Stereotactic Radiosurgery for Spinal Cord Compression

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Radiosensitive histologies, Prior irradiation, Pregnancy, others

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

Compensation: Varies

Number of Visits: 4

Duration: 1 day

43 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a one-time high-dose radiation treatment called Spine Stereotactic Radiosurgery (SSRS) for patients with spinal cord compression from cancer who can't have surgery. The goal is to see if this precise treatment can stop tumor growth and prevent spinal cord injury. Patients will be monitored regularly to check their progress. Spine stereotactic radiosurgery (SSRS) is increasingly being used to treat metastatic spinal tumors and has shown high rates of local tumor control.

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 coordinators or your doctor.

What data supports the effectiveness of the treatment Spine Stereotactic Radiosurgery (SSRS) for spinal cord compression?

Research shows that Spine Stereotactic Radiosurgery (SSRS) is effective in controlling tumors in the spine, even those that are resistant to traditional radiation. Studies have demonstrated high rates of tumor control, over 85%, with limited side effects, making it a promising option for treating spinal cord compression. ^{1 2 3 4 5}

Is stereotactic radiosurgery for spinal cord compression safe?

Research shows that stereotactic radiosurgery (a precise form of radiation therapy) for the spine generally has a low risk of causing serious side effects like radiation myelopathy (damage to the spinal cord from radiation). Studies have looked at safety in various conditions, and while some cases of spinal cord damage have been reported, they are rare. ^{1 2 3 6 7}

How is the treatment Spine Stereotactic Radiosurgery (SSRS) unique for spinal cord compression?

Spine Stereotactic Radiosurgery (SSRS) is unique because it delivers precise, high-dose radiation directly to the spine, offering better local control of tumors compared to conventional radiation. This method is particularly beneficial for patients with inoperable spinal cord compression, as it can target tumors with minimal damage to surrounding tissues, reducing the need for invasive surgery. ^{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 inoperable, unirradiated metastatic epidural spinal cord compression confirmed by MRI. Candidates must have a certain level of physical function (KPS >/= 40) and motor strength (>/= 4/5), and can't be pregnant or intolerant to lying flat for extended periods. It's not for those with radiosensitive cancers like lymphoma or prior spine irradiation.

Inclusion Criteria

Signed Informed consent

My spine cancer affects up to 3 connected vertebrae.

I have been diagnosed with cancer, but it's not highly sensitive to radiation.

Exclusion Criteria

My cancer type is likely to respond well to standard radiation therapy.

Patients who are pregnant

My spinal cord is compressed due to bone issues.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single session of spine stereotactic radiosurgery (SSRS) with a target dose of 18 or 24 Gy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up visits at specified intervals

24 months

Visits at Months 3, 6, 9, 12, 18, 24, and every 6 months thereafter

Treatment Details

Interventions

• Spine Stereotactic Radiosurgery (SSRS)

Trial Overview The study tests the feasibility of using a single session of spine stereotactic radiosurgery (SSRS) to treat patients with specific types of cancer that have spread to the spinal cord, affecting up to three contiguous vertebral levels.

Participant Groups

Group I: Stereotactic Radiosurgery (SSRS) Experimental Treatment 1 Intervention

Target dose of 18 or 24 Gy to spine in single session of radiation treatment.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

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]

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

The Feasibility of Spinal Stereotactic Radiosurgery for Spinal Metastasis with Epidural Cord Compression. [2022]

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

Spinal radiosurgery: a neurosurgical perspective. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

A Nationwide Study of Stereotactic Radiosurgery in a Newly Diagnosed Spine Metastasis Population. [2018]

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

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

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

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

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

Spinal radiosurgical treatment for thoracic epidural cavernous hemangioma presenting as radiculomyelopathy: technical case report. [2016]