Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06173401

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

Led by Stanford University · Updated on 2025-07-16

274

Participants Needed

1

Research Sites

258 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically, cytologically, or radiographically confirmed diagnosis of metastatic cancer
  • Age 18 years or older
  • Presence of cervical, thoracic, or lumbar spine metastasis needing treatment
  • 1 to 3 separate spinal sites requiring treatment
  • Each spinal site covers 1-2 contiguous vertebral levels
  • ECOG performance status 0 to 2
  • Negative serum or urine pregnancy test within 14 days before enrollment for people of childbearing potential or not postmenopausal
  • People of childbearing potential and sexually active males must agree to use effective birth control
  • Ability and willingness to provide informed consent (personally or by legal representative)
Not Eligible

You will not qualify if you...

  • Prior or planned radiation overlapping or within the study treatment site outside the study
  • Inability to have either an MRI or CT scan (pacemaker patients allowed CT)
  • Pediatric patients under 18 years old
  • Pregnant or nursing women
  • Diagnosis of myeloma or lymphoma
  • Muscle strength of 1-3 out of 5, bladder or bowel incontinence, or bladder retention related to the spinal site to be treated
  • Prior surgery to the spinal site intended for study SRS 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

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Trial Site Locations

Total: 1 location

1

Stanford University School of Medicine

Palo Alto, California, United States, 94305

Actively Recruiting

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Research Team

K

Kelly Huang

CONTACT

A

Alyssa Yauger

CONTACT

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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