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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000047
Receipt No. R000000088
Scientific Title A phase I/II study of percutaneous radiofrequency ablation for metastatic bone tumor (JIVROSG-0208)
Date of disclosure of the study information 2005/08/07
Last modified on 2012/03/10

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Basic information
Public title A phase I/II study of percutaneous radiofrequency ablation for metastatic bone tumor (JIVROSG-0208)
Acronym Percutaneous radiofrequency ablation for metastatic bone tumor (JIVROSG-0208)
Scientific Title A phase I/II study of percutaneous radiofrequency ablation for metastatic bone tumor (JIVROSG-0208)
Scientific Title:Acronym Percutaneous radiofrequency ablation for metastatic bone tumor (JIVROSG-0208)
Region
Japan

Condition
Condition Symptomatic metastatic bone tumor
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Pneumology
Hematology and clinical oncology Nephrology Gastrointestinal surgery
Hepato-biliary-pancreatic surgery Chest surgery Breast surgery
Obsterics and gynecology Dermatology Oto-rhino-laryngology
Orthopedics Urology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of percutaneous radiofrequency ablation for metastatic bone 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 Imrovement of symptom measured by Visual Analogue Scale at 1 week after the procedure.

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 Radiofrequency ablation needle is percutaneouly inserted into the metastatic bone tumor and radiofrequency 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) Symptomatic and uncontrollable metastatic bone tumor.
2) Histologically confirmed malignant lesion.
3) No influence of previous treatments.
4) Measurable lesion on CT or MRI.
5) Adequate cardiac, hepatic, renal, respiratory, and bone marrow functions.
6) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3.
7) Expected survival more than 4 weeks.
8) Written informed consent.
Key exclusion criteria 1) Cardiac pacemaker.
2) Artery or nerve along the puncture route.
3) Pregnancy.
4) No symptom or VAS of less than 3.
Target sample size 33

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noboru Tanigawa
Organization Kansai Medical University
Division name Department of Radiology
Zip code
Address 10-15, Fumizono-cho, Moriguchi-shi, Osaka 570-8507, Japan
TEL 06-6992-1001
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,Chuo-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
2005 Year 08 Month 07 Day

Related information
URL releasing protocol http://jivrosg.umin.jp/
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
2003 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2004 Year 03 Month 01 Day
Last follow-up date
2011 Year 09 Month 01 Day
Date of closure to data entry
2011 Year 10 Month 01 Day
Date trial data considered complete
2011 Year 10 Month 01 Day
Date analysis concluded
2012 Year 01 Month 01 Day

Other
Other related information

Management information
Registered date
2005 Year 08 Month 07 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=R000000088

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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