A phase II study of percutaneous osteoplasty for painful malignant bone tumor (JIVROSG-0703)
Phase 2
- Conditions
- Malignant vertebral and pelvic bone tumor
- Registration Number
- JPRN-UMIN000001500
- Lead Sponsor
- Japan Interventional Radiology in Oncology Study Group (JIVROSG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 33
Inclusion Criteria
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical efficacy
- Secondary Outcome Measures
Name Time Method Adverse events and QO