Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-25 @ 3:24 AM
NCT ID:
NCT02131805
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT02131805
Study Brief:
Protocol Section:
NCT02131805