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临床试验/ACTRN12616001265460
ACTRN12616001265460已完成未知

A Phase II study of local therapy only (stereotactic radiosurgery and/or surgery) for treatment of up to 5 brain metastases from HER2 positive Breast Cancer

Trans Tasman Radiation Oncology Research Group (TROG)0 个研究点目标入组 25 人开始时间: 2016年9月8日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
25

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-randomised trial
主要目的
Treatment
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 o limit(—)
性别
All

入选标准

  • 18 years or older
  • - metastatic HER2 positive breast cancer
  • - 1-5 synchonous brain metastases (At least 1 lesion must require treatment with surgery or SRS, Maximum volume of any single PTV <10cm3 and Summated volume of all lesions to be treated with SRS is < 15cm3. If a lesion is too small for treatment and will be observed, then its volume is not included in this summation).
  • - ECOG 0-2
  • - Absent or stable extracranial disease or active extracranial disease that is likely to be controlled with further HER-2 targeted therapy.
  • - Receiving systemic HER2 targeted therapy, or planned to receive within 4 weeks of completion of brain metastasis treatment
  • - Able to undergo MRI scanning

排除标准

  • - Previous treatment to the target brain metastases (excluding surgery within 6 weeks of registration)
  • - Previous whole brain radiotherapy (WBRT)
  • - Any brain metastasis that is greater than 40mm in size and unable to be resected
  • - Leptomeningeal disease
  • - Pregnant or breastfeeding

研究者

发起方
Trans Tasman Radiation Oncology Research Group (TROG)

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