Spine MetastasisNCT07346170
Short Interval Postoperative Stereotactic Body Radiation Therapy (SBRT) After Surgical Intervention for Spine Metastases
A study testing Stereotactic Body Radiation Therapy (SBRT), Computed Tomography (CT) Simulation and Magnetic Resonance Imaging (MRI) in people with Spine Metastasis and Stereotactic Body Radiation Therapy (SBRT), run by University of California, San Francisco at 1 site in United States.
Trial summary
Current guidelines suggest postoperative spine Stereotactic Body Radiation Therapy (SBRT) should be delivered within 2-4 weeks after surgery. This approach is rife with logistical complications that create delays and barriers for patients accessing care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spine Metastasis, Stereotactic Body Radiation Therapy (SBRT)
- What is being tested?
- Stereotactic Body Radiation Therapy (SBRT), Computed Tomography (CT) Simulation and Magnetic Resonance Imaging (MRI)
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 30 Nov 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Participants must be considered candidates for postoperative SBRT by the treating radiation oncologist.
- 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.
- Disease at any spine level is allowed.
- Prior therapy
- 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.
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- There is no limit on the number of courses or types of radiotherapy for radiation delivered outside the planned treatment field.
- 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.
- Age ≥18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 70%, see Appendix 1) 1 month prior to presentation for surgery.
- Estimated survival >3 months or survival considered adequate to undergo spine surgery as assessed by the primary surgical team.
- Ability to understand and the willingness to sign a written informed consent document.
- 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.
- 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.
- 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.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Prior radiation of any type within the anticipated treatment field (prior radiation outside the anticipated field is acceptable as above).
- Primary malignancy of the spine (examples: chordoma or sarcoma).
- Persistent high-grade metastatic spinal cord compression following surgery (Bilsky Grade 3 or higher).
- Involvement of 3 or more contiguous spinal levels.
- Involvement of more than 2 non-contiguous spinal levels.
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- American Spinal Injury Association Impairment Scale (ASIA) Grade 3 status.
- Surgery was a biopsy only.
- Unable to undergo MRI for any reason.
- Estimated survival <3 months.
- Active infection requiring systemic therapy.
- Active wound complication requiring medical intervention.
- History of radiation-induced myelopathy from prior spine radiation.
- History of a collagen vascular disorder (examples: lupus, scleroderma).
- History of psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- . 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
Imani Dunn, Imani.Dunn@ucsf.edu
877-827-3222, cancertrials@ucsf.edu
About this study
Official title: A Phase 2 Study of Short Interval Postoperative Stereotactic Body Radiation Therapy (SBRT) After Surgical Intervention for Spine Metastases
Current guidelines suggest postoperative spine Stereotactic Body Radiation Therapy (SBRT) should be delivered within 2-4 weeks after surgery. This approach is rife with logistical complications that create delays and barriers for patients accessing care. An alternative approach delivers postoperative spine SBRT soon after surgery, starting within a single hospital stay. This study will investigate the effects of short-term postoperative spine SBRT on wound complications in a safety lead-in, then will transition to a phase 2 trial investigating local tumor control.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate the local control rate (LC) of treated metastatic sites in patients who undergo surgery for spinal metastasis followed by short interval postoperative spine Stereotactic Body Radiation Therapy (SBRT).
SECONDARY OBJECTIVE:
- Evaluate the postoperative wound complication rate in participants who undergo surgery for spinal metastasis followed by short-interval postoperative spine SBRT.
II. Determine the radiation toxicity of short-interval postoperative spine SBRT in participants.
III. Determine the progression-free survival (PFS) in participants who undergo surgery for spinal metastasis followed by short-interval postoperative spine SBRT.
IV. Determine the overall survival (OS) in participants who undergo surgery for spinal metastasis followed by short-interval postoperative spine SBRT.
- Evaluate the quality of life (QoL) of participants who undergo surgery for spinal metastasis followed by short-interval postoperative spine SBRT.
OUTLINE: Participants will received a short interval postoperative SBRT 3-14 days after standard of care surgery for spinal metastases. The SBRT treatment will be delivered up to five sessions in an inpatient or outpatient setting. Participants are follow-up for at month 1, 6, and 12 after SBRT, until removal from study or death, whichever comes first.
- Being tested
- Stereotactic Body Radiation Therapy (SBRT), Computed Tomography (CT) Simulation, Magnetic Resonance Imaging (MRI), Questionnaires
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body Radiation Therapy (SBRT)Radiation
Undergo radiation
Computed Tomography (CT) SimulationProcedure or surgery
Undergo imaging
Magnetic Resonance Imaging (MRI)Procedure or surgery
Undergo imaging
QuestionnairesBehavioural
Participant complete health related, quality of life questionnaire (HRQoL)
| Study group | Role | What they receive |
|---|---|---|
| Treatment - Decompression Surgery | Experimental | Participants diagnosed with metastatic spinal cancer who have undergone spinal decompression surgery will receive Stereotactic Body Radiation Therapy (SBRT) after their operation. The radiation dose, ranging from 16 to 40 Gy, will be determined by the radiation oncologist in accordance with expert guidelines. Precise targeting of the treatment area and identification of nearby organs will be achieved using CT and MRI imaging. SBRT will be administered in one to five sessions (1-5 fractions) in either an inpatient setting or a combination of inpatient and outpatient settings. Participants are followed for 1 year after their last treatment. Participants removed from the study for unacceptable treatment or study-related adverse event(s) are followed until resolution or stabilization of all treatment-related adverse events to grade 2 or lower. Receives: Radiation: Stereotactic Body Radiation Therapy (SBRT); Procedure: Computed Tomography (CT) Simulation; Procedure: Magnetic Resonance Imaging (MRI); Behavioral: Questionnaires |
| Treatment - Debulking Surgery | Experimental | Participants diagnosed with metastatic spinal cancer who have undergone spinal debulking surgery will receive SBRT after their operation. The radiation dose, ranging from 16 to 40 Gy, will be determined by the radiation oncologist in accordance with expert guidelines. Precise targeting of the treatment area and identification of nearby organs will be achieved using CT and MRI imaging. SBRT will be administered in one to five sessions (1-5 fractions) in either an inpatient setting or a combination of inpatient and outpatient settings. Participants are followed for 1 year after their last treatment. Participants removed from the study for unacceptable treatment or study-related adverse event(s) are followed until resolution or stabilization of all treatment-related adverse events to grade 2 or lower. Receives: Radiation: Stereotactic Body Radiation Therapy (SBRT); Procedure: Computed Tomography (CT) Simulation; Procedure: Magnetic Resonance Imaging (MRI); Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Control (LC) Rate
Local control (LC) is defined as the time from SBRT radiotherapy to metastatic lesions (event) within the SBRT treatment field with stable or decreased size as measured by a board-certified radiologist on follow-up imaging. Participants without any documented events or death will be censored. Estimates and confidence interval will be reported using the Kaplan Meier method.
Measured: 6 months after SBRT
Secondary outcomes (9)
Median Wound Complication Rate
Wound complication rate is defined as the rate of participants with wound complications by Centers for Disease Control and Prevention (CDC) criteria. Estimates and the 95% confidence interval will be reported using exact binomial confidence interval (CIs).
Measured: 1 month after surgery
Proportion of Participants with Treatment-emergent Adverse Events (TrAE)
Proportion of participants with treatment-emergent adverse events as graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 5.0) will be reported.
Measured: 1 month after SBRT
Median Progression-Free Survival (PFS)
PFS is defined as the time after enrollment to radiographic progression by RECIST 1.1 criteria on MRI, CT, or Positron Emission Tomography/Computed Tomography (PETCT) at any site of disease, primary or metastatic, or any clinical evidence of progression. Tumor progression is defined as any increase in size within the radiation treatment field (determined by a radiologist), not consistent with or attributable to radiation treatment effect. Hazard ratio and 95% confidence interval will be reported using Kaplan Meier method.
Measured: Up to 6 months after SBRT
Median Progression-Free Survival (PFS)
PFS is defined as the time after enrollment to radiographic progression by RECIST 1.1 criteria on MRI, CT, or PETCT at any site of disease, primary or metastatic, or any clinical evidence of progression. Tumor progression is defined as any increase in size within the radiation treatment field (determined by a radiologist), not consistent with or attributable to radiation treatment effect. Hazard ratio and 95% confidence interval will be reported using Kaplan Meier method.
Measured: Up to 12 months after SBRT
Median Overall Survival (OS)
Overall survival is defined as the time after enrollment to death by any cause. Hazard ratio and 95% confidence interval will be reported using Kaplan Meier method.
Measured: Up to 6 months after SBRT
Median Overall Survival (OS)
Overall survival is defined as the time after enrollment to death by any cause. Hazard ratio and 95% confidence interval will be reported using Kaplan Meier method.
Measured: Up to 12 months after SBRT
Median Score on the Functional Assessment of Cancer therapy, General- 7 (FACT-G7) at 1 month
The FACT-G7 is a 7-item questionnaire designed to measure general health related quality of life (HRQOL) in cancer patients. Each item response score ranges from 0 (not at all) to 5 (very much). The total score is calculated by taking the sum of the scores x 7 divided by the number of items answered, with a total score range from 0 - 28. The higher the score, the better the HRQOL.
Measured: 1 month
Median score on the FACT-G7 at 6 months
The FACT-G7 is a 7-item questionnaire designed to measure general health related quality of life (HRQOL) in cancer patients. Each item response score ranges from 0 (not at all) to 5 (very much). The total score is calculated by taking the sum of the scores x 7 divided by the number of items answered, with a total score range from 0 - 28. The higher the score, the better the HRQOL.
Measured: 6 months
Median score on the FACT-G7 at 12 months
The FACT-G7 is a 7-item questionnaire designed to measure general health related quality of life (HRQOL) in cancer patients. Each item response score ranges from 0 (not at all) to 5 (very much). The total score is calculated by taking the sum of the scores x 7 divided by the number of items answered, with a total score range from 0 - 28. The higher the score, the better the HRQOL.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 May 2029 (estimated)
- Study completion30 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine MetastasisStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steve Braunstein, MD, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07346170
- Sponsor's protocol ID
- 25721
- Other IDs
- NCI-2026-00112
- Status last verified
- Sep 2026
- First submitted
- 14 Jan 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Short Interval Postoperative Stereotactic Body Radiation Therapy (SBRT) After Surgical Intervention for Spine Metastases
- ClinicalTrials.gov ID
- NCT07346170
- Acronym / sponsor ID
- 25721
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 May 2029 (estimated)
- Study completion
- 30 Nov 2029 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Current guidelines suggest postoperative spine Stereotactic Body Radiation Therapy (SBRT) should be delivered within 2-4 weeks after surgery. This approach is rife with logistical complications that create delays and barriers for patients accessing care. An alternative approach delivers postoperative spine SBRT soon after surgery, starting within a single hospital stay. This study will investigate the effects of short-term postoperative spine SBRT on wound complications in a safety lead-in, then will transition to a phase 2 trial investigating local tumor control.
Detailed description
PRIMARY OBJECTIVE:
- To evaluate the local control rate (LC) of treated metastatic sites in patients who undergo surgery for spinal metastasis followed by short interval postoperative spine Stereotactic Body Radiation Therapy (SBRT).
SECONDARY OBJECTIVE:
- Evaluate the postoperative wound complication rate in participants who undergo surgery for spinal metastasis followed by short-interval postoperative spine SBRT.
II. Determine the radiation toxicity of short-interval postoperative spine SBRT in participants.
III. Determine the progression-free survival (PFS) in participants who undergo surgery for spinal metastasis followed by short-interval postoperative spine SBRT.
IV. Determine the overall survival (OS) in participants who undergo surgery for spinal metastasis followed by short-interval postoperative spine SBRT.
- Evaluate the quality of life (QoL) of participants who undergo surgery for spinal metastasis followed by short-interval postoperative spine SBRT.
OUTLINE: Participants will received a short interval postoperative SBRT 3-14 days after standard of care surgery for spinal metastases. The SBRT treatment will be delivered up to five sessions in an inpatient or outpatient setting. Participants are follow-up for at month 1, 6, and 12 after SBRT, until removal from study or death, whichever comes first.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment - Decompression Surgery | Experimental | Radiation: Stereotactic Body Radiation Therapy (SBRT), Procedure: Computed Tomography (CT) Simulation, Procedure: Magnetic Resonance Imaging (MRI), Behavioral: QuestionnairesParticipants diagnosed with metastatic spinal cancer who have undergone spinal decompression surgery will receive Stereotactic Body Radiation Therapy (SBRT) after their operation. The radiation dose, ranging from 16 to 40 Gy, will be determined by the radiation oncologist in accordance with expert guidelines. Precise targeting of the treatment area and identification of nearby organs will be achieved using CT and MRI imaging. SBRT will be administered in one to five sessions (1-5 fractions) in either an inpatient setting or a combination of inpatient and outpatient settings. Participants are followed for 1 year after their last treatment. Participants removed from the study for unacceptable treatment or study-related adverse event(s) are followed until resolution or stabilization of all treatment-related adverse events to grade 2 or lower. |
| Treatment - Debulking Surgery | Experimental | Radiation: Stereotactic Body Radiation Therapy (SBRT), Procedure: Computed Tomography (CT) Simulation, Procedure: Magnetic Resonance Imaging (MRI), Behavioral: QuestionnairesParticipants diagnosed with metastatic spinal cancer who have undergone spinal debulking surgery will receive SBRT after their operation. The radiation dose, ranging from 16 to 40 Gy, will be determined by the radiation oncologist in accordance with expert guidelines. Precise targeting of the treatment area and identification of nearby organs will be achieved using CT and MRI imaging. SBRT will be administered in one to five sessions (1-5 fractions) in either an inpatient setting or a combination of inpatient and outpatient settings. Participants are followed for 1 year after their last treatment. Participants removed from the study for unacceptable treatment or study-related adverse event(s) are followed until resolution or stabilization of all treatment-related adverse events to grade 2 or lower. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
- Participants must be considered candidates for postoperative SBRT by the treating radiation oncologist.
- 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.
- Disease at any spine level is allowed.
- Prior therapy
Key exclusion criteria (16 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Prior radiation of any type within the anticipated treatment field (prior radiation outside the anticipated field is acceptable as above).
- Primary malignancy of the spine (examples: chordoma or sarcoma).
- Persistent high-grade metastatic spinal cord compression following surgery (Bilsky Grade 3 or higher).
- Involvement of 3 or more contiguous spinal levels.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT)Undergo radiation | Radiation | Treatment - Debulking Surgery, Treatment - Decompression Surgery |
| Computed Tomography (CT) SimulationUndergo imaging | Procedure or surgery | Treatment - Debulking Surgery, Treatment - Decompression Surgery |
| Magnetic Resonance Imaging (MRI)Undergo imaging | Procedure or surgery | Treatment - Debulking Surgery, Treatment - Decompression Surgery |
| QuestionnairesParticipant complete health related, quality of life questionnaire (HRQoL) | Behavioural | Treatment - Debulking Surgery, Treatment - Decompression Surgery |
Primary outcome
Local Control (LC) Rate
Time frame: 6 months after SBRT
Local control (LC) is defined as the time from SBRT radiotherapy to metastatic lesions (event) within the SBRT treatment field with stable or decreased size as measured by a board-certified radiologist on follow-up imaging. Participants without any documented events or death will be censored. Estimates and confidence interval will be reported using the Kaplan Meier method.
9 secondary outcomes
Median Wound Complication Rate
Time frame: 1 month after surgery
Proportion of Participants with Treatment-emergent Adverse Events (TrAE)
Time frame: 1 month after SBRT
Median Progression-Free Survival (PFS)
Time frame: Up to 6 months after SBRT
Median Progression-Free Survival (PFS)
Time frame: Up to 12 months after SBRT
Median Overall Survival (OS)
Time frame: Up to 6 months after SBRT
Median Overall Survival (OS)
Time frame: Up to 12 months after SBRT
Median Score on the Functional Assessment of Cancer therapy, General- 7 (FACT-G7) at 1 month
Time frame: 1 month
Median score on the FACT-G7 at 6 months
Time frame: 6 months
Median score on the FACT-G7 at 12 months
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No
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Spine Metastasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Steve Braunstein, MD, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic Body Radiation Therapy (SBRT), Computed Tomography (CT) Simulation and Magnetic Resonance Imaging (MRI) in people with Spine Metastasis and Stereotactic Body Radiation Therapy (SBRT), run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Imani Dunn (877-827-3222, Imani.Dunn@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local Control (LC) Rate (time frame: 6 months after SBRT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.