NCT02941835终止不适用
Preoperative Breast Irradiation, the PROBI Trial. A Phase I/II Feasibility Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Postoperative surgical complications
研究概览
简要总结
The PROBI is a phase I/II trial assessing the feasibility of preoperative whole breast irradiation in female patients with low to intermediate risk breast cancer, who undergo breast conserving therapy, including a boost dose of irradiation.
An additional goal of this study is to assess tumor response to radiotherapy, by imaging modalities (PET-CT and MRI) and pathology
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically proven invasive breast carcinoma
- •cT1-2N0 breast cancer
- •female patients ≤ 50 years
- •planned breast conserving surgery
- •ability to undergo irradiation and surgery
- •signed written informed consent
排除标准
- •prior surgery or radiotherapy for the protocol tumor (neoadjuvant chemotherapy or endocrine therapy is allowed)
- •planned oncoplastic reduction mammoplasty
- •extensive calcifications on mammagram (Birads 3,4 or 5)
- •cT3-4 and/or cN1-3 invasive carcinoma
- •distant metastasis
研究组 & 干预措施
radiation
Other
intervention: pre-operative breast irradiation of 21 fx of 2.2Gy and boost 2.66Gy
干预措施: pre-operative irradiation (Radiation)
结局指标
主要结局
Postoperative surgical complications
时间窗: within six weeks after surgery
postoperative complication will be scored by a specific list
次要结局
- Radiological response(6 weeks post-radiation)
- Pathological response(at surgery)
- cosmetic outcome(1,3 and 5 years post-treatment)
研究者
研究点 (2)
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