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NCT06173401
Comparing SingLe- Vs Multi-Fraction Spine STereotActic Radiosurgery in Spinal Metastases
Conditions: Spinal Metastases
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 274
Sponsor: Stanford University
Location: Stanford University School of Medicine Palo Alto California
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
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 \
Source: ClinicalTrials.gov (NCT06173401). StuddyBuddy aggregates publicly available trial information.