Malignant vertebral and pelvic bone tumor
Conditions
Interventions
Under local anesthesia and fluoroscopic or CT guidance, a needle is percutaneously inserted into the malignant bone tumor and the cement is injected.
Sponsors
Japan Interventional Radiology in Oncology Study Group (JIVROSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Primary or metastatic malignant tumor in thoracic or lumber vertebral or pelvic bone tumor. 2) Severe pain adversely influencing on QOL. 3) Adequate cardiac, hepatic, renal, respiratory, and bone marrow functions. 4) Age =>20 5) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3. 6) Expected survival more than 4 weeks. 7) Written informed consent.
Exclusion criteria
Exclusion criteria: 1) Cardiac failure requiring medication. 2) Vertebral tumor with destruction of the posterior part of vertebral body or compression of spinal cord. 3) Require the treatment of more than 4 vertebral bodies at single session. 4) Destruction of the bone cortex of aceatabulum. 5) No severe pain (less than 2 of VAS). 6) Uncontrolled bleeding tendency. 7) Severe drug allergy. 8) Comorbid infectious disease. 9) Active inflammatory process in the target lesion. 10) Radiation therapy for the target lesion. 11) Within 4 weeks after the completion of radiation therapy with a treatment response. 12) Unable to keep prone position for 1 hour. 13) Pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical efficacy | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events and QOL | — |
Countries
Japan
Contacts
Public ContactYasuaki Arai
JIVROSG, Coordinating Office Division of Diagnostic Radiology, National Cancer Center Hospital
Outcome results
None listed