A Retrospective Analysis to Evaluate Long Term Outcomes of Squamous Cell Carcinoma Patients Previously Treated With Alpha Diffusing Alpha-emitters Radiation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
Evaluation of long-term efficacy outcomes of patients previously treated with the Alpha DaRT seeds for management of their malignancy following initial response.
详细描述
Medical records of patients that previously underwent the Alpha DaRT treatment will be reviewed by an authorized staff member.
Evaluation of long-term outcomes of patients previously treated with the Alpha DaRT seeds for management of their malignancy following initial response. These outcomes include:
-
Safety - assessment of late onset of Alpha DaRT related AE in patients treated with the Alpha DaRT seeds
-
Efficacy -
-
assessment of local recurrence rates in patients who achieved initial complete response (CR) following the Alpha DaRT treatment
-
assessment of duration of response in patients who achieved initial CR following the Alpha DaRT treatment
-
assessment of survival status in patients treated with the Alpha DaRT seeds
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients previously treated with the Alpha DaRT seeds for management of either skin or oral cavity SCC
- •Available information in medical charts and records (electronic or paper)
排除标准
- 未提供
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: Up to 60 months following DaRT insertion
Time from DaRT insertion to disease progression (according to RECIST V1.1) or death, whichever occurs first
Adverse Events (AE)
时间窗: Up to 60 months following DaRT insertion
Assessment of late onset of Alpha DaRT related AE
次要结局
- Overall Survival (OS)(Up to 60 months following DaRT insertion)
- Duration of Response(Up to 60 months following DaRT insertion)