UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000050
Receipt number 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 15:11:01

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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
Obstetrics 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 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

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

Value
https://center6.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