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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Hypofractionated SBRT delivered in 1-3 fractions within 10 days before surgery, using MRI-based planning and institutional immobilization standards according to ESTRO guidelines.
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)
University Medical Center Goettingen
Göttingen, Germany
RECRUITINGLocal Tumor Control
Time frame: 3 months after treatment
Local Tumor Control
Time frame: 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").
Time frame: at discharge from initial hospitalization (typically within 5-10 days after surgery), 3 and 6 months after treatment
Wound Healing Complications at Hospital Discharge
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months after surgery
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