Finding studies
Finding studies
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The Ohio State University Comprehensive Cancer Center
CONTACT
Lead
Ohio State University Comprehensive Cancer Center
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) risk in cancer patients with spinal metastases (SM). VI. To assess changes in pain from baseline with patient reported measures, medication changes, and quality of life (QoL) measures. EXPLORATORY OBJECTIVES: I. To assess changes in immune-stimulatory effect via Trex1 relative to radiation dose. II. To evaluate whether changes in Trex1 correlates with PD-L1 expression. III. To validate known molecular signatures predicting metastatic potential and molecular mechanisms that have previously been documented. IV. To develop novel molecular biomarker signatures that predict local spinal metastasis control. V. To evaluate molecular signatures at the time of spinal metastasis, and potentially define the "molecular evolution" of a tumor after treatment. OUTLINE: INDETERMINATE COHORT: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo vertebroplasty 2-4 weeks later, undergo SRS over 1-3 fractions depending upon the number of affected vertebral bodies in the absence of disease progression or unacceptable toxicity. ARM II: Patients undergo SRS over 1-3 fractions depending upon the number of affected vertebral bodies in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 1 year.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
