Metastatic CancerPhase 2NCT00855803
Stereotactic Body Radiation Therapy and Vertebroplasty in Treating Patients With Localized Spinal Metastasis
A Phase 2 study testing radiation in people with Metastatic Cancer and Pain, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer, Pain, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to 20 Jan 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, 75390
About this study
Official title: 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.
Read the 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.
- Being tested
- radiation
- Keywords
- spinal cord metastases, unspecified adult solid tumor, protocol specific, pain
- Medical subject headings
- Neoplasm Metastasis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiationRadiation
Also called stereotactic body radiation therapy
Given in 1 or 5 fractions
| Study group | Role | What they receive |
|---|---|---|
| Radiation followed by Vertebroplasty | Experimental | 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. Receives: Radiation: radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 month
Secondary outcomes (4)
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
Measured: 1 month
Overall Survival
Overall survival measured from the date of accession to the date of death. Median times will be reported.
Measured: 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.
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2009 (estimated)
- Study startFeb 2009
- Primary completion20 Jan 2021
- Study completion20 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Timmerman, University of Texas Southwestern Medical Center
- Investigators
- Robert D. Timmerman, MD, Principal investigator, Simmons Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00855803
- Sponsor's protocol ID
- STU 072010-134
- Status last verified
- Feb 2022
- First submitted
- 3 Mar 2009
- Last updated
- 16 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Stereotactic Body Radiation Therapy and Vertebroplasty for Localized Spinal Metastasis (SBRT Spine)
- ClinicalTrials.gov ID
- NCT00855803
- Acronym / sponsor ID
- STU 072010-134
- Keywords
- spinal cord metastases, unspecified adult solid tumor, protocol specific, pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- 20 Jan 2021 (actual)
- Study completion
- 20 Jan 2021 (actual)
- First posted
- 4 Mar 2009 (estimated)
- Results
- Posted 16 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiation followed by Vertebroplasty | Experimental | Radiation: radiationIntervention: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radiationAlso: stereotactic body radiation therapyGiven in 1 or 5 fractions | Radiation | Radiation followed by Vertebroplasty |
Primary outcome
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
4 secondary outcomes
Pain Response
Time frame: 1 month
Overall Survival
Time frame: 5 year
Daily Function
Time frame: Baseline
Quality of Life Questionnaire Responses
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert D. Timmerman, MD principal investigator
Simmons Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing radiation in people with Metastatic Cancer and Pain, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Response as Measured by VAS at 3 Months (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2022.