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Radiation Therapy
Stereotactic Radiosurgery for Spinal Cord Compression
Phase 1
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 3 contiguous vertebral levels involved with metastasis in the spine to be irradiated in a single session
Greater than or equal to 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months following radiation
Awards & highlights
Study Summary
This trial will test whether a single session of radiation can effectively treat metastatic epidural spinal cord compression.
Who is the study for?
This trial is for adults over 18 with inoperable, unirradiated metastatic epidural spinal cord compression confirmed by MRI. Candidates must have a certain level of physical function (KPS >/= 40) and motor strength (>/= 4/5), and can't be pregnant or intolerant to lying flat for extended periods. It's not for those with radiosensitive cancers like lymphoma or prior spine irradiation.Check my eligibility
What is being tested?
The study tests the feasibility of using a single session of spine stereotactic radiosurgery (SSRS) to treat patients with specific types of cancer that have spread to the spinal cord, affecting up to three contiguous vertebral levels.See study design
What are the potential side effects?
While side effects are not detailed here, SSRS may cause skin irritation at the treatment site, fatigue, temporary pain flare-ups, nausea, and potential damage to nearby organs or tissues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My spine cancer affects up to 3 connected vertebrae.
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I am 18 years old or older.
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I can care for myself but may not be able to do active work.
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My muscle strength in the limbs affected by spinal compression is mostly preserved.
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My MRI shows cancer has spread to my spine, affecting it.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months following radiation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months following radiation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Occurrences of Paralysis caused by Radiation Myelitis (RM)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Stereotactic Radiosurgery (SSRS)Experimental Treatment1 Intervention
Target dose of 18 or 24 Gy to spine in single session of radiation treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Radiosurgery (SSRS)
2010
Completed Phase 1
~20
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,296 Total Patients Enrolled
Amol J. Ghia, MDPrincipal InvestigatorM.D. Anderson Cancer Center
5 Previous Clinical Trials
353 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer type is likely to respond well to standard radiation therapy.My spinal cord is compressed due to bone issues.I cannot lie flat for more than 30 minutes.My spine cancer affects up to 3 connected vertebrae.I have had radiation treatment on the same part of my spine before.I have been diagnosed with cancer, but it's not highly sensitive to radiation.I am 18 years old or older.I can care for myself but may not be able to do active work.My muscle strength in the limbs affected by spinal compression is mostly preserved.I cannot undergo surgery for my condition, either by choice or medical advice.My MRI shows cancer has spread to my spine, affecting it.
Research Study Groups:
This trial has the following groups:- Group 1: Stereotactic Radiosurgery (SSRS)
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.
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