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

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

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.