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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010162
Receipt No. R000011901
Scientific Title Randomized pilot study evaluating indisetron tablets for the prevention of acute-onset diarrhea, nausea and vomiting with IRIS or FOLFIRI for metastatic colorectal cancer patients: HGCSG 0704
Date of disclosure of the study information 2013/03/10
Last modified on 2013/03/05

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Basic information
Public title Randomized pilot study evaluating indisetron tablets for the prevention of acute-onset diarrhea, nausea and vomiting with IRIS or FOLFIRI for metastatic colorectal cancer patients: HGCSG 0704
Acronym Randomized study to explore indisetron for the prevention of acute-onset diarrhea, nausea, vomiting with IRIS/FOLFIRI: HGCSG 0704
Scientific Title Randomized pilot study evaluating indisetron tablets for the prevention of acute-onset diarrhea, nausea and vomiting with IRIS or FOLFIRI for metastatic colorectal cancer patients: HGCSG 0704
Scientific Title:Acronym Randomized study to explore indisetron for the prevention of acute-onset diarrhea, nausea, vomiting with IRIS/FOLFIRI: HGCSG 0704
Region
Japan

Condition
Condition colorectal cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare the efficacy and tolerability of indisetron for irinotecan-induced acute-onset diarrhea, nausea, and vomiting with granisetron.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Incidence of acute-onset diarrhea
Complete protection from vomiting
Key secondary outcomes Complete protection from nausea
No use of rescue therapy
Tolerability

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 indisetrone
Interventions/Control_2 garnisetrone
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1. with advanced or metastatic colorectal cancer
2. scheduled to receive the IRIS or FOLFIRI, with or without molecular targeted agents
3. age 20&#8211;80 years
4. ECOG PS 0&#8211;2
5. written informed consent
Key exclusion criteria 1. had any known central nervous system malignancy
2. had any seizure disorder needing anticonvulsants
3. had active gastrointestinal ulcers or obstruction
4. had any other organic cause of nausea or vomiting unrelated to chemotherapy
5. were scheduled to undergo radiotherapy
6. were pregnant or nursing women
7. had any history of drug hypersensitivity
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshito Komatsu
Organization Hokkaido University Hospital
Division name Cancer Center
Zip code
Address 14-5 Kitaku, Sapporo, Hokkaido, 060-8648, JPN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiraku Fukushima
Organization Hokkaido University Hospital
Division name Cancer Center
Zip code
Address
TEL
Homepage URL
Email hirakuarata@gmail.com

Sponsor
Institute Hokkaido University Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
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 北海道大学病院(北海道)、苫小牧日翔病院(北海道)、苫小牧市立病院(北海道)、札幌北楡病院(北海道)、岩見沢市立病院(北海道)、釧路労災病院(北海道)、北見赤十字病院(北海道)、北海道消化器科病院(北海道)

Other administrative information
Date of disclosure of the study information
2013 Year 03 Month 10 Day

Related information
URL releasing protocol
Publication of results Unpublished

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
2007 Year 12 Month 25 Day
Date of IRB
Anticipated trial start date
2008 Year 04 Month 01 Day
Last follow-up date
2012 Year 07 Month 31 Day
Date of closure to data entry
2012 Year 11 Month 07 Day
Date trial data considered complete
2012 Year 11 Month 07 Day
Date analysis concluded
2013 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2013 Year 03 Month 05 Day
Last modified on
2013 Year 03 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011901

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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