Comparing SingLe- Vs Multi-Fraction Spine STereotActic Radiosurgery in Spinal Metastases
NCT ID: NCT06173401
Last Updated: 2025-07-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
274 participants
INTERVENTIONAL
2023-12-18
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Single-fraction spine SRS
Single-fraction spine SRS (22 Gy x 1)
Single-fraction spine SRS
Treatment Arm 1: Single-fraction spine SRS (22 Gy x 1)
Multi-fraction spine SRS
Multi-fraction spine SRS (14 Gy x 2)
Multi-fraction spine SRS
Treatment Arm 2: Multi-fraction spine SRS (14 Gy x 2)
Interventions
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Single-fraction spine SRS
Treatment Arm 1: Single-fraction spine SRS (22 Gy x 1)
Multi-fraction spine SRS
Treatment Arm 2: Multi-fraction spine SRS (14 Gy x 2)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Stanford University
OTHER
Responsible Party
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Principal Investigators
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Erqi Pollom, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Stanford University School of Medicine
Palo Alto, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BRN0060
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2024-00695
Identifier Type: REGISTRY
Identifier Source: secondary_id
IRB-72248
Identifier Type: -
Identifier Source: org_study_id
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