A Single-center Observational Clinical Trial of Stereotactic Radiotherapy on Metastatic Spinal Tumors Using TomoTherapy

Inclusion Criteria:

1. Spinal metastasis diagnosed by emission computed tomography, X-ray examination, computed tomography, magnetic resonance imaging (MRI) or 18F-fluorodeoxy glucose positron emission tomography within 6 weeks before enrollment;
2. Patients with unresectable spinal metastases;
3. SBRT was for patients with painful spinal metastases, physiological hypofunction, decreased behavioral capacity and quality of life. And SBRT was used to help to prevent or delay skeletal related event (SRE). Including postoperative radiotherapy (especially post-separation), single or salvage radiotherapy;
4. age 18-75 years old;
5. KPS score equal to 70 points or over;
6. Patients were required to have histologically confirmed metastatic disease from solid tumors, such as breast cancer, renal carcinoma or liver cancer;
7. The distance between metastatic lesion and spinal cord was more than 3mm；
8. Hemoglobin \>90g/L, white cells count≥3.5×109/L, platelet count≥80×109/L, within 1 week before treatment;
9. No birth plans for the duration of study participation and up to 3 months following completion of therapy;
10. Sign the informed consent.

Exclusion Criteria:

1. Spinal cord or cauda equina compression, the rapid decrement of neurological function or paralysis;
2. A compression fracture of the spine, spinal instability and subsequent inability to lie on back;
3. Metastatic lesions more than 5cm;
4. Multilevel segments involvement, including more than 5 metastatic segments, or 3 isolated lesions, or exceed two adjacent vertebrae;
5. The treatment site had received prior radiotherapy prior to the initiation of the study;
6. Complicated with other malignant tumors or severe internal diseases affected the prognosis;
7. Cannot tolerate radiation therapy, including the ones with scleroderma or connective tissue diseases, or cann't complete the radiation treatment according to the research;
8. Pregnant women or breast feeding mothers;
9. Systemic radionuclide therapy within 30 days before SBRT, or external radiotherapy within 90 days before SBRT;
10. Pathologically confirmed as myeloma or lymphoma.