NCT02055937终止不适用
Immediate Implant Breast Reconstruction for Patients With Mastectomy Ans Post opérative Chest Wall Radiotherapy
Institut du Cancer de Montpellier - Val d'Aurelle2 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2013年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Success is defined as a complete therapeutic sequence (surgery + RT) without any significant complication at 6 months.
研究概览
简要总结
The purpose of this study is to study the impact of the immediate implant breast reconstruction for patients with mastectomy and postoperative chest wall radiotherapy
详细描述
non applicable
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Histologically confirmed breast carcinoma
- •Patients planned for mastectomy with immediate single stage breast reconstruction using an acellular dermal matrix (Strattice™, LifeCell Corporation)
- •Patients planned to receive postoperative chest wall irradiation
- •Age ≥ 18 years old
- •WHO performance status 0-1
- •Affiliation to a social security system
- •Informed consent signed prior any study specific procedures
排除标准
- •Inflammatory breast cancer
- •Tumors with extensive involvement of the skin
- •Use of tissue expander
- •Indication of postoperative chemotherapy
- •Patients planned for bilateral mastectomy
- •History of previously treated ipsilateral breast carcinoma
- •Usual contraindications for ADM
- •Medical debility precluding surgical treatment
- •Psychological, social, geographical disorders or any other condition that would preclude study compliance (treatment modalities and study follow-up).
- •Pregnancy or breast feeding
- •Inability to attend or comply with interventions or follow-up scheduling, disability or difficulty preventing a proper understanding of trial instructions
- •Legal inability or restricted legal ability
结局指标
主要结局
Success is defined as a complete therapeutic sequence (surgery + RT) without any significant complication at 6 months.
时间窗: confirm the feasibility of the therapeutic sequence at 6 months
Success is defined as a complete therapeutic sequence (surgery + RT) without any significant complication at 6 months. Significant complication is defined as: * Any event delaying RT (delay surgery/RT \> 3 months) * Any event preventing patients from receiving radiotherapy within 6 months after surgery
次要结局
- The rate of Baker(up to 36 months after surgery)
研究者
研究点 (2)
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