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

9 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Single-Fraction Radiation for Spine Lesions?

Research shows that single-fraction radiation therapy is effective for treating spine metastases, providing pain relief and being as effective as multiple sessions. It is also convenient for patients and hospitals, making it a practical choice for managing bone metastases. ^{1 2 3 4 5}

Is single-fraction radiation for spine lesions safe for humans?

Research shows that single-fraction radiation for spine lesions, like vertebral body hemangiomas, has been used without causing acute or chronic toxicities such as esophagitis (inflammation of the esophagus), vertebral compression fractures, or myelopathy (spinal cord disease). However, further studies are needed to confirm these findings and optimize treatment. ^{6 7 8 9 10}

How is single-fraction radiation treatment for spine lesions different from other treatments?

Single-fraction radiation treatment for spine lesions is unique because it delivers a high dose of radiation in just one session, which can be more precise and effective compared to conventional methods that use multiple sessions. This approach can target the tumor more accurately while minimizing exposure to surrounding sensitive areas like the spinal cord, although it carries a risk of vertebral body fractures. ^{3 4 11 12 13}

What is the purpose of this trial?

This is a phase I clinical trial investigating the use of single fraction re-irradiation following local progression of spine and cauda equina (L2 to sacrum) lesions that have previously received radiation therapy. Patients will be treated with single-fraction radiation therapy at 3 dose levels using image-guided stereotactic radiosurgery techniques.

Research Team

Yoshiya Yamada, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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.

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

I can care for myself but may need occasional help.

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.

Patients with a life expectancy of < 6 months as predicted by the Adult Comorbidity Index (ACE-27)

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

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

Recommendations for Single-Fraction Radiation Therapy and Stereotactic Body Radiation Therapy in Palliative Treatment of Bone Metastases: A Statewide Practice Patterns Survey. [2022]

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

Adverse Outcomes After Palliative Radiation Therapy for Uncomplicated Spine Metastases: Role of Spinal Instability and Single-Fraction Radiation Therapy. [2022]

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

Local failure and vertebral body fracture risk using multifraction stereotactic body radiation therapy for spine metastases. [2022]

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

Evolving Role of Stereotactic Body Radiation Therapy in the Management of Spine Metastases: Defining Dose and Dose Constraints. [2020]

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

Single fraction external beam radiation therapy in the treatment of localized metastatic bone pain. A review. [2022]

6. Scotland pubmed.ncbi.nlm.nih.gov

Linear accelerator-based single-fraction stereotactic body radiotherapy for symptomatic vertebral body hemangiomas: The Mayo Clinic experience. [2021]

7. Ireland pubmed.ncbi.nlm.nih.gov

Diabetes increases the risk of serious adverse events after re-irradiation of the spine. [2020]

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

High-dose, single-fraction image-guided intensity-modulated radiotherapy for metastatic spinal lesions. [2022]

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

Patient outcomes and tumor control in single-fraction versus hypofractionated stereotactic body radiation therapy for spinal metastases. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Fractionated radiosurgery for painful spinal metastases: DOSIS - a phase II trial. [2021]

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

A prospective, phase II study demonstrating the potential value and limitation of radiosurgery for spine metastases. [2022]

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

Single-fraction radiosurgery for the treatment of spinal breast metastases. [2022]

13. Ireland pubmed.ncbi.nlm.nih.gov

Sub-millimeter spine position monitoring for stereotactic body radiotherapy using offline digital tomosynthesis. [2022]