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DESSRTDose-Escalated Spine SbRT for Localized Spinal Metastasis

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Study Aim

This study aims to evaluate how dose-escalated spine Stereotactic Body Radiotherapy affects pain, quality of life, and well-being in patients with localized spinal metastasis.

What is being tested

Spine stereotactic body radiotherapy

Radiation
Who is being recruted

Over 18 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: March 2021
See protocol details

Summary

Principal SponsorBaptist Health South Florida
Study ContactRupesh Kotecha, MDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 14, 2021

Actual date on which the first participant was enrolled.

This study is exploring a new treatment method for people with cancer that has spread to their spine, known as localized spine metastasis. Traditional methods, like external-beam radiotherapy, have limitations, so researchers are using a technique called spine stereotactic radiosurgery as an alternative. This method has shown promise over the past decade in controlling pain and improving nerve function in patients who have compression of the spine. The study is important because it could offer better pain management and improve quality of life for those dealing with this challenging condition. Participants in this study undergo a specialized form of radiation therapy, called Stereotactic Body Radiotherapy (SBRT), which is directed precisely at the spine. The treatment aims to see how well it controls pain and other symptoms. Researchers use several tools to measure the outcomes: the Brief Pain Inventory assesses pain levels, the EQ-5D-5L evaluates overall health dimensions like mobility and anxiety, and the FACT-G measures well-being in physical, social, emotional, and functional areas. By collecting this data, the study evaluates the effectiveness and tolerability of this escalated dose treatment, which could lead to better care practices for patients with spine metastases.

Official TitleDose-Escalated Spine SbRT (DESSRT) for Localized Metastasis to the Spinal Column
NCT04802603
Principal SponsorBaptist Health South Florida
Study ContactRupesh Kotecha, MDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

6 inclusion criteria required to participate
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

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7 exclusion criteria prevent from participating
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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Cohort 1 (De novo) No Prior radiotherapy Cohort 2 (Prior radiotherapy) Prior radiotherapy

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Miami Cancer Institute at Baptist Health, Inc

Miami, United StatesOpen Miami Cancer Institute at Baptist Health, Inc in Google Maps
Recruiting
One Study Center