Same-day treatment for spinal metastases
Official title: Stereotactic Body Radiotherapy and pedicLE Screw fixatioN During One Hospital Visit for Patients With Painful Unstable Spinal Metastases: A Randomized Trial (BLEND)
Run by UMC Utrecht · NCT05575323 · Data updated 2026-11-12
This study tests if giving patients with painful spinal cancer both surgery and radiation on the same day can help them feel better and recover faster compared to the usual treatment of surgery followed by radiation later.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | UMC Utrecht Academic / other |
| Drugs / interventions | Bevacizumab |
| Locations | 1 site (Utrecht) |
| Status | Recruiting |
| Started | October 15, 2022 |
| Main results expected | December 31, 2026 |
| Study ends | June 30, 2027 |
| Registry record updated | May 8, 2026 |
| Trial ID | NCT05575323 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 with symptomatic spinal metastases requiring surgical stabilization and radiotherapy.
✕Probably not a fit
Patients with conditions that prevent SBRT delivery or those with multiple myeloma may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The BLEND RCT evaluates the effectiveness of providing same-day stereotactic body radiotherapy (SBRT) and surgical stabilization for patients with symptomatic, unstable spinal metastases. This approach aims to reduce the time between surgery and radiotherapy, potentially leading to quicker pain relief and faster recovery. The study compares this method to the standard care of surgery followed by conventional radiotherapy after wound healing. It is a phase II randomized controlled trial within a larger cohort focused on bone metastases.
Why it matters
Potential benefit: If successful, this treatment could lead to improved physical functioning and quicker recovery for patients with spinal metastases.
How similar studies have gone: Other studies have shown promise in using same-day treatments for similar conditions, indicating potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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's running
-
University Medical Center Utrecht
Utrecht, Netherlands Recruiting
Study contacts
- Principal investigator: Helena M. Verkooijen, Prof — UMC Utrecht
- Study coordinator: Roxanne Gal, PhD
- Email: R.Gal@umcutrecht.nl
- Phone: +31 88 75 69624
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Stereotactic body radiation therapy for spinal metastases with epidural compression
This study tests whether SBRT can safely help adults with spinal metastases that compress the spinal cord see if the treatment works in reducing issues from their cancer.
-
Postoperative Edge SBRT for Spinal Metastases
This observational study tests whether high-precision postoperative SBRT with the Edge system can improve local control and neurological outcomes in patients with spinal metastases after surgery.
-
Radiotherapy after Separation Surgery for Spinal Metastases
This study tests whether giving radiotherapy after separation surgery helps people with spinal metastases live longer and feel better.
-
Focused high-dose SBRT for spinal tumors
This program will try focused high-dose SBRT for adults with spinal metastases to track side effects and local tumor control during routine care.
-
Pre-surgery focused radiation for spinal metastases.
This trial will test whether short-course, focused radiation given before surgery can improve local tumor control and reduce pain and disability in adults with spinal metastases.
-
Evaluating autologous blood transfusion in spinal surgery for lung cancer with spinal metastasis
This study is testing whether using a patient's own blood during spinal surgery for lung cancer with spinal metastases is safer and more effective than using donated blood.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.