Comparing SingLe- Vs Multi-Fraction Spine STereotActic Radiosurgery in Spinal Metastases
Recruiting now · Phase 3
Conditions studied: Spinal Metastases
In brief
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.
Key facts
- Study ID
- NCT06173401
- Run by
- Stanford University
- People needed
- 274
- Starts
- 2023-12-18
- Expected to finish
- 2028-12-01
- Last updated by the study team
- 2026-07-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Stanford University School of Medicine — Palo Alto, California, United States (enrolling)
Full record on ClinicalTrials.gov
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