UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000044 |
|---|---|
| Receipt number | 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 13:22:06 |
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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 |
| Obstetrics 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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000084
