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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for spinal cord compression caused by cancer spreading to the spine. It uses a single session of precise radiation therapy, called spine stereotactic radiosurgery (SSRS), to target the affected area. The trial aims to determine if this focused treatment is feasible and effective. Suitable candidates have cancer causing spinal compression, confirmed by a recent MRI, and have been advised that surgery is not an option. As a Phase 1 trial, this research seeks to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

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 prior data suggests that spine stereotactic radiosurgery (SSRS) is safe for treating spinal cord compression?

Research has shown that spine stereotactic radiosurgery (SSRS) is generally well-tolerated by patients. One study found that this treatment can stop cancer from growing in the treated area in 80% to 96% of cases over one year.

SSRS carries a moderate risk of long-term side effects. Some patients may experience late toxicity, where side effects appear long after treatment. Additionally, about 9% of patients may develop vertebral compression fractures, meaning the bones in the spine can weaken or break.

Despite these risks, the treatment's ability to control cancer growth is promising. Prospective trial participants should consider these factors when deciding whether to join the study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for spinal cord compression, which often involves surgery or conventional radiation therapy over several sessions, Spine Stereotactic Radiosurgery (SSRS) is unique because it delivers a highly focused, high dose of radiation in just a single session. This precise targeting means there's potentially less damage to surrounding healthy tissue and a quicker recovery time. Researchers are excited about SSRS because it could offer a more efficient and less invasive treatment option, providing relief faster and with fewer side effects than current methods.

What evidence suggests that spine stereotactic radiosurgery is effective for spinal cord compression?

Research has shown that spine stereotactic radiosurgery (SSRS), the treatment under study in this trial, can effectively treat cancer that has spread to the spine and may press on the spinal cord. Studies indicate that SSRS provides significant pain relief and helps control tumor growth. Specifically, at 3 and 6 months after treatment, 45.4% and 55.7% of patients, respectively, experienced complete pain relief. Additionally, the treatment is considered safe, with a lower risk of causing spinal fractures compared to traditional treatments. These findings suggest that SSRS could be a promising option for those dealing with cancer-related spinal cord compression. ^{2 4 6 7 8}

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 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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11352806/

Stereotactic Radiosurgery in Metastatic Spine Disease—A ... This study highlights SRS as a safe and effective technique for managing spinal metastases. It offers good pain control and tumor control with minimal ...

2. 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 ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0360301625045067

Long-term Results From a phase 1 Study of Spinal Cord ... The high-cord Dmax cohort demonstrated 2- and 5-year LC of 93% compared with 63% in the low-cord Dmax cohort. Cord constraint relaxation may be ...

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

Efficacy and safety of SBRT for spine metastases Pre-existing fractures were reported in a median of 19.8 % (range 0–63) of the patients, and the median proportion of patients with metastatic ...

5. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2803769

Stereotactic Radiosurgery vs Conventional Radiotherapy ... The proportion of vertebral compression fractures at 24 months was 19.5% after SRS and 21.6% after cEBRT (P = .59; eTable 9 in Supplement 2).

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

Spine Stereotactic Body Radiotherapy: Indications ... Local control ranges from 80% to 96% at 1 year, and pain response is generally achieved in the majority of patients although high-quality data is lacking. Table ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7453968/

Radiation Dose–Response for Late Toxicity - PMC Stereotactic radiosurgery for primary treatment and reirradiation of spinal metastases is associated with a moderate risk of late toxicity with 10-year follow- ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1879850025002206

Long-Term Outcomes After Reirradiation With Spine ... At 1 year, overall survival was 61% with a cumulative incidence of local failure at 12% and vertebral compression fracture at 9% considering ...