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
Conditions
Spinal Metastases
Locations
Stanford University School of Medicine
Palo Alto, California 94305
United States