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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 below
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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.
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My spine issue affects up to 3 connected vertebrae.
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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 weeks
Treatment ~ Varies
Follow Up ~1 months, 3 months, 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 months, 3 months, 6 months for reporting.

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 more

Awards & 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
222 Previous Clinical Trials
42,005 Total Patients Enrolled
The University of Texas Health Science Center at San AntonioOTHER
476 Previous Clinical Trials
92,949 Total Patients Enrolled
Kartik Mani, MD PhDPrincipal InvestigatorStony Brook Cancer Center
~16 spots leftby May 2026
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