Feasibility Study of the Xoft® Axxent® Electronic Brachytherapy System for the Treatment of Cervical Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Xoft, Inc.
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Safety - Adverse Event Rate and Severity
研究概览
简要总结
The purpose of this study is to evaluate the safety, performance and usability of the Xoft Axxent Electronic Brachytherapy System and Cervical Applicator as incorporated into the physician's current standard treatment practice and in replacement of high-dose-rate after-loaders using Iridium-192 or low-dose-rate Cesium treatments. Data will be collected on treatment delivery, safety, and acute toxicity.
Our hypothesis is that the treatment is safe as incorporated into the physician's current standard of practice.
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Brachytherapy is indicated after EBRT for all cases of locally advanced disease (Stages Ib2 - IVA)
- •Inoperable Stage Ia1 and Stage Ia2 may be treated with tandem-based brachytherapy alone
- •Inoperable Stage Ib1 should be treated radically with brachytherapy in conjunction with EBRT. Concurrent chemotherapy may be considered at the physician's discretion and based on the presence of high risk features.
- •Subjects can be treated with brachytherapy regardless of lymph node status, grade, and presence of lymphovascular invasion, tumor size, age, or histology.
- •Medically fit for general or spinal anesthesia, or conscious sedation, for the insertion process
- •Subjects of childbearing potential must have a negative serum pregnancy test at Screening inclusion Criteria:
排除标准
- •Medical Contraindications to Brachytherapy (scleroderma, collagen vascular disease, active lupus )
- •Prior pelvic radiotherapy with brachytherapy
- •Hemoglobin level at screening < 8
- •Life expectancy < 6 months
研究组 & 干预措施
Treatment
Subjects enrolled will undergo brachytherapy treatment in combination with EBRT. The maximum length of treatment will be 56 days. The treating physician will determine the appropriate course of treatment based on the physician's current practice or experience using Iridium-192 or Cesium HDR after-loaders to administer cervical brachytherapy treatments.
Subjects enrolled will be treated with approximately 80-90 Gy total treatment dose over 4-6 fractions. Examples of commonly used dose regimens in the US are listed in section 7.6.7. This study will include data collection from the initiation of EBRT through administration of the final Xoft Axxent treatment fraction, and at one (1) month and three (3) months.
干预措施: Treatment with Electronic Brachytherapy (Device)
结局指标
主要结局
Safety - Adverse Event Rate and Severity
时间窗: Study Exit (90 days)
Adverse event rate and severity during and following the administration of brachytherapy treatment, through discharge from the treatment facility, and for 3 months after treatment.
次要结局
- Device Performance(Study Exit (90 days))