Actively Recruiting
A Randomized Phase III Trial Comparing Single- Versus Multi-Fraction Spine Stereotactic Radiosurgery for Patients With Spinal Metastases
Led by Stanford University · Updated on 2025-07-16
274
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of fractionated Stereotactic radiosurgery (SRS) for treating spinal metastases compared to single-fraction SRS. This randomized phase III trial aims to determine if multi-fraction SRS improves local tumor control in patients with spine metastases. The study is led by Stanford University and focuses on patients with metastatic cancer affecting the cervical, thoracic, or lumbar spine. Participants will receive either a single dose of 22 Gy in one fraction or a multi-fraction treatment of 28 Gy divided into 2 sessions (14 Gy each). Both treatment approaches use spine SRS, a precise radiation therapy technique. Patients have 1 to 3 spinal sites requiring treatment, each spanning 1 to 2 contiguous vertebral levels. During the study, participants will be monitored for tumor control at 1 year and assessed for quality of life and pain at various intervals up to 2 years. Researchers will also track medication use, adverse effects, vertebral compression fractures, and local treatment failure. The total involvement includes follow-up evaluations with health questionnaires and clinical assessments to measure treatment outcomes and safety.
CONDITIONS
Brief Title
Comparing SingLe- Vs Multi-Fraction Spine STereotActic Radiosurgery in Spinal Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed metastatic cancer confirmed by tissue or imaging
- Age 18 years or older
- Cervical, thoracic, or lumbar spine metastasis requiring treatment
- 1 to 3 spinal sites needing treatment
- Each site spans 1 to 2 contiguous vertebral levels
- ECOG performance status 0 to 2
- Negative pregnancy test within 14 days before enrollment for those of childbearing potential
- Agreement to use effective birth control if sexually active and of childbearing potential
- Ability to understand and sign informed consent
You will not qualify if you...
- Prior or planned radiation overlapping the study treatment site outside the study
- Unable to undergo MRI or CT scan (CT allowed if pacemaker present)
- Patients under 18 years old, pregnant, or nursing
- Diagnosed with myeloma or lymphoma
- Muscle strength 1-3 (of 5), bladder or bowel incontinence related to spinal site
- Previous surgery to spinal site planned for study treatment
- Spinal Instability Neoplastic Score (SINS) between 13 and 18
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single session for single-fraction or two sessions for multi-fraction
Participants receive either single-fraction or multi-fraction spine stereotactic radiosurgery to treat spinal metastases.
1 to 2 visits depending on treatment arm
Duration - Up to 2 years
Participants are monitored for tumor control, pain, medication intake, adverse effects, and quality of life after treatment.
Visits at 1-2 weeks, 1, 3, 6, 12, 18, and 24 months post-treatment
Trial Site Locations
Total: 1 location
1
Stanford University School of Medicine
Palo Alto, California, United States, 94305
Actively Recruiting
Research Team
K
Kelly Huang
A
Alyssa Yauger
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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