UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000046 |
|---|---|
| Receipt number | R000000086 |
| Scientific Title | A phase I/II study of percutaneous radiofrequency ablation for malignant tumor in the pelvis (JIVROSG-0204) |
| Date of disclosure of the study information | 2005/08/06 |
| Last modified on | 2015/02/09 22:48:41 |
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Basic information
Public title
A phase I/II study of percutaneous radiofrequency ablation for malignant tumor in the pelvis (JIVROSG-0204)
Acronym
Percutaneous radiofrequency ablation for intrapelvic tumor (JIVROSG-0204)
Scientific Title
A phase I/II study of percutaneous radiofrequency ablation for malignant tumor in the pelvis (JIVROSG-0204)
Scientific Title:Acronym
Percutaneous radiofrequency ablation for intrapelvic tumor (JIVROSG-0204)
Region
| Japan |
Condition
Condition
Symptomatic intrapelvic malignant tumor
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Hematology and clinical oncology |
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery | Breast surgery |
| Obstetrics and Gynecology | Urology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of percutaneous radiofrequency ablation for malignant tumor in the pelvis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adverse events
Key secondary outcomes
Improvement 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 intrapelvic malignant 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 intrapelvic malignant tumor.
2) Histologically confirmed malignant lesion.
3) Maximum diameter of lesion on image not exceed 5cm.
4) No influence of previous treatment.
5) Measurable disease on CT or MRI.
6) Any ascites in Douglas pouch allowed.
7) Lesion mainly located in intrapelvic space.
8) Adequate cardiac, hepatic, renal, respiratory, coagulation, and bone marrow functions.
9) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3.
10) Expected survival more than 4 weeks.
11) Written informed consent.
Key exclusion criteria
1) No symptom or VAS of less than 3.
2) Cardiac pacemaker.
3) Artery or nerve along the puncture route.
4) Lesion or target area adjacent to critical organs.
5) Infection in the target area.
6) Pregnancy.
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Anai |
Organization
Nara Medical University
Division name
Department of Radiology
Zip code
Address
804, Shijo-cho, Kashihara 634-8558, Japan,
TEL
0744-29-8900
msone@athena.ocn.ne.jp
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
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
Terminated
Date of protocol fixation
| 2003 | Year | 09 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 09 | Month | 22 | Day |
Date of closure to data entry
| 2015 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2005 | Year | 08 | Month | 06 | Day |
Last modified on
| 2015 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000086
