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

24 Participants Needed

Trial Summary

What is the purpose of this trial?

The main purpose of this study is to see if treating cancer with the magnetic resonance imaging guided adaptive radiotherapy (MRIdian) can control patient's tumor and eliminate the need for surgery used to treat nerves in the spine flattened by pressure (compressed).

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 data supports the effectiveness of the treatment ViewRay MRIdian Stereotactic Radiosurgery for cancer-related spinal cord compression?

Stereotactic radiosurgery (SRS) is being studied as a potential treatment for metastatic spinal cord compression, with research suggesting it could be as effective as the current standard treatment of surgery followed by radiotherapy, especially for patients with minor neurological issues. Additionally, SRS has shown promise in treating spinal metastases from melanoma, indicating its potential effectiveness in precisely targeting spinal tumors while minimizing damage to surrounding sensitive areas like the spinal cord. ^{1 2 3 4 5}

Is stereotactic radiosurgery safe for treating spinal conditions?

Stereotactic radiosurgery (SRS) for spinal conditions, including spinal tumors, is generally considered safe with a low risk of complications. The risk of myelopathy (spinal cord damage) is estimated to be about 0.4% of treated patients, indicating that serious side effects are rare. ^{6 7 8 9 10}

How is the treatment ViewRay MRIdian Stereotactic Radiosurgery unique for spinal cord compression?

ViewRay MRIdian Stereotactic Radiosurgery is unique because it allows for precise targeting of spinal lesions with high doses of radiation while minimizing exposure to the spinal cord, potentially avoiding the need for invasive surgery and reducing associated risks. ^{2 3 11 12 13}

Research Team

Benjamin Spieler, MD

Principal Investigator

University of Miami

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Management of metastatic spinal cord compression. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Stereotactic radiosurgery versus decompressive surgery followed by postoperative radiotherapy for metastatic spinal cord compression (STEREOCORD): Study protocol of a randomized non-inferiority trial. [2020]

3. United States 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. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Radiosurgery for the treatment of spinal melanoma metastases. [2022]

5. Ireland pubmed.ncbi.nlm.nih.gov

Image-guided robotic radiosurgery for spinal metastases. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Dosimetric Feasibility of Utilizing the ViewRay Magnetic Resonance Guided Linac System for Image-guided Spine Stereotactic Body Radiation Therapy. [2020]

7. Italy pubmed.ncbi.nlm.nih.gov

Stereotactic radiosurgery for spinal neoplasms: current status and future perspective. [2017]

8. United States pubmed.ncbi.nlm.nih.gov

Tolerance of the spinal cord to stereotactic radiosurgery: insights from hemangioblastomas. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Reirradiation of the spine with stereotactic radiosurgery: Efficacy and toxicity. [2018]

10. Korea (South) pubmed.ncbi.nlm.nih.gov

Clinical results of cyberknife(r) radiosurgery for spinal metastases. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Stereotactic radiosurgery and radiation therapy for spinal tumors. [2015]

12. United States pubmed.ncbi.nlm.nih.gov

Spinal radiosurgery for metastatic disease of the spine. [2022]

13. Korea (South) pubmed.ncbi.nlm.nih.gov

Evaluation of risk factors for vertebral compression fracture after stereotactic radiosurgery in spinal tumor patients. [2020]