Hypofractionated Partial Breast Irradiation After Breast-conserving Surgery for Low-risk Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- The change of breast cosmetic outcome
研究概览
简要总结
The study was designed to evaluate the feasibility and safety of hypofractionated partial breast irradiation after breast-conserving surgery for low-risk breast cancer patients.
详细描述
A total dose of 40.05Gy in 15 fractions was delivered to the tumor bed for each eligible breast cancer patients. The endpoints including loco-regional recurrence, cosmetic outcomes, and toxicities, were evaluated after treatment.
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
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age≥ 50 years
- •Treated with breast conversing surgery and sentinel lymph node biopsy or axillary lymph node dissection
- •Negative surgical margins
- •Pathologically confirmed invasive breast cancer
- •A pathological T1N0M0 tumor -IHC: ER+/PR+/HER2-
- •Tumor bed is labeled with Titanium clips
- •Received adjuvant hormonal treatment
- •No adjuvant chemotherapy
- •Written informed consent.
排除标准
- •Age<50 years
- •Treated with neoadjuvant chemotherapy
- •Treated or being treated with chemotherapy
- •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-PBI
Hypofractionated partial breast irradiation was delivered to the tumor bed areas for low recurrence risk breast cancer patients, with prescription dose 40Gy in 15 fractions in 3 weeks.
干预措施: hypofractionated partial breast irradiation (Radiation)
结局指标
主要结局
The change of breast cosmetic outcome
时间窗: Baseline, and three years after the completion of radiation therapy
The breast cosmetic outcome was measured by Harvard 4 scale (poor, moderate, good, excellent) evaluation system
次要结局
- Disease free survival(5 years)
- Ipsilateral breast tumor recurrence rate(5 years)
- Late complications(3 years)
- Acute radiation-induced toxicity assessed by CTCAE v4.0(3weeks, 5weeks,1 and 3 months after treatment beginning)
- Local-regional recurrence(5 years)
- Overall survival(5 years)
研究者
Jinli Ma
Associate Professor of department of radiation oncology
Fudan University