A Randomized Phase III TriaL Comparing SingLe- Versus Multi-Fraction Spine STereotActic Radiosurgery for Patients With Spinal Metastases (ALL-STAR)
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.
Arms & interventions
- RadiationSingle-fraction spine SRS
Treatment Arm 1: Single-fraction spine SRS (22 Gy x 1)
- RadiationMulti-fraction spine SRS
Treatment Arm 2: Multi-fraction spine SRS (14 Gy x 2)
Outcome measures
Primary
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.
Time frame: 1 year
Secondary
Euro-QOL EQ-5D-3L health-related quality of life questionnaire
Time frame: 2 years
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 health-related quality of life scale score
Time frame: 2 years
EORTC QLQ-BM22 health-related quality of life questionnaire
Time frame: 2 years
Pain Score
Time frame: 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
Number of participants with CTCAE grade grade 2 or higher adverse effects
Time frame: 1 year
Rate of vertebral compression fracture
Time frame: 1 year
Rate of local failure
Time frame: 2 years
Eligibility criteria
Study locations (1)
Stanford University School of Medicine
Palo Alto, California, 94305