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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called cord dose escalated spine stereotactic radiosurgery (CDE-SSRS) to determine its safety for individuals with spinal cord compression due to cancer spread. The treatment is a non-invasive procedure that delivers precise radiation to spinal cancer while sparing healthy tissue. The trial seeks participants diagnosed with cancer that has spread to the spine and causes spinal cord compression, excluding those with very sensitive cancer types like lymphoma. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important findings.

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 cord dose escalated spine stereotactic radiosurgery is safe for patients with MESCC?

Research shows that spine stereotactic body radiation therapy (SBRT) is generally safe and well-tolerated. This treatment precisely targets cancer in the spine while sparing nearby healthy tissue. This precision is crucial for individuals with cancer that has spread to the spine, especially those with challenging tumors.

Further evidence suggests that increasing the radiation dose to spine tumors can be done safely, particularly for patients whose cancer resists standard radiation. This treatment helps with pain relief and disease management, proving both effective and safe.

Earlier studies found that patients who received higher doses of radiation to the spine tolerated the treatment well. Researchers continue to study its safety to ensure it remains a viable option for treating spine cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for spinal cord compression, like surgery and conventional radiation therapy, can be invasive or affect healthy tissue. However, Cord Dose Escalated Spine Stereotactic Radiosurgery (CDE-SSRS) stands out because it precisely delivers radiation to cancerous areas on the spine while sparing surrounding healthy tissue. This non-invasive approach minimizes damage to the spinal cord and other critical structures, potentially leading to fewer side effects and a quicker recovery. Researchers are excited about CDE-SSRS because it offers a targeted, effective treatment option that could improve outcomes for patients with spinal cord compression.

What evidence suggests that cord dose escalated spine stereotactic radiosurgery is effective for MESCC?

Research has shown that stereotactic radiosurgery, specifically cord dose escalated spine stereotactic radiosurgery (CDE-SSRS), effectively treats cancer that has spread to the spine. This method uses precise, high-dose radiation to target cancer while protecting nearby healthy tissue. Participants in this trial will receive this treatment. In earlier studies, about 45% of patients experienced complete pain relief three months after treatment, increasing to about 56% at six months. Most patients also achieved successful local control, meaning the cancer was effectively managed at the treatment site. Additionally, the risk of serious side effects, such as spine fractures requiring surgery, was low, affecting less than 2% of patients. ^{1 3 4 6 7}

Who Is on the Research Team?

Amol J. Ghia

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

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]

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]

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]

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 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]

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 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]

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S245210942500048X

Phase 2 Trial of Stereotactic Body Radiation Therapy with ... Dose-escalated SIB–SBRT for spinal metastases demonstrates excellent LC with acceptable toxicity, supporting the need for a larger comparative trial. Previous ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5415159/

Spine Stereotactic Body Radiotherapy: Indications ... Spine SBRT is a highly effective treatment that is capable of delivering ablative doses to the target while sparing the critical organs-at-risk.

3. advancesradonc.org advancesradonc.org/article/S2452-1094(23)00155-0/fulltext

Oncologic and Functional Outcomes After Stereotactic ... Pain response at 3 and 6 months post-SBRT was complete in 45.4% and 55.7%, partial in 26.9% and 13.1%, stable in 24.1% and 27.9%, and worse in ...

4. thegreenjournal.com thegreenjournal.com/article/S0167-8140(23)89863-2/fulltext

Efficacy and safety of SBRT for spine metastases Spine SBRT is associated with high rates of local control. •. ∼10 % get post-SBRT vertebral compression fractures with < 2 % needing surgery.

5. redjournal.org redjournal.org/article/S0360-3016(22)03401-0/abstract

Dose-Escalated 2-Fraction Spine Stereotactic Body ... Stereotactic body radiation therapy (SBRT) for spine metastases improves pain response rates compared with conventional external beam ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S187985002200265X

Safety and Efficacy of Dose-Escalated Radiation Therapy ... Our data suggest that dose escalation to spine metastases using SSIB can be safe and efficacious for patients, especially those with radioresistant disease.

7. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-00049

Cord Dose Escalated Spine Stereotactic Radiosurgery in ... This phase I trial studies the safety of a procedure called cord dose escalated spine stereotactic radiosurgery (CDE-SSRS) in treating patients with spinal ...