Prospective Pilot Study of Partial Chest Wall Radiation Therapy (PCWRT) for Positive or Close Margins After Modified Radical Mastectomy for Lymph Node-Negative Breast Cancer
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Delayed toxicity
研究概览
简要总结
The standard treatment for breast cancer when cancer cells were found near or within the margins of the tissue that is removed during breast surgery, is radiation of the entire chest wall. This may be considered overtreatment since the only reason for doing so is that cancer cells were near or in the margins of the breast tissue that was removed. In this study, the amount of radiation treatment will be limited to the area where the remaining cancer cells were found after surgery.
The purpose of this study is to find out if partial chest wall radiation therapy is as good as whole chest wall radiation therapy in reducing the risk of breast cancer cancer coming back.
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
- •DCIS or stage T1 or T2 invasive breast cancer, lymph node negative
- •Must have undergone mastectomy
- •Presence of cancer cells on or close to surgical margins
- •Negative pregnancy test for women
- •Must receive radiation at Stony Brook University Hospital
- •Exclusion Criteria
- •Received prior radiation to are to be irradiated
排除标准
- 未提供
结局指标
主要结局
Delayed toxicity
时间窗: 5 years
Frequency of radiation-related adverse events
Surgical complications
时间窗: 5 years
Number of patients with surgical complications
Breast cancer recurrence
时间窗: 5 years
Number of patients with recurrent breast cancer
Acute toxicity
时间窗: 3 months
Frequency of radiation-related adverse events
次要结局
未报告次要终点
研究者
Alexander Stessin
Associate Professor of Medicine
Stony Brook University