Part A: Effect of Prophylactic Vertebroplasty Combined With Radiation Therapy for Spine Metastatic Cancer Patients With Indeterminate Lesion (SINS Criteria)
Ohio State University Comprehensive Cancer Center
Summary
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.
Description
PRIMARY OBJECTIVE: I. To determine the overall efficacy and safety of stereotactic radiosurgery (SRS) with or without vertebroplasty or separation surgery in patients with radiation resistant histologies metastatic to the spine with or without concurrent immunotherapy with PD1 blockade. SECONDARY OBJECTIVES: I. To assess 6 month vertebral compression fracture (VCF) rate. II. To assess local control (LC) and distant disease control rates. III. To assess the progression free survival (PFS). IV. To assess the overall survival (OS). V. To assess potential vertebral compression fracture (VCF) ri…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 * Prior radiation therapy will be allowed at the discretion of the Radiation Oncologist based on current standard operating procedures. * Tumor tissue from the core biopsy or resected site of disease will be collected, if available for biomarker analyses. * Four or less consecutive spinal segments involved by t…
Interventions
- OtherImmunotherapy
Receive SOC immunotherapy
- RadiationStereotactic Radiosurgery
Undergo SRS
- ProcedureVertebroplasty
Undergo vertebroplasty
Location
- Ohio State University Comprehensive Cancer CenterColumbus, Ohio