Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07135817

Preoperative Stereotactic Radiotherapy for Treatment of Spinal Metastases

Led by University Medical Center Goettingen · Updated on 2025-08-22

20

Participants Needed

1

Research Sites

74 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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)

CONDITIONS

Official Title

Preoperative Stereotactic Radiotherapy for Treatment of Spinal Metastases

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Indication for surgical treatment of a spinal tumor
  • Age 18 years or older
  • Estimated survival longer than 6 months
  • Ability to understand the study information and make a decision to participate
Not Eligible

You will not qualify if you...

  • Age under 18 years
  • Motor deficit or loss of bladder and bowel control requiring emergency surgical decompression
  • Tumor extent not suitable for hypofractionated SBRT (1-3 fractions)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University Medical Center Goettingen

Göttingen, Germany, 37073

Actively Recruiting

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Research Team

C

Carla Marie Zwerenz, Dr. med.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Preoperative Stereotactic Radiotherapy for Treatment of Spinal Metastases | DecenTrialz