This clinical trial studies the side effects of stereotactic radiosurgery and how well it works with or without vertebroplasty, separation surgery, or immunotherapy in patients with cancer that is radiation resistant and has spread to the spine (spinal metastases). Spinal metastases are rapidly progressive, have poor prognosis, are extremely difficult to treat, and can effect patient quality of life and overall health. Immunotherapy is a type of standard of care therapy to boost or restore the ability of the immune system to fight cancer. Stereotactic radiosurgery is a type of external radiation therapy that uses special equipment to position the patient and precisely give a single large dose of radiation to a tumor. A vertebroplasty is a procedure used to repair a bone in the spine that has a break caused by cancer, osteoporosis, or trauma. The purpose of this trial is to test different combinations of immunotherapy, stereotactic radiosurgery, and surgery to improve overall survival and quality of life in patients with spinal metastases.
At least 18 years of age and older with indeterminate Spine Metastasis.
All patients with histology that requires stereotactic RT as a part of their treatment.
Eastern Cooperative Oncology Group (ECOG) performance status =< 2
Disease visualized by CT or MRI
Patients < 18 years of age
Inability to get a standard MRI or CT myelogram for radiation treatment target delineation
Patients with prior radiation to the spinal segment to be treated may be included if the radiation dose can be delivered safely, per the treating radiation oncologist.
Patients with symptomatic spinal cord compression requiring emergent surgery
Parallel
Immunotherapy
Other interventionReceive SOC immunotherapy
Stereotactic Radiosurgery
RadiationUndergo SRS
Vertebroplasty
Procedure/SurgeryUndergo vertebroplasty
Vertebral compression fracture (VCF) rate
Will be summarized for all patients overall and by each cohort. The confidence interval of the overall VCF rate within 6 months will be calculated using binomial exact test for each cohort.
Local control
Will be summarized for all patients overall and by each cohort. Will be summarized using Kaplan-Meier survival analysis.
Overall survival
Will be summarized for all patients overall and by each cohort. Will be summarized using Kaplan-Meier survival analysis.
Progression-free survival
Will be summarized for all patients overall and by each cohort. Will be summarized using Kaplan-Meier survival analysis.
Objective response rate
Will be summarized for all patients overall and by each cohort.
Change in health-related quality of life
Will be summarized for all patients overall and by each cohort and estimated using the linear mixed model for repeated measures for each group and overall.
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