Hypofractionated Versus Standard Fractionated Whole Breast Irradiation to Node-negative Breast Cancer Patients
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)
研究概览
地位
详细说明
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.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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-
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Copenhagen、丹麦、DK-2100 Ø
- The Danish Breast Cancer Cooperative Group
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
operated with breast conserving strategy for:
- invasive breast cancer, pT1-2, pN0-1mi, M0 OR
- carcinoma in situ of the breast
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：standard fractionated radiotherapy
50 Gy/25 fractions, 2.00 Gy/fraction, 5 fractions per week
|
standard fractionated radiotherapy 50 Gy/25 fractions
|
|
实验性的：hypofractionated radiotherapy
hypofractionated radiotherapy 40 Gy/15 fractions
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hypofractionated radiotherapy 40 Gy/15 fractions
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Grade 2 or 3 fibrosis 3 years after radiotherapy
大体时间：3 years
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3 years
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Any other late morbidity after adjuvant radiotherapy, genetic risk profile for late morbidity, recurrence/survival
大体时间：10 years
|
10 years
|
合作者和调查者
调查人员
- 学习椅：Birgitte Offersen, MD, Ph.D、Aarhus University Hospital
- 学习椅：Erik Jakobsen, MD、Vejle Hospital
- 学习椅：Mechthild Krause, M.D., Prof、University Clinic Carl Gustav Carus Dresden
- 学习椅：Andreas Schreiber, M.D., Ph.D.、Praxis für Strahlentherapie am Klinikum Dresden-Friedrichstadt
- 学习椅：Ingvil Mjaaland, M.D.、Helse Stavanger HF, Sorlandet Sykehus HF
- 学习椅：Unn-Miriam Kasti, M.D.、Kristiansand sykehus
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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