NCT00165243已完成2 期
Tangential Radiation Therapy Without Axillary Dissection in Early-Stage Breast Cancer
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- To determine if patients with early-stage breast tumors can be effectively treated by tangential breast radiation.
研究概览
简要总结
The purpose of this study is to evaluate whether treatment to the axilla (area under the arm) can be safely minimized by omitting axillary surgery and full axillary radiation therapy and replacing it with radiation therapy to the breast and lower axilla.
详细描述
- Patients will have undergone conservative breast surgery without axillary dissection prior to enrollment in this study.
- Patients will receive radiation therapy to the breast, including the lowest axillary lymph nodes, over a period of 6 1/2 weeks.
- No radiation will be specifically directed toward the upper axilla or supraclavicular lymph nodes.
- Patients will also receive 5 years of tamoxifen or another type of hormone therapy determined by the medical oncologist.
- Follow-up visits will occur every 6 months and mammograms every 12 months.
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have clinical stage I or II breast cancer, clinically uninvolved axillary nodes.
- •Patients must be 55 years or older.
- •Patients must undergo total excision of the primary invasive tumor
- •Final pathologic margin status must be negative
- •Only estrogen receptor (ER) or progesterone receptor (PR) positive tumors will be permitted
排除标准
- •Prior history of malignancy, except for non-melanoma skin cancers and carcinoma in situ fo the cervix
结局指标
主要结局
To determine if patients with early-stage breast tumors can be effectively treated by tangential breast radiation.
时间窗: 5 years
次要结局
- To determine the safety of this treatment.(5 years)
研究者
Julia S. Wong, MD
Principal Investigator
Dana-Farber Cancer Institute
研究点 (4)
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