NCT06173401

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
274

participants targeted

Target at P50-P75 for phase_3

Timeline
31mo left

Started Dec 2023

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress48%
Dec 2023Dec 2028

First Submitted

Initial submission to the registry

November 28, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 15, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

December 18, 2023

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

July 16, 2025

Status Verified

July 1, 2025

Enrollment Period

5 years

First QC Date

November 28, 2023

Last Update Submit

July 15, 2025

Conditions

Spinal Metastases

Keywords

spine stereotactic radiosurgerycervicallumbarthoracicmetastases

Outcome Measures

Primary Outcomes (1)

  • Tumor control

    To determine whether fractionated Stereotactic Radiosurgery (SRS) for spine metastases is associated with improved local tumor control at 1 year following SRS compared to single-fraction SRS.

    1 year

Secondary Outcomes (8)

  • Euro-QOL EQ-5D-3L health-related quality of life questionnaire

    2 years

  • European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 health-related quality of life scale score

    2 years

  • EORTC QLQ-BM22 health-related quality of life questionnaire

    2 years

  • Pain Score

    1-2 weeks after SRS and 1, 3, 6, 12, 18, and 24 months following SRS

  • Medication Intake

    1-2 weeks after SRS and 1, 3, 6, 12, 18, and 24 months following SRS

  • +3 more secondary outcomes

Study Arms (2)

Single-fraction spine SRS

EXPERIMENTAL

Single-fraction spine SRS (22 Gy x 1)

Radiation: Single-fraction spine SRS

Multi-fraction spine SRS

EXPERIMENTAL

Multi-fraction spine SRS (14 Gy x 2)

Radiation: Multi-fraction spine SRS

Interventions

Single-fraction spine SRSRADIATION

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

Single-fraction spine SRS
Multi-fraction spine SRSRADIATION

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

Multi-fraction spine SRS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Palo Alto, California, 94305, United States

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Erqi Pollom, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelly Huang

CONTACT

650-724-4606kelhuang@stanford.edu

Alyssa Yauger

CONTACT

650-498-5271ayauger@stanford.edu

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2023

First Posted

December 15, 2023

Study Start

December 18, 2023

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

July 16, 2025

Record last verified: 2025-07

Locations

US(1)