Stereotactic Radiosurgery for Cancer-Related Spinal Cord Compression

Overseen By Benjamin Spieler, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Unknown primary histology, Rapid neurologic decline, Non-ambulatory, Prior radiation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new type of radiation therapy, called MRIdian stereotactic radiosurgery, can manage tumors in the spine and eliminate the need for surgery. It targets individuals with specific cancers, such as breast or prostate, who have a tumor pressing on their spinal cord. Participants should be able to walk and have mild to moderate symptoms that improve with steroids. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could transform future cancer treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that this stereotactic radiosurgery is safe for treating cancer-related spinal cord compression?

Research has shown that the ViewRay MRIdian Stereotactic Radiosurgery is generally manageable for patients with spinal issues. Studies indicate that this treatment accurately targets spinal tumors while protecting nearby healthy tissue, resulting in fewer side effects compared to traditional radiation methods.

In one study with 30 patients, only a few experienced significant side effects, and none had the most severe type. This suggests that the treatment is safe, making it a promising option for those considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The ViewRay MRIdian Stereotactic Radiosurgery is unique because it combines precise radiation delivery with real-time MRI guidance, making it a standout option for treating cancer-related spinal cord compression. Unlike traditional radiation therapies, which can sometimes affect surrounding healthy tissues, this approach allows doctors to target the tumor more accurately, potentially reducing side effects. Researchers are excited about this treatment because it offers the possibility of better outcomes with fewer complications, improving patients' quality of life during and after treatment.

What evidence suggests that ViewRay MRIdian Stereotactic Radiosurgery is effective for cancer-related spinal cord compression?

Studies have shown that stereotactic body radiotherapy (SBRT) effectively controls cancer in the spine and relieves symptoms. In this trial, participants will receive treatment with MRIdian, a type of SBRT that uses advanced imaging to accurately target tumors, protecting healthy tissue. Research indicates that this method successfully manages spinal tumors, controlling the tumor's size and symptoms without surgery. Such treatments have been linked to better outcomes for patients with spinal cord compression due to cancer. ^{1 2 3 4 6}

Who Is on the Research Team?

Benjamin Spieler, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

You are expected to live for at least 3 more months.

Your pain level, as measured on a scale, needs to be within a certain range in the week before you join the study.

Exclusion Criteria

You cannot have an MRI.

I am unable to make medical decisions for myself.

My neurological condition is worsening quickly.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Therapy

Participants receive five doses of radiation therapy over four weeks using MRI-guided adaptive radiotherapy

4 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• ViewRay MRIdian Stereotactic Radiosurgery

Trial Overview

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.

How Is the Trial Designed?

Group I: ViewRay MRidian Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Viewray Inc.

Industry Sponsor

Trials

13

Recruited

1,100+

Published Research Related to This Trial

Stereotactic radiosurgery (SSRS) is a safe and effective treatment for inoperable patients with metastatic epidural spinal cord compression (MESCC), showing a median overall survival of 28.6 months and a 1-year local control rate of 89% based on a study of 32 patients.

The study suggests that relaxing spinal cord dose constraints to 16 Gy can optimize local control without increasing the risk of radiation-induced myelopathy, as no cases were reported among patients receiving this dose during a median follow-up of 17 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 1 Study of Spinal Cord Constraint Relaxation With Single Session Spine Stereotactic Radiosurgery in the Primary Management of Patients With Inoperable, Previously Unirradiated Metastatic Epidural Spinal Cord Compression. Ghia, AJ., Guha-Thakurta, N., Hess, K., et al.[2019]

Stereotactic radiosurgery (SRS) is a highly effective treatment for primary and metastatic spinal tumors, achieving an 85% pain improvement rate and a 90% local control rate, which can lead to better patient outcomes.

SRS is considered safe, with a low risk of complications, such as myelopathy occurring in only 0.4% of treated patients, making it a reliable option for managing spinal neoplasms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic radiosurgery for spinal neoplasms: current status and future perspective. Chang, UK., Lee, DH.[2017]

The study demonstrated that using the MR-Linac for spine stereotactic body radiation therapy (SBRT) is feasible and can improve cord sparing compared to traditional VMAT techniques, with a maximum dose to the spinal cord showing a trend towards reduction.

Real-time MRI visualization of the spinal cord during treatment may allow for more precise targeting and potentially safer treatment options, enabling adaptive therapy and improved patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dosimetric Feasibility of Utilizing the ViewRay Magnetic Resonance Guided Linac System for Image-guided Spine Stereotactic Body Radiation Therapy. Redler, G., Stevens, T., Cammin, J., et al.[2020]

Citations

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a new indication for the MR-linac

Stereotactic body radiotherapy (SBRT) is associated with good local control and symptom relief in the management of spinal metastases.

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