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

Study ID
CDR0000634640

Cancer Related
Yes

Healthy Volunteers
No

Study Sites

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

Contact
Susan Cooley
214/648-1895
susan.cooley@utsouthwestern.edu

Principal Investigator
Robert Timmerman

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.

Summary


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.

Participant Eligibility


DISEASE CHARACTERISTICS:

- Histologically confirmed cancer as determined by biopsy, prior surgery, or re-biopsy
at the discretion of the treating physician

- Must have localized spinal metastasis, defined as 1 of the following:

- Solitary lesion

- Lesion that spans 2 contiguous levels

- Lesion with a para-spinal component

- Lesion with up to 3 separate single vertebral levels

- Visual analog scoring system pain score ≥ 4 at any of the planned treatment site(s)

- No instability of the spine requiring instrumentation, as judged by a neurosurgeon

- No compression fractures, paraspinal extension, or bony fragments

- No radiation sensitive histology (e.g., lymphoma, multiple myeloma, or plasmacytoma)

- Epidural, spinal nerve, and/or cord compression by MRI allowed

PATIENT CHARACTERISTICS:

- Zubrod performance status 0-2

- Platelet count normal

- PT/PTT normal

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Must be or have been ambulatory within 1 week prior to study treatment

- No history of significant psychiatric illness

- No severe, active co-morbidity that would preclude vertebroplasty or stereotactic
body radiotherapy, defined as any of the following:

- Unstable angina and/or congestive heart failure requiring hospitalization within
the past 6 months

- Transmural myocardial infarction within the past 6 months

- Acute bacterial or fungal infection requiring IV antibiotics

- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

PRIOR CONCURRENT THERAPY:

- More than 1 week since prior chemotherapy

- At least 3 months since prior fractionated radiotherapy to the planned treatment
site(s)

- No planned systemic treatment within 1 week after study treatment