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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000044
Receipt No. R000000084
Scientific Title A phase II study of palliative treatment with metallic stents for inoperable malignant colorectal strictures. (JIVROSG-0206)
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 II study of palliative treatment with metallic stents for inoperable malignant colorectal strictures. (JIVROSG-0206)
Acronym Colorectal stent (JIVROSG-0206)
Scientific Title A phase II study of palliative treatment with metallic stents for inoperable malignant colorectal strictures. (JIVROSG-0206)
Scientific Title:Acronym Colorectal stent (JIVROSG-0206)
Region
Japan

Condition
Condition Inoperable malignant colorectal strictures.
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Hematology and clinical oncology
Gastrointestinal surgery Hepato-biliary-pancreatic surgery Breast surgery
Obsterics and gynecology Urology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of palliative treatment with metallic stents for inoperable malignant colorectal strictures.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Improvement of subjective symptoms at 1 day, 1,2 and 4 weeks after stenting.
Key secondary outcomes Adverse events, improvement of abdominal radiography findings at 1 day, 1,2 and 4 weeks after stenting.

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 A bare stent is placed in the stenotic portion of sigmoid colon or rectum caused by malignant tumor via the trans-anal route.
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 acute colonic obstruction due to unresectable malignant tumor of sigmoid colon or rectum.
2) Stenosis or obstruction of sigmoid colon or rectum confirmed by colography. The lesion confined within the lower margin more than 5cm distant from the anal ring, and the higher margin up to the level of the iliac crest.
3) No clinically definitive obstruction in upper gastrointestional tract other than sigmoid colon or rectal lesion.
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) The operation for colostomy scheduled.
2) Stenting as the preoperative preparation for the resection.
3) Serious bleeding from the lesion.
4) Pregnancy.
Target sample size 33

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshitaka Inaba
Organization Aichi Cancer Center
Division name Department of Diagnostic Radiology
Zip code
Address 1-1, Kankoden, Chikusaku, Nagoya 464-8681, Japan
TEL 052-762-6111
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 Partially published

Result
URL related to results and publications http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=55&abstractID=30530
Number of participants that the trial has enrolled
Results
Technical success: 97.0% (32/33)
Clinical success (SE+ME, ≥2w): 81.8% (27/33)
Mortality within 30 days: 3 (progression of the primary disease)
Clinical failure due to the obstruction of other sites: 1
Stent removal from anal pain: 1
Adverse events (grade 2-3): diarrhea 12, pain 5, bleeding 1, dysuria 1
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
2007 Year 02 Month 01 Day
Date of closure to data entry
2007 Year 03 Month 01 Day
Date trial data considered complete
2007 Year 03 Month 01 Day
Date analysis concluded
2007 Year 05 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=R000000084

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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