Comparing SingLe- Vs Multi-Fraction Spine STereotActic Radiosurgery in Spinal Metastases
A Randomized Phase III TriaL Comparing SingLe- Versus Multi-Fraction Spine STereotActic Radiosurgery for Patients With Spinal Metastases (ALL-STAR)
Stanford University
274 participants
Dec 18, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria8
- 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 Criteria7
- 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
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Interventions
Treatment Arm 1: Single-fraction spine SRS (22 Gy x 1)
Treatment Arm 2: Multi-fraction spine SRS (14 Gy x 2)
Locations(1)
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NCT06173401