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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:
Participants will receive hypofractionated SBRT to spinal metastases shortly before surgical intervention.
Participants will undergo preoperative and follow-up assessments, including:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypofractionated Stereotactic Body Radiotherapy + Surgery | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preoperative Stereotactic Body Radiotherapy (SBRT) | Radiation | Hypofractionated SBRT delivered in 1-3 fractions within 10 days before surgery, using MRI-based planning and institutional immobilization standards according to ESTRO guidelines. |
| Measure | Description | Time Frame |
|---|---|---|
| Local Tumor Control | 3 months after treatment |
| 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"). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carla Marie Zwerenz, Dr. med. | Contact | +49 551 39 64501 | carlamarie.zwerenz@med.uni-goettingen.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Goettingen | Recruiting | Göttingen | 37073 | Germany |
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| Spinal Surgery for Decompression and/or Stabilization | Procedure | 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) |
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| 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 |