The Skagen Trial 1, Moderately Hypofractionated Loco-regional Adjuvant Radiation Therapy of Early Breast Cancer Combined With a Simultaneous Integrated Boost: a Randomised Clinically Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,963
- 试验地点
- 1
- 主要终点
- Development of ipsilateral arm lymphedema
研究概览
简要总结
The purpose of the study is to investigate the difference in late radiation morbidity between hypofractionated and normofractionated loco-regional breast irradiation irrespective of mastectomy or lumpectomy. In patients who a candidates for a boost, the boost will be provided as a simultaneous integrated boost.
详细描述
The randomization is between 50 Gy / 25 fractions and 40 Gy/15 fractions, 5 fractions weekly. In patients treated with boost 2 dose levels are accepted: 16 Gy/8 fractions and 10 Gy/5 fractions. These boost treatments will be provided as simultaneous integrated boost, where the overall treatment time in general is shortened 5 days. Thus the dose levels for boost patients are:
63 Gy / 51.52 Gy / 28 fractions, 57 Gy / 50 Gy / 25 fractions, 52.2 Gy / 42.3 Gy / 18 fractions, and 45.75 Gy / 40 Gy / 15 fractions.
The primary endpoint is arm lymphedema 3 years after radiation therapy, but other late radiation morbidities will also be evaluated along with recurrence and sites of recurrence. Follow up of morbidity will continue for 10 years.
The hypothesis is that women operated for early breast cancer with indication for loco-regional radiation therapy can be offered moderately hypofractionated therapy without developing more late radiation induced morbidity compared to normofractionated radiation therapy.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Operated for early node-positive breast cancer with indication for loco-regional breast radiotherapy
排除标准
- •Previous radiotherapy to chest wall, pregnant/lactating, comorbidity which may hinder 10 years follow up
结局指标
主要结局
Development of ipsilateral arm lymphedema
时间窗: 3 years
\>=10% increased arm circumference compared to the other arm defines edema
次要结局
- Development of dyspigmentation(3 years)
- Development of edema on breast / chest wall(3 years)
- Fibrosis grade 2-3(3 years)
- Arm range of motion(3 years)
- Development of pain in the irradiated area(3 years)
- Development of telangiectasia in irradiated area(3 years)
- Recurrence(10 years)
- Change in sensibility(3 years)
研究者
Birgitte Offersen
MD, professor, ph.d.
Danish Breast Cancer Cooperative Group