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Radiation
Single-Session SBRT for Spinal Cancer
Phase 1 & 2
Waitlist Available
Led By Amol J. Ghia, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Maximum of 2 metastatic sites in the spine to be irradiated in single session
Karnofsky performance status of at least 40 (i.e., not requiring active hospitalization)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
Study Summary
This trial will help researchers learn if a single session of SBRT to the spine is safe and effective in treating metastatic spine tumors.
Who is the study for?
This trial is for individuals with up to two metastatic spine tumors, confirmed by MRI within the last month. Participants can have various cancer types and must be able to lie flat for treatment without hospitalization (Karnofsky status of at least 40). Exclusions include prior radiation at the site, cervical spine tumors, unstable spines needing surgery, inability to undergo MRI or lie flat for over 30 minutes, pacemakers, urgent spinal cord compression cases, and recent chemotherapy.Check my eligibility
What is being tested?
The study tests if a single session of Stereotactic Body Radiotherapy (SBRT) using CT-on-Rails is safe and effective against metastatic spine tumors. It will assess pain levels, symptoms interference with life quality before and after treatment as well as changes in neurological function.See study design
What are the potential side effects?
Potential side effects may include localized pain or discomfort from lying still during treatment; skin reactions similar to sunburn; fatigue; temporary worsening of existing symptoms due to inflammation caused by radiation; rare risk of more serious complications like bone damage.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have up to 2 cancer spots in my spine that need radiation in one session.
Select...
I do not need to stay in the hospital for my condition.
Select...
I have agreed to radiation treatment for my spinal or near-spinal tumor.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete Pain Relief Using Stereotactic Body Radiotherapy (SBRT) to Treat Spine and para-Spinal Tumors in a Single Session
Side effects data
From 2008 Phase 2 trial • 20 Patients • NCT0035014215%
ulcer
10%
vomiting
5%
Perforation
5%
pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
SBRT With Gem
Trial Design
1Treatment groups
Experimental Treatment
Group I: Single Session Stereotactic Body Radiotherapy (SBRT)Experimental Treatment1 Intervention
On day 1 of radiation treatment, a CT scan using CT-on-Rails in the same treatment room, immediately before the radiation treatment will be performed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiotherapy
2017
Completed Phase 2
~220
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,976 Previous Clinical Trials
1,789,437 Total Patients Enrolled
2 Trials studying Spinal Tumors
52 Patients Enrolled for Spinal Tumors
Amol J. Ghia, MDPrincipal InvestigatorM.D. Anderson Cancer Center
5 Previous Clinical Trials
325 Total Patients Enrolled
1 Trials studying Spinal Tumors
41 Patients Enrolled for Spinal Tumors
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Delaying my radiation treatment could harm my brain function.My spine needs surgery to stabilize it.I have not had chemotherapy in the last 30 days.My cancer has not spread to areas like the lung or liver.I have multiple myeloma.My MRI shows cancer spread to my spine or near it within the last month.I have up to 2 cancer spots in my spine that need radiation in one session.I have been diagnosed with a specific type of cancer such as lung, breast, or prostate cancer.I do not need to stay in the hospital for my condition.My cancer has not spread to the bones in my neck.I cannot lie flat for more than 30 minutes.I have agreed to radiation treatment for my spinal or near-spinal tumor.I need urgent surgery or radiation due to spinal cord pressure shown on scans.I have had radiation therapy on the part of my spine that is now of interest.
Research Study Groups:
This trial has the following groups:- Group 1: Single Session Stereotactic Body Radiotherapy (SBRT)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open slots available for volunteers in this study?
"As detailed on clinicaltrials.gov, this medical investigation is not actively seeking candidates at the moment. The trial was initially launched in October of 2005 and had its most recent update in December 2022; however, there are currently 10 other trials that are recruiting patients right now."
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