A phase I/II study of percutaneous vertebroplasty (JIVROSG-0202)
- Conditions
- Malignant vertebral bone tumor.
- Registration Number
- JPRN-C000000041
- Lead Sponsor
- Japan Interventional Radiology in Oncology Study Group (JIVROSG)
- Brief Summary
Procedures were completed in all 33 patients (42 vertebrae). Thirty days after PVP, two patients died of primary disease progression, but no major adverse reactions (>grade 2) were observed. Response rate was 70% (95% confidence interval 54% to 83%) [61% (n = 20) with SE, 9% (n = 3) with ME, and 30% (n = 10) with NE] and increased to 83% at week 4. Median time to response was 1 day (mean 2.4). Median pain-mitigated survival period was 73 days.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 33
Not provided
1) Bleeding time more than 5 minutes. 2) Fever above 38 degrees Celsius. 3) Cardiac failure requiring medication. 4) Active inflammation in vertebrae 5) Severely collapsed vertebrae (less than one third of normal height). 6) No severe pain (less than 2 of VAS). 7) Unable to keep prone position for 1 hour. 8) Necessity of procedure for more than 5 contiguous vertebral bodies. 9) Necessity of single session procedure for more than 4 vertebral bodies. 10) Severe drug allergy. 11) Pregnancy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse events
- Secondary Outcome Measures
Name Time Method Pain evaluated by Visual Analogue Scale (VAS).