A Pilot Study of CyberKnife Radiosurgery Delivered to the Partial Breast (CK-PBI)
A Pilot Study of CyberKnife Radiosurgery Delivered to the Partial Breast for Women With Stage 0, 1, or IIA (<=3cm) Breast Cancer
This pilot study will evaluate the technical feasibility and acute toxicity of Partial Breast Irradiation (PBI) with the CyberKnife in anticipation of a larger multi-institutional Phase II study. It will evaluate quality of life (QOL) issues as they relate to treatment related side effects, cosmetic result, and patient convenience.
Radiosurgery is defined as the stereotactic delivery of ionizing radiation in 5 stages or less to a designated target with sub-millimeter accuracy. Radiosurgery in the context of this protocol will be given to the region of the tumor bed within 7 weeks of lumpectomy and sentinel/axillary node sampling over a period of five to ten days using the CyberKnife (CK). Subjects will receive CK before chemotherapy, if applicable.
研究概览
研究类型
阶段
- 不适用
联系人和位置
学习地点
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District of Columbia
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Washington、District of Columbia、美国、20057
- Georgtown University Medical Center
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- DCIS or infiltrating ductal carcinoma of the breast <= 3cm
- margins clear by at least 2 mm
- age >=45 years
Exclusion Criteria:
- invasive lobular carcinoma
- multicentric disease
- nodal metastases
- breast implants
- pregnancy
- connective tissue disease
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：1
CyberKnife Partial Breast Irradiation (PBI)
|
Body radiosurgery will be delivered to the lumpectomy cavity with specified margin.
Radiation dose will be 600 cGy x 5 stages = 3000 cGy over five to ten total days.
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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1. To evaluate the feasibility of CyberKnife body radiosurgery as the sole radiation therapy for this patient population 2. To evaluate the complication rate of CyberKnife body radiosurgery as the sole radiation therapy for this patient population
大体时间：1 year
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1 year
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次要结果测量
结果测量 |
大体时间 |
|---|---|
|
1. To evaluate the local control rate of CyberKnife body radiosurgery as the sole radiation therapy for this patient population. 2. To evaluate Quality of Life after CyberKnife body radiosurgery PBI.
大体时间：1 - 5 years
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1 - 5 years
|
合作者和调查者
调查人员
- 首席研究员：Jefferson EC Moulds, MD、Georgetown University
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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