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)

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.

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