Stereotactic Radiosurgery for Spinal Cord Compression

Recruiting in Palo Alto (17 mi)

Overseen by Amol J. Ghia

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Lymphoma, Multiple myeloma, Pregnancy, others

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

To learn about the safety of a procedure called cord dose escalated spine stereotactic radiosurgery (CDE-SSRS) in patients with MESCC.

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 Cord Dose Escalated Spine Stereotactic Radiosurgery (CDE-SSRS) for spinal cord compression?

Research shows that spine stereotactic radiosurgery (SSRS) is effective in controlling tumors in the spine, with control rates over 85% for various types of tumors. Additionally, stereotactic body radiation therapy (SBRT) has been shown to provide excellent local control and pain relief in patients with spine metastases, suggesting its potential effectiveness for spinal cord compression. ^{1 2 3 4 5}

Is stereotactic radiosurgery for spinal cord compression safe?

Stereotactic radiosurgery for the spine, including treatments for spinal cord compression, generally shows limited toxicity with rare cases of radiation-induced myelopathy (damage to the spinal cord from radiation). Studies suggest that it is a safe treatment option when proper dose limits are observed, although more high-quality research is needed for certain conditions. ^{1 2 3 6 7}

How is Cord Dose Escalated Spine Stereotactic Radiosurgery (CDE-SSRS) different from other treatments for spinal cord compression?

Cord Dose Escalated Spine Stereotactic Radiosurgery (CDE-SSRS) is unique because it uses precise, high-dose radiation to target spine tumors while allowing for relaxed dose constraints on the spinal cord, which may reduce the risk of radiation-induced damage. This approach offers better local tumor control compared to conventional radiation, especially for tumors that are typically resistant to radiation. ^{1 2 3 4 8}

Research Team

Amol J. Ghia

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adults over 18 with spinal metastasis near the spinal cord or cauda equina, affecting up to three vertebral levels. Candidates must have sufficient motor strength in affected limbs and a performance status allowing daily activity. Excluded are those with certain sensitive cancers, prior radiation at the site, MRI contraindications, pregnancy, or inability to lie still for an hour.

Inclusion Criteria

Signed informed consent

I can undergo a specific type of radiation therapy that is safe for my spinal cord.

My cancer is not extremely sensitive to radiation.

Exclusion Criteria

Participants who are pregnant

I have a highly radiation-sensitive cancer type like lymphoma or multiple myeloma.

I cannot lie on my back comfortably for an hour.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cord dose escalated spine stereotactic radiosurgery (CDE-SSRS) to treat metastatic epidural spinal cord compression

1-2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety, adverse events, and effectiveness after treatment

1 year

Regular MRI scans and assessments

Treatment Details

Interventions

• Cord Dose Escalated Spine Stereotactic Radiosurgery (CDE-SSRS) (Radiation)

Trial Overview The trial tests a procedure called cord dose escalated spine stereotactic radiosurgery (CDE-SSRS) on patients with metastatic epidural spinal cord compression (MESCC). It aims to safely increase radiation doses near the spinal cord/cauda equina while treating spine tumors.

Participant Groups

Group I: Stereotactic Radiosurgery Experimental Treatment 1 Intervention

A non-invasive, non-surgical procedure that precisely delivers radiation to cancer on the spine while avoiding surrounding, healthy tissue.

Cord Dose Escalated Spine Stereotactic Radiosurgery (CDE-SSRS) is already approved in Canada for the following indications:

Approved in Canada as Cord Dose Escalated Spine Stereotactic Radiosurgery for:

• Metastatic epidural spinal cord compression
• Spinal and para-spinous tumors
• Surgically unresectable ependymomas and other radiosensitive primary central nervous system tumors

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

MD Anderson Cancer Center Houston, TX

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3107

Patients Recruited

1,813,000+

Brainlab AG

Industry Sponsor

Trials

6

Patients Recruited

590+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low risk of radiation myelopathy with relaxed spinal cord dose constraints in de novo, single fraction spine stereotactic radiosurgery. Diao, K., Song, J., Thall, PF., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal radiosurgery: a neurosurgical perspective. Bilsky, MH., Angelov, L., Rock, J., et al.[2020]

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiation Therapy With Simultaneous Integrated Boost in Patients With Spinal Metastases. Pontoriero, A., Iatì, G., Cacciola, A., et al.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of setup accuracy and efficiency between the Klarity system and BodyFIX system for spine stereotactic body radiation therapy. Quan, E., Krafft, SP., Briere, TM., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Dancing Cord: Inherent Spinal Cord Motion and Its Effect on Cord Dose in Spine Stereotactic Body Radiation Therapy. Oztek, MA., Mayr, NA., Mossa-Basha, M., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of stereotactic radiosurgery for intramedullary spinal lesions. Park, HK., Chang, JC.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Detailed Dosimetric Analysis of Spinal Cord Tolerance in High-Dose Spine Radiosurgery. Katsoulakis, E., Jackson, A., Cox, B., et al.[2018]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Low risk of radiation myelopathy with relaxed spinal cord dose constraints in de novo, single fraction spine stereotactic radiosurgery. [2023]

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

Spinal radiosurgery: a neurosurgical perspective. [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. United States pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiation Therapy With Simultaneous Integrated Boost in Patients With Spinal Metastases. [2020]

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

Comparison of setup accuracy and efficiency between the Klarity system and BodyFIX system for spine stereotactic body radiation therapy. [2022]

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

The Dancing Cord: Inherent Spinal Cord Motion and Its Effect on Cord Dose in Spine Stereotactic Body Radiation Therapy. [2022]

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

Review of stereotactic radiosurgery for intramedullary spinal lesions. [2021]

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

A Detailed Dosimetric Analysis of Spinal Cord Tolerance in High-Dose Spine Radiosurgery. [2018]