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

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 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


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

Value
https://center6.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