NCT06173401RecruitingPhase 3
A Randomized Phase III TriaL Comparing SingLe- Versus Multi-Fraction Spine STereotActic Radiosurgery for Patients With Spinal Metastases (ALL-STAR)
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Stanford University
- Enrollment
- 274
- Locations
- 1
- Primary Endpoint
- Tumor control
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Single-fraction spine SRS
Experimental
Single-fraction spine SRS (22 Gy x 1)
Intervention: Single-fraction spine SRS (Radiation)
Multi-fraction spine SRS
Experimental
Multi-fraction spine SRS (14 Gy x 2)
Intervention: Multi-fraction spine SRS (Radiation)
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)
- 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)
- Number of participants with CTCAE grade grade 2 or higher adverse effects(1 year)
- EORTC QLQ-BM22 health-related quality of life questionnaire(2 years)
- Rate of local failure(2 years)
Investigators
Study Sites (1)
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