UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001123 |
|---|---|
| Receipt number | 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 18:56:12 |
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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
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/
jivrosgoffice@ml.res.ncc.go.jp
Sponsor or person
Institute
Japan Interventional Radiology in Oncology Study Group (JIVROSG)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001371
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