Preoperative Stereotactic Radiotherapy for Treatment of Spinal Metastases
NCT ID: NCT07135817
Last Updated: 2025-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2025-08-01
2027-01-31
Brief Summary
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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)
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
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)
Interventions
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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.
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)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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University Medical Center Goettingen
OTHER
Responsible Party
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Prof. Dr. Rami El Shafie
Principal Investigator
Locations
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University Medical Center Goettingen
Göttingen, , Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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14/5/24
Identifier Type: -
Identifier Source: org_study_id
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