UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000050
Receipt No. R000000095
Scientific Title A phase II study of stent therapy for malignant vena cava syndrome. (JIVROSG-0402)
Date of disclosure of the study information 2005/08/07
Last modified on 2010/02/11

* 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 II study of stent therapy for malignant vena cava syndrome. (JIVROSG-0402)
Acronym Stent therapy for vena cava syndrome (JIVROSG-0402)
Scientific Title A phase II study of stent therapy for malignant vena cava syndrome. (JIVROSG-0402)
Scientific Title:Acronym Stent therapy for vena cava syndrome (JIVROSG-0402)
Region
Japan

Condition
Condition Malignant vena cava stenosis.
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Pneumology
Endocrinology and Metabolism Hematology and clinical oncology Nephrology
Gastrointestinal surgery Hepato-biliary-pancreatic surgery Vascular surgery
Chest surgery Endocrine surgery Breast surgery
Obsterics and gynecology Dermatology Orthopedics
Urology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of stent therapy for malignant vena cava syndrome.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Improvement of clinical symptoms
Key secondary outcomes Adverse events, improvement of findings on venography, techinical success rate.

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 Metallic stents are placed in malignant vena cava stenosis using angiography technique.
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 malignant vana cava stenosis in superior vena cava or inferior vena cava confirmed by contrast enhanced CT.
2) Uncontrolled symptom by medical treatment.
3) Adequate cardiac, hepatic, renal, respiratory, and bone marrow functions.
4) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3.
5) Expected survival more than 4 weeks.
6) Written informed consent.
Key exclusion criteria 1) Potential benefit for symptom relief by chemotherapy, radiotherapy, or surgery.
2) Intraluminal tumor thrombus resulting in stenosis of vena cava.
3) Floating thrombus distal to stenosis.
4) Stenoses both in superior and inferior vena cava.
5) Central venous pressure higher than 8cm H2O.
6) Deformity of cardiac cavity, cardiac tamponade or severe functional disorder oberved by electrocardiogram and ultrasound examination.
7) Stenosis existinf both in SVC and IVC.
8) Active inflammatory disease.
9) Acute active bleeding.
10) Pregnancy.
Target sample size 28

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshito Takeuchi
Organization Kyoto 1st Redcross Hospital
Division name Department of Radiology
Zip code
Address 15-749, Honmachi, Higashiyama-ku, Kyoto, 605-0981, Japan
TEL 075-561-1121
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, Tukiji, Chuo-ku, Tokyo, 104-0045, Japan
TEL 03-3352-2511
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 07 Day

Related information
URL releasing protocol http://jivrosg.umin.jp/
Publication of results Unpublished

Result
URL related to results and publications http://jivrosg.umin.jp/
Number of participants that the trial has enrolled
Results
Patients: age (median) 60.5y (29-91), male 16/female 12, SVC 16/ IVC 12
Technical success: 100%
Angiographic success: 96.4%
Clinical success: 71.4% (95% CI: 54.7-88.1%)
Time-to-improvement (median): 1 day
Adverse events (>=G3): 7.14
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
2005 Year 06 Month 13 Day
Date of IRB
Anticipated trial start date
2005 Year 10 Month 01 Day
Last follow-up date
2008 Year 12 Month 01 Day
Date of closure to data entry
2008 Year 12 Month 01 Day
Date trial data considered complete
2009 Year 03 Month 01 Day
Date analysis concluded
2009 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2005 Year 08 Month 07 Day
Last modified on
2010 Year 02 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000095

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.