Stereotactic Radiosurgery for Spinal Cord Compression

Overseen By Amol Ghia, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Lymphoma, Multiple myeloma, Pregnancy, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1-2 weeks

60 Participants Needed

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.

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)

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 United States, European Union, Canada for the following indications:

Approved in United States as 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

Approved in European Union as Stereotactic Body Radiation Therapy (SBRT) for:

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

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

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Brainlab AG

Industry Sponsor

Trials

6

Recruited

590+

Findings from Research

In a study of 132 patients receiving spine stereotactic radiosurgery (SSRS), there were no observed cases of radiation myelopathy (RM) after treatment, even with spinal cord doses exceeding 12 Gy, suggesting a very low risk of RM.

The 1-year local control rate for spine metastases was high at 94%, indicating that SSRS is an effective treatment option while allowing for a safe increase in radiation dose to the spinal cord without significant risk of complications.

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]

Spine stereotactic radiosurgery (SSRS) has shown over 85% local tumor control rates for both metastatic and primary spine tumors, outperforming conventional radiation, especially for radioresistant tumors like renal cell carcinoma and melanoma.

SSRS is increasingly being used as a primary treatment or in combination with surgery, allowing for less aggressive surgical approaches due to its effectiveness in controlling residual disease, while maintaining low toxicity levels, including rare cases of radiation-induced myelopathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

In a study of 20 patients with spine metastases treated with stereotactic body radiation therapy-simultaneous integrated boost, 100% of patients experienced pain remission, with 85% achieving complete remission, indicating high efficacy in pain management.

The treatment demonstrated excellent local control with an 86.36% rate of local progression-free survival over a median follow-up of 35 months, and it was found to be safe, with no reported adverse radiation events or vertebral compression fractures.

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]

In a study involving 23 patients with metastatic spinal lesions, the Klarity SBRT patient immobilization system showed larger initial setup discrepancies compared to the BodyFIX system, particularly in vertical and lateral alignment, indicating a need for careful consideration in patient positioning.

Despite the initial alignment differences, the Klarity system achieved similar setup efficiency and stability as the BodyFIX system, suggesting it could be a viable alternative for spine SBRT with potential workflow advantages.

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]

In a study of 21 patients undergoing spine SBRT, spinal cord motion was found to increase radiation dose to the cord in 62% of cases, with doses exceeding static measurements by up to 13.8%.

The research suggests that a planning organ at risk volume (PRV) margin of at least 1.5 to 2 mm should be used to ensure safety, as spinal cord motion can lead to higher doses than anticipated, particularly when the cord moves beyond the standard margins.

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]

Stereotactic spine radiosurgery (SSR) is emerging as an effective and safe treatment for intramedullary spinal lesions, showing favorable outcomes compared to conventional radiation therapy, based on several studies.

SSR should be carefully guided by intracranial radiosurgery principles to minimize damage to the spinal cord while delivering high doses of radiation, although the risk of radiation-induced myelopathy necessitates selective patient scenarios for its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

In a study of 228 patients undergoing single-fraction spinal stereotactic radiosurgery (SRS), a median spinal cord maximum dose (Dmax) of 13.85 Gy was found to be safe, with a very low incidence of radiation myelitis at 0.7%.

The findings suggest that a Dmax limit of 14 Gy is associated with a myelopathy rate of less than 1%, indicating that higher doses can be administered with minimal risk of adverse effects.

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]