Xoft Electronic Brachytherapy Clinical Protocol For The Primary Treatment Of Non-Melanoma Skin Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Xoft, Inc.
- 入组人数
- 187
- 试验地点
- 5
- 主要终点
- Local recurrence of NMSC
研究概览
简要总结
The objective of this study is to record recurrence in patients treated for nonmelanoma (basal cell and squamous cell carcinomas) skin cancer using the Xoft Axxent Electronic Brachytherapy System. Additional objectives include evaluate the appearance of the treated area in patients treated for nonmelanoma skin cancer using the Xoft Axxent Electronic Brachytherapy System and record the occurrence of radiation therapy related skin changes in patients treated for nonmelanoma skin cancer.
详细描述
The objective of this study is to record local recurrence in patients treated for nonmelanoma (basal cell and squamous cell carcinomas) skin cancer using the Xoft Axxent Electronic Brachytherapy System. Additional objectives include evaluate the cosmetic outcomes in patients treated for nonmelanoma skin cancer using the Xoft Axxent Electronic Brachytherapy System and record the occurrence of radiation therapy related skin toxicities in patients treated for nonmelanoma skin cancer using the Xoft Axxent Electronic Brachytherapy System.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has signed the informed consent form
- •Pathological diagnosis confirmed of squamous cell or basal cell carcinoma
- •Histopathological Grade: G1 (well differentiated), G2 (moderately differentiated), or Gx (Not assessed in report)
- •Clinical Staging Tis, T1, or T2 (Must be ≤ 4 cm in diameter)
- •One lesion is treated, or more than 1 lesion is treated with a minimum of a 5 mm gap between the edges of the lesion margins.
排除标准
- •T2 > 4 cm and T3 and T4
- •American Joint Committee Staging for NMSC Stages III and IV
- •Histopathologic Grade 3 (poorly differentiated) or higher grade
- •Target area is adjacent to a burn scar
- •Target area is on the lip
- •Patient < 50 years of age
- •Any prior definitive surgical resection of the cancer
- •Perineural invasion
- •Lesion depth > 5mm on clinical assessment or as assessed by ultrasound or CT.
- •Patient is pregnant (pregnancy test required if standard of care).
- •Target area is prone to trauma.
- •Target area with compromised lymphatic or vascular drainage.
- •Participation in another investigational device or drug study concurrently.
- •Patient has undergone prior radiation therapy to this specific anatomic location.
- •Patient is receiving pharmacologic agent(s) at or around the time of the Radiation therapy that is/are known to produce skin reactions that will influence cosmesis grading during study.
- •Patient is receiving chemotherapeutic agent(s) Six (6) weeks before or six (6) weeks after radiation therapy.
- •Life expectancy less than five (5) years.
结局指标
主要结局
Local recurrence of NMSC
时间窗: at six (6) months, one (1) year, two (2) years, three (3) years, four (4) years, and five (5) years.
Local recurrence
次要结局
- Cosmetic outcomes for patients treated for NMSC((1) month, three (3) months, six (6) months, one (1) year, two (2) years, three (3) years, four (4) years, and five (5) years.)
- Occurrence of radiation therapy related skin toxicities(1, 3, 6 months, and 1, 2, 3, 4, and 5 years)