A UW Phase II Trial of Multi-catheter HDR Brachytherapy Following Lumpectomy for Early Stage Breast Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 127
- 试验地点
- 2
- 主要终点
- To Determine if Brachytherapy Will Produce Non-inferior Local Regional Control at 5 Years Post Treatment When Compared to Historical Results of Conventional XRT
研究概览
简要总结
Breast conservation therapy (BCT) is now widely accepted as a treatment option for most women with Stage I and II invasive breast cancer and most patients with ductal carcinoma in situ (DCIS). Despite superior cosmetic outcome, BCT is more complex and requires a protracted treatment regimen comprised of 6 weeks of daily external beam radiation therapy to the whole breast. The purpose of this study is to determine if an acceptable outcome can be achieved with radiation delivered only to the region of the tumor bed. If this is true, partial breast irradiation may lend itself to much shorter treatment times (one week) and the toxicities to adjacent normal structures (heart, lung, chest wall) will be greatly reduced.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Invasive breast cancer or DCIS, tumor stage of Tis, T1, T2 if lesion is < 3 cm, N0 or N1 if 1-3 + nodes with no extracapsular extension
排除标准
- 未提供
研究组 & 干预措施
1
breast brachytherapy to a dose of 34 Gy
干预措施: brachytherapy (Radiation)
结局指标
主要结局
To Determine if Brachytherapy Will Produce Non-inferior Local Regional Control at 5 Years Post Treatment When Compared to Historical Results of Conventional XRT
时间窗: 5 years
次要结局
- To Determine if Brachytherapy Will Produce Non-inferior Toxicity to XRT at 3 Years(3 years)