A phase II study of percutaneous radiofrequency ablation for malignant reanl tumor (JIVROSG-0701)

UMIN ID: UMIN000001123

Registered date:22/04/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: malignant renal tumor
• Date of first enrollment: 2008/04/01
• Target sample size: 33
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): A radiofrequency needle is inserted into the renal tumor percutaneously, and then, radiofrequency tumor ablation is performed.

Outcome(s)

• Primary Outcome: Adverse events
• Secondary Outcome: Response rate of tumor shrinkage on RECIST

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Cardiac pacemaker. 2) Artery, nerve or ureter exists on the puncture route. 3) Target lesion adjacent to renal pelvis, or a RFA needle can not be inserted without passing through renal pelvis or alimentary tract. 4) Non-mesurable target lesion on CT. 5) Colinically significant bleeding tendency or abnormal coagulation. 6) Tentative stop of anti-platelet or anti-coagulant medication is not allowed. 7) Drug allergy 8) With active infection 9) With active inflammation 10) Fever above 38 degrees Celsius. 11) If having multiple lesions, no treatment of tumors except a target lesion for 4 weeks after the treatment for a target lesion is not allowed. 12) Stop of chemotherapy or immunotherapy for 4 weeks after the treatment for a target lesion is not allowed. 13) Previous reginal therapy for the target lesion. 14) Pregnancy.

Related Information

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