The Treatment of Stage I and II Carcinoma of the Breast With Mastectomy and Axillary Dissection vs. Excisional Biopsy Axillary Dissection, and Definitive Irradiation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 256
- 试验地点
- 2
- 主要终点
- Results of excisional biopsy followed by radiation therapy versus modified radiacal mastectomy
研究概览
简要总结
Patients with biopsy proven breast cancer, clinical stage I and II, will be randomized to receive treatment by one of two methods: (1) total mastectomy and axillary dissection; or (2) excisional biopsy, axillary dissection, and definitive irradiation.
Data from single institutions and from retrospective comparisons suggest that definitive irradiation with cosmetically acceptable breast preservation offers survival and local control results equivalent to extirpative surgery. This study will test this hypothesis in a prospective, randomized manner. After primary therapy, subjects will be followed for: (1) survival; (2) sites of recurrence; (3) anatomic function; (4) complications of therapy; and (5) cosmesis.
详细描述
Patients with biopsy proven breast cancer, clinical stage I and II, will be randomized to receive treatment by one of two methods: (1) total mastectomy and axillary dissection; or (2) excisional biopsy, axillary dissection, and definitive irradiation.
Data from single institutions and from retrospective comparisons suggest that definitive irradiation with cosmetically acceptable breast preservation offers survival and local control results equivalent to extirpative surgery. This study will test this hypothesis in a prospective, randomized manner. After primary therapy, subjects will be followed for: (1) survival; (2) sites of recurrence; (3) anatomic function; (4) complications of therapy; and (5) cosmesis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Results of excisional biopsy followed by radiation therapy versus modified radiacal mastectomy
时间窗: survival rate completion of study
To compare the results of excisional biopsy followed by radiation therapy versus modified radiacal mastectomy
次要结局
未报告次要终点