Recruiting
Phase 3

Single & Multi-Fraction

Sponsor:

Stanford University

Code:

NCT06173401

Conditions

Spinal Metastases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Single-fraction spine SRS

Multi-fraction spine SRS

Study Details

Brief 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.

Conditions

Spinal Metastases

Study ID

NCT06173401

Start date

Dec 18, 2023

Status verified date

Jul, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Histologically, cytologically, or radiographically confirmed diagnosis of metastatic cancer Age ≥ 18 years
  • Patients who have cervical, thoracic, or lumbar spine metastasis that need treatment.
  • Patients will have 1 to 3 separate spinal sites that require treatment.
  • Each spinal site to be treated on trial will span 1-2 contiguous vertebral levels
  • ECOG 0-2
  • Negative serum or urine pregnancy test within 14 days prior to enrollment for people of childbearing potential or who are not postmenopausal
  • people of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control
  • Ability to understand and the willingness to sign (personally or by a legal authorized representative) the written IRB approved informed consent document

Exclusion Criteria:

  • Prior or planned radiation off study within or overlapping with study treatment site
  • Inability to have either an MRI or a CT scan. Patients with pacemaker will be allowed to undergo CT instead of MRI
  • Pediatric patients (age <18 years old), pregnant women, and nursing patients will be excluded
  • Histology's of myeloma or lymphoma
  • Patients with strength 1-3 (of 5), bladder incontinence, bowel incontinence, and/or bladder retention that is associated with spinal site to be treated
  • Prior surgery to spinal site intended to be treated with protocol SRS
  • Excluded those with SINS 13-18

Study Design

Enrollment

274 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Single-fraction spine SRS

Single-fraction spine SRS (22 Gy x 1)

experimental: Multi-fraction spine SRS

Multi-fraction spine SRS (14 Gy x 2)

Interventions

Single-fraction spine SRS

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

Multi-fraction spine SRS

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

Primary outcome measure

  • Tumor control [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Kelly Huang

650-724-4606kelhuang@stanford.edu

Alyssa Yauger

650-498-5271ayauger@stanford.edu

Locations

Stanford University School of Medicine

Recruiting

Palo Alto, California, United States, 94305

Contacts

Kelly Huang

650-724-4606kelhuang@stanford.edu

Alyssa Yauger

650-498-5271ayauger@stanford.edu

Principal Investigator:

Erqi L Pollom, M.D.

More Information

Sponsor

Stanford University

Last update posted

Jul 27, 2026

Last verified

Jul, 2026

Keywords

  • spine stereotactic radiosurgery
  • cervical
  • lumbar
  • thoracic
  • metastases

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2026-07-27.