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| Name | Class |
|---|---|
| James Graham Brown Cancer Center | OTHER |
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The purpose of this study is to determine pain control rate (Percentage of patients in each arm that achieve pain control) at the treated site(s) at 1 month, 2-4 months and 5-6 months post-treatment.
Eligible Vertebral Metastatic Lesion/s-> randomized-> SRT versus SRT+ VAP Stereotactic Radiation Therapy(SRT): 16 Gy X 1 Evaluation: prior to treatment; 1 month, 2-4 months, 5-6 months and 1 year post-treatment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Active Comparator | Baseline Assessments and followup assessments are the same for both arms. Control group Intervention: Stereotactic Radiation Therapy only |
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| Treatment Group | Experimental | SRT with Vertebral Augmentation Procedure Baseline Assessments and followup assessments are the same for both arms. Treatment group Intervention: Stereotactic Radiation Therapy with Vertebral Augmentation Procedure |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Radiation Therapy | Radiation | SRT only |
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| Measure | Description | Time Frame |
|---|---|---|
| Numerical Rating Pain Scale (NRPS) Change in Patients | To determine pain control rate (Percentage of patients in each arm that achieve pain control) at the treated site(s)at 1 month, 2-4 months and 5-6 months post-treatment and to validate of the movement-related pain score | For 6 months post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of Pain Estimate | To estimate the relative quantitative reduction of pain from baseline in patients in each arm. | For 1 year post treatment |
| Quality of Life Estimate | To estimate the quality of life using the Oswestry Disability Questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shiao Y Woo, MD | James Graham Brown Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| James Graham Brown Cancer Center | Louisville | Kentucky | 40202 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | Baseline Assessments and followup assessments are the same for both arms. Control group Intervention: Stereotactic Radiation Therapy only Stereotactic Radiation Therapy: SRT only |
| FG001 | Treatment Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| SRT with Vertebral Augmentation Procedure | Radiation | SRT with VAP |
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| For 1 year post treatment |
| Feasibility Rate Estimation | To estimate the feasibility rate of the study procedure (the percentage of patients in overall and each arm that complete the treatment). | For 1 year post treatment |
| Toxicity Rate Estimation | To estimate the toxicities of the treatment | For 1 year post treatment |
| Vertebra Measurement | To measure the dimensions of the treated vertebra(e) at 1 year | For 1 year post treatment |
Baseline Assessments and followup assessments are the same for both arms. Treatment group Intervention: Stereotactic Radiation Therapy with Vertebral Augmentation Procedure
SRT with Vertebral Augmentation Procedure: SRT with VAP
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| NOT COMPLETED |
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Trial did not meet enrollment goal. Investigator did not analyze data due to low enrollment and early termination of trial
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | Baseline Assessments and followup assessments are the same for both arms. Control group Intervention: Stereotactic Radiation Therapy only Stereotactic Radiation Therapy: SRT only |
| BG001 | Treatment Group | Baseline Assessments and followup assessments are the same for both arms. Treatment group Intervention: Stereotactic Radiation Therapy with Vertebral Augmentation Procedure SRT with Vertebral Augmentation Procedure: SRT with VAP |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Numerical Rating Pain Scale (NRPS) Change in Patients | To determine pain control rate (Percentage of patients in each arm that achieve pain control) at the treated site(s)at 1 month, 2-4 months and 5-6 months post-treatment and to validate of the movement-related pain score | Data not analyzed due to low enrollment and early termination of study | Posted | For 6 months post treatment |
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| Secondary | Reduction of Pain Estimate | To estimate the relative quantitative reduction of pain from baseline in patients in each arm. | Data not analyzed due to low enrollment and early termination of study | Posted | For 1 year post treatment |
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| Secondary | Quality of Life Estimate | To estimate the quality of life using the Oswestry Disability Questionnaire | Data not analyzed due to low enrollment and early termination of study | Posted | For 1 year post treatment |
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| Secondary | Feasibility Rate Estimation | To estimate the feasibility rate of the study procedure (the percentage of patients in overall and each arm that complete the treatment). | Data not analyzed due to low enrollment and early termination of study | Posted | For 1 year post treatment |
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| Secondary | Toxicity Rate Estimation | To estimate the toxicities of the treatment | Data not analyzed due to low enrollment and early termination of study | Posted | For 1 year post treatment |
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| Secondary | Vertebra Measurement | To measure the dimensions of the treated vertebra(e) at 1 year | Data not analyzed due to low enrollment and early termination of study | Posted | For 1 year post treatment |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | Baseline Assessments and followup assessments are the same for both arms. Control group Intervention: Stereotactic Radiation Therapy only Stereotactic Radiation Therapy: SRT only | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | Treatment Group | Baseline Assessments and followup assessments are the same for both arms. Treatment group Intervention: Stereotactic Radiation Therapy with Vertebral Augmentation Procedure SRT with Vertebral Augmentation Procedure: SRT with VAP | 0 | 3 | 0 | 3 | 0 | 3 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shiao Woo | University of Louisville, James Graham Brown Cancer Center | 502-561-2700 | sywoo001@exchange.louisville.edu |
| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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| >=65 years |
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