Single-Fraction Radiation for Spine Lesions

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Bevacizumab, Anticoagulants

Disqualifiers: Life expectancy < 6 months, Intradural lesions, Circumferential epidural disease, Abnormal blood count, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach for treating spine and cauda equina (lower back) lesions using a single dose of radiation. The goal is to determine if single-fraction radiation can safely treat tumors that have recurred after previous radiation treatments. The study seeks patients with non-blood-related cancer and evidence of tumors in the spine or lower back that have worsened after earlier radiation therapy. Participants should have received prior radiation at least six months ago and require treatment for a tumor no larger than two vertebrae. As a Phase 1 trial, this research focuses on understanding 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 does not specify if you need to stop taking your current medications, but you cannot have systemic chemotherapy within 5 days of the treatment or have taken bevacizumab within 12 weeks prior. Also, if you are on anticoagulation medication, it must be safely held for a certain period before the procedure.

What prior data suggests that single-fraction radiation is safe for spine lesions?

Research shows that single-dose radiation is generally safe for treating spine issues, with studies indicating that serious side effects are uncommon. Approximately 2.5% of patients experienced some nerve damage, and around 8% had a temporary increase in pain. These side effects occurred with radiation doses between 16 and 26 Gy, a unit of measurement for radiation. Additionally, there is a small risk (about 9%) of a vertebral compression fracture, where a bone in the spine collapses.

These findings suggest that single-dose radiation is usually well-tolerated. Most people do not experience severe problems, and many benefit from the treatment. However, discussing potential risks with a doctor is important to understand their personal implications. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Most treatments for spine lesions involve multiple sessions of radiation therapy spread out over several weeks. However, single-fraction radiosurgery is unique because it delivers a high dose of radiation in just one session. This approach is exciting for researchers because it could potentially reduce the overall treatment time and improve patient convenience. Additionally, the precise targeting of radiosurgery may minimize damage to surrounding healthy tissues, potentially leading to fewer side effects compared to traditional radiation therapy.

What evidence suggests that single-fraction radiation might be an effective treatment for spine lesions?

Research has shown that single-dose radiation, which participants in this trial will receive, effectively treats spine lesions. Studies demonstrate that this method provides excellent local control, successfully targeting and treating the affected area. In one study, the overall survival rate at one year was 61%, with only 12% experiencing local failure, meaning the treatment didn't work as planned. Another study confirmed that this type of radiation therapy effectively treats spine metastases, which are cancerous growths. Although risks exist, such as a small chance of nerve injury, the benefits often outweigh these. Overall, single-dose radiation is notable for its ability to manage pain and control lesions effectively. ^{1 2 3 4 5}

Who Is on the Research Team?

Yoshiya Yamada, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with non-blood related cancers that have spread to the spine or cauda equina and worsened after previous radiation. They must have had prior radiation at least 6 months ago, a KPS score of at least 60%, and their cancer should be confirmed by pathology review. Excluded are those with less than a six-month life expectancy, certain blood count issues, recent bevacizumab treatment, specific spinal conditions, planned chemotherapy around re-irradiation time, inability to undergo imaging tests required for the study or if they're pregnant.

Inclusion Criteria

I had radiation therapy in the same area where I'm now planned for a focused re-irradiation, at least 6 months ago.

I can care for myself but may need occasional help.

For patients who were previously treated at an outside institution, adequate records must be available to determine the true dose the cord/cauda received during prior RT. Sufficiency of the treatment records will be assessed and signed-off by the Medical Physics investigator

Exclusion Criteria

My cancer has spread near my spine but not to the lower spine or sacral area.

My blood does not clot properly, and I can't safely stop my blood thinners for the procedure.

My cancer has spread around my spinal cord.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive single-fraction radiation therapy at 3 dose levels using image-guided stereotactic radiosurgery techniques

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including evaluation of toxicities and tumor control

1 year

Long-term follow-up

Overall survival and local failure are evaluated for up to 2 years

2 years

What Are the Treatments Tested in This Trial?

Interventions

• MRI and/or CT
• Single-fraction radiation

Trial Overview The trial is testing single-fraction stereotactic radiosurgery on patients whose spine lesions from cancer have progressed despite earlier radiation therapy. It uses advanced imaging like MRI/CT for guidance and will explore three different doses to find out which one is safe and effective.

How Is the Trial Designed?

Group I: single-fraction radiosurgery Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

In a study of 220 patients who received re-irradiation for metastatic spinal cord compression, the incidence of serious adverse events like radiation-induced myelopathy (RIM) and radiation-induced vertebral fracture (RIF) was low, with only 6 and 9 cases respectively.

Diabetes was identified as a significant risk factor for increased toxicity from re-irradiation, suggesting that careful consideration of a patient's diabetes status is important before proceeding with spinal re-irradiation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes increases the risk of serious adverse events after re-irradiation of the spine. Suppli, MH., Munck Af Rosenschöld, P., Pappot, H., et al.[2020]

In a study of 156 patients with spinal metastases, those treated with three-fraction (3F) SBRT experienced greater pain relief and improved functional outcomes compared to those receiving single-fraction (SF) SBRT, despite starting with worse baseline conditions.

Both treatment groups achieved similar local tumor control, indicating that while 3F-SBRT may offer better pain management and functional improvement, it does not compromise the effectiveness of tumor control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient outcomes and tumor control in single-fraction versus hypofractionated stereotactic body radiation therapy for spinal metastases. Park, C., Howell, EP., Mehta, VA., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11999723/

Five-Year Outcomes of High-Dose Single-Fraction Spinal ... The histopathologic findings for the 5-year survivors included radiation-resistant metastases in 58%, radiation-sensitive metastases in 22%, and primary bone ...

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

Efficacy and safety of SBRT for spine metastases Conclusion. The currently available data including 5 randomized trials of SBRT for spine metastases confirm that spine SBRT is an effective ...

3. 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 ...

4. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-025-13655-6

Single- versus multi-fraction spine stereotactic radiosurgery ... For patients with spine metastases, stereotactic radiosurgery (SRS) provides excellent local control and pain response.

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.e24116

Morbidity of single-fraction spine radiosurgery for ... The rate of peripheral nervous system injury was 2.5% (at 18-26 Gy) and pain flare was 8% (at 16-24 Gy). The rate of ureteral and esophageal ...