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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000045
Receipt No. R000000085
Scientific Title A phase I/II study of percutaneous radiofrequency ablation for malignant lung tumor (JIVROSG-0203)
Date of disclosure of the study information 2005/08/06
Last modified on 2010/02/11

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Basic information
Public title A phase I/II study of percutaneous radiofrequency ablation for malignant lung tumor (JIVROSG-0203)
Acronym Percutaneous radiofrequency ablation for lung tumor (JIVROSG-0203)
Scientific Title A phase I/II study of percutaneous radiofrequency ablation for malignant lung tumor (JIVROSG-0203)
Scientific Title:Acronym Percutaneous radiofrequency ablation for lung tumor (JIVROSG-0203)
Region
Japan

Condition
Condition Unresectable malignant lung 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 Orthopedics
Urology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of percutaneous radiofrequency ablation for malignant lung 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 Decrease of tumor accumulation on the image obtained by FDG-PET.

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 lung 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 confirmed malignant lung tumor.
2) Maximum diameter of the lesion on CT image between 1.0cm and 2.5cm.
3) No previous loco-regional therapy for the tumor.
4) Definitive accumulation of the tumor on FDG-PET study.
5) No vessel more than 5mm in diameter on the puncture route.
6) Adequate cardiac, hepatic, renal, respiratory, coagulation, and bone marrow functions.
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) Unmeasurable lesion on CT.
2) Lesion with ground-glass opacity on CT.
3) Lesion adjacent to heart, mediastinum, pleura and vessel or bronchus more than 5mm in diameter.
4) Active inflammation or infection.
5) Fever above 38 degrees Celsius.
6) Cardiac pacemaker.
7) Anti-coagulant medication.
8) Severe dysfunction in the contra-lateral lung.
9) Pulmonary hypertension.
10) Difficulty of normal activity due to cerebrovascular disease, prior neurosurgery or trauma.
11) Pregnancy.
Target sample size 33

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiyuki Matsuoka
Organization Osaka City University Medical School
Division name Department of Radiology
Zip code
Address 1-4-3, Asahimachi, Abeno-ku, Osaka 545-8585, Japan
TEL 06-6645-3831
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 06 Day

Related information
URL releasing protocol http://jivrosg.umin.jp/
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Materials: Lung cancer 13 (Primary 3, Recurrent 10), Metastatic lung cancer 20(colorectal 3, breast 2, uterine 2, others 7)
Device: Cool-tip 26, RF2000/3000 7
Technical success rate: 100%
Mortality with 30 days: 0
Adverse events:
Grade>2
Grade 2 (Pneumothrax 3, pleural effusion 1) Grade 1 (Pneumothrax 11, Liver dysfunction 2, others 3)
Efficacy: Overall 92.0%, Evaluable cases 69.7%
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 09 Month 24 Day
Date of IRB
Anticipated trial start date
2004 Year 04 Month 01 Day
Last follow-up date
2007 Year 03 Month 01 Day
Date of closure to data entry
2007 Year 05 Month 01 Day
Date trial data considered complete
2007 Year 05 Month 01 Day
Date analysis concluded
2007 Year 09 Month 01 Day

Other
Other related information

Management information
Registered date
2005 Year 08 Month 06 Day
Last modified on
2010 Year 02 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000085

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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