One-Day fix for spinal tumors? new trial combines surgery and radiation

NCT ID NCT05575323

Symptom relief Sponsor: UMC Utrecht Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether having spine surgery and radiation on the same day helps people with painful spinal tumors recover physical function faster than the usual approach of surgery followed by radiation weeks later. About 100 adults with unstable spinal metastases will be randomly assigned to either same-day treatment or standard care. The main goal is to see if physical functioning improves more at four weeks after treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: same-day stereotactic body radiotherapy and spinal surgery
What this could lead to: If it works, this could mean faster pain relief and better mobility for patients with spinal tumors, reducing hospital visits.
What could go wrong: This is a small early trial (100 people) comparing two procedures; same-day treatment may not be safer or more effective than standard care, and surgery always carries risks like infection or bleeding.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2022

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

metastatic malignant neoplasm in the spinal cord

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Spinal metastases

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

One-Day fix for spinal tumors? new trial combines surgery and radiation

What the study statuses mean