Preoperative Stereotactic Radiotherapy for Treatment of Spinal Metastases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Preoperative Stereotactic Body Radiotherapy (SBRT), Spinal Surgery for Decompression and/or Stabilization.
- Who it may be relevant to
- Registry conditions: Spinal Metastases, Solid Tumor Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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)
Interventions
- 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)
Primary outcome measures
- Local Tumor Control [Time frame: 3 months after treatment]
Secondary outcome measures (7)
- Local Tumor Control [Time frame: 6 months after treatment]
- Pain relief [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 [Time frame: 3 and 6 months after treatment]
- EORTC QLQ-BM22 Scores [Time frame: 3 and 6 months after treatment]
- Oswestry Disability Index (ODI) [Time frame: 3 and 6 months after treatment]
- Number of participants with radiologically confirmed instrumentation failure [Time frame: 6 months after surgery]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Germany · 1 center
- University Medical Center Goettingen — Göttingen
Identifiers
NCT: NCT07135817 · 14/5/24