UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003579 |
|---|---|
| Receipt number | R000004335 |
| Scientific Title | Randomized controlled trial of metallic stent placement in patients with malignant vena cava syndrome (JIVROSG-0807) |
| Date of disclosure of the study information | 2010/05/08 |
| Last modified on | 2018/10/31 16:57:54 |
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Basic information
Public title
Randomized controlled trial of metallic stent placement in patients with malignant vena cava syndrome (JIVROSG-0807)
Acronym
Randomized controlled trial of metallic stent placement in patients with malignant vena cava syndrome
Scientific Title
Randomized controlled trial of metallic stent placement in patients with malignant vena cava syndrome (JIVROSG-0807)
Scientific Title:Acronym
Randomized controlled trial of metallic stent placement in patients with malignant vena cava syndrome
Region
| Japan |
Condition
Condition
Malignant vena cava syndrome
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical efficacy of stenting in patients with malignant vena cava syndrome comparing with other treatments in a randomized controlled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Improvement of the symptoms from malignant vena cava syndrome.
Key secondary outcomes
Improvement of health-related QOL, toxicity profile, and survival time.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Placement of vena cava stent (VCS).
Interventions/Control_2
Treatments other than VCS.
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. Vena cava syndrome interfering the daily life.
2. Palliative prognosis index less than 6.
3. Written informed consent from the patients.
4. Twice measurement of symptom score and health-related quality-of-life.
Key exclusion criteria
1. Possible rapid reduction in symptom with chemotherapy or radiotherapy.
2. Not significant symptom from stenosis of vena cava.
3. Platelet count <50,000/mm3 or serum creatinine >=2.0mg/dL or total bilirubin >=3.0mg/dL.
4. Massive floating thrombus in periphery to stenosis.
5. (1) Significant cardiac disease, (2) deformity of the cardiac contour by tumor, (3) impaired cardiac function from cardiac tamponade or pulmonary thromboembolism evaluated with EKG and cardiac echo.
6. Symptomatic stenoses both in superior and inferior vena cava.
7. Candidate to bypass surgery for stenosis of vena cava.
8. Active infection.
9. Presence of acute bleeding conditions.
10. Difficulties in the evaluation of symptomatic score or quality-of-life.
11. Pregnancy.
12. Contraindication decided by the participating physician.
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshito Takeuchi |
Organization
National Cancer Center Hospital
Division name
Division of Diagnostic Radiology
Zip code
Address
5-1-1,Tsukiji,Chuo-ku,Tokyo,104-0045,Japan
TEL
03-3542-2511
arai-y3111@mvh.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuaki Arai |
Organization
National Cancer Center Hospital
Division name
Division of Diagnostic Radiology
Zip code
Address
5-1-1,Tsukiji,Chuo-ku,Tokyo,104-0045,Japan
TEL
03-3542-2511
Homepage URL
http://jivrosg.umin.jp/
arai-y3111@mvh.biglobe.ne.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
Japanese Governmental office
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
愛知県がんセンター中央病院（愛知県）、旭川厚生病院（北海道）、岩手医科大学（岩手県）、岡山大学病院（岡山県）、金沢大学附属病院（石川県）、京都第一赤十字病院（京都府）、群馬大学医学部附属病院（群馬県）、国立がんセンター中央病院（東京都）、静岡県立静岡がんセンター（静岡県）、栃木県立がんセンター（栃木県）、獨協医科大学（栃木県）、社会医療法人敬愛会中頭病院（沖縄県）、奈良県立医科大学（奈良県）、福岡大学病院（福岡県）、防衛医科大学校病院（埼玉県）、三重大学医学部附属病院（三重県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 05 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/30112721
Number of participants that the trial has enrolled
Results
In the phase II trial, the median patients' symptom scores significantly decreased from 10.50 before the procedure to 3.00 after the procedure. Technical success and technical feasibility rates were 96.4% and 100%, respectively. The incidence of treatment-related grade 3 or higher adverse events was 14.3%. In the phase III trial, significant superiority of stent placement was observed in the test, compared to that in the control, group. There was no significant difference in most other evaluations between the groups.
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
| 2009 | Year | 06 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2013 | Year | 08 | Month | 30 | Day |
Date trial data considered complete
| 2013 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2013 | Year | 10 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 05 | Month | 08 | Day |
Last modified on
| 2018 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004335
| Research Plan | |
|---|---|
| Registered date | File name |
| 2018/10/31 | JIVROSG0807計画書第1.1版_090811.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2018/10/31 | 付2_JIVROSG0807_CRF20090727.pdf |
| Research case data | |
|---|---|
| Registered date | File name |
