Comparing SingLe- Vs Multi-Fraction Spine STereotActic Radiosurgery in Spinal Metastases
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.
Conditions:
🦠 Spinal Metastases
🗓️ Study Start (Actual) 18 December 2023
🗓️ Primary Completion (Estimated) December 2028
✅ Study Completion (Estimated) December 2028
👥 Enrollment (Estimated) 274
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE3
Locations:
📍 Palo Alto, California, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 28 November 2023
  • First Submitted that Met QC Criteria 7 December 2023
  • First Posted 15 December 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 2 July 2024
  • Last Update Posted 3 July 2024
  • Last Verified July 2024