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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001123
Receipt No. R000001371
Scientific Title A phase II study of percutaneous radiofrequency ablation for malignant reanl tumor (JIVROSG-0701)
Date of disclosure of the study information 2008/04/22
Last modified on 2012/03/10

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Basic information
Public title A phase II study of percutaneous radiofrequency ablation for malignant reanl tumor (JIVROSG-0701)
Acronym Percutaneous radiofrequency ablation for malignant renal tumor (JIVROSG-0701)
Scientific Title A phase II study of percutaneous radiofrequency ablation for malignant reanl tumor (JIVROSG-0701)
Scientific Title:Acronym Percutaneous radiofrequency ablation for malignant renal tumor (JIVROSG-0701)
Region
Japan

Condition
Condition malignant renal tumor
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Hematology and clinical oncology Nephrology Surgery in general
Vascular surgery Endocrine surgery Urology
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of percutaneous radiofrequency ablation for malignant renal tumor.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase I,II

Assessment
Primary outcomes Adverse events
Key secondary outcomes Response rate of tumor shrinkage on RECIST

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 A radiofrequency needle is inserted into the renal tumor percutaneously, and then, radiofrequency tumor ablation is performed.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Histologically or imaging confirmed malignant renal tumor.
2) Having at least one target lesion with maximum diameter on CT image between 1.0cm and 3.cm.
3) Target lesion shows the increase of HU more than 20 on CT by contrast enhacement.
4) Surgical treatment is out of indication or refused.
ous loco-regional therapy for the tumor.
5) Adequate cardiac, hepatic, renal, respiratory, coagulation, and bone marrow functions.
6) Age less than 20 at informed consent.
7) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
8) Expected survival more than 2 months.
9) Written informed consent.
Key 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.
Target sample size 33

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Susumu Kanazawa
Organization Okayama University
Division name Department of Radiology
Zip code
Address 2-5-1, Shikada-cho, Okayama, 700-8558, Japan
TEL 086-235-7313
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yasuaki Arai
Organization JIVROSG, Coordinating Office
Division name Division of Diagnostic Radiology, National Cancer Center Hospital
Zip code
Address 5-1-1, Tsukiji, Chu0-ku, Tokyo, 104-0045, Japan
TEL 03-3542-2511
Homepage URL http://jivrosg.umin.jp/
Email jivrosgoffice@ml.res.ncc.go.jp

Sponsor
Institute Japan Interventional Radiology in Oncology Study Group (JIVROSG)
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2008 Year 04 Month 22 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2008 Year 02 Month 29 Day
Date of IRB
Anticipated trial start date
2008 Year 04 Month 01 Day
Last follow-up date
2010 Year 08 Month 01 Day
Date of closure to data entry
2010 Year 08 Month 01 Day
Date trial data considered complete
2010 Year 08 Month 01 Day
Date analysis concluded
2010 Year 10 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 04 Month 21 Day
Last modified on
2012 Year 03 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001371

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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