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New 5-session radiation plan aims to ease spine tumor pain with fewer side effects

NCT ID NCT04802603

Symptom relief Sponsor: Baptist Health South Florida 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a new way to deliver radiation to spine tumors that have spread from other cancers. Instead of the usual 1-2 high-dose sessions, the radiation is given in 5 smaller doses over several days, which may reduce side effects. The trial will enroll 60 adults with spine metastases and measure pain relief, quality of life, and how well the treatment is tolerated.

What this could mean

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

Active substance
Spine stereotactic body radiotherapy (radiation)
What this could lead to
If successful, this could offer a safer, more tolerable radiation option for people with spine tumors that have spread from other cancers, potentially reducing pain and improving daily function.
What could go wrong
This is a small, early-phase study with only 60 participants, so results may not apply to everyone. Radiation still carries risks like nerve damage or fatigue, and the approach may not work better than standard care.

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 60 people

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

Started

Mar 2021

Expected to finish

Dec 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: * Zubrod Performance Status 0-2 * Localized spine metastasis from a solid tumor from the C1 to L5 levels (a solitary spine metastasis, two separate spine levels, or up to 3 separate sites; each of the separate sites may have a maximal involvement of 2 contiguous vertebral bodies) * Patients with epidural extension are eligible as long as there is a ≥ 2 mm gap between the spinal cord and the edge of the epidural lesion * Paraspinal disease extension is allowed as long as it measures ≤ 5 cm in the greatest dimension and that it is contiguous with the spine metastasis * For patients enrolled in cohort 2, the minimum time to re-irradiation should be 6 months * Numerical Rating Pain Scale (NRPS) score of ≥ 5 at the index site(s) (as rated when the patient is not taking pain medication) Exclusion Criteria: * Radiosensitive histologies (myeloma, lymphoma, germ cell tumors, small cell lung cancer) * Non-ambulatory patients * \>50% loss of vertebral body height or spinal instability to due pathologic compression fracture * Frank spinal cord compression, spinal cord displacement, or epidural extension within 2 mm of the spinal cord * Rapid neurologic decline * Patients for whom an MRI of the spine is medically contraindicated * Pregnant women

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Conditions

The condition(s) this trial relates to.

metastatic carcinoma in the bone metastatic malignant neoplasm in the spinal cord

As listed by the trial registrant

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

Metastasis spine Spine 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

    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

  • Miami Cancer Institute at Baptist Health, Inc

    RECRUITING

    Miami, Florida, 33176, United States

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