Stereotactic Body Radiation Therapy and Vertebroplasty in Treating Patients With Localized Spinal Metastasis
Condition: Metastatic Cancer; Pain; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Neoplasm Metastasis
Intervention: radiation
Intervention description: Given in 1 or 5 fractions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: spinal cord metastases; unspecified adult solid tumor, protocol specific; pain

Summary:

      RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the
      tumor and cause less damage to normal tissue. Vertebroplasty may help prevent fractures and
      spinal cord compression caused by spinal metastasis. Giving stereotactic body radiation
      therapy together with vertebroplasty may help lessen pain and improve quality of life of
      patients with spinal metastasis.

      PURPOSE: This phase II trial is studying how well giving stereotactic body radiation therapy
      together with vertebroplasty works in treating patients with localized spinal metastasis.
    

Eligibility criteria:

        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