Short Interval Postoperative Stereotactic Body Radiation Therapy (SBRT) After Surgical Interventi… (NCT07346170) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Short Interval Postoperative Stereotactic Body Radiation Therapy (SBRT) After Surgical Intervention for Spine Metastases
United States50 participantsStarted 2026-07-15
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.
Exclusion criteria
. 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.
. American Spinal Injury Association Impairment Scale (ASIA) Grade 3 status.