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Can targeted radiation after surgery protect the spinal cord?

NCT ID NCT07801274

Disease control Sponsor: Tianjin Medical University Cancer Institute and Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

This study looks at whether high-precision radiation therapy, delivered by the Edge system, can improve outcomes for people with spinal metastases from solid tumors. After surgery to relieve pressure on the spinal cord, patients receive radiation in five sessions to target remaining tumor cells while sparing healthy tissue. Researchers will track local tumor control, neurological function, survival, and quality of life to see if this approach offers benefits.

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 radiotherapy using the Edge system, given as 35 Gy in 5 sessions after surgery
What this could lead to
If it works, this approach could improve local tumor control and neurological function, potentially easing pain and improving quality of life for people with spinal metastases.
What could go wrong
This is an observational study with 50 participants, so results may not apply broadly. Radiation can cause side effects, and the treatment may not prevent neurological decline or recurrence in all cases.

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.

Participants

About 50 people

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

Started

Jun 2025

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.

Who is studied

Patients diagnosed with spinal metastases from solid tumors who underwent surgery and had residual metastatic epidural spinal cord compression (MESCC) requiring postoperative radiotherapy. All participants were enrolled at Tianjin Medical University Cancer Institute and Hospital.

Ages

18 to 80 years

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: 1. Age 18 to 80 years, any sex. 2. Karnofsky Performance Status (KPS) \>= 60 or ECOG Performance Status \<= 2. 3. Confirmed spinal metastases from solid tumors by pathology or imaging (MRI/CT). 4. Postoperative imaging confirming residual epidural spinal cord compression (MESCC) requiring adjuvant radiotherapy. 5. Number of lesions \<= 5, and maximum diameter of a single lesion \<= 5 cm. 6. Interval between surgery and radiotherapy \<= 4 weeks. 7. Signed informed consent and willingness to participate in the study. Exclusion Criteria: 1. Uncontrolled primary tumor (e.g., extensive metastasis or progressive disease). 2. Concurrent brain metastases or other active malignancies. 3. Pathological fracture or severe spinal instability requiring emergency surgical intervention. 4. Prior cumulative spinal cord radiation dose exceeding the tolerance threshold (e.g., previous spinal cord Dmax \>= 45 Gy). 5. Contraindications to radiotherapy (e.g., severe cardiopulmonary dysfunction, coagulation disorders). 6. Severe postoperative complications (e.g., infection, poor wound healing) requiring delayed radiotherapy. 7. Incomplete or unreliable medical records from external hospitals. 8. Pregnant or lactating women.

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Conditions

The condition(s) this trial relates to.

metastatic malignant neoplasm in the spinal cord Spinal Cord Compression

As listed by the trial registrant

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

Metastatic epidural spinal cord compression Spinal cord compression Spinal metastases

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

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Contacts and locations

Locations

  • 300060

    RECRUITING

    Tianjin, Tianjin Municipality, China

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