A Phase Ⅲ Randomized Clinical Trial of Postmastectomy Hypofractionation Radiotherapy in High-risk Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 810
- 试验地点
- 2
- 主要终点
- locoregional control rate
研究概览
简要总结
The purpose of this study is to compare the efficacy and toxicities of hypofractionation radiotherapy with conventional fractionation radiotherapy in breast cancer patients treated with mastectomy.It is hypothesized that the efficacy and toxicities are similar between the two groups.
详细描述
Eligible breast cancer patients with mastectomy and axillary dissection are randomized into 2 groups:conventional fractionation radiotherapy of 50 Gy in 25 fractions within 5 weeks to ipsilateral chest wall and supraclavicular nodal region,and hypofractionation radiotherapy of 43.5Gy in 15 fractions within 3 weeks to the same region.
During and after radiotherapy, the patients are followed and the efficacy and toxicities of radiotherapy are evaluated.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Ipsilateral histologically confirmed invasive breast cancer
- •Undergone total mastectomy and axillary dissection
- •T3-4,or >=4 positive axillary lymph nodes
- •Fit for chemotherapy(if indicated),endocrine therapy(if indicated)and postoperative irradiation
- •Written,informed consent
- •cT3-4,or cN2, or pathological positive axillary lymph nodes during mastectomy for patients who had received neoadjuvant chemotherapy or hormone therapy
- •no supraclavicular or internal mammary nodes metastases
- •no distant metastases
- •enrollment date no more than 8 months after surgery or no more than 2 months after chemotherapy for patients who didn't receive neoadjuvant systemic therapy.
- •enrollment date no more than 2 months after surgery for patients who had received neoadjuvant systemic therapy and didn't need adjuvant chemotherapy.
排除标准
- •Patients who undergone previous irradiation to the ipsilateral chest wall and supraclavicular region
- •Previous or concurrent malignant other than non-melanomatous skin cancer
- •Unable or unwilling to give informed consent
- •bilateral breast cancer
- •immediate or delayed ipsilateral breast cancer reconstruction
研究组 & 干预措施
hypofractionation radiotherapy
breast cancer women with mastectomy high-risk: T3-4 and/or 4 or more axillary nodes involvement postmastectomy hypofractionation radiotherapy of 43.5Gy/15f/3w to the chest wall and supraclavicular nodal region
干预措施: hypofractionation radiotherapy (Radiation)
conventional fractionation radiotherapy
breast cancer women with mastectomy high-risk with T3-4 and/or 4 or more axillary nodes postmastectomy conventional fractionation radiotherapy of 50Gy/25f/5w to the chest wall and supraclavicular nodal region
干预措施: conventional fractionation radiotherapy (Radiation)
结局指标
主要结局
locoregional control rate
时间窗: 5 years
ipsilateral chest wall, axilla, supraclavicular and internal mammary nodal relapse
次要结局
- overall survival(5 years)
研究者
Shu lian Wang
M.D.
Chinese Academy of Medical Sciences