Status:
RECRUITING
Comparing SingLe- Vs Multi-Fraction Spine STereotActic Radiosurgery in Spinal Metastases
Lead Sponsor:
Stanford University
Conditions:
Spinal Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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. Patien...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
274 Patients enrolled
Trial Details
Trial ID
NCT06173401
Start Date
December 18 2023
End Date
December 1 2028
Last Update
July 16 2025
Active Locations (1)
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1
Stanford University School of Medicine
Palo Alto, California, United States, 94305