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Radiation + Radiofrequency Ablation for Spinal Metastases

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 0-3

Patients with epidural compression are eligible provided that there is a ≥ 3 mm gap between the spinal cord and the edge of the epidural lesion.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months, 6, 12, 24 months

Awards & highlights

Study Summary

This trial is studying whether adding radiofrequency ablation to radiation therapy improves treatment for back pain caused by spine metastases. Participants will receive either radiation therapy alone or radiation therapy with radiofrequency ablation, with or without vertebral augmentation.

Who is the study for?

This trial is for adults with cancer that has spread to the spine, causing significant back pain. They must have a certain level of physical ability (Zubrod Performance Status 0-3), not be pregnant, agree to use birth control if applicable, and have a specific level of back pain despite medication. Excluded are those with certain cancers like myeloma or lymphoma, non-walkers, prior radiation on the spine area, or needing immediate surgery.Check my eligibility

What is being tested?

The study compares two treatments for spinal metastases-related back pain: Radiation Therapy alone versus Radiation Therapy combined with Radiofrequency Ablation and possibly Vertebral Augmentation. The goal is to see which treatment better alleviates pain while patients continue their usual pain medications.See study design

What are the potential side effects?

Radiation therapy can cause skin changes, fatigue, mild swelling or discomfort at the treatment site. Radiofrequency ablation may include side effects such as local soreness or discomfort post-procedure.

Eligibility Criteria

Inclusion Criteria

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

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I can care for myself but may not be able to do heavy physical work.

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My spinal cord has a safe distance from my epidural lesion.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months, 6, 12, 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months, 6, 12, 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months, 6, 12, 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 pain control

Secondary outcome measures

Change in pain response

Measure increases in the duration of pain response

Measure the potential benefit on quality of life

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Radiotherapy plus radiofrequency ablationExperimental Treatment2 Interventions

Radiotherapy plus radiofrequency ablation / vertebral augmentation(Combination therapy)

Group II: RadiotherapyExperimental Treatment1 Intervention

Radiotherapy alone

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation Therapy

2017

Completed Phase 3

~7250

Radiofrequency Ablation (RFA)

2016

Completed Phase 2

~130

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

MedtronicIndustry Sponsor

606 Previous Clinical Trials

828,585 Total Patients Enrolled

Baptist Health South FloridaLead Sponsor

48 Previous Clinical Trials

7,751 Total Patients Enrolled

Rupesh Kotecha, MDPrincipal InvestigatorMiami Cancer Institute (MCI) at Baptist Health South Florida

3 Previous Clinical Trials

83 Total Patients Enrolled

Media Library

Radiation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT04375891 — N/A

Cancer Research Study Groups: Radiotherapy, Radiotherapy plus radiofrequency ablation

Cancer Clinical Trial 2023: Radiation Therapy Highlights & Side Effects. Trial Name: NCT04375891 — N/A

Radiation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04375891 — N/A

Frequently Asked Questions

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

Is the enrollment period of this trial still open?

"Yes, the clinical trial is currently enrolling participants. The information posted on clinicaltrials.gov reveals that the trial was first launched in May 2020 and has been updated most recently in February 2022."

Answered by AI

What is the sample size of this clinical experiment?

"Affirmative. Clinicaltrials.gov showcases that this medical trial, which was initially published on May 22nd 2020, is actively enrolling volunteers. 80 participants are being sought across a single centre."

Answered by AI

Recent research and studies

TrialsJournal

Radiation Therapy Alone Versus Radiation Therapy Plus Radiofrequency Ablation/vertebral Augmentation for Spine Metastasis: Study Protocol for a Randomized Controlled Trial

Kotecha, Rupesh, Brian J. Schiro, Justin Sporrer, Muni Rubens, Haley R. Appel, Kathleen S. Calienes, Belinda Boulanger, et al.. 2020. “Radiation Therapy Alone Versus Radiation Therapy Plus Radiofrequency Ablation/vertebral Augmentation for Spine Metastasis: Study Protocol for a Randomized Controlled Trial”. Trials. Springer Science and Business Media LLC. doi:10.1186/s13063-020-04895-x.

clinicaltrials.govStudy

Radiation Therapy Alone Versus Radiation Therapy Plus Radiofrequency Ablation (RFA)/Vertebral Augmentation

2020. "Radiation Therapy Alone Versus Radiation Therapy Plus Radiofrequency Ablation (RFA)/Vertebral Augmentation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04375891.