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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
274
Treatment Arm 1: Single-fraction spine SRS (22 Gy x 1)
Treatment Arm 2: Multi-fraction spine SRS (14 Gy x 2)
Stanford University School of Medicine
Palo Alto, California, United States
RECRUITINGTumor 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
Euro-QOL EQ-5D-3L health-related quality of life questionnaire
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.
Time frame: 2 years
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 health-related quality of life scale score
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.
Time frame: 2 years
EORTC QLQ-BM22 health-related quality of life questionnaire
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.
Time frame: 2 years
Pain Score
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")
Time frame: 1-2 weeks after SRS and 1, 3, 6, 12, 18, and 24 months following SRS
Medication Intake
Collect medications taken within the last 24 hours.
Time frame: 1-2 weeks after SRS and 1, 3, 6, 12, 18, and 24 months following SRS
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Number of participants with CTCAE grade grade 2 or higher adverse effects
To determine 1-year rate CTCAE grade 2 or higher adverse effects, following SRS
Time frame: 1 year
Rate of vertebral compression fracture
To determine 1-year rate of vertebral compression fracture (VCF), following SRS
Time frame: 1 year
Rate of local failure
To determine 2-year rate of local failure following SRS
Time frame: 2 years