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临床试验/DRKS00014558
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

发起方
Städtisches Klinikum Dessau

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