A single-center observational clinical trial will be performed for metastatic spinal tumors by stereotactic radiotherapy using TomoTherapy. In this study, we will explore the local control rate (LCR), disease-free progression time (PFS), overall survival time (OS), and pain relief in patients with spinal metastasis, so as to provide a basis for developing relevant guidelines or consensus.
In this observational single-arm study, a total of 45 patients with metastatic spinal tumors will be enrolled. The patients were aged between 18 and 75 years old. And all the subjects should meet the inclusion criteria and sign the informed consent. Meanwhile, the patients' medical history characteristics, including gender, age, imaging data (X-ray, CT, MRI, or PET-CT, etc.), primary tumor type, pathological type, previous treatment, previous disease history, tumor markers and bone metabolism indexes were collected and recorded on the CRF. The metastatic spinal tumors by stereotactic radiotherapy(SBRT) using TomoTherapy. The adiotherapy dose is 6Gy×5Fx, 5Gy×5Fx or 4Gy×5Fx according to the irradiation site. Treatment should be interrupted if there is severe bone marrow suppression, vertebral compression fracture, or radiation myelitis. The adjacentnormal tissue constrains refer to the UK SABR Consortium Guidelines (2022 version). Follow-up was performed 1 month after radiotherapy, thereafter every 3 months for 1-4 years. The parameters includ blood routine, liver and kidney function, bleeding and coagulation function, bone metabolism index, tumor markers, bone metastasis imaging examination. Tumor response will refer to the Cancer Response Criteria and Bone Metastases: RECIST 1.1, MDA and PERCIST.
Study Type
OBSERVATIONAL
Enrollment
45
Stereotactic body radiotherapy using TomoTherapy
1-year local control rate
The proportion of complete remission, partial remission, stable disease, and disease progression patients in the total number of enrolled cases. Tumor response will refer to the Cancer Response Criteria and Bone Metastases: RECIST 1.1, MDA and PERCIST.
Time frame: 2024.4-2025.4
1- and 2- year overall survival (OS)
year overall survival (OS): From day of radiotherapy until the date of death or the end in 1 year, 2-year OS: From day of radiotherapy until the date of death or the end in 2 years
Time frame: 2024.4-2026.4
1- and 2-year Progression-Free Survival(PFS)
1-year Progression-Free Survival (PFS):From day of radiotherapy until the Progression of bone metastases sites in 1 year, 2-year PFS:From day of radiotherapy until the Progression of bone metastases sites in 2 years
Time frame: 2024.4-2026.4
Pain relief
Assessment of pain will be according to the Numerical Rating Scale (NRS).
Time frame: 2024.4-2026.4
Bone metastasis-related events (SRE)
Bone metastasis-related events will be recorded, including pathological fracture and spinal cord compression, etc.
Time frame: 2024.4-2026.4
Epidural spinal cord compression (ESCC) grade
Epidural spinal cord compression (ESCC) grade will be assessed refer to ESCC scale.
Time frame: 2024.4-2026.4
Adverse reactions
1-Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
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Time frame: 2024.4-2026.4