Phase II Study of Stereotactic Body Radiation Therapy and Vertebroplasty for Localized Spinal Metastasis (SBRT Spine)
18 Years
N/A
Both
Metastatic Cancer, Pain, Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
Phase II Study of Stereotactic Body Radiation Therapy and Vertebroplasty for Localized Spinal Metastasis (SBRT Spine)
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Pain
Outcome Description:
Pain reduction as measured by Visual Analogue Scoring System (VAS) at 3 months
Outcome Time Frame:
3 month
Safety Issue:
No
Principal Investigator
Robert D. Timmerman, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Simmons Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000634640
NCT ID:
NCT00855803
Start Date:
February 2009
Completion Date:
Related Keywords:
- Metastatic Cancer
- Pain
- Unspecified Adult Solid Tumor, Protocol Specific
- spinal cord metastases
- unspecified adult solid tumor, protocol specific
- pain
- Neoplasm Metastasis
- Neoplasms
- Neoplasms, Second Primary
Name | Location |
|---|---|
| University of Texas Southwestern Medical Center - Dallas | Dallas, Texas 75390 |
