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Efficacy and safety of stereotactic body radiation therapy for spinal metastases with epidural spinal cord compression (Bilsky grade 1c-3): a prospective, multicenter, Single-Arm phase II study

NCT ID NCT07809672

NEW Sponsor: Tianjin Medical University Cancer Institute and Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 09, 2026 · Last updated Sep 09, 2026

Summary

This prospective, multicenter, single-arm phase II clinical trial is designed to enroll patients with spinal metastases classified as Bilsky grade 1c-3 who will receive stereotactic body radiation therapy (SBRT). The objective of this study is to assess the efficacy and safety of SBRT in the treatment of spinal metastases with epidural spinal cord compression (Bilsky grade 1c-3).

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 50 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2028

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: * · Participants must be capable of understanding and voluntarily signing the written informed consent form;· Age ≥ 18 years;· (ECOG) performance status score ≤ 3;· The primary tumor is histologically or cytologically confirmed as a solid malignant tumor (excluding multiple myeloma, lymphoma, and germ cell tumors);· Has clear radiological evidence of spinal metastases;· Has acceptable spinal stability (Spinal Instability Neoplastic Score \[SINS\] ≤ 6, or between 7-12 but assessed as stable by surgical consultation), or has previous spinal instability that has been determined to be stable after surgical intervention;· Bilsky grade of spinal metastases confirmed by magnetic resonance imaging (MRI) as 1c-3;· Number of consecutive involved vertebral segments ≤ 3;· The involved vertebral level is above the conus medullaris;· Laboratory tests indicate adequate organ function. Exclusion Criteria: * ·Histologically confirmed primary spinal tumor or central nervous system disease;· Intramedullary lesions;· Prior radiotherapy to the same vertebral level;· Presence of contraindications to MRI examination;· Unable to lie flat for ≥ 30 minutes;· Presence of other severe comorbidities, such as uncontrollable cardiovascular disease, pulmonary disease, or other organ dysfunction, with poor overall health status and intolerance to treatment;· Pregnant or breastfeeding women;· Currently participating in other interventional clinical research treatments, or having received other investigational drugs or investigational device treatments within 4 weeks prior to the first treatment.

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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 Stereotactic body radiation therapy (SBRT)

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

  • Tianjin Medical University Cancer Institute and Hospital

    RECRUITING

    Tianjin, China

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