Preoperative Stereotactic Radiotherapy for Treatment of Spinal Metastases

Status: Recruiting
Location: See location...
Intervention Type: Radiation, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Germany
University Medical Center Goettingen
RECRUITING
Göttingen
Contact Information
Primary
Carla Marie Zwerenz, Dr. med.
carlamarie.zwerenz@med.uni-goettingen.de
+49 551 39 64501
Time Frame
Start Date: 2025-08-01
Estimated Completion Date: 2027-01
Participants
Target number of participants: 20
Treatments
Experimental: Hypofractionated Stereotactic Body Radiotherapy + Surgery
Participants will receive hypofractionated Stereotactic Body Radiotherapy (SBRT) to spinal metastases in 1-3 fractions within one week after informed consent. SBRT will be planned using MRI co-registered with planning CT and delivered following institutional immobilization standards and ESTRO guidelines. Surgical intervention will follow within a maximum of 10 days after informed consent and includes decompression of the spinal canal and/or dorsal instrumentation, depending on clinical indication.
Related Therapeutic Areas
Sponsors
Leads: University Medical Center Goettingen

This content was sourced from clinicaltrials.gov