Neoadjuvant Radiotherapy and Immediate Implant-Based Breast Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Postoperative complications at 3 months following skin-sparing mastectomy and immediate implant-based breast reconstruction after NART
研究概览
简要总结
Neoadjuvant radiotherapy(NART) followed by mastectomy and immediate DIEP flap reconstruction is feasible and technically safe. However, reports of NACT followed immediate implant-based breast reconstruction are rare. Some studies have shown that NART followed immediate implant-based breast reconstruction seems feasible and can be safely attempted. It's well known that radiotherapy after implant-based breast reconstruction have negative effects on implant and cosmetic results. So, investigators conducted a polit study to learn about acute post-surgical complications following skin-sparing mastectomy and immediate implant-based breast reconstruction after NART.
详细描述
Radiotherapy after implant-based breast reconstruction have negative effects on implant and cosmetic results, including severe capsular contracture, mastectomy flap necrosis ,reoperation and so on. Postmastectomy radiotherapy( PMRT )is associated with implant reconstruction failure. PRADA study has shown neoadjuvant radiotherapy followed by skin-sparing mastectomy and immediate DIEP flap reconstruction is feasible and technically safe. The investigators assume that neoadjuvant radiotherapy can avoid the negative effects of PMRT on an implant and the capsule of an implant and would lead to better cosmetic results and less complications compared to PMRT. Furthermore, some studies have shown that NART could potentially result in shorter time between diagnosis and treatment completion. So, investigators conducted a polit study to learn about acute post-surgical complications following skin-sparing mastectomy and immediate implant-based breast reconstruction after NART.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women >18 years with histopathologically-confirmed breast cancer, who:
- •require mastectomy for any reason
- •a known indication for (adjuvant) radiotherapy
- •require implant-based breast reconstruction
排除标准
- •Inability to give informed consent
- •MDT unable to make recommendation for radiotherapy based on pre-operative histopathological and imaging findings
- •Previous history of breast cancer or another malignancy for which radiotherapy of the breast or axilla
- •Pregnant or lactating
- •inflammatory breast cancer
结局指标
主要结局
Postoperative complications at 3 months following skin-sparing mastectomy and immediate implant-based breast reconstruction after NART
时间窗: 3 months following skin-sparing mastectomy and immediate breast reconstruction
Surgical complications are defined as any complication requiring surgical intervention necessary within a period up to three months after the final reconstruction. Including Infection, hematoma , loss of implant or flap, fat necrosis, wound breakdown,defined and scored using the C-DC37.
次要结局
- Patient satisfaction.(3 months and 12 months after surgery)
- Number of participants with removal of implant.(6 months after surgery)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 .(Within 3 months after both breast reconstruction and radiotherapy)
- Pathological complete response (pCR) assessed in skin-sparing mastectomy specimen(Within 2 weeks after skin-sparing mastectomy)
研究者
Xinhong Wu, PhD
vice-president
Hubei Cancer Hospital