UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000041 |
|---|---|
| Receipt number | 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 13:21:20 |
* 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 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 | Obstetrics 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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000081
