- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00855803
Stereotactic Body Radiation Therapy and Vertebroplasty in Treating Patients With Localized Spinal Metastasis
Phase II Study of Stereotactic Body Radiation Therapy and Vertebroplasty for Localized Spinal Metastasis (SBRT Spine)
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.
Study Overview
Status
Intervention / Treatment
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.
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75390
- University of Texas Southwestern Medical Center - Dallas
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Radiation followed by Vertebroplasty
Intervention: This study is one arm. All patients will undergo radiotherapy followed by vertebroplasty. Patients who had prior radiotherapy will undergo 5 fractions of stereotactic body radiotherapy (SBRT) over 30-90 minutes each. Patients has no prior radiotherapy will undergo 1 fraction of SBRT over 30-90 minutes. The full patient population will then undergo vertebroplasty*. *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. |
Given in 1 or 5 fractions
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 |
3 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Response
Time Frame: 1 month
|
Duration of pain response as measured by VAS at 1 month 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 |
1 month
|
Overall Survival
Time Frame: 5 year
|
Overall survival measured from the date of accession to the date of death.
Median times will be reported.
|
5 year
|
Daily Function
Time Frame: Baseline
|
Time to functional decline as measure by the Brief Pain Inventory (BPI) at baseline.
BPI has two sections that are scored- pain severity and pain interference.
For each of these a numeric scale from 0-10 is used, with 0 being the worst pain and 10 being the worst pain.
|
Baseline
|
Quality of Life Questionnaire Responses
Time Frame: 12 months
|
Number of participants who filled out the Functional Assessment of Cancer Therapy- General (FACT-G) and the European Quality of Life Five Dimension (EQ-5D) questionnaires at baseline, 1, 3, 6, and 12 months
|
12 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU 072010-134
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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