NCT04789889终止不适用
Comparison of Satisfaction With Conserved Breast, Postoperative Complications and Tumor Control Between IORT and Postoperative Radiotherapy in Breast Conserving Surgery
Xiangyun Zong1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年3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
- 80
- 试验地点
- 1
- 主要终点
- Rate of successful surgical procedure
研究概览
简要总结
To compare the satisfaction with conserved breast, acute and chronic postoperative complications and tumor control between intraoperative radiotherapy(IORT) and traditional postoperative radiotherapy following breast-conserving surgery (BCS).
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
- •Primary invasive breast cancer confirmed by pathology.
- •Maximum tumor diameter ≤3.5cm.
- •Clinical lymph nodes are negative.
- •Single or multiple tumors are located on the same side of the nipple and in the same quadrant.
- •ECOG status score ≤
- •With informed Consents.
排除标准
- •Previous history of breast cancer or other malignant tumors.
- •Inflammatory breast cancer;
- •Previous radiotherapy history.
- •Other diseases affecting radiotherapy, such as connective tissue disease, heart disease, lung disease and so on.
- •Patients who are not going to have the axillary lymph node surgery (including SLN and ALND) were excluded.
结局指标
主要结局
Rate of successful surgical procedure
时间窗: immediately after surgery
the rate of successful breast conserving surgery
satisfaction with conserved breast
时间窗: 1 month after surgery
the patients' satisfaction to postoperative breast including shape and feeling(Harvard/NSABP/RTOG BREAST COSMETIC SCALE: excellent, good, fair, poor)
次要结局
- DFS(2-3 years after surgery)
- OS(2-3 years after surgery)
- Rate of acute and chronic postoperative complications（CTCAE 3.0)(1-month, 6-month after surgery)
研究者
Xiangyun Zong
Director of Breast Cancer
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
研究点 (1)
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