Intra-operative Radiotherapy For Women With Ductal Carcinoma in Situ Breast Cancer After Nipple-sparing Mastectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Ipsilateral breast tumor recurrence rate after surgery within five years
研究概览
简要总结
The role of NSM is still controversial, mainly because of concern about the oncologic safety of the nipple-areola complex (NAC).INTRABEAM (Carl Zeiss, Oberkochen, Germany) is the most widely used mobile intraoperative radiotherapy (IORT) device to date. This study aims to assess the value of the INTRABEAM system for breast cancer.
详细描述
Despite the advancement and increasing use of nipple-sparing mastectomy (NSM) is still carried out in a portion of breast cancer patients. However, the role of NSM is still controversial, mainly because of concern about the oncologic safety of the nipple-areola complex (NAC). Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation during surgery followed by external-beam radiation to the entire breast may kill more tumor cells.INTRABEAM (Carl Zeiss, Oberkochen, Germany) is the most widely used mobile intraoperative radiotherapy (IORT) device to date. This study aims to broaden the application of the INTRABEAM system for breast cancer, investigating the feasibility of INTRABEAM IORT in NSM with breast reconstruction.
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
- 17 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Tumor diameter ≤3 cm
- •Tumor from the papilla>2cm
- •Low grade ductal carcinoma in situ
- •Candidate for breast-conserving surgery
- •Must have undergone lumpectomy with negative margins or minimal margin involvement
- •Currently undergoing re-excision of the biopsy cavity and/or sentinel lymph node biopsy or axillary lymph node dissection
- •No evidence of metastatic disease
- •Informed consent
排除标准
- •No informed consent
- •Tumor size > 3 cm
- •Tumor from the papilla≤2cm
- •Intermediate or high grade ductal carcinoma in situ
- •Invasive carcinoma
- •No indication for a boost
研究组 & 干预措施
Without Radiotherapy
Patients just accept nipple-sparing mastectomy (NSM) without radiotherapy.
Intraoperative Radiotherapy
Followed by nipple-sparing mastectomy (NSM),INTRABEAM IORT was carried out with a single dose of 16 Gy for nipple-areola complex (NAC).
干预措施: INTRABEAM (Carl Zeiss, Oberkochen, Germany) (Device)
结局指标
主要结局
Ipsilateral breast tumor recurrence rate after surgery within five years
时间窗: Within 5 years after surgery
Within 5 years after surgery,we should evaluate ipsilateral breast tumor recurrence and Disease free survival as the most important outcome measure
次要结局
- Overall survival after surgery within ten years(Within ten years after surgery)
- Disease free survival after surgery within five years(Within 5 years after surgery)
研究者
Liao Ning
MD,PhD
Guangdong Academy of Medical Sciences