DRKS00014558招募中1 期
Preoperative fractionated Stereotactic Radiosurgery for Breast Cancer (PROBE) - PROBE
Städtisches Klinikum Dessau0 个研究点目标入组 50 人开始时间: 2018年6月28日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 50 Years 至 one(—)
- 性别
- Female
入选标准
- •age = 50 years
- •Invasive ductal, monofocal carcinoma of the breast G1– G3, cT1c to cT2 (1 cm to 4 cm) without any evidence of lobular carcinoma or in situ DCIS (>10%)
- •Complete histological characterization including: ER expression status, PR expression status, Her-2/neu expression status, Ki-67 und PD-L1
- •no indication for preoperative chemotherapy
- •The patient is candidate for primary breast-conserving resection and sentinel lymph node biopsy.
- •Ability to understand protocol and ability and willingness to comply with follow-up
- •The patient agrees, that her case will be discussed repeatedly in interdisciplinary tumor boards.
- •Negative pregnancy test in premenopausal patients
- •If premenopausal and sexually active, maintained contraception for at least 12 months after radiotherapy
- •The patient agrees to have an Au-tissue marker placed to define localization oft the tumor.
排除标准
- •previous radiotherapy of affected breast
- •Pregnancy test positive
- •rheumatoide arthritis, systemic lupus erythematoides, scleroderma
- •breast implant of affected breast
- •Lack of tissue marker at the start of radiotherapy
- •Planned mastectomy or skin-sparing mastectomy
- •Planning constrains cannot be achieved (Drop-out after planning)
- •Inability to tolerate prone positioniong during radiotherapy.
研究者
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