Preoperative Stereotactic Radiotherapy for Treatment of Spinal Metastases (PRESTRASM)

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)

Study Overview

• Status: Recruiting
• Conditions: Solid Tumor Cancer; Spinal Metastases
• Intervention / Treatment: Radiation: Preoperative Stereotactic Body Radiotherapy (SBRT); Procedure: Spinal Surgery for Decompression and/or Stabilization

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carla Marie Zwerenz, Dr. med.; Phone Number: +49 551 39 64501; Email: carlamarie.zwerenz@med.uni-goettingen.de

Study Locations

• Germany
  • Göttingen, Germany, 37073
    • Recruiting
    • University Medical Center Goettingen
    • Contact: Anna-Lena Simmert; Phone Number: +49 551 39 64567; Email: anna-lena.simmert@med.uni-goettingen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

Radiation: Preoperative Stereotactic Body Radiotherapy (SBRT); Hypofractionated SBRT delivered in 1-3 fractions within 10 days before surgery, using MRI-based planning and institutional immobilization standards according to ESTRO guidelines.; Procedure: Spinal Surgery for Decompression and/or Stabilization; Surgical intervention is performed following SBRT, based on clinical indication. It includes decompression of the spinal canal in cases of spinal cord or nerve compression (via laminectomy and/or foraminotomy), and/or dorsal instrumentation for unstable spines using pedicle screws guided by a neuronavigation system (Brainlab, Munich, Germany)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Local Tumor Control	3 months after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local Tumor Control		6 months after treatment
Pain relief	Pain rating measured by numerical rating scale (zero to ten): This is conducted by asking the patients to rate their 1) present pain, as well as 2) the worst pain they had experienced in the last 24 hours, and 3) the average pain experienced in the last 24 hours on a numeric rating scale (NRS: 0 = "no pain", 10 = "worst pain imaginable").	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	The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) is a validated 30-item questionnaire to assess cancer patients' general health status and quality of life. Scores range from 0 to 100. For global health and functioning scales, higher scores indicate better outcomes. For symptom scales, higher scores indicate worse symptoms.	3 and 6 months after treatment
EORTC QLQ-BM22 Scores	The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Bone Metastases module (EORTC QLQ-BM22) is a validated 22-item patient-reported outcome measure designed to assess quality of life specifically in patients with bone metastases. It includes functional and symptom domains. Scores range from 0 to 100. Higher scores in symptom scales indicate worse symptoms; higher scores in functional scales indicate better function.	3 and 6 months after treatment
Oswestry Disability Index (ODI)	The Oswestry Disability Index (ODI) is a validated patient-reported outcome questionnaire used to assess the degree of disability and functional impairment due to low back pain. It consists of 10 items covering activities of daily living. Scores range from 0% to 100%, with higher scores indicating greater disability.	3 and 6 months after treatment
Number of participants with radiologically confirmed instrumentation failure	Instrumentation failure will be assessed based on postoperative spinal imaging (CT and MRI). Failure is defined as signs of implant loosening, breakage, displacement, or the need for surgical revision. Imaging will be evaluated by a radiologist according to institutional standards. The number of affected participants will be reported.	6 months after surgery

Collaborators and Investigators

• Sponsor: University Medical Center Goettingen

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: August 1, 2025
• First Submitted That Met QC Criteria: August 15, 2025
• First Posted (Actual): August 22, 2025

Study Record Updates

• Last Update Posted (Actual): August 22, 2025
• Last Update Submitted That Met QC Criteria: August 15, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: 14/5/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No