Phase II Trial of Stereotactic Radiation Therapy (SRT) Versus SRT Plus Vertebral Augmentation Procedure (VAP) for Vertebral Metastasis

Inclusion Criteria

• •1. Age ≥ 18 years.
• •2. ECOG performance status 0-1.
• •3. Known histologically proven malignancy.
• •4. Localized osteolytic spine metastases from T7 to L5 demonstrated by MRI, CT, PET or bone scan: a solitary spine metastasis; two separate spine levels; or up to 3 separate sites (each site may have a maximal involvement of 2 contiguous vertebral bodies with or without a paraspinal mass of no more than 5 cm).
• •5. Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential.
• •6. Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control.
• •7. Numerical Rating Pain Scale (NRPS) and movement-related pain score(MRPS) within two (2) weeks prior to registration.
• •8. The patient must have a score of ≥ 5 for at least one of the planned sites for SRT.
• •9. Patients must provide study specific informed consent prior to study entry.
• •10. Required Pre-treatment Evaluations: baseline Numerical Rating Pain Scale (NRPS), movement-related pain score, dose and frequency of all pain medications; QOL Measure using the Oswestry Disability Questionnaire, and EuroQOL(EQ-5D).