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| ID | Type | Description | Link |
|---|---|---|---|
| BRN0060 | Other Identifier | OnCore number | |
| NCI-2024-00695 | Registry Identifier | NCI- Clinical Trials Reporting Program |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-fraction spine SRS | Experimental | Single-fraction spine SRS (22 Gy x 1) |
|
| Multi-fraction spine SRS | Experimental | Multi-fraction spine SRS (14 Gy x 2) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single-fraction spine SRS | Radiation | Treatment Arm 1: Single-fraction spine SRS (22 Gy x 1) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 years |
| European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 health-related quality of life scale score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kelly Huang | Contact | 650-724-4606 | kelhuang@stanford.edu | |
| Alyssa Yauger | Contact | 650-498-5271 | ayauger@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| Erqi Pollom, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Recruiting | Palo Alto | California | 94305 | United States |
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Multi-fraction spine SRS | Radiation | Treatment Arm 2: Multi-fraction spine SRS (14 Gy x 2) |
|
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. |
| 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. | 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") | 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. | 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 | To determine 1-year rate CTCAE grade 2 or higher adverse effects, following SRS | 1 year |
| Rate of vertebral compression fracture | To determine 1-year rate of vertebral compression fracture (VCF), following SRS | 1 year |
| Rate of local failure | To determine 2-year rate of local failure following SRS | 2 years |