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

Phase 1
Conditions
malignant renal tumor
Registration Number
JPRN-UMIN000001123
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 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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Adverse events
Secondary Outcome Measures
NameTimeMethod
Response rate of tumor shrinkage on RECIST
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