Spinal Metastases
Conditions
Keywords
spine stereotactic radiosurgery, cervical, lumbar, thoracic, metastases
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.
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)
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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") |
| 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 |
| Rate of vertebral compression fracture | 1 year | To determine 1-year rate of vertebral compression fracture (VCF), following SRS |
| Rate of local failure | 2 years | To determine 2-year rate of local failure following SRS |
Countries
United States
Contacts
CONTACTKelly Huang
CONTACTAlyssa Yauger
PRINCIPAL_INVESTIGATORErqi Pollom, MD
Stanford University
Outcome results
None listed