Randomized Trial on Same-day SBRT and Surgical Stabilization for Symptomatic Spinal Metastases
Stereotactic Body Radiotherapy and pedicLE Screw fixatioN During One Hospital Visit for Patients With Painful Unstable Spinal Metastases: A Randomized Trial (BLEND)
UMC Utrecht
100 participants
Oct 15, 2022
INTERVENTIONAL
Conditions
Summary
The BLEND RCT aims to evaluate the (cost-)effectiveness of same-day SBRT and surgical stabilization with or without decompression for the treatment of symptomatic, unstable spinal metastases on physical functioning four weeks after the start of treatment, compared with the standard of care (surgery followed by radiotherapy as soon as the wound healed sufficiently).
Eligibility
Inclusion Criteria7
- Symptomatic (cervical, thoracic and/or lumbar) spinal metastases from solid tumors and (impending) spinal instability requiring radiotherapy and surgical decompression and/or stabilization
- Histologic proof of malignancy or radiographic/clinical characteristics indicating malignancy beyond reasonable doubt
- Radiographic evidence of spinal metastases
- Participation in PRESENT cohort, including consent for randomization into future trials
- Fit for (radio)surgery
- Age >18 years
- Written informed consent
Exclusion Criteria7
- SBRT cannot be delivered, e.g. in patients who cannot lie on the treatment table because of pain
- Routine surgical decompression and/or stabilization and radiotherapy cannot be performed, e.g., multiple spinal metastases requiring surgical bridging of more than five vertebral levels and/or requiring radiotherapy on more than one location
- Prior surgery or radiotherapy to the index level(s)
- Multiple myeloma
- Neurological deficits (ASIA C, B or A), or partial neurological deficits (ASIA D) with rapid progression (hours to days)
- Treated with Bevacizumab and other medication with long half-life that interferes with radiotherapy
- Life expectancy of less than 3 months
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Interventions
SBRT and surgical stabilization with or without decompression within 24 hours
Surgical stabilization with or without decompression followed by cRT or SBRT as soon as the wound is healed sufficiently
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05575323