC that was previously treated (ie, recurrent BCC/SCC)
BCC/SCC on irregular surface (ie, target area not flat)
Genetic disorder predisposing patient to skin cancers or radiation sensitivity (basal cell nevus syndrome, xeroderma pigmentosum, ataxia telangiectasia mutans)
High likelihood of protocol non-compliance (in opinion of investigator)
Diabetes that is poorly controlled
Receipt of drug that will affect biologic response to radiation (radiosensitizer or radioprotector)
BCC/SCC within 3 cm of another treated or untreated BCC/SCC
BCC/SCC in region adjacent to or overlapping with region of prior radiotherapy
Receipt of treatment with another investigational device or drug
Inflammatory process in target area
BCC/SCC adjacent to or overlapping with burn or scar
BCC/SCC in area with compromised lymphatic drainage or vascular supply

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