NCT00805597终止3 期
A Phase Ⅲ Randomized Clinical Trial of Postmastectomy Radiotherapy in Breast Cancer With One to Three Positive Nodes
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- overall survival
研究概览
简要总结
The purpose of this study is to evaluate postmastectomy radiotherapy in breast cancer patients with one to three positive nodes.
详细描述
Eligible breast cancer patients with mastectomy and axillary dissection are randomized into 2 groups:radiotherapy of 50 Gy in 25 fractions within 5 weeks to ipsilateral chest wall and supraclavicular nodal region,and no radiotherapy.
During and after radiotherapy, the patients are followed and the efficacy and toxicities of radiotherapy are evaluated.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Ipsilateral histologically confirmed invasive breast cancer
- •Undergone total mastectomy and axillary dissection
- •T1-2 and one to three axillary lymph nodes positive
- •A minimum of 10 axillary nodes dissected
- •Fit for chemotherapy(if indicated),endocrine therapy(if indicated)and postoperative irradiation
- •Written,informed consent
排除标准
- •Patients who undergone previous irradiation to the ipsilateral chest wall and supraclavicular region
- •Previous or concurrent malignant other than non-melanomatous skin cancer
- •Unable or unwilling to give informed consent
研究组 & 干预措施
radiotherapy
Experimental
radiotherapy of 50Gy/25/f/5w to the ipsilateral chest wall and supraclavicular region
干预措施: radiation (Radiation)
no radiotherapy
Active Comparator
no radiotherapy
干预措施: no radiation (Radiation)
结局指标
主要结局
overall survival
时间窗: 10 years
次要结局
- loco-regional recurrence(5 years)
研究者
Shu lian Wang
M.D.
Chinese Academy of Medical Sciences
研究点 (1)
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