Phase II Study of Stereotactic Body Radiation Therapy and Vertebroplasty for Localized Spinal Metastasis (SBRT Spine)
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 35
- Locations
- 2
- Primary Endpoint
- Pain Response as Measured by VAS at 3 Months
Study Overview
Brief 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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Pain Response as Measured by VAS at 3 Months
Time Frame: 3 month
Pain reduction as measured by Visual Analogue Scoring System (VAS) at 3 months Patient pain was recorded on a 10-point scale (0: no pain, 10: most severe pain). At baseline patients were required to have a pain score of 4 or higher associated with spine metastases. Pain response was recorded again during follow-up visits to determine the pain response: A pain score of 0 represents a complete response A decrease in the pain score by at least 2 points represents a partial response VAS scores were used to determine the number of patients with a partial pain response, with a complete pain response, and without a pain response
Secondary Outcomes
- Pain Response(1 month)
- Overall Survival(5 year)
- Daily Function(Baseline)
- Quality of Life Questionnaire Responses(12 months)
Investigators
Robert Timmerman
Professor
University of Texas Southwestern Medical Center