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NCT06173401PHASE3Recruiting

Comparing SingLe- Vs Multi-Fraction Spine STereotActic Radiosurgery in Spinal Metastases

Stanford University

Start Date

12/18/2023

Completion Date

12/1/2028

Summary

The goal of this study is to determine whether fractionated Stereotactic radiosurgery (SRS) for spine metastases is associated with improved local tumor control compared to single-fraction SRS. Patients will be randomized to treatment with spine SRS using either 22 Gy in 1 fraction or 28 Gy in 2 fractions.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Histologically, cytologically, or radiographically confirmed diagnosis of metastatic cancer Age ≥ 18 years * Patients who have cervical, thoracic, or lumbar spine metastasis that need treatment. * Patients will have 1 to 3 separate spinal sites that require treatment. * Each spinal site to be treated on trial will span 1-2 contiguous vertebral levels * ECOG 0-2 * Negative serum or urine pregnancy test within 14 days prior to enrollment for people of childbearing potential or who are not postmenopausal * people of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control * Ability to understand and the willingness to sign (personally or by a legal authorized representative) the written IRB approved informed consent document Exclusion Criteria: * Prior or planned radiation off study within or overlapping with study treatment site * Inability to have either an MRI or a CT scan. Patients with pacemaker will be allowed to undergo CT instead of MRI * Pediatric patients (age \<18 years old), pregnant women, and nursing patients will be excluded * Histology's of myeloma or lymphoma * Patients with strength 1-3 (of 5), bladder incontinence, bowel incontinence, and/or bladder retention that is associated with spinal site to be treated * Prior surgery to spinal site intended to be treated with protocol SRS * Excluded those with SINS 13-18

Interventions

RADIATION

Single-fraction spine SRS

RADIATION

Multi-fraction spine SRS

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Conditions

Spinal Metastases

Locations

Stanford University School of Medicine

Palo Alto, California 94305

United States