NCT01199354Unknown2 期
Phase II Study: Assessing the Feasibility and Morbidity of Skin Sparing Mastectomy and Immediate Breast Reconstruction With Latissimus Dorsi Flap After Neoadjuvant Chemotherapy and Radiotherapy in Invasive Breast Carcinoma.
Clinique Clementville10 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2010年7月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 80
- 试验地点
- 10
- 主要终点
- Incidence of skin necrosis
研究概览
简要总结
The aim of the study is to evaluate the feasibility and morbidity of skin sparing mastectomy and immediate breast reconstruction with latissimus dorsi flap after neoadjuvant chemotherapy and radiotherapy in invasive breast carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Women < 75 year old
- •Invasive breast carcinoma, indication for mastectomy
- •Women Health Organization (WHO) score of 0 and 1, primary chemotherapy, external radiotherapy performed less than 8 week earlier...
排除标准
- •Women older than 75
- •Metastatic breast carcinoma
- •Antecedents of previously treated homolateral breast carcinoma
- •Documented cancer progression
- •Smoker at the moment of the indication surgery
- •Known diabetes, neoadjuvant hormonal treatment...
结局指标
主要结局
Incidence of skin necrosis
To evaluate the incidence of skin necrosis in case of treatment with skin sparing mastectomy and immediate breas reconstruction with latissimus dorsi myocutaneous flap after neoadjuvant chemotherapy and radiotherapy.
次要结局
- Rate of histological remission of the surgical specimen based on the anatomopathological examination
研究者
研究点 (10)
Loading locations...
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