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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000041
Receipt No. R000000081
Scientific Title A phase I/II study of percutaneous vertebroplasty (JIVROSG-0202)
Date of disclosure of the study information 2005/08/06
Last modified on 2012/09/21

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Basic information
Public title A phase I/II study of percutaneous vertebroplasty (JIVROSG-0202)
Acronym Percutaneous vertebroplasty for malignant vertebral tumor (JIVROSG-0202)
Scientific Title A phase I/II study of percutaneous vertebroplasty (JIVROSG-0202)
Scientific Title:Acronym Percutaneous vertebroplasty for malignant vertebral tumor (JIVROSG-0202)
Region
Japan

Condition
Condition Malignant vertebral bone tumor.
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Pneumology
Hematology and clinical oncology Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Chest surgery Breast surgery Obsterics and gynecology
Orthopedics Urology Radiology
Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of percutaneous vertebroplasty for malignant vertebral tumors.
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 Pain evaluated by Visual Analogue Scale (VAS).

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 Under local anesthesia and fluoroscopic or CT guidance, a needle is percutaneously inserted into the vertebral body involved by malignant tumor and 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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Primary or metastatic malignant tumor in thoracic or lumber vertebral bone.
2) Severe pain adversely influencing on QOL.
3) No involvement into the spinal canal.
4) Adequate cardiac, hepatic, renal, respiratory, and bone marrow functions.
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) Bleeding time more than 5 minutes.
2) Fever above 38 degrees Celsius.
3) Cardiac failure requiring medication.
4) Active inflammation in vertebrae
5) Severely collapsed vertebrae (less than one third of normal height).
6) No severe pain (less than 2 of VAS).
7) Unable to keep prone position for 1 hour.
8) Necessity of procedure for more than 5 contiguous vertebral bodies.
9) Necessity of single session procedure for more than 4 vertebral bodies.
10) Severe drug allergy.
11) Pregnancy.
Target sample size 33

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ken Kobayashi
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
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
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 Published

Result
URL related to results and publications http://annonc.oxfordjournals.org/cgi/content/abstract/20/12/1943
Number of participants that the trial has enrolled
Results
Procedures were completed in all 33 patients (42 vertebrae). Thirty days after PVP, two patients died of primary disease progression, but no major adverse reactions (>grade 2) were observed. Response rate was 70% (95% confidence interval 54% to 83%) [61% (n = 20) with SE, 9% (n = 3) with ME, and 30% (n = 10) with NE] and increased to 83% at week 4. Median time to response was 1 day (mean 2.4). Median pain-mitigated survival period was 73 days. 
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
2002 Year 11 Month 30 Day
Date of IRB
Anticipated trial start date
2003 Year 02 Month 01 Day
Last follow-up date
2006 Year 04 Month 01 Day
Date of closure to data entry
2006 Year 05 Month 01 Day
Date trial data considered complete
2006 Year 05 Month 01 Day
Date analysis concluded
2006 Year 10 Month 01 Day

Other
Other related information

Management information
Registered date
2005 Year 08 Month 06 Day
Last modified on
2012 Year 09 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000081

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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