Comparison of the Efficacy of Intra-operative Radiation Therapy After Conserving Surgery With Post-operative Whole Breast Radiotherapy for Women With Ductal Carcinoma in Situ
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 74
- 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
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.The clinical trial is conducting to compare the effectiveness of radiation therapy during surgery and whole-breast radiation therapy in treating women who have undergone breast-conversing surgery for Intermediate or high grade ductal carcinoma in situ breast cancer.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Tumor diameter < 5 cm
- •Intermediate or high grade ductal carcinoma in situ
- •Informed consent
排除标准
- •No informed consent
- •Tumor size > 3,5 cm
- •Low grade ductal carcinoma in situ
- •Invasive carcinoma
- •No indication for a boost
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
Disease free survival after surgery within five years
时间窗: Within 5 years after surgery
Within 5 years after adjuvant chemotherapy,we should evaluateDisease free survival(DFS) rates as thet important outcome measure.
次要结局
- Overall survival after surgery within ten years(Within ten years after surgery)
研究者
Liao Ning
Guangdong Academy of Medical Sciences
Guangdong Academy of Medical Sciences