UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000045 |
|---|---|
| Receipt number | 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 15:03:19 |
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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 |
| Obstetrics 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
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/
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000085
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