Hypofractionated Versus Standard Fractionated Whole Breast Irradiation to Node-negative Breast Cancer Patients: a Randomized Phase III Trial, CIRRO (The Lundbeck Foundation Center for International Research in Radiation Oncology)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 976
- 试验地点
- 2
- 主要终点
- Grade 2 or 3 fibrosis 3 years after radiotherapy
研究概览
简要总结
The purpose of this study is to investigate the difference in late radiation morbidity between hypofractionated and standard fractionated breast irradiation given to women operated with breast conservation for early breast cancer.
详细描述
The randomization is between 50 Gy/25 fractions, 2.0 Gy per fraction, 5 fractions weekly, and 40 Gy/15 fractions, 2.67 Gy per fraction, 5 fractions weekly. The primary endpoint is late radiation morbidity; secondly, we want to investigate the frequency of local recurrences, and try to establish a genetic risk profile for development of late radiation morbidity.
The hypothesis is that women operated with breast conserving strategy for early breast cancer can be offered moderately hypofractionated radiotherapy without developing more late radiation morbidity compared to standard fractionated radiotherapy.
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
- 41 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •operated with breast conserving strategy for:
- •invasive breast cancer, pT1-2, pN0-1mi, M0 OR
- •carcinoma in situ of the breast
排除标准
- •previous radiation of the breast/thorax
- •breast implants
- •pregnant/lactating
- •comorbidity which may hinder the patient in completing the therapy and complete follow up for 10 years
结局指标
主要结局
Grade 2 or 3 fibrosis 3 years after radiotherapy
时间窗: 3 years
次要结局
- Any other late morbidity after adjuvant radiotherapy, genetic risk profile for late morbidity, recurrence/survival(10 years)
研究者
Birgitte Offersen
M.D., ph.d., associate professor
Danish Breast Cancer Cooperative Group