Vertebral MetastasisNCT01527292
Phase II Trial of Stereotactic Radiation Therapy (SRT) Versus SRT Plus Vertebral Augmentation Procedure (VAP) for Vertebral Metastasis
A study testing Stereotactic Radiation Therapy and SRT with Vertebral Augmentation Procedure in people with Vertebral Metastasis, run by University of Louisville at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vertebral Metastasis
- What is being tested?
- Stereotactic Radiation Therapy and SRT with Vertebral Augmentation Procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to 2 Sep 2015
- Phase
- Interventional
- 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
- Age ≥ 18 years.
- ECOG performance status 0-1.
- Known histologically proven malignancy.
- Localized osteolytic spine metastases from T7 to L5 demonstrated by MRI, CT, PET or bone scan: a solitary spine metastasis; two separate spine levels; or up to 3 separate sites (each site may have a maximal involvement of 2 contiguous vertebral bodies with or without a paraspinal mass of no more than 5 cm).
- Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential.
- Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control.
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- Numerical Rating Pain Scale (NRPS) and movement-related pain score(MRPS) within two (2) weeks prior to registration.
- The patient must have a score of ≥ 5 for at least one of the planned sites for SRT.
- Patients must provide study specific informed consent prior to study entry.
- Required Pre-treatment Evaluations: baseline Numerical Rating Pain Scale (NRPS), movement-related pain score, dose and frequency of all pain medications; QOL Measure using the Oswestry Disability Questionnaire, and EuroQOL(EQ-5D).
Who cannot join
- Non-ambulatory patients.
- Frank spinal cord compression or epidural compression within 3 mm of the spinal cord.
- Osteoblastic vertebral metastasis.
- Prior radiation to the index spine.
- Patients with rapid neurologic decline.
Trial locations and contacts
1 site in 1 country.
United States1 site
James Graham Brown Cancer Center
Louisville, Kentucky, 40202
About this study
Official title: Randomized Phase II Trial of Stereotactic Radiation Therapy (SRT) Versus SRT Plus Vertebral Augmentation Procedure (VAP) for Vertebral Metastasis
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.
Read the detailed description
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
- Conditions
- Vertebral Metastasis
- Being tested
- Stereotactic Radiation Therapy, SRT with Vertebral Augmentation Procedure
- Keywords
- Vertebral Metastasis, pain control, VAP, SRT+VAP
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Radiation TherapyRadiation
Also called Stereotactic Radiosurgery
SRT only
SRT with Vertebral Augmentation ProcedureRadiation
Also called Stereotactic Radiosurgery with VAP
SRT with VAP
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Baseline Assessments and followup assessments are the same for both arms. Control group Intervention: Stereotactic Radiation Therapy only Receives: Radiation: Stereotactic Radiation Therapy |
| 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 Receives: Radiation: SRT with Vertebral Augmentation Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: For 6 months post treatment
Secondary outcomes (5)
Reduction of Pain Estimate
To estimate the relative quantitative reduction of pain from baseline in patients in each arm.
Measured: For 1 year post treatment
Quality of Life Estimate
To estimate the quality of life using the Oswestry Disability Questionnaire
Measured: 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).
Measured: For 1 year post treatment
Toxicity Rate Estimation
To estimate the toxicities of the treatment
Measured: For 1 year post treatment
Vertebra Measurement
To measure the dimensions of the treated vertebra(e) at 1 year
Measured: For 1 year post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completion2 May 2015
- Study completion2 Sep 2015
Why it stopped: Unable to enroll
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 Vertebral MetastasisStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- James Graham Brown Cancer Center
- Responsible party
- Principal investigator, Shiao Yuo Woo, University of Louisville
- Investigators
- Shiao Y Woo, MD, Principal investigator, James Graham Brown Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01527292
- Sponsor's protocol ID
- BCC-RAD-11-01
- Status last verified
- Jan 2016
- First submitted
- 2 Feb 2012
- Last updated
- 5 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Trial of Stereotactic Radiation Therapy (SRT) Versus SRT Plus Vertebral Augmentation Procedure (VAP) for Vertebral Metastasis
- ClinicalTrials.gov ID
- NCT01527292
- Acronym / sponsor ID
- BCC-RAD-11-01
- Conditions
- Vertebral Metastasis
- Keywords
- Vertebral Metastasis, pain control, VAP, SRT+VAP
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to enroll
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- James Graham Brown Cancer Center
- Study start
- Feb 2012 (actual)
- Primary completion
- 2 May 2015 (actual)
- Study completion
- 2 Sep 2015 (actual)
- First posted
- 7 Feb 2012 (estimated)
- Results
- Posted 5 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Radiation: Stereotactic Radiation TherapyBaseline Assessments and followup assessments are the same for both arms. Control group Intervention: Stereotactic Radiation Therapy only |
| Treatment Group | Experimental | Radiation: SRT with Vertebral Augmentation ProcedureSRT 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 years.
- ECOG performance status 0-1.
- Known histologically proven malignancy.
- Localized osteolytic spine metastases from T7 to L5 demonstrated by MRI, CT, PET or bone scan: a solitary spine metastasis; two separate spine levels; or up to 3 separate sites (each site may have a maximal involvement of 2 contiguous vertebral bodies with or without a paraspinal mass of no more than 5 cm).
- Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential.
Key exclusion criteria (5 listed)
- Non-ambulatory patients.
- Frank spinal cord compression or epidural compression within 3 mm of the spinal cord.
- Osteoblastic vertebral metastasis.
- Prior radiation to the index spine.
- Patients with rapid neurologic decline.
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 |
|---|---|---|
| Stereotactic Radiation TherapyAlso: Stereotactic RadiosurgerySRT only | Radiation | Control Group |
| SRT with Vertebral Augmentation ProcedureAlso: Stereotactic Radiosurgery with VAPSRT with VAP | Radiation | Treatment Group |
Primary outcome
Numerical Rating Pain Scale (NRPS) Change in Patients
Time frame: For 6 months post treatment
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
5 secondary outcomes
Reduction of Pain Estimate
Time frame: For 1 year post treatment
Quality of Life Estimate
Time frame: For 1 year post treatment
Feasibility Rate Estimation
Time frame: For 1 year post treatment
Toxicity Rate Estimation
Time frame: For 1 year post treatment
Vertebra Measurement
Time frame: For 1 year post treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Shiao Y Woo, MD principal investigator
James Graham Brown Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic Radiation Therapy and SRT with Vertebral Augmentation Procedure in people with Vertebral Metastasis, run by University of Louisville 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 5 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: stopped early, as of the sponsor's last update on 5 Feb 2019. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2019). 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?
Numerical Rating Pain Scale (NRPS) Change in Patients (time frame: For 6 months post treatment). 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 5 Feb 2019.