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
- 1
- 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
- •INCLUSION CRITERIA:
- •Female patients of any age with a dominant breast mass meeting the following requirements are eligible for this protocol:
- •On clinical evaluation the tumor must be confined to the breast and axillary lymph nodes (stage I and II).
- •Biopsy of the tumor must be classified as a primary breast neoplasm of epithelial origin.
- •Patients must be geographically accessible for follow-up and willing to return for the follow-up at the NCI.
- •Patient must be mentally competent to understand and give informed consent for the protocol.
排除标准
- •Patients will be excluded from this protocol for the following reasons:
- •Advanced local disease or distant metastases (stage III and IV);
- •Inflammatory cancer;
- •Chronic diseases such as heart, lung, liver, kidney, blood, or metabolic disorders which may render the patient a poor operative risk;
- •History of another cancer other than skin cancer (non-melanoma);
- •Concurrent pregnancy or lactation;
- •Non-palpable lesions manifested only by nipple discharge or skin rash (Paget's disease);
- •Previous therapy to the breast cancer other than excisional biopsy;
- •Multiple masses or multiple suspicious areas on mammogram unless all but one are proven histologically benign; and
- •Bilateral breast carcinoma, either invasive or in-situ.
研究组 & 干预措施
X
Excisional biopsy plus radiation
干预措施: X (Radiation)
M
Modified radical mastectomy
干预措施: M (Procedure)
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