UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN C000000046
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Obsterics 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
Email 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/
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000086

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.