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

Stanford University1 site in 1 country274 target enrollmentDecember 18, 2023

ConditionsSpinal Metastases

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Spinal Metastases
Sponsor: Stanford University
Enrollment: 274
Locations: 1
Primary Endpoint: Tumor control
Status: Recruiting
Last Updated: 9 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 18, 2023

End Date

December 1, 2028

Last Updated

9 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Stanford University

Responsible Party

Sponsor

Eligibility Criteria

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
•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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

Euro-QOL EQ-5D-3L 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)
Number of participants with CTCAE grade grade 2 or higher adverse effects(1 year)
Rate of vertebral compression fracture(1 year)
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 health-related quality of life scale score(2 years)
Medication Intake(1-2 weeks after SRS and 1, 3, 6, 12, 18, and 24 months following SRS)
EORTC QLQ-BM22 health-related quality of life questionnaire(2 years)
Rate of local failure(2 years)