UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000047
Receipt number 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 18:54:40

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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
Obstetrics 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 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


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

Value
https://center6.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