Accelerated Partial Breast Irradiation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Acute toxicity as assessed by NCI CTC at 1 week, 4 weeks, and 3 months after completion of study therapy
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells.
PURPOSE: This clinical trial is studying the side effects of partial breast radiation therapy and how well it works in treating women undergoing breast conservation therapy for early-stage breast cancer.
详细描述
OBJECTIVES:
- To allow women undergoing breast conservation therapy for early-stage breast cancer to have access to accelerated partial breast irradiation therapy on a controlled trial.
- To capture prospective data on acute and late toxicity and disease recurrence in patients treated with this therapy.
- To summarize the institutional experience of these patients treated with this experimental therapy.
OUTLINE: Within 9 weeks after surgery, patients undergo accelerated partial breast irradiation (including conformal external-beam irradiation, interstitial brachytherapy, intracavitary brachytherapy, or proton beam irradiation) twice daily for 5 days (10 fractions).
After completion of study therapy, patients are followed every 3 to 6 months for at least 5 years and then annually thereafter.
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 120 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Acute toxicity as assessed by NCI CTC at 1 week, 4 weeks, and 3 months after completion of study therapy
时间窗: 11 months
次要结局
- Time to locoregional recurrence(11 months)
- Time to recurrence(11 months)
- Late toxicity and cosmesis as assessed at or before 3 years from the start of radiotherapy and every 3 months during follow-up(11 months)
- Site of disease recurrence (i.e., local, regional, or distant)(11 months)