UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001500 |
|---|---|
| Receipt number | R000001568 |
| Scientific Title | A phase II study of percutaneous osteoplasty for painful malignant bone tumor (JIVROSG-0703) |
| Date of disclosure of the study information | 2008/11/12 |
| Last modified on | 2011/05/14 15:14:23 |
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Basic information
Public title
A phase II study of percutaneous osteoplasty for painful malignant bone tumor (JIVROSG-0703)
Acronym
Percutaneous osteoplasty for bone tumor.
Scientific Title
A phase II study of percutaneous osteoplasty for painful malignant bone tumor (JIVROSG-0703)
Scientific Title:Acronym
Percutaneous osteoplasty for bone tumor.
Region
| Japan |
Condition
Condition
Malignant vertebral and pelvic bone tumor
Classification by specialty
| Orthopedics | Radiology | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical efficacy, safety, and QOL of percutaneous osteoplasty in patients with malignant bone tumors.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Clinical efficacy
Key secondary outcomes
Adverse events and QOL
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
| Device,equipment | Maneuver |
Interventions/Control_1
Under local anesthesia and fluoroscopic or CT guidance, a needle is percutaneously inserted into the malignant bone tumor and the cement is injected.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Primary or metastatic malignant tumor in thoracic or lumber vertebral or pelvic bone tumor.
2) Severe pain adversely influencing on QOL.
3) Adequate cardiac, hepatic, renal, respiratory, and bone marrow functions.
4) Age =>20
5) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3.
6) Expected survival more than 4 weeks.
7) Written informed consent.
Key exclusion criteria
1) Cardiac failure requiring medication.
2) Vertebral tumor with destruction of the posterior part of vertebral body or compression of spinal cord.
3) Require the treatment of more than 4 vertebral bodies at single session.
4) Destruction of the bone cortex of aceatabulum.
5) No severe pain (less than 2 of VAS).
6) Uncontrolled bleeding tendency.
7) Severe drug allergy.
8) Comorbid infectious disease.
9) Active inflammatory process in the target lesion.
10) Radiation therapy for the target lesion.
11) Within 4 weeks after the completion of radiation therapy with a treatment response.
12) Unable to keep prone position for 1 hour.
13) Pregnancy.
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Matsui |
Organization
Kanazawa University Graduate School of Medicine
Division name
Department of Radiology
Zip code
Address
13-1, Takaramachi, Kanazawa 920-8641, Japan
TEL
076-265-2323
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/
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
| 2008 | Year | 11 | Month | 12 | 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
| 2008 | Year | 02 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 11 | Month | 12 | Day |
Last modified on
| 2011 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001568
