Conformal Partial Breast Irradiation With CyberKnife After Resection for Early Stage Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- To determine the feasibility of using CyberKnife radiotherapy to deliver partial breast radiotherapy for early stage breast cancer.
研究概览
简要总结
The purpose of this study is to determine if it is feasible, safe, and effective to use Cyberknife radiotherapy to deliver partial breast radiotherapy after lumpectomy.Patients meeting eligibility criteria will be invited to participate. Adjuvant radiotherapy will be delivered using CyberKnife radiotherapy using twice daily sessions for five days for a total of ten sessions. Short-term and long-term toxicity will be assessed as well as Tumor control and site of failure (if any).
详细描述
This study will determine the feasibility and toxicity of a short course of accelerated radiotherapy as adjuvant treatment for early stage breast cancer. Successful completion of this project may provide a rationale to offer this treatment for select patients with the benefit of potentially less tissue damage and a shorter overall course of therapy. These improvements may ultimately allow more patients the opportunity of breast conserving therapy to treat their cancer
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
- 60 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of breast malignancy, stage T1
- •Surgical treatment with lumpectomy
- •age 60 or older
- •resection margins negative by at least 2mm
- •ER positive
- •invasive ductal
- •pathologic free of nodal metastases (N0, i- or i+)
- •Post-lumpectomy cavity to whole breast ratio must be less than or equal to 30%
- •Exclusion criteria
- •Prior radiotherapy to the breast
- •Neoadjuvant chemotherapy
- •multicentric disease
- •Pure DCIS histology
- •Presence of extensive intraductal component
- •Node positive disease (N1 or greater)
排除标准
- 未提供
结局指标
主要结局
To determine the feasibility of using CyberKnife radiotherapy to deliver partial breast radiotherapy for early stage breast cancer.
时间窗: one year
Subjects will undergo a treatment plan for partial breast irradiation with cyberknife. Feasibility will be determined by monitoring the number of potential eligible subjects enrolled that can be treated while also respecting normal tissue tolerances.
次要结局
- To determine if conformal irradiation to the operative bed using CyberKnife produces acceptable local control(1 year)
研究者
Ken Dornfeld
Radiation Oncologist
Essentia Health