RecruitingPhase 3NCT06173401

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

A Randomized Phase III TriaL Comparing SingLe- Versus Multi-Fraction Spine STereotActic Radiosurgery for Patients With Spinal Metastases (ALL-STAR)


Sponsor

Stanford University

Enrollment

274 participants

Start Date

Dec 18, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two radiation therapy approaches for people with cancer that has spread to the spine: a single large dose of targeted radiation (single-fraction) versus several smaller doses over multiple sessions (multi-fraction stereotactic radiosurgery), to see which approach is safer and more effective. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of metastatic cancer that has spread to the spine (cervical, thoracic, or lumbar) - You have 1 to 3 separate spinal sites that need treatment - You are in reasonably good health (ECOG performance status 0-2) - You are willing to use birth control if applicable **You may NOT be eligible if...** - You have already had radiation at or overlapping with the spinal area that needs to be treated in this study - You cannot have an MRI or CT scan - Your spinal cord is already being compressed by cancer - You have widespread cancer spread to many spinal levels Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONSingle-fraction spine SRS

Treatment Arm 1: Single-fraction spine SRS (22 Gy x 1)

RADIATIONMulti-fraction spine SRS

Treatment Arm 2: Multi-fraction spine SRS (14 Gy x 2)


Locations(1)

Stanford University School of Medicine

Palo Alto, California, United States

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NCT06173401


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