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Radiation Therapy
Spine SbRT for Spinal Metastases (DESSRT Trial)
N/A
Recruiting
Led By Rupesh Kotecha, MD
Research Sponsored by Baptist Health South Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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)
Must not have
Rapid neurologic decline
>50% loss of vertebral body height or spinal instability to due pathologic compression fracture
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months, 24 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will test whether a new, more tolerable way of delivering spine stereotactic radiosurgery is feasible and tolerable.
Who is the study for?
This trial is for adults with cancer that has spread to their spine. They must have a certain level of pain, be able to perform daily activities with minimal assistance, and not be pregnant or unable to undergo an MRI. Patients should not have rapid neurological decline, severe spinal damage, or tumors too close to the spinal cord.
What is being tested?
The study tests a new way of giving spine stereotactic body radiotherapy (SSRS) for metastatic cancer in the spine. Instead of 1-2 high-dose treatments, it will use lower doses over 5 sessions aiming for fewer side effects while maintaining effectiveness.
What are the potential side effects?
Potential side effects include skin reactions at the treatment site, fatigue, nausea, and inflammation around the treated area. There may also be risks associated with radiation exposure such as tissue damage.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up more than 50% of my waking hours.
Select...
My cancer has spread to my spine at specific levels but is limited in number and area.
Select...
My pain level is 5 or higher without taking pain medication.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My neurological condition is worsening quickly.
Select...
I have a spinal fracture causing more than 50% height loss or instability.
Select...
My cancer type responds well to radiation therapy.
Select...
My cancer is very close to or affecting my spinal cord.
Select...
I cannot walk by myself.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months, 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months, 24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in response to spine Stereotactic Body Radiotherapy (SBRT) for Brief Pain Inventory (BPI)
Change in response to spine Stereotactic Body Radiotherapy (SBRT) for EQ-5D-5L
Change in response to spine Stereotactic Body Radiotherapy (SBRT) for FACT-G
Secondary study objectives
Change in response over time for the EQ-5D-5L
Change in response over time for the FACT-G
Pain
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: RadiotherapyExperimental Treatment1 Intervention
Cohort 1 (De novo) No Prior radiotherapy Cohort 2 (Prior radiotherapy) Prior radiotherapy
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Who is running the clinical trial?
Baptist Health South FloridaLead Sponsor
52 Previous Clinical Trials
7,939 Total Patients Enrolled
1 Trials studying Metastasis
46 Patients Enrolled for Metastasis
Rupesh Kotecha, MDPrincipal InvestigatorMiami Cancer Institute (MCI) at Baptist Health, Inc.
3 Previous Clinical Trials
103 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My neurological condition is worsening quickly.I can take care of myself and am up more than 50% of my waking hours.I have a spinal fracture causing more than 50% height loss or instability.My cancer type responds well to radiation therapy.It has been at least 6 months since my last radiation treatment.My cancer has spread to my spine at specific levels but is limited in number and area.My spinal cord has a safe distance from my epidural lesion.My spine-related cancer spread is less than 5 cm and directly connected to the spine.My cancer is very close to or affecting my spinal cord.My pain level is 5 or higher without taking pain medication.I cannot walk by myself.
Research Study Groups:
This trial has the following groups:- Group 1: Radiotherapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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