Short Interval Postoperative Stereotactic Body Radiation Therapy (SBRT) After Surgical Intervention for Spine Metastases

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.