Stereotactic Body Radiation Therapy and Vertebroplasty in Treating Patients With Localized Spinal Metastasis

OBJECTIVES:

Primary

• To determine the efficacy of stereotactic body radiotherapy in reducing pain at 3 months in patients with localized spinal metastasis.

Secondary

• To determine the duration of pain response at the treated site(s) scored as the time of maximal pain relief to an increase of 2 points on the Visual Analogue Scoring System.
• To determine the functional preservation of improvement as measured by the Brief Pain Inventory.
• To prospectively assess quality of life using the FACT-G and EQ-5D questionnaires.
• To determine the long-term stability of the treated vertebral bone (e.g., fracture, sclerotic change, vertebral body height, or malalignment) as measured by MRI, CT scan, and plain radiographs.

OUTLINE: Patients are assigned to 1 of 2 treatment groups according to prior radiotherapy to the planned treatment site(s).

• Group 1 (prior radiotherapy): Patients undergo 5 fractions of stereotactic body radiotherapy (SBRT) over 30-90 minutes each.
• Group 2 (no prior radiotherapy): Patients undergo 1 fraction of SBRT over 30-90 minutes.

Within 1 month after the initiation of SBRT, patients in both groups undergo percutaneous vertebroplasty.

Patients complete pain and quality-of-life questionnaires at baseline and periodically during study. Patients also undergo MRI and CT scan at baseline, at 1, 3, and 6 months, and then every 6 months for 3 years to assess changes in vertebral bone strength and stability.

After completion of study therapy, patients are followed at 2 weeks, at 1, 3, and 6 months, and then every 6 months for 3 years.

Eligibility:

Inclusion:

• Patients must have localized spine metastasis (a solitary spine metastasis; two contiguous levels, or up to three separate single vertebral levels are permitted)
• Patients must have a VAS of ≥4 at any of the planned treatment sites
• Patient with epidural, spinal nerve, and/or cord compression on MRI may be included
• Histologic confirmation of cancer is required by biopsy, prior surgery, or re-biopsy
• Narcotic pain prescription and usage information must be available and documented
• Patients must sign study specific consent
• Above the age of 18
• For women of childbearing age a negative pregnancy test is required
• Patients considered for the retreatment arm, must not of had prior radiation to the proposed spinal site within a 3 month interval prior to treatment
• Zubrod score of 0-2

Exclusion:

• Patients who have been non-ambulatory for more than 7 days
• Patients with compression fractures
• Spine instability requiring fixation
• Patients with paraspinal extension
• Patients with bony fragments
• Planned systemic treatment within one week after treatment.
• Absence of pathological diagnosis of cancer
• Chemotherapy within one week of treatment
• Patients with Multiple Myeloma, Lymphoma, or Plasmacytoma
• Patient suffered from unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
• Patient had a transmural myocardial infarction within the last 6 months
• Patient has an acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
• Patient has hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
• PT is not within normal limits or planned and feasible to be corrected to normal limits prior to vertebroplasy
• PTT is not within normal limits or planned and feasible to be corrected to normal limits prior to vertebroplasy
• Platelet count is < 50,000
• History of significant psychiatric illness

Note: Vertebroplasty may not be possible for certain patients due to tumor location or safety. In such cases, patients will omit the vertebroplasty but receive all other protocol care and follow-up Visual Analog Scoring