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