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临床试验/ACTRN12614000484640
ACTRN12614000484640招募中未知

A pilot Study to assess the feasibility and tolerability of stereotactic ablative body radiosurgery in patients with oligometastases from breast cancer.

Peter MacCallum Cancer Centre0 个研究点目标入组 30 人开始时间: 2014年5月9日最近更新:
适应症

试验速览

阶段
未知
状态
招募中
发起方
入组人数
30

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

  • * Aged > 18 years.
  • * Has provided signed written informed consent for participation in this trial.
  • * Histological or cytologically confirmed breast cancer.
  • * Primary breast cancer controlled.
  • * Whole Body Bone Scan (WBBS), CT Scan (Chest, Abdo + Pelvis) and Na-18F PET Scan evidence of 1 to 3 active metastases (bone only) within 8 weeks of study registration.
  • * An ECOG performance status score of 2 or less.
  • * Life expectancy greater than 12 months.
  • * Willing and able to comply with all study requirements, including treatment, attending required assessments and follow-up.

排除标准

  • * Previous high dose radiotherapy (BED > 20Gy) to an area to be treated which includes vertebral bodies
  • * Visceral Metastases (e.g. liver, lung or brain)
  • * Treatment with any chemotherapy agent within +/- 3 weeks of SABR
  • * Evidence of Spinal Cord Compression.
  • * Spinal Instability Neoplastic Score greater than or equal 7 unless lesion reviewed by a neurosurgical service and considered stable. A dose of 28Gy in 2 fractions can be considered after review at SABR chart round.
  • * Surgical fixation of lesion required for stability.
  • * Lesion in a long bone (femur or humerus) which involves the cortex.

研究者

发起方
Peter MacCallum Cancer Centre

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A pilot study of patients with oligometastases from... | 临床试验