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

July 15, 2025 updated by: Stanford University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

274

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94305
        • Recruiting
        • Stanford University School of Medicine
        • Principal Investigator:
          • Erqi L Pollom, M.D.
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single-fraction spine SRS
Single-fraction spine SRS (22 Gy x 1)
Radiation: Single-fraction spine SRS
Treatment Arm 1: Single-fraction spine SRS (22 Gy x 1)
Experimental: Multi-fraction spine SRS
Multi-fraction spine SRS (14 Gy x 2)
Radiation: Multi-fraction spine SRS
Treatment Arm 2: Multi-fraction spine SRS (14 Gy x 2)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor control
Time Frame: 1 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Euro-QOL EQ-5D-3L health-related quality of life questionnaire
Time Frame: 2 years
To compare health-related quality of life (EQ-5D-3L) following SRS and assess patient-reported health related quality of life pertaining to mobility, self-care, usual activities, pain, and anxiety.
2 years
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 health-related quality of life scale score
Time Frame: 2 years
To compare health-related quality of life (EORTC QLQ-C30) following SRS and assess patient-reported health related quality of life pertaining to overall health and quality of daily life.
2 years
EORTC QLQ-BM22 health-related quality of life questionnaire
Time Frame: 2 years
To compare health-related quality of life (EORTC QLQ-BM22) following SRS and assess patient-reported health related quality of life pertaining to pain associated with performing activities of daily life.
2 years
Pain Score
Time Frame: 1-2 weeks after SRS and 1, 3, 6, 12, 18, and 24 months following SRS
Pain associated with the treated area will be assessed by asking patients to rate their pain on a 0-10 scale ("no pain" to "pain as bad as you can imagine")
1-2 weeks after SRS and 1, 3, 6, 12, 18, and 24 months following SRS
Medication Intake
Time Frame: 1-2 weeks after SRS and 1, 3, 6, 12, 18, and 24 months following SRS
Collect medications taken within the last 24 hours.
1-2 weeks after SRS and 1, 3, 6, 12, 18, and 24 months following SRS
Number of participants with CTCAE grade grade 2 or higher adverse effects
Time Frame: 1 year
To determine 1-year rate CTCAE grade 2 or higher adverse effects, following SRS
1 year
Rate of vertebral compression fracture
Time Frame: 1 year
To determine 1-year rate of vertebral compression fracture (VCF), following SRS
1 year
Rate of local failure
Time Frame: 2 years
To determine 2-year rate of local failure following SRS
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Erqi Pollom, MD, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2023

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

November 28, 2023

First Submitted That Met QC Criteria

December 7, 2023

First Posted (Actual)

December 15, 2023

Study Record Updates

Last Update Posted (Actual)

July 16, 2025

Last Update Submitted That Met QC Criteria

July 15, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-72248
  • BRN0060 (Other Identifier: OnCore number)
  • NCI-2024-00695 (Registry Identifier: NCI- Clinical Trials Reporting Program)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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