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

• Reduction of Pain Estimate [ Time Frame: For 1 year post treatment ] [ Designated as safety issue: No ]
  To estimate the relative quantitative reduction of pain from baseline in patients in each arm.
• Quality of Life Estimate [ Time Frame: For 1 year post treatment ] [ Designated as safety issue: No ]
  To estimate the quality of life using the Oswestry Disability Questionnaire
• Feasibility Rate Estimation [ Time Frame: For 1 year post treatment ] [ Designated as safety issue: No ]
  To estimate the feasibility rate of the study procedure (the percentage of patients in overall and each arm that complete the treatment).
• Toxicity Rate Estimation [ Time Frame: For 1 year post treatment ] [ Designated as safety issue: Yes ]
  To estimate the toxicities of the treatment
• Vertebra Measurement [ Time Frame: For 1 year post treatment ] [ Designated as safety issue: No ]
  To measure the dimensions of the treated vertebra(e) at 1 year

The purpose of this study is to determine pain control rate (Percentage of patients in each arm that achieve pain control) at the treated site(s) at 1 month, 2-4 months and 5-6 months post-treatment.

Eligible Vertebral Metastatic Lesion/s-> randomized-> SRT versus SRT+ VAP Stereotactic Radiation Therapy(SRT): 16 Gy X 1 Evaluation: prior to treatment; 1 month, 2-4 months, 5-6 months and 1 year post-treatment

• Radiation: Stereotactic Radiation Therapy
  SRT only
  Other Name: Stereotactic Radiosurgery
• Radiation: SRT with Vertebral Augmentation Procedure
  SRT with VAP
  Other Name: Stereotactic Radiosurgery with VAP

• Active Comparator: Control Group
  Baseline Assessments and followup assessments are the same for both arms. Control group Intervention: Stereotactic Radiation Therapy only
  Intervention: Radiation: Stereotactic Radiation Therapy
• Experimental: Treatment Group
  Baseline Assessments and followup assessments are the same for both arms. Treatment group Intervention: Stereotactic Radiation Therapy with Vertebral Augmentation Procedure
  Intervention: Radiation: SRT with Vertebral Augmentation Procedure

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).

Exclusion Criteria:

1. Non-ambulatory patients.
2. Frank spinal cord compression or epidural compression within 3 mm of the spinal cord.
3. Osteoblastic vertebral metastasis.
4. Prior radiation to the index spine.
5. Patients with rapid neurologic decline.