Actively Recruiting
Randomized Trial on Same-day SBRT and Surgical Stabilization for Symptomatic Spinal Metastases
Led by UMC Utrecht · Updated on 2026-05-08
100
Participants Needed
1
Research Sites
245 weeks
Total Duration
On this page
Sponsors
U
UMC Utrecht
Lead Sponsor
R
Radboud University Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Randomized Trial on Same-day SBRT and Surgical Stabilization for Symptomatic Spinal Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Symptomatic spinal metastases (cervical, thoracic, and/or lumbar) from solid tumors with (impending) spinal instability needing radiotherapy and surgical decompression and/or stabilization
- Histologic proof of malignancy or radiographic/clinical signs clearly indicating malignancy
- Radiographic evidence of spinal metastases
- Participation in PRESENT cohort with consent to be randomized into future trials
- Fit for radiotherapy and surgery
- Age over 18 years
- Provided written informed consent
You will not qualify if you...
- Unable to receive SBRT, for example, if unable to lie on the treatment table due to pain
- Routine surgical decompression/stabilization and radiotherapy not feasible, such as multiple spinal metastases requiring surgery on more than five vertebral levels or radiotherapy at multiple spine locations
- Prior surgery or radiotherapy at the target spinal levels
- Diagnosis of multiple myeloma
- Neurological deficits classified as ASIA C, B, or A, or rapidly progressing partial deficits (ASIA D)
- Treatment with Bevacizumab or other medications with long half-lives interfering with radiotherapy
- Life expectancy less than 3 months
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Medical Center Utrecht
Utrecht, Netherlands
Actively Recruiting
Research Team
R
Roxanne Gal, PhD
CONTACT
E
Eline Huele, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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