Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
29

Inclusion Criteria

Histopathologic diagnosis of basal or squamous cell carcinoma
Eastern Cooperative Oncology Group (ECOG) performance status of 0-3 (Appendix C)
Low risk pathologic features (by AJCC 2010 criteria)
...
Histopathologic diagnosis of basal or squamous cell carcinoma
Eastern Cooperative Oncology Group (ECOG) performance status of 0-3 (Appendix C)
Low risk pathologic features (by AJCC 2010 criteria)
Ability to provide informed consent
Able and willing to complete the Skindex16 and Skin Cancer Index (must be able to speak English)
Men or women ≥ 60 years old with estimated life expectancy of ≥ 5 years

Exclusion Criteria

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

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
Eastern Cooperative Oncology Group (ECOG) performance status of 0-3 (Appendix C)
Low risk pathologic features (by AJCC 2010 criteria)
...
Histopathologic diagnosis of basal or squamous cell carcinoma
Eastern Cooperative Oncology Group (ECOG) performance status of 0-3 (Appendix C)
Low risk pathologic features (by AJCC 2010 criteria)
Ability to provide informed consent
Able and willing to complete the Skindex16 and Skin Cancer Index (must be able to speak English)
Men or women ≥ 60 years old with estimated life expectancy of ≥ 5 years

Exclusion Criteria

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

Locations

Montvale, New Jersey, 07645
Basking Ridge, New Jersey
Middletown, New Jersey, 07748
New York, New York, 10065
Harrison, New York, 10604
...
Montvale, New Jersey, 07645
Basking Ridge, New Jersey
Middletown, New Jersey, 07748
New York, New York, 10065
Harrison, New York, 10604
Boca Raton, Florida, 33486
Commack, New York, 11725
Uniondale, New York, 11553

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