Randomized Trial on Same-day SBRT and Surgical Stabilization for Symptomatic Spinal Metastases
Recruiting now · Not applicable
Conditions studied: Spinal Metastases
In brief
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).
Key facts
- Study ID
- NCT05575323
- Run by
- UMC Utrecht
- People needed
- 100
- Starts
- 2022-10-15
- Expected to finish
- 2027-06-30
- Last updated by the study team
- 2026-05-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University Medical Center Utrecht — Utrecht, Netherlands (enrolling)
Full record on ClinicalTrials.gov
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