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Comparing SingLe- Vs Multi-Fraction Spine STereotActic Radiosurgery in Spinal Metastases

Recruiting
18 years of age
Both
Phase 3

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Overview

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 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

Study details

Spinal Metastases

NCT06173401

Stanford University

7 March 2024

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