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Could less radiation be better for spine cancer?

NCT ID NCT07538024

Disease control Sponsor: IRCCS Sacro Cuore Don Calabria di Negrar Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether using a smaller, more precise radiation target for spinal tumors can control cancer just as well as treating the whole vertebra. One hundred adults with spine metastases will be randomly assigned to standard or smaller-target radiation. The goal is to see if the smaller approach works and causes fewer side effects.

What this could mean

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

Active substance
Stereotactic Body Radiation Therapy (SBRT)
What this could lead to
If successful, this could show that targeting only the visible tumor with radiation is as effective as treating the whole vertebra, potentially reducing side effects.
What could go wrong
This is a small, early pilot study. It may not prove that the smaller target is as good as the standard approach, and results may not apply to all patients.

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

Nov 2025

Expected to finish

May 2029

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: * Patients affected by spinal metastases eligible for SBRT * All histologies are allowed * Oligometastatic disease (maximum 5 metastases) in every setting (oligopersistent, oligorecurrent and oligoprogressive, according to ESTRO consensus) * Metastases treated with ablative intent * Both symptomatic and asymptomatic vertebral metastases * Spine Instability Neoplastic Score (SINS) score \< 7 \[18\] * Age \> 18 years * Life expectancy \> 12 months * PS ECOG 0-1 * Vertebral pathological lesion on the diagnostic MRI * Single active lesion on the target vertebra * More lesions in different vertebrae can be simultaneously treated * Informed consent to trial participation and personal data treatment Exclusion Criteria: * More than 2 adjoining vertebrae involved * Palliative intent * 2 or more lesions on the target vertebra * Contraindications to MRI * More than 5 metastases

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Conditions

The condition(s) this trial relates to.

metastatic carcinoma in the bone

As listed by the trial registrant

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

Metastases to bone

How to take part

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

  1. The places running it

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

  2. The official record

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

    Open the record ↗

  3. 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.

Contacts and locations

Locations

  • IRCCS Sacro Cuore Don Calabria

    RECRUITING

    Negrar, Verona, 37024, Italy

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