Cutaneous Basal Cell, Squamous Cell Carcinoma
Conditions
Keywords
skin, Brachytherapy, 14-001
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.
Interventions
RADIATIONElectronic Skin Surface Brachytherapy
BEHAVIORALQuality of life assessment
Sponsors
Lynn Cancer Institute
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| efficacy of Electronic Skin Surface Brachytherapy (ESSB) | 3 years | Efficacy will be measured by local control of the irradiated BCC/SCC three years after brachytherapy. |
| assess the cosmetic outcome of ESSB | 3 years | Cosmetic outcome will be patient-reported and clinician-assessed after brachytherapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| severity of adverse events | 3 years | (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 | 3 years | Patient reported health-related quality of life outcomes will be assessed using the Skindex-16 (Appendix A) and the Skin Cancer Index (Appendix B). |
Countries
United States
Outcome results
None listed