New study tests speedy radiation after spine surgery to beat cancer spread
NCT ID NCT07346170
First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 2 times
Summary
This study tests giving radiation therapy (SBRT) to the spine soon after surgery, while patients are still in the hospital, instead of waiting 2-4 weeks. The goal is to see if this faster approach is safe and helps control cancer growth in the spine. About 50 adults with cancer that has spread to the spine will take part.
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 approach could make radiation treatment after spine surgery faster and more convenient, potentially improving local tumor control without increasing wound complications.
- What could go wrong
- This is a small, early-phase study (50 participants) with no control group, so results may not apply broadly. There is a risk of wound complications or that the short interval may not be as effective as standard timing.
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
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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
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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. Participants must have a histologically or cytologically confirmed diagnosis of metastatic malignancy or must have preliminary histology or cytology consistent with a diagnosis of metastatic malignancy. 2. Participants must be considered candidates for postoperative SBRT by the treating radiation oncologist. 3. Participants must have undergone, within the past 13 days, or are planned to undergo minimally invasive or open surgery for the management of a spine metastasis. 4. Disease at any spine level is allowed. 5. Prior therapy 1. There is no limit on the number of prior spine surgeries or prior courses of radiotherapy directed at the spine if prior therapies occurred at different spinal levels outside the anticipated treatment field. 2. There is no limit on the number of courses or types of radiotherapy for radiation delivered outside the planned treatment field. 6. Cleared by the primary surgical team for postoperative SBRT, including but not limited to hemodynamic, respiratory, and neurologic stability postoperatively, without immediate postoperative complications noted. 7. Age ≥18 years. 8. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 70%, see Appendix 1) 1 month prior to presentation for surgery. 9. Estimated survival \>3 months or survival considered adequate to undergo spine surgery as assessed by the primary surgical team. 10. Ability to understand and the willingness to sign a written informed consent document. 11. Ability to understand and willingness to comply with treatment schedule, follow-up visits, laboratory testing, and other requirements of the study, including disease assessment by MRI. 12. Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. 13. The effects of radiation on the developing human fetus are generally considered detrimental. Because the radiation therapy used in this trial is known to be teratogenic, individuals of reproductive potential must agree to use adequate contraception (e.g., hormonal or barrier methods, abstinence) for the duration of study participation and for at least 120 days after the last administration of radiation therapy. Should a study participant or their partner become pregnant or suspect pregnancy while participating in this study, they should inform their treating physician immediately. Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: 1. Prior radiation of any type within the anticipated treatment field (prior radiation outside the anticipated field is acceptable as above). 2. Primary malignancy of the spine (examples: chordoma or sarcoma). 3. Persistent high-grade metastatic spinal cord compression following surgery (Bilsky Grade 3 or higher). 4. Involvement of 3 or more contiguous spinal levels. 5. Involvement of more than 2 non-contiguous spinal levels. 6. American Spinal Injury Association Impairment Scale (ASIA) Grade 3 status. 7. Surgery was a biopsy only. 8. Unable to undergo MRI for any reason. 9. Estimated survival \<3 months. 10. Active infection requiring systemic therapy. 11. Active wound complication requiring medical intervention. 12. History of radiation-induced myelopathy from prior spine radiation. 13. History of a collagen vascular disorder (examples: lupus, scleroderma). 14. History of psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 15. . A woman of childbearing potential (WOCBP) who has a positive urine pregnancy test within 72 hours prior to allocation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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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.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Locations
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University of California, San Francisco
San Francisco, California, 94143, United States
Contact Email: •••••@•••••
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