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临床试验/NL-OMON44250
NL-OMON44250已完成不适用

Randomized controlled trial comparing conVEntional RadioTherapy with stereotactIC body radiotherapy in patients with spinAL metastases - VERTICAL study

niversitair Medisch Centrum Utrecht0 个研究点目标入组 110 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
110

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99(—)

入选标准

  • Radiographic evidence of bone metastases;
  • Per spinal lesion no more than 3 consecutive spine segments involved with one unaffected vertebral body above and below;
  • No more than 2 painful lesions needing treatment;
  • Histologic proof of malignancy;
  • No compression of spinal cord;
  • No or mild neurological signs (i.e. radiculopathy, dermatomal sensory change, and muscle strength of involved extremity is Medical Research Counsil (MRC) 4/5);
  • Medically inoperable or patient refused surgery;
  • Karnofsky performance score (KPS) * 50;
  • Numeric rating scale (NRS) * 3;
  • Age * 18 years;
  • Written informed consent;
  • Filling out PRESENT-questionnaires.

排除标准

  • General exclusion criteria:
  • Radiosensitive histology such as multiple myeloma, lymphoma, small cell and germ cell;
  • MRI cannot be completed for any reason (in according with the MRI protocol of the Department of Radiology);
  • Impossible to delineate metastasis and organs at risk (OAR) due to artefacts on CT or MRI from previous surgical stabilisation;
  • Unable to undergo SBRT treatment, according to treating doctor*s opinion;
  • Severe, worsening or progressive neurological deficit;
  • Unstable bone requiring surgical stabilization;
  • Patient with < 3 months life expectancy;
  • Previous EBRT or SBRT to same location with bone metastases as target volume;
  • Chemotherapy or systemic radionuclide delivery within 24 hours before and after SBRT;
  • Patients with oligometastases who are selected for SBRT after multidisciplinary consultation;
  • Maximum diameter of target volume > 10 cm;
  • Extension of the tumour to the skin. ;Spinal metastases specific exclusion criteria:
  • Lesion in C1 and C2;
  • Epidural disease.;Specific exclusion criteria for bone metastases in the extremities:
  • Fixation material in target volume;
  • Impending fracture (if surgery or stabilisation is an option).

研究者

发起方
niversitair Medisch Centrum Utrecht

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