A phase II study of percutaneous osteoplasty for painful malignant bone tumor (JIVROSG-0703)

UMIN ID: UMIN000001500

Registered date:12/11/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Malignant vertebral and pelvic bone tumor
• Date of first enrollment: 2008/04/01
• Target sample size: 33
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Under local anesthesia and fluoroscopic or CT guidance, a needle is percutaneously inserted into the malignant bone tumor and the cement is injected.

Outcome(s)

• Primary Outcome: Clinical efficacy
• Secondary Outcome: Adverse events and QOL

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Japan Interventional Radiology in Oncology Study Group (JIVROSG)
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare