Preoperative Stereotactic Radiotherapy for Treatment of Spinal Metastases

Recruiting now · Not applicable

Conditions studied: Spinal Metastases, Solid Tumor Cancer

In brief

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)

Key facts

Study ID

NCT07135817

Run by

University Medical Center Goettingen

People needed

20

Starts

2025-08-01

Expected to finish

2027-01-01

Last updated by the study team

2025-08-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• University Medical Center Goettingen — Göttingen, Germany (enrolling)

Full record on ClinicalTrials.gov

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