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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000521
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute University of Tsukuba
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000630

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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