UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000521 |
|---|---|
| Receipt number | R000000630 |
| Scientific Title | Study on the efficacy of octreotide acetate for cancer-related bowel obstruction |
| Date of disclosure of the study information | 2006/11/14 |
| Last modified on | 2008/12/09 13:39:20 |
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Basic information
Public title
Study on the efficacy of octreotide acetate for cancer-related bowel obstruction
Acronym
Study on the efficacy of octreotide acetate for cancer-related bowel obstruction
Scientific Title
Study on the efficacy of octreotide acetate for cancer-related bowel obstruction
Scientific Title:Acronym
Study on the efficacy of octreotide acetate for cancer-related bowel obstruction
Region
| Japan |
Condition
Condition
cancer-related bowel obstruction
Classification by specialty
| Gastroenterology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In a multiple-institution study, we prospectively evaluated the therapeutic efficacy of octreotide acetate in patients with cancer-related bowel obstruction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Amelioration of abdominal symptoms (subjective parameters)
Key secondary outcomes
1) Reduction in the number of vomiting episodes and the volume of drainage from a gastric tube (Objective parameters)
2) Correlation between subjective and objective parameters
3) Differences in the efficacy of treatment with octreotide acetate among different cancer types or obstruction sites
4) Assessment of safety in octreotide acetate therapy
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
| Medicine |
Interventions/Control_1
Octreotide acetate of 300 ug/day is administered primarily as a continuous subcutaneous infusion using a continuous infusion pump. Dosage is fixed at 300 ug/day until Day 4. In patients extubated by Day 4, dosage is fixed at 300 ug/day until Day 7.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)In-patients with solid cancer, irrespective of type, who developed bowel obstruction
2)Patients diagnosed with cancer-related bowel obstruction using plain abdominal radiography or computed tomography in addition to symptoms of bowel obstruction such as nausea/vomiting, abdominal pain, and abdominal fullness
3)Patients aged 20 years or over
4)Patients in whom surgery is not indicated
5)Patients providing written informed consent
Key exclusion criteria
1)Patients with cognitive dysfunction
2)Patients with esophageal obstruction
3)Patients with symptomatic brain metastases or meningeal dissemination
4)Patients undergoing anticancer treatment or radiotherapy within the last 2 weeks
5)Patients judged by the physician in charge to be unsuitable for this study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ichinosuke Hyodo |
Organization
University of tsukuba
Division name
Division of Gastroenterology
Zip code
Address
1-1-1, Tennoudai, Tsukuba-city, Ibaraki-ken, Japan
TEL
029-853-3218
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takayuki Hisanaga |
Organization
Tsukuba Medical Center Hospital
Division name
Division of Palliative care
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
| 2006 | Year | 11 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
| 2006 | Year | 08 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2006 | Year | 11 | Month | 14 | Day |
Last modified on
| 2008 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000630
