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

Study ID
STU 072010-134

Cancer Related

Healthy Volunteers

Study Sites

  • Clements University Hospital
  • UT Southwestern Ambulatory Services
  • Parkland Health & Hospital System

Sarah Hardee

Principal Investigator
Robert Timmerman, M.D.

Official Title

Phase II Study of Stereotactic Body Radiation Therapy and Vertebroplasty for Localized Spinal Metastasis (SBRT Spine)

Brief Overview

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.




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


- 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

- 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

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

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.

Participant Eligibility



- 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


- 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

- 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