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

Trial ID or NCT#

NCT06173401

Status

recruiting iconRECRUITING

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)

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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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Investigator(s)

Erqi Pollom
Erqi Pollom
Radiation oncologist
Associate Professor of Radiation Oncology (Radiation Therapy) and, by courtesy, of Neurosurgery
Melanie Hayden Gephart
Melanie Hayden Gephart
Neurosurgeon
Professor of Neurosurgery and, by courtesy, of Neurology

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Contact

Aniket Pratapneni
650-723-3110

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View on ClinicalTrials.gov