AzTrials
AzTrials

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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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
  • Miami Cancer Institute at Baptist Health, Inc

    Miami, Florida, 33176

    Rupesh Kotecha, MD, 786-596-2000, RupeshK@baptisthealth.net

    Rupesh Kotecha, MD

    Recruiting

Other trials in United States

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.

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 groups in NCT04802603
Study groupRoleWhat they receive
RadiotherapyOtherCohort 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.

  1. 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

  2. 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

  3. 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)
  1. 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

  2. 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

  3. 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

  4. Number of safety events

    To assess the safety and tolerability of treatment using CTCAE v5.0 criteria

    Measured: 12 months

  5. 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

  6. 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

  7. 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

  8. 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.

  1. First posted17 Mar 2021
  2. Study start14 Mar 2021
  3. Primary completion28 Sep 2029 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in