NCT02617043Unknown2 期
Hypofractionated Whole-breast Irradiation With Simultaneously Integrated Boost For Early-Stage Breast Cancer After Breast-conserving Surgery
适应症
干预措施
试验速览
- 阶段
- 2 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Numbers of participants with treatment-related toxicity assessed by CTCAE v4.0
研究概览
简要总结
The study was designed to evaluate the feasibility and safety of hypofractionated whole-breast irradiation with simultaneously integrated boost for early-stage breast cancer after breast conserving surgery in Chinese population.
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 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18-60 years old
- •Treated with breast conversing surgery and sentinel lymph node biopsy or axillary lymph node dissection
- •Pathologically confirmed invasive breast cancer
- •A pathological T1-2N0M0 tumor
- •Tumor bed is labeled with Titanium clips
- •Negative surgical margins
- •Written informed consent.
排除标准
- •Treated with neoadjuvant chemotherapy
- •Sentinel lymph nodes only containing isolated tumour cells (<0.2 mm)
- •With severe comorbidity
- •Previous breast cancer or other malignant tumor history
- •Previous radiotherapy for breast or thorax
- •Medical contraindication for radiotherapy
- •Pregnant or nursing
研究组 & 干预措施
HF-WBI
Experimental
Hypofractionated whole breast irradiation for early breast cancer with prescription dose 40Gy in 15 fractions in 3 weeks. Tumor bed is simultaneously integrated boosted to 48Gy.
干预措施: hypofractionated whole breast irradiation with simultaneously integrated boost (Radiation)
结局指标
主要结局
Numbers of participants with treatment-related toxicity assessed by CTCAE v4.0
时间窗: 2 year
acute toxicity related to irradiation such as lung and skin
次要结局
- Late complications(1,2,3,4,5years)
- acute radiation-induced toxicity assessed by CTCAE v4.0(during radiotherapy; 3months; 6 months)
- local-regional recurrence(5 years)
- Disease free survival(5 years)
- cosmetic effect measured by Harvard 4 scale evaluation system(2,3,4,5years)
- Overall survival Over survival(5 years)
研究者
Xiaoli Yu
Associate Professor of department of radiation oncology
Fudan University
研究点 (1)
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