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Radiation

Stereotactic Radiosurgery for Cancer-Related Spinal Cord Compression

N/A

Waitlist Available

Led By Benjamin Spieler, MD

Research Sponsored by University of Miami

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Solid tumors causing MESCC for which surgery is an option as first-line treatment

Bilsky scale ≥ 1c MESCC with tumor ≤ 1 mm from the spinal cord or cauda equina nerve roots anywhere from C1 to terminus of cauda equina on screening MRI

Must not have

Unknown primary histology

Patients with rapid neurologic decline

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up 2 years

Awards & highlights

Summary

This trial tests if MRIdian can treat cancer without needing spine surgery due to pressure-flattened nerves.

Who is the study for?

Adults over 18 with a good performance status and prognosis of living more than 3 months, who have solid tumors pressing on the spinal cord that could be treated with surgery. They must be able to walk, handle daily MRI scans, use contraception for 6+ months post-therapy, and give informed consent. Excluded are those with certain sensitive tumor types, rapid neurological decline or unrelated neuro problems.

What is being tested?

The trial is testing if MRIdian Stereotactic Radiosurgery can control tumors in the spine without needing surgery. This involves using advanced imaging (MRI) to guide precise radiation therapy aimed at relieving pressure on the spinal cord caused by cancer.

What are the potential side effects?

While specific side effects aren't listed here, stereotactic radiosurgery like MRIdian may cause skin irritation at treatment sites, fatigue, mild swelling or pain around the spine area due to inflammation from targeted radiation.

Eligibility Criteria

Inclusion Criteria

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

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I have a solid tumor with spinal cord compression and surgery is an option.

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My spinal tumor is very close to the spinal cord or nerve roots.

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My spinal cord compression affects no more than 3 connected spine bones.

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I am able to care for myself but may need occasional help.

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I am medically fit for surgery.

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I can walk on my own without help.

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I am willing and can have a daily MRI during my treatment.

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I am able to care for myself and perform daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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The origin of my cancer is unknown.

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My neurological condition is worsening quickly.

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I have received radiation therapy at the cancer site before.

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I have neurological issues not caused by my spinal cord cancer.

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I am unable to make medical decisions for myself.

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I cannot walk by myself.

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I have a spinal condition affecting my nerves.

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My cancer type is known to respond well to radiation therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

One-year failure rate

Secondary study objectives

Area under the curve (AUC) for receiving operating characteristic analysis

Change in mean relative in epidural tumor

Change in mean relative thecal sac patency

+25 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: ViewRay MRidianExperimental Treatment1 Intervention

Participants will receive five (5) doses of radiation therapy over four (4) weeks. The first dose will be given during week 1; after at least 36 hours from the first dose, participants will receive the second dose. The remaining doses will be three (3) doses will be administered once per week during weeks 2, 3, and 4. The treatment plan may change at the discretion of the treating physician. Participants will have three additional doses each week in Weeks 2, 3, and 4.

0 / 16Eligibility criteria met

Find a Location

Who is running the clinical trial?

Viewray Inc.Industry Sponsor

12 Previous Clinical Trials

1,065 Total Patients Enrolled

University of MiamiLead Sponsor

935 Previous Clinical Trials

422,193 Total Patients Enrolled

Benjamin Spieler, MDPrincipal InvestigatorUniversity of Miami

1 Previous Clinical Trials

130 Total Patients Enrolled

~16 spots leftby Dec 2028

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