Single-Fraction Radiation for Spine Lesions

Recruiting in Palo Alto (17 mi)

Overseen byYoshiya Yamada, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Trial Summary

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.

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.

+5 more

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)

+10 more

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: single-fraction radiosurgeryExperimental Treatment2 Interventions