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Radiation

Spine Radiosurgery for Spinal Cancer Spread

Phase 3
Recruiting
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically, cytologically, or radiographically confirmed diagnosis of metastatic cancer Age ≥ 18 years
ECOG 0-2
Must not have
Prior or planned radiation off study within or overlapping with study treatment site
Pediatric patients (age <18 years old), pregnant women, and nursing patients will be excluded
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial will study whether a higher dose of radiation spread out over two sessions can better control spine tumors than a single session.

Who is the study for?
This trial is for individuals with cancer that has spread to the spine. Specific details about who can join are not provided, but typically participants would need a confirmed diagnosis and may have certain health requirements.
What is being tested?
The study is testing two different radiation therapy schedules for treating spinal tumors: one single high-dose treatment versus two slightly lower doses on separate days. Patients will be randomly assigned to one of these treatments.
What are the potential side effects?
Potential side effects from Stereotactic radiosurgery (SRS) include fatigue, skin reactions at the treatment site, nausea, and in rare cases, more serious complications like damage to the spinal cord or surrounding tissues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 or older with a confirmed diagnosis of metastatic cancer.
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I am able to care for myself and perform daily activities.
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I need treatment for cancer spread to my spine.
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I need treatment for up to 3 areas in my spine.
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My spinal treatment will cover 1-2 connected vertebrae.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had or will have radiation therapy in the same area being studied.
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I am not pregnant, nursing, or under 18.
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My cancer is either myeloma or lymphoma.
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I have weakness, bladder or bowel issues due to my spinal condition.
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I have had surgery on the spine where I will receive SRS treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Tumor control
Secondary study objectives
EORTC QLQ-BM22 health-related quality of life questionnaire
Euro-QOL EQ-5D-3L health-related quality of life questionnaire
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 health-related quality of life scale score
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Single-fraction spine SRSExperimental Treatment1 Intervention
Single-fraction spine SRS (22 Gy x 1)
Group II: Multi-fraction spine SRSExperimental Treatment1 Intervention
Multi-fraction spine SRS (14 Gy x 2)

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Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,474 Previous Clinical Trials
17,501,666 Total Patients Enrolled
~183 spots leftby Dec 2028
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