A Phase 2 interventional study of radiation in Metastatic Cancer, Pain and Unspecified Adult Solid Tumor, Protocol Specific, sponsored by University of Texas Southwestern Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-16.
Sponsored by University of Texas Southwestern Medical Center · Phase 2, Interventional, and Treatment
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.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients are assigned to 1 of 2 treatment groups according to prior radiotherapy to the planned treatment site(s).
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.
3,514 studies on the registry are indexed under Neoplasm Metastasis; 883 are open to participants now.
This study's enrollment of 35 is below the median of 54 across 2,765 interventional studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.
Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Eligibility:
Inclusion:
Exclusion:
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
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.
Radiation: radiation
Given in 1 or 5 fractions
Also known as: stereotactic body radiation therapy
Pain Response as Measured by VAS at 3 Months
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
Time frame: 3 month
Pain Response
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
Time frame: 1 month
Overall Survival
Overall survival measured from the date of accession to the date of death. Median times will be reported.
Time frame: 5 year
Daily Function
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.
Time frame: Baseline
Quality of Life Questionnaire Responses
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
Time frame: 12 months
3 withdrew before starting treatment, 1 had clinical decline prior to treatment and was removed, 1 was removed prior to treatment for local progression, and 1 was removed due to a pre-existing compression fracture prior to treatment, These 6 patients did start the study but were assessed for other outcomes.
| Milestone | Total Population |
|---|---|
| Started | 35 |
| Completed | 21 |
| Not completed | 14 |
| Withdrew: Death | 2 |
| Withdrew: Lost to follow-up | 2 |
| Withdrew: Technical inability to undergo procedure | 2 |
| Withdrew: Not evaluable at 3 month timepoint | 2 |
| Withdrew: Withdrawal by subject | 3 |
| Withdrew: Physician decision | 3 |
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
| Participants | Total Population |
|---|---|
| Patients with a partial pain response at 3 months | 8 |
| Patients with a complete pain response at 3 months | 12 |
| Patients without a pain response | 1 |
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
| Participants | Total Population |
|---|---|
| Patients with a complete pain response | 10 |
| Patients with a partial pain response | 10 |
| Patients with no pain response | 5 |
Overall survival measured from the date of accession to the date of death. Median times will be reported.
| months | Total Population |
|---|---|
| Overall Survival | 9 (0 to 63.4) |
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.
| score on a scale | Total Population |
|---|---|
| Pain Severity | 5.8 ± 1.8 |
| Pain Interference | 6.0 ± 2.2 |
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
| participant responses | Total Population |
|---|---|
| Number of responses at baseline | 35 |
| Number of responses at 1 month | 29 |
| Number of responses at 3 months | 21 |
| Number of responses at 6 months | 16 |
| Number of responses at 12 months | 7 |
Collected over 5 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Total Population | 2/29 (6.9%) | 1/29 (3.4%) | 3/29 (10.3%) |
| Event | Total Population |
|---|---|
| Acute myelopathyNervous system disorders | 1/29 |
| Event | Total Population |
|---|---|
| EsophagitisGastrointestinal disorders | 1/29 |
| Acute hematomaInjury, poisoning and procedural complications | 1/29 |
| Urinary retentionRenal and urinary disorders | 1/29 |
| Metastatic renal cell carcinomaRenal and urinary disorders | 1/29 |
| Spinal canal stenosisNervous system disorders | 1/29 |
| LaminectomySurgical and medical procedures | 1/29 |
35 patients enrolled to the study, 29 patients started protocol treatment and had study specific measures completed.
| Age, Continuous(years) | Total Population |
|---|---|
| Median | 60 (40 to 77) |
| Sex: Female, Male(Participants) | Total Population |
|---|---|
| Female | 16 |
| Male | 19 |
| Race (NIH/OMB)(Participants) | Total Population |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 7 |
| White | 27 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Primary Site(participants) | Total Population |
|---|---|
| Lung | 10 |
| Breast | 4 |
| Prostate | 4 |
| Kidney | 4 |
| Melanoma | 3 |
| Colorectal | 2 |
| Oropharyngeal | 1 |
| Thyroid | 1 |
| Spine Location(participants) | Total Population |
|---|---|
| Cervical | 4 |
| Thoracic | 12 |
| Lumbar | 13 |
| Number of vertebrae treated(participants) | Total Population |
|---|---|
| 1 | 23 |
| 2 | 6 |
| Preexisting endplate fracture(participants) | Total Population |
|---|---|
| Yes | 5 |
| No | 24 |
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University of Texas Southwestern Medical Center