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临床试验/NCT07135817
NCT07135817招募中不适用

Preoperative Stereotactic Radiotherapy for Treatment of Spinal Metastases

University Medical Center Goettingen2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
20
试验地点
2
主要终点
Local Tumor Control

研究概览

简要总结

The goal of this interventional clinical trial is to evaluate the efficacy and safety of preoperative hypofractionated Stereotactic Body Radiotherapy (SBRT) in the treatment of patients undergoing surgery for spinal metastases.

The main questions this study aims to answer are:

  • Does preoperative SBRT result in local tumor control at the involved spinal segments as assessed by MRI/CT scan at 3 and 6 months postoperatively?
  • What are the postoperative outcomes in terms of pain intensity, functional status and quality of life?

Participants will receive hypofractionated SBRT to spinal metastases shortly before surgical intervention.

Participants will undergo preoperative and follow-up assessments, including:

  • MRI and CT scans before and after surgery and at 3 and 6 months after surgery to measure tumor size
  • Pain questionnaires where patients rate their current pain, worst pain, and average pain in the last 24 hours on a scale from 0 (no pain) to 10 (worst pain imaginable)
  • A short questionnaire (Karnofsky Performance Status) to assess the patient's general ability to carry out daily activities
  • Several patient questionnaires to evaluate back pain, physical limitations, and overall quality of life (Oswestry Disability Index, EORTC QLQ-C30, and EORTC QLQ-BM22)

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Indication for surgical treatment of a spinal tumor
  • Age: older or 18 years
  • Estimated survival > 6 months
  • The patient is able to understand the nature, significance and scope of the clinical study in the context of patient information and to base the decision to participate in the study on this.

排除标准

  • Age: < 18 years
  • Motor deficit or loss of bladder and bowel control that urges an emergency surgical decompression
  • Tumor extent does not allow hypofractioned SBRT (1-3 fractions)

结局指标

主要结局

Local Tumor Control

时间窗: 3 months after treatment

次要结局

  • EORTC QLQ-C30 Scores(3 and 6 months after treatment)
  • EORTC QLQ-BM22 Scores(3 and 6 months after treatment)
  • Local Tumor Control(6 months after treatment)
  • Pain relief(at discharge from initial hospitalization (typically within 5-10 days after surgery), 3 and 6 months after treatment)
  • Wound Healing Complications at Hospital Discharge(at discharge from initial hospitalization (typically within 5-10 days after surgery))
  • EORTC QLQ-C30 Scores(3 and 6 months after treatment)
  • EORTC QLQ-BM22 Scores(3 and 6 months after treatment)
  • Oswestry Disability Index (ODI)(3 and 6 months after treatment)
  • Number of participants with radiologically confirmed instrumentation failure(6 months after surgery)

研究者

发起方
University Medical Center Goettingen
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Dr. Rami El Shafie

Principal Investigator

University Medical Center Goettingen

研究点 (2)

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