A Prospective Study of Risk-Stratified Hypofractionated Radiotherapy After Breast-Conserving Surgery for Early Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 649
- 试验地点
- 1
研究概览
简要总结
This prospective study is designed to evaluate the feasibility, efficacy, and safety of risk-stratified hypofractionated radiotherapy after breast-conserving surgery in patients with early breast cancer.
详细描述
Eligible patients with early breast cancer who have undergone breast-conserving surgery will be stratified into a high-risk group or a low-risk group according to the presence or absence of predefined high-risk factors.
Patients in the high-risk group will receive whole-breast irradiation with a simultaneous integrated boost to the tumor bed. The prescribed dose will be 36 Gy in 15 fractions over 3 weeks to the whole breast and 48 Gy in 15 fractions over 3 weeks to the tumor bed.
Patients in the low-risk group will receive partial-breast irradiation. Two hypofractionated schedules may be used: 40.05 Gy in 15 fractions over 3 weeks or 26 Gy in 5 fractions over 1 week.
Patients will be followed during and after radiotherapy to evaluate treatment efficacy, recurrence rates, and acute and late radiation-related toxicities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ECOG performance status score of 0 to
- •Pathologically confirmed breast cancer, including invasive carcinoma or ductal carcinoma in situ.
- •Clinical stage cT0-2N0M
- •Underwent breast-conserving surgery.
- •Negative surgical margins greater than 2 mm.
排除标准
- •Regional lymph node metastasis.
- •Distant metastasis.
- •Bilateral breast cancer.
- •Prior thoracic radiotherapy.
- •Life expectancy of less than 5 years.
- •Lactating or pregnant women.