Multicenter Phase-II-Trial of Evaluation of Acute Toxicity in Hypofractionation With Simultaneous Integrated Boost for Early Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 38
- 主要终点
- Acute Skin Toxicity
研究概览
简要总结
Hypofractionation with simultaneous integrated boost has been investigated in a few trials and appears to be safe and feasible with less lung toxicity in smaller studies.
Investigators initiated this multicenter phase II prospective trial to analyse acute toxicity of hypofractionation with simultaneous integrated boost in patients with early breast cancer under the hypothesis that the ratio of patients with acute radiogenic toxicity Grad II according NCI-CTCAE amounts maximum 20%.
详细描述
Hypofractionated radiotherapy of the breast 16 × 2.50 Gy with simultaneous integrated boost to the tumor bed (total dose within the boost volume 16 × 3.00 Gy).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Histopathologically confirmed breast cancer operated by breast conserving surgery with clear margins
- •Indication to adjuvant radiotherapy including boost radiotherapy
- •Clearly identified primary tumor region preferably by radiopaque clips
- •Primary wound healing after breast conserving therapy without signs of infection
- •Pre- and/or postoperative chemotherapy and endocrine therapy were permitted when indicated
- •Written informed consent
排除标准
- •Patients operated by mastectomy
- •No indication for boost radiation
- •Resection margins positive for disease or insufficient identification of the boost volume
- •Indication for radiotherapy of the regional lymph nodes
- •History of prior breast or thoracic radiotherapy
- •Extended postoperative seroma at the beginning of radiotherapy
- •Psychiatric disorders or psychological disabilities thought to adversely affect treatment compliance
- •Pregnant or lactating patients and woman of child bearing potential, who lacked effective contraception
结局指标
主要结局
Acute Skin Toxicity
时间窗: 6 months
Acute skin radiogenic toxicity grade II or higher according to NCI-CTCAE
次要结局
- Performance(0 to 6 months)
- Number of Patients treated on Protocol(22-29 days (16 fractions))
- Acute General Toxicity(0 to 6 months)
- Quality of life Score(0 to 6 months)
研究者
Juergen Dunst, Prof.
Prof. Dr. med. Juergen Dunst
University Hospital Schleswig-Holstein