Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05575323

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

University Medical Center Utrecht

Utrecht, Netherlands

Actively Recruiting

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here