What side effects are associated with this type of intervention?

Common side effects of Spine Stereotactic Radiosurgery (SSRS) for treating Epidural Spinal Cord Compression include fatigue, skin reactions at the treatment site, and gastrointestinal symptoms like nausea. Specific risks associated with SSRS include vertebral compression fractures and potential damage to the spinal cord or nerves, which can lead to neurological deficits. These side effects are typically managed with supportive care and careful monitoring.

What other types of research exist?

Promising novel alternatives to SSRS for Epidural Spinal Cord Compression patients in 2024 include: 1) Radium-223, an alpha particle-emitting radiopharmaceutical that prolongs survival and decreases symptomatic skeletal-related events in metastatic castration-resistant prostate cancer. 2) Beta particle-emitting radioisotopes like Samarium-153 and Strontium-89, which are effective for pain palliation in osteoblastic bone metastases. 3) Advanced systemic therapies such as abiraterone/prednisone, enzalutamide, and docetaxel, which have shown efficacy in reducing skeletal-related events and improving quality of life in metastatic prostate cancer. 4) External Beam Radiation Therapy (EBRT) for localized pain management when systemic therapy is insufficient.

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Radiation Therapy

Stereotactic Radiosurgery for Spinal Cord Compression

Q: What prior FDA approvals exist?

For the treatment of Epidural Spinal Cord Compression (ESCC), fractionated radiation therapy (RT) is commonly used to maintain neurological function. This approach is similar to the investigational Spine Stereotactic Radiosurgery (SSRS), which delivers high-dose, precise radiation to metastatic spinal lesions. While specific FDA approvals for SSRS in ESCC are not detailed, the use of radiation therapy, including techniques like fractionated RT, is a well-established treatment modality for managing spinal cord tumors and 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

Must not have

Patients who have cord compression from bone components or configuration

Inability to tolerate lying flat on treatment table for greater than 30 minutes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months following radiation

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a one-time high-dose radiation treatment called Spine Stereotactic Radiosurgery (SSRS) for patients with spinal cord compression from cancer who can't have surgery. The goal is to see if this precise treatment can stop tumor growth and prevent spinal cord injury. Patients will be monitored regularly to check their progress. Spine stereotactic radiosurgery (SSRS) is increasingly being used to treat metastatic spinal tumors and has shown high rates of local tumor control.

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.

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.

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 below

Select...

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.

Select...

My muscle strength in the limbs affected by spinal compression is mostly preserved.

Select...

My MRI shows cancer has spread to my spine, affecting it.

Exclusion Criteria

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

Select...

My spinal cord is compressed due to bone issues.

Select...

I cannot lie flat for more than 30 minutes.

Select...

I have had radiation treatment on the same part of my spine before.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months following radiation for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of Occurrences of Paralysis caused by Radiation Myelitis (RM)

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: 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

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Epidural Spinal Cord Compression (ESCC) include surgery, radiation therapy, and stereotactic radiosurgery. Surgery aims to physically remove or stabilize the compressive lesion, providing immediate relief from spinal cord pressure. Radiation therapy, including External Beam Radiation Therapy (EBRT) and Stereotactic Body Radiation Therapy (SBRT), works by targeting and shrinking the tumor cells, thereby reducing compression on the spinal cord. SSRS, a form of SBRT, delivers high-dose, precise radiation to metastatic spinal lesions, minimizing damage to surrounding healthy tissue. This precision is crucial for ESCC patients as it effectively alleviates symptoms and controls tumor growth while preserving spinal cord function and reducing the risk of further neurological damage.