Spine metastasis
Conditions
Interventions
A:Vertebra augmentation combined with intraoperative radiotherapy
B:External beam radiotherapy
Sponsors
Sun Yat-sen memorial hospital, Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 65; 2. Pathological or imaging proved spine metastasis; 3. Involved T3-T12 or L1-L5 vertebrae; 4. Predicted Survival longer than 3 months; 5. Documented consent.
Exclusion criteria
Exclusion criteria: 1. Not tolerated with general anesthesia/surgery; 2. Coagulation disorders; 3. Not tolerated with MRI/CT scan during follow-up; 4. Malignant epidural spinal cord compression; 5. Severe spinal instability; 6. Pregnant/breast-feeding women; 7. Hypersensitive to bone cement; 8. Previous external radiotherapy; 9. Puncture failure; 10. Complicated with psychological disorders that not able to provide informed consent; 11. Complicated with severe diseases that shorten survival or cause chronic pain; 12. Dyscrasia or multi-organ dysfunction; 13. Multi primary tumors; 14. Drug abuse or other medical, psychological or social conditions affect participation or assessing of our trial; 15. Hypersensitive to given drugs in our trial; 16. Any conditions affecting the safety or participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year tumor progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain release rate;spinal stability;neurological function;ambulation;complication rate;economical indexes;6-month survival;1-year survival; | — |
Countries
China
Contacts
Public ContactHUANG Lin
Outcome results
None listed