Spine MetastasesDESSRTNCT04802603
Dose-Escalated Spine SbRT for Localized Metastasis to the Spinal Column
A study testing Spine stereotactic body radiotherapy in people with Spine Metastases and Metastasis Spine, run by Baptist Health South Florida at 1 site in United States.
Trial summary
This study is being done to determine the feasibility and tolerability of a novel regimen of spine stereotactic radiosurgery (SSRS). SSRS delivers high doses of radiation to tumors of the spine using precision techniques. In standard medical care, conventional SSRS is delivered in only 1 or 2 treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spine Metastases, Metastasis Spine
- What is being tested?
- Spine stereotactic body radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2021to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Zubrod Performance Status 0-2
- Localized spine metastasis from a solid tumor from the C1 to L5 levels (a solitary spine metastasis, two separate spine levels, or up to 3 separate sites; each of the separate sites may have a maximal involvement of 2 contiguous vertebral bodies)
- Patients with epidural extension are eligible as long as there is a ≥ 2 mm gap between the spinal cord and the edge of the epidural lesion
- Paraspinal disease extension is allowed as long as it measures ≤ 5 cm in the greatest dimension and that it is contiguous with the spine metastasis
- For patients enrolled in cohort 2, the minimum time to re-irradiation should be 6 months
- Numerical Rating Pain Scale (NRPS) score of ≥ 5 at the index site(s) (as rated when the patient is not taking pain medication)
Who cannot join
- Radiosensitive histologies (myeloma, lymphoma, germ cell tumors, small cell lung cancer)
- Non-ambulatory patients
- >50% loss of vertebral body height or spinal instability to due pathologic compression fracture
- Frank spinal cord compression, spinal cord displacement, or epidural extension within 2 mm of the spinal cord
- Rapid neurologic decline
- Patients for whom an MRI of the spine is medically contraindicated
- Pregnant women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Miami Cancer Institute at Baptist Health, Inc
Miami, Florida, 33176
Rupesh Kotecha, MD, 786-596-2000, RupeshK@baptisthealth.net
Rupesh Kotecha, MD
About this study
Official title: Dose-Escalated Spine SbRT (DESSRT) for Localized Metastasis to the Spinal Column
This study is being done to determine the feasibility and tolerability of a novel regimen of spine stereotactic radiosurgery (SSRS). SSRS delivers high doses of radiation to tumors of the spine using precision techniques.
In standard medical care, conventional SSRS is delivered in only 1 or 2 treatments. When this treatment is delivered in only 1-2 treatments, a high dose is used which can increase the side effects of treatment. This study aims to test an alternative technique of delivering SSRS over 5 treatments. By delivering the radiation therapy over multiple treatments, the dose of radiation is less per treatment.
Read the detailed description
Given the limitations with conventional external-beam radiotherapy, spine stereotactic radiosurgery was developed as an alternative treatment for localized spine metastasis. Stereotactic radiosurgery is an alternative treatment option to conventional palliative radiotherapy, which has gained acceptance over the last decade. Clinical experience with spine stereotactic radiosurgery has showed high rates of pain control and improvement in neurological function in patients with epidural compression.
- Conditions
- Spine Metastases, Metastasis Spine
- Being tested
- Spine stereotactic body radiotherapy
- Keywords
- Localized Metastasis, Spinal Column
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spine stereotactic body radiotherapyRadiation
Cohort 1 - De novo: Spine stereotactic body radiotherapy to a dose of 40 Gy in 5 fractions.
Cohort 2 - Prior radiotherapy: Risk-adapted spinal cord tolerance based on prior spine stereotactic body radiotherapy to a dose of 40 Gy in 5 fractions.
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy | Other | Cohort 1 (De novo) No Prior radiotherapy Cohort 2 (Prior radiotherapy) Prior radiotherapy Receives: Radiation: Spine stereotactic body radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in response to spine Stereotactic Body Radiotherapy (SBRT) for Brief Pain Inventory (BPI)
Assess the change in the feasibility and tolerability response of dose-escalated spine SBRT in patients with de novo or recurrent spine metastases with the Brief Pain Inventory questionnaire. The scale is from 0-10.
Measured: within 5 days of treatment completion
Change in response to spine Stereotactic Body Radiotherapy (SBRT) for FACT-G
4 scales: physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items) and functional well-being (7 items). The FACT-G, developed by Cella, et al.20 is a five point patient self-rating scale (from "not at all" to "very much").
Measured: within 5 days of treatment completion
Change in response to spine Stereotactic Body Radiotherapy (SBRT) for EQ-5D-5L
Consists of 5 items covering 5 dimensions including: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension can be graded on 3 levels including: 1=no problems; 2= moderate problems; and 3=extreme problems
Measured: within 5 days of treatment completion
Secondary outcomes (8)
Pain relief
To assess the rate of complete or partial pain relief at 3 months using the Numerical Rating Pain Scale. Complete pain relief is defined as a pain score of 0 at the index site at 3 months post-treatment. Complete pain relief is based on no increase in narcotic pain medication, and a self-rated score of 0. Partial pain relief is defined as a reduction in the numerical pain score of at least 2 points from the baseline NRPS at the index site, as long as none of the other treated lesions have increased in pain score and as long as the patient did not require an increase in the level of narcotic pain medication.
Measured: 3 months
Pain response
To assess the rapidity of pain response using the Numerical Rating Pain Scale. Pain response will be categorized as following: 1) complete response, post-treatment pain score of 0 at the index site; 2) partial response, post-treatment improvement of at least 3 points at the index site; 3) stable response, post-treatment pain score within 3 points of the initial pain score at the index site, or 4) progressive response, a post-treatment increase of at least 3 points at the index site.
Measured: 12 months
Duration of pain response
To assess the duration of pain response using the Numerical Rating Pain Scale. The NRPS is an 11-point scale (0-10). Patients are instructed that 0 indicates no pain and that 10 indicates the worst pain imaginable. In general, scores of 1-4 indicate mild pain, scores of 5-6 indicate moderate pain, and scores of 7-10 indicate severe pain. Patients will be instructed to report the pain score of each treated site. Patients can complete the NRPS in approximately 1 minute.
Measured: 12 months
Number of safety events
To assess the safety and tolerability of treatment using CTCAE v5.0 criteria
Measured: 12 months
Change in response over time for the FACT-G
Comparing the long-term effects (12 months) of dose-escalated spine Stereotactic Body Radiotherapy (SBRT) on vertebral bone integrity and spinal cord using the change response for the quality of life questionnaires. Test-retest reliability is high for the subscales with correlation coefficients ranging from a high of .88 for physical well-being to .82 for social and emotional well-being. It is written at the 4th grade reading level, and patients can complete the FACT-G in 5-10 minutes.
Measured: baseline, 12 months
Change in response over time for the EQ-5D-5L
Comparing the long-term effects (12 months) of dose-escalated spine Stereotactic Body Radiotherapy (SBRT) on vertebral bone integrity and spinal cord using the change response for the quality of life questionnaires. Each dimension can be graded on 3 levels including: 1=no problems; 2= moderate problems; and 3=extreme problems.
Measured: baseline, 12 months
Functional Assessment of Cancer Therapy-General (FACT-G)
To assess the effect of dose-escalated spine Stereotactic Body Radiotherapy (SBRT) on FACT-G. The FACT-G is a commonly used tool measuring the multidimensional components of health related quality of life (HRQOL) across 4 scales: physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items) and functional well-being (7 items) The FACT, developed by Cella, et al.20 is a five point patient self-rating scale (from "not at all" to "very much").
Measured: 12 months, 24 months
EuroQol (EQ-5D-5L)
To assess the effect of dose-escalated spine Stereotactic Body Radiotherapy (SBRT) on EQ-5D-5L. The EQ-5D is a two-part, patient-completed questionnaire that takes approximately 5 minutes to complete. Consists of 5 items covering 5 dimensions including: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension can be graded on 3 levels including: 1=no problems; 2= moderate problems; and 3=extreme problems.
Measured: 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start14 Mar 2021
- Primary completion28 Sep 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine MetastasesStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Sequential
- Model description
- Cohort 1 (De novo) Cohort 2 (Prior radiotherapy)
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baptist Health South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rupesh Kotecha, MD, Principal investigator, Miami Cancer Institute (MCI) at Baptist Health, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04802603
- Sponsor's protocol ID
- 2020-KOT-003
- Acronym
- DESSRT
- Status last verified
- Nov 2025
- First submitted
- 15 Mar 2021
- Last updated
- 14 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-Escalated Spine SbRT (DESSRT) for Localized Metastasis to the Spinal Column
- ClinicalTrials.gov ID
- NCT04802603
- Acronym / sponsor ID
- DESSRT / 2020-KOT-003
- Conditions
- Spine Metastases, Metastasis Spine
- Keywords
- Localized Metastasis, Spinal Column
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Baptist Health South FloridaUniversity, hospital or other
- Study start
- 14 Mar 2021 (actual)
- Primary completion
- 28 Sep 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 17 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to determine the feasibility and tolerability of a novel regimen of spine stereotactic radiosurgery (SSRS). SSRS delivers high doses of radiation to tumors of the spine using precision techniques.
In standard medical care, conventional SSRS is delivered in only 1 or 2 treatments. When this treatment is delivered in only 1-2 treatments, a high dose is used which can increase the side effects of treatment. This study aims to test an alternative technique of delivering SSRS over 5 treatments. By delivering the radiation therapy over multiple treatments, the dose of radiation is less per treatment.
Detailed description
Given the limitations with conventional external-beam radiotherapy, spine stereotactic radiosurgery was developed as an alternative treatment for localized spine metastasis. Stereotactic radiosurgery is an alternative treatment option to conventional palliative radiotherapy, which has gained acceptance over the last decade. Clinical experience with spine stereotactic radiosurgery has showed high rates of pain control and improvement in neurological function in patients with epidural compression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cohort 1 (De novo) Cohort 2 (Prior radiotherapy)
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy | Other | Radiation: Spine stereotactic body radiotherapyCohort 1 (De novo) No Prior radiotherapy Cohort 2 (Prior radiotherapy) Prior radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Zubrod Performance Status 0-2
- Localized spine metastasis from a solid tumor from the C1 to L5 levels (a solitary spine metastasis, two separate spine levels, or up to 3 separate sites; each of the separate sites may have a maximal involvement of 2 contiguous vertebral bodies)
- Patients with epidural extension are eligible as long as there is a ≥ 2 mm gap between the spinal cord and the edge of the epidural lesion
- Paraspinal disease extension is allowed as long as it measures ≤ 5 cm in the greatest dimension and that it is contiguous with the spine metastasis
- For patients enrolled in cohort 2, the minimum time to re-irradiation should be 6 months
Key exclusion criteria (7 listed)
- Radiosensitive histologies (myeloma, lymphoma, germ cell tumors, small cell lung cancer)
- Non-ambulatory patients
- >50% loss of vertebral body height or spinal instability to due pathologic compression fracture
- Frank spinal cord compression, spinal cord displacement, or epidural extension within 2 mm of the spinal cord
- 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 |
|---|---|---|
| Spine stereotactic body radiotherapyCohort 1 - De novo: Spine stereotactic body radiotherapy to a dose of 40 Gy in 5 fractions. Cohort 2 - Prior radiotherapy: Risk-adapted spinal cord tolerance based on prior spine stereotactic body radiotherapy to a dose of 40 Gy in 5 fractions. | Radiation | Radiotherapy |
Primary outcome
Change in response to spine Stereotactic Body Radiotherapy (SBRT) for Brief Pain Inventory (BPI)
Time frame: within 5 days of treatment completion
Assess the change in the feasibility and tolerability response of dose-escalated spine SBRT in patients with de novo or recurrent spine metastases with the Brief Pain Inventory questionnaire. The scale is from 0-10.
Change in response to spine Stereotactic Body Radiotherapy (SBRT) for FACT-G
Time frame: within 5 days of treatment completion
4 scales: physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items) and functional well-being (7 items). The FACT-G, developed by Cella, et al.20 is a five point patient self-rating scale (from "not at all" to "very much").
Change in response to spine Stereotactic Body Radiotherapy (SBRT) for EQ-5D-5L
Time frame: within 5 days of treatment completion
Consists of 5 items covering 5 dimensions including: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension can be graded on 3 levels including: 1=no problems; 2= moderate problems; and 3=extreme problems
8 secondary outcomes
Pain relief
Time frame: 3 months
Pain response
Time frame: 12 months
Duration of pain response
Time frame: 12 months
Number of safety events
Time frame: 12 months
Change in response over time for the FACT-G
Time frame: baseline, 12 months
Change in response over time for the EQ-5D-5L
Time frame: baseline, 12 months
Functional Assessment of Cancer Therapy-General (FACT-G)
Time frame: 12 months, 24 months
EuroQol (EQ-5D-5L)
Time frame: 12 months, 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2025.
- MCI - WebsiteLink provided by the sponsor.
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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.
Rupesh Kotecha, MD principal investigator
Miami Cancer Institute (MCI) at Baptist Health, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spine stereotactic body radiotherapy in people with Spine Metastases and Metastasis Spine, run by Baptist Health South Florida 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 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 14 Nov 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rupesh Kotecha, MD (786-596-2000, RupeshK@baptisthealth.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in response to spine Stereotactic Body Radiotherapy (SBRT) for Brief Pain Inventory (BPI) (time frame: within 5 days of treatment completion). The study lists 3 primary outcomes in all. 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 14 Nov 2025.