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Radiation
Radiation for Spine Cancer
Phase 2
Recruiting
Led By Kartik Mani, MD PhD
Research Sponsored by Stony Brook University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Intact neurologic function, or only minor neurologic deficits with muscle strength greater or equal to 4 out of 5 with or without steroids
Any pathologically proven solid tumor diagnosis not of central nervous system origin with radiographic or pathologic evidence of metastatic disease
Must not have
Previous surgery or radiation to address the target spinal metastases
Radiosensitive tumors (e.g. small cell lung cancer, lymphoma, multiple myeloma, and germ-cell tumors)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 months, 3 months, 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a radiation therapy to treat cancer in the spine without the need for major surgery.
Who is the study for?
This trial is for patients with solid tumor cancers, excluding brain origin, that have spread to the spine. Participants must have a maximum of 3 affected spinal segments and maintain basic neurological function or minor deficits. They should be evaluated by specialists and have an ECOG Performance Status score between 0-3.
What is being tested?
The study tests if stereotactic body radiation therapy (SBRT) can effectively treat aggressive spinal metastases in cancer patients without needing major surgery.
What are the potential side effects?
Potential side effects of SBRT may include localized pain, temporary swelling, fatigue, skin reactions at the treatment site, and less commonly nerve damage which could affect sensation or movement.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My muscle strength is mostly normal, at least 4 out of 5, with or without medication.
Select...
I have a diagnosed solid tumor cancer that has spread, not originating from the brain or spinal cord.
Select...
My cancer has spread to my spine, confirmed by scans.
Select...
My spine issue affects up to 3 connected vertebrae.
Select...
I can care for myself but may not be able to do heavy physical work.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had surgery or radiation for cancer in my spine.
Select...
My cancer type is known to respond well to radiation therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 months, 3 months, 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 months, 3 months, 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Cumulative incidence of spinal surgery/stabilization within 6 months following SBRT
Secondary study objectives
Changes on EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) questionnaire
Changes on Neck Disability index
Changes on Oswestry Low Back Disability Questionnaire
+1 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: SBRT to the spineExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Stony Brook UniversityLead Sponsor
223 Previous Clinical Trials
41,526 Total Patients Enrolled
The University of Texas Health Science Center at San AntonioOTHER
476 Previous Clinical Trials
92,884 Total Patients Enrolled
Kartik Mani, MD PhDPrincipal InvestigatorStony Brook Cancer Center