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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months, 24 months

Awards & highlights

DESSRT Trial 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.Check my eligibility

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.See study design

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.

DESSRT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and am up more than 50% of my waking hours.

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My cancer has spread to my spine at specific levels but is limited in number and area.

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My pain level is 5 or higher without taking pain medication.

DESSRT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months, 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months, 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months, 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Change in response over time for the EQ-5D-5L

Change in response over time for the FACT-G

Pain

+5 more

DESSRT Trial Design

1Treatment groups

Experimental Treatment

Group I: RadiotherapyExperimental Treatment1 Intervention

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Baptist Health South FloridaLead Sponsor

48 Previous Clinical Trials

7,771 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

Media Library

Spine stereotactic body radiotherapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04802603 — N/A

Metastasis Research Study Groups: Radiotherapy

Metastasis Clinical Trial 2023: Spine stereotactic body radiotherapy Highlights & Side Effects. Trial Name: NCT04802603 — N/A

Spine stereotactic body radiotherapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04802603 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the core objectives of this trial?

"The primary aim of this trial, to be evaluated within 5 days of treatment conclusion, is to analyse the changes in response to spine Stereotactic Body Radiotherapy (SBRT) as measured by Functional Assessment of Cancer Therapy-General (FACT-G). Secondary objectives involve comparison between pre and post intervention HRQOL scores according to EuroQol(EQ-5D-5L), a five point patient self rating scale. Additionally, FACT-G will assess physical well being with 7 items, social/family wellbeing with 7 items emotional wellbeing 6 items and functional wellbeing with 7 items. EQ-5D"

Answered by AI

Are there any enrollment opportunities available for this trial?

"Indeed, according to clinicaltrials.gov, this research endeavour is actively searching for participants. The trial was first shared on March 14th 2021 and updated as recently as June 29th 2022; 60 patients need to be enrolled from a single site."

Answered by AI

What is the current aggregate of participants enrolled in this trial?

"Indeed, the information on clinicaltrials.gov attests to this trial's ongoing recruitment process - beginning on March 14th 2021 and most recently updated June 29th 2022 - for a total of 60 participants from one location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Dose-Escalated Spine SbRT for Localized Metastasis to the Spinal Column

2021. "Dose-Escalated Spine SbRT for Localized Metastasis to the Spinal Column". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04802603.

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