A Multicenter Pilot Study of Electronic Skin Surface Brachytherapy for Cutaneous Basal Cell and Squamous Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 15
- 主要终点
- efficacy of Electronic Skin Surface Brachytherapy (ESSB)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
efficacy of Electronic Skin Surface Brachytherapy (ESSB)
时间窗: 3 years
Efficacy will be measured by local control of the irradiated BCC/SCC three years after brachytherapy.
assess the cosmetic outcome of ESSB
时间窗: 3 years
Cosmetic outcome will be patient-reported and clinician-assessed after brachytherapy.
次要结局
- severity of adverse events(3 years)
- reported quality of life(3 years)