Metastasis, Metastatic Breast Cancer, Metastatic Cancer, Metastatic Lung Cancer, Metastatic Tumor, Metastatic Tumor of Bone, Metastatic Tumor to the Spine, Spine Metastases
Conditions
Brief summary
This study is looking at whether patients with cancer that has aggressively spread to the spine can be treated with stereotactic body radiation therapy only and avoid a large spine surgery
Interventions
RADIATIONSBRT to the spine
Stereotactic body radiation therapy (SBRT) administered to spine metastases
Sponsors
The University of Texas Health Science Center at San Antonio
Stony Brook University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Eligible patients must have: * Any pathologically proven solid tumor diagnosis not of central nervous system origin with radiographic or pathologic evidence of metastatic disease * Metastatic spine involvement documented by imaging * Involvement of maximum 3 contiguous vertebral bodies at the index site * Intact neurologic function, or only minor neurologic deficits with muscle strength greater or equal to 4 out of 5 with or without steroids * An evaluation by an radiation oncology and orthopedic spine/neurosurgery attending * ECOG Performance Status of 0-3 Patients are ineligible if they have: * An unstable spine defined as a Spinal Instability Neoplastic Score (SINS) greater than 12 * Had previous surgery or radiation to address the target spinal metastases * Radiosensitive tumors (e.g. small cell lung cancer, lymphoma, multiple myeloma, and germ-cell tumors)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative incidence of spinal surgery/stabilization within 6 months following SBRT | 6 months | Assess the efficacy of spine SBRT alone in controlling spine metastases |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes on Neck Disability index | 1 months, 3 months, 6 months | The Neck Disability Index measures neck pain and disabilities in patients with neck pain, with scores varying from 0 to 50. Lower scores indicate better outcomes, higher scores indicate a worse outcome. |
| Changes on Oswestry Low Back Disability Questionnaire | 1 months, 3 months, 6 months | The Oswestry Disability Index measures disability in patients with low back pain, with scores varying from 0 to 50. Lower scores indicate better outcomes, higher scores indicate a worse outcome. |
| Reduction in epidural tumor volume | 3 months | Percent reduction of epidural volume of the treated metastatic lesions |
| Progression-free survival | 6 months | — |
| Overall survival | 6 months | — |
| Changes on EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) questionnaire | 1 months, 3 months, 6 months | The EuroQol 5D-5L questionnaire measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each health dimension is scored from 1 to 5, with 1 indicating a better health state, and 5 the worse state possible. Respondents also indicate their overall health status on visual analogue score, with values ranging from 0 (worst health imaginable) to 100 (best health imaginable) |
Countries
United States
Contacts
Primary ContactHermina Munoz, RN
Backup ContactLucia Joya
Outcome results
None listed