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Radiation

Multi-fraction spine SRS for Spinal Metastases

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Tumor control

Secondary outcome measures

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

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)

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,395 Previous Clinical Trials

17,341,076 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an ongoing recruitment for participants in this study?

"Reportedly, this clinical trial has finished recruiting - last updated on December 7th 2023. However, there are 651 other trials actively enrolling individuals at the moment."

Answered by AI

Has the FDA given the green light to Single-fraction spine SRS?

"The safety of single-fraction spine SRS is assessed to be a 3 on our team's scale, due to the available evidence in favor of its efficacy and multiple studies verifying that this intervention is safe."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Comparing SingLe- Vs Multi-Fraction Spine STereotActic Radiosurgery in Spinal Metastases". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06173401.

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