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

Phase 3

Recruiting

• Conditions: Spinal Metastases
• Interventions: Radiation: Single-fraction spine SRS; Radiation: Multi-fraction spine SRS

• Registration Number: NCT06173401
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-28
• Study First Submitted QC: 2023-12-07
• Study First Posted: 2023-12-15
• Study Start: 2023-12-18
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-05
• Primary Completion: 2028-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 274

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single-fraction spine SRS	Single-fraction spine SRS	Single-fraction spine SRS (22 Gy x 1)
Multi-fraction spine SRS	Multi-fraction spine SRS	Multi-fraction spine SRS (14 Gy x 2)

Primary Outcome Measures

Name	Time	Method
Tumor control	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 Outcome Measures

Name	Time	Method
Euro-QOL EQ-5D-3L health-related quality of life questionnaire	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.
Pain Score	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")
Rate of vertebral compression fracture	1 year	To determine 1-year rate of vertebral compression fracture (VCF), following SRS
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 health-related quality of life scale score	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.
Medication Intake	1-2 weeks after SRS and 1, 3, 6, 12, 18, and 24 months following SRS	Collect medications taken within the last 24 hours.
Number of participants with CTCAE grade grade 2 or higher adverse effects	1 year	To determine 1-year rate CTCAE grade 2 or higher adverse effects, following SRS
EORTC QLQ-BM22 health-related quality of life questionnaire	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.
Rate of local failure	2 years	To determine 2-year rate of local failure following SRS

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Palo Alto, California, United States