Phase 3 Open-labeled Randomized Clinical Study of Comparing Hypofractionated and Conventional Radiotherapy for Breast Cancer Patients After Breast Conservative Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 720
- 试验地点
- 7
- 主要终点
- in-breast recurrence rate
研究概览
简要总结
Early-stage breast cancer patients treated with breast conservative surgery are enrolled in this study if they meet defined criteria. Patients are randomized into two groups: conventional fractionation radiotherapy and hypofractionated radiotherapy.The hypothesis is that conventional fractionation radiotherapy and hypofractionated radiotherapy have similar efficacy and toxicity.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •histology confirmed invasive breast cancer
- •received breast conservative surgery(wide local excision and axilla dissection, or axillary sentinel node biopsy if sentinel node is negative)
- •surgical margins negative
- •primary tumor ≤5cm in the largest diameter
- •no internal mammary node or supraclavicular node metastases or distant metastasis
- •can tolerate chemotherapy,hormone therapy (if needed) and radiotherapy
- •for patients not need chemotherapy，enrollment date is required no more than 8 weeks from surgery date
- •for patients with chemotherapy first,enrollment date is required no more than 8 weeks from the last date of chemotherapy
- •patients signed written inform consent form
排除标准
- •ductal carcinoma in situ
- •prior neoadjuvant chemotherapy
- •prior breast cancer history
- •bilateral breast cancer
- •pregnant or during lactation
- •prior or concomitant malignant tumor excluded skin cancer(not malignant melanoma) and cervix carcinoma in situ
- •active collagen vascular disease
- •prior neoadjuvant hormone therapy
- •immediate ipsilateral breast reconstruction
研究组 & 干预措施
hypofractionation radiotherapy
irradiation to the whole breast to a total dose of 43.5Gy,at 2.9Gy per fraction, 5 fractions a week, followed by tumor bed boost of 8.7Gy, at 2.9Gy per fraction 5 fractions a week.
干预措施: radiotherapy (Radiation)
conventional fractionation radiotherapy
irradiation to the whole breast to a total dose of 50Gy,at 2.0Gy per fraction, 5 fractions a week, followed by tumor bed boost of 10Gy, at 2.0Gy per fraction 5 fractions a week.
干预措施: radiotherapy (Radiation)
结局指标
主要结局
in-breast recurrence rate
时间窗: 5 year
evidence of ipsilateral breast local recurrence confirmed by histology
次要结局
- acute toxicity(6 months)
- regional node recurrence rate(5 year)
- disease-free survival(5 year)
- overall survival(5 year)
- late complication(3 -10 year)
研究者
Shulian Wang
M.D.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences