Solid Tumor Cancer, Spinal Metastases
Conditions
Brief summary
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
Hypofractionated SBRT delivered in 1-3 fractions within 10 days before surgery, using MRI-based planning and institutional immobilization standards according to ESTRO guidelines.
PROCEDURESpinal 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)
Sponsors
University Medical Center Goettingen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Local Tumor Control | 3 months after treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain relief | at discharge from initial hospitalization (typically within 5-10 days after surgery), 3 and 6 months after treatment | 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). |
| Wound Healing Complications at Hospital Discharge | at discharge from initial hospitalization (typically within 5-10 days after surgery) | — |
| EORTC QLQ-C30 Scores | 3 and 6 months after treatment | 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. |
| Local Tumor Control | 6 months after treatment | — |
| Oswestry Disability Index (ODI) | 3 and 6 months after treatment | 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. |
| Number of participants with radiologically confirmed instrumentation failure | 6 months after surgery | 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. |
| EORTC QLQ-BM22 Scores | 3 and 6 months after treatment | 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. |
Countries
Germany
Contacts
Primary ContactCarla Marie Zwerenz, Dr. med.
Outcome results
None listed