Spinal metastases
Conditions
Interventions
Same-day SBRT and surgical stabilization with or without decompression.
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Symptomatic (cervical, thoracic and/or lumbar) spinal metastases and impending spinal instability requiring radiotherapy and surgical stabilization • Histologic proof of malignancy or radiographic/clinical characteristics indicating malignancy beyond reasonable doubt • Radiographic evidence of spinal metastases • Fit for (radio)surgery • Age >18 years • Written informed consent
Exclusion criteria
Exclusion criteria: • SBRT cannot be delivered, e.g. in patients who cannot lie on the treatment table because of pain • Surgery cannot be performed, e.g., multiple spinal metastases requiring surgical bridging of more than five vertebral levels • Prior surgery or radiotherapy to the index levels • Neurological deficits (ASIA C, B or A), or partial neurological deficits (ASIA D) with rapid progression (hours to days) • Life expectancy of less than 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Physical functioning, four weeks after the start of the treatment, which is a functional scale from the EORTC QLQ-C15-PAL questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary goals are to compare the pain response, duration of pain relief, length of hospital stay, time to return to systemic therapy, neurological deterioration, adverse events (e.g. wound complications), quality of life and survival between intervention and control. In addition, we will study the cost-effectiveness. | — |
Countries
Netherlands
Contacts
Public ContactR. Gal
Universitair Medisch Centrum Utrecht
Outcome results
None listed