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Comparing SingLe- Vs Multi-Fraction Spine STereotActic Radiosurgery in Spinal Metastases
Recruiting
I'm InterestedTrial ID: NCT06173401
Purpose
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.
Official Title
A Randomized Phase III TriaL Comparing SingLe- Versus Multi-Fraction Spine STereotActic Radiosurgery for Patients With Spinal Metastases (ALL-STAR)
Stanford Investigator(s)
Erqi Pollom
Associate Professor of Radiation Oncology (Radiation Therapy) and, by courtesy, of Neurosurgery
Melanie Hayden Gephart
Professor of Neurosurgery and, by courtesy, of Neurology
Eligibility
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 women of
childbearing potential or who are not postmenopausal
- Women 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
Intervention(s):
radiation: Single-fraction spine SRS
radiation: Multi-fraction spine SRS
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Aniket Pratapneni
650-723-3110