NCT01906112撤回3 期
Role of Surgery for the Primary in Patients With Breast Cancer Stage IV - A Prospective Randomized Multicenter Controlled Trial
National Cancer Institute, Thailand9 个研究点 分布在 1 个国家开始时间: 2013年8月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 9
- 主要终点
- Overall survival
研究概览
简要总结
The purpose of this study is to determine benefits of surgery for the primary in patients with breast cancer stage IV in randomized controlled study.
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
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy breast cancer stage IV patients with resectable primary breast tumor.
- •Resectable breast cancer stage IV patients who well response of visceral metastasis to systemic therapy and fit for surgery.
排除标准
- •Breast cancer stage IV patients with local complication of primary breast tumor that require surgery for palliation such as uncontrolled bleeding,large and non-healing ulcer or intractable pain.
- •Breast cancer stage IV patients with unresectable primary breast tumor or extensive chest wall disease.
研究组 & 干预措施
Controlled
No Intervention
No surgery for primary breast tumor.
Study
Experimental
Surgery for primary breast tumor.
干预措施: Surgery for primary breast tumor. (Procedure)
结局指标
主要结局
Overall survival
时间窗: Five years
次要结局
- Quality of life & Uncontrolled chest wall disease(Five years)
研究者
AKANIST PIYAPANT, MD.,FRCST.
Surgical Oncologist.
National Cancer Institute, Thailand
研究点 (9)
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