NCT06984250招募中不适用
Hybrid Techniques Combining Hypofractionated Whole Breast Radiotherapy With Concomitant Tumor Bed Boost in Patients With Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 315
- 试验地点
- 2
- 主要终点
- Ipsilateral breast tumor recurrence
研究概览
简要总结
Hypofractionated breast radiotherapy with concomitant tumor bed boost for early breast cancer or ductal breast carcinoma in situ after partial mastectomy
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients with histologically confirmed early-stage breast cancer (T1-2 and N0-1) or ductal carcinoma in situ (DCIS).
- •Patients undergoing breast-conserving surgery
- •Age ≥ 20 years
- •Karnofsky Performance Status (KPS) ≥70%
- •Life expectancy ≥ 5 years
- •Adequate renal and hepatic function
排除标准
- •Pregnant patients
- •Patients requiring re-irradiation of the thoracic region
结局指标
主要结局
Ipsilateral breast tumor recurrence
时间窗: From enrollment to the end of treatment at 2 years
The time from the date of completion of radiotherapy to the date of ipsilateral breast recurrence or death, whichever occurs first. Unit of Measure: Time-to-event (months)
次要结局
- Early Phase Acute Skin Toxicity(Up to 3 months following completion of radiotherapy)
- Late Phase Breast Fibrosis(From 3 months up to 5 years following completion of radiotherapy)
- Patient Quality of Life (EORTC QLQ-C30)(At baseline (before radiotherapy), between 1 week and 1 month following radiotherapy completion, then every 3 to 4 months thereafter until study completion (up to 5 years))
- Patient Quality of Life (EORTC QLQ-BR23)(At baseline (before radiotherapy), between 1 week and 1 month following radiotherapy completion, then every 3 to 4 months thereafter until study completion (up to 5 years))
研究者
研究点 (2)
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