UMIN-CTR Clinical Trial

Basic information
Public title	A randomized controlled, open-labelled early phase II trial comparing incidence of FOLFIRI.3-induced diarrhea between Hangeshashinto and oral alkalization in Japanese patients with colorectal cancer
Acronym	A randomized controlled, open-labelled early phase II trial comparing incidence of FOLFIRI.3-induced diarrhea between Hangeshashinto and oral alkalization in Japanese patients with colorectal cancer
Scientific Title	A randomized controlled, open-labelled early phase II trial comparing incidence of FOLFIRI.3-induced diarrhea between Hangeshashinto and oral alkalization in Japanese patients with colorectal cancer
Scientific Title:Acronym	A randomized controlled, open-labelled early phase II trial comparing incidence of FOLFIRI.3-induced diarrhea between Hangeshashinto and oral alkalization in Japanese patients with colorectal cancer
Region	Japan

Condition
Condition	colorectal cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	to investigate whether oral alkalization could be substituted by Hangeshashin-to (TJ-14) in patients who planned chemotherapy by FOLFIRI.3 regimen towards colorectal cancer (CRC).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	the incidence of all grade of a late-onset diarrhea during the treatment period
Key secondary outcomes	-the number of times taking antidiarrheal drug such as loperamide -medication compliance of the test drugs -response rate of FOLFIRI-3 therapy -duration of FOLFIRI-3 therapy -the incidence of all grade of adverse events other than diarrhea

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Hangeshashinto(TJ-14)
Interventions/Control_2	Oral alkalization
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	-Eastern Cooperative Oncology Group performance status (PS)0-1 -Patients who have treated with FOLFORI-3 regimen -Patients with written informed consent
Key exclusion criteria	-patients who were contraindicated to the test drugs -patients with the record of serious (grade 3,4) drug allergy -patients with severe complication such as ileus uncontrolled diabetes hepatic or renal failure -pregnant or lactating women
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hideaki Miyauchi
Organization	Graduate School of Medicine, Chiba University
Division name	Department of Frontier Surgery
Zip code
Address	1-8-1 Inohana, Chuo-Ku, Chiba 260-8670
TEL	043-222-7171
Email	miyahide@faculty.chiba-u.jp

Public contact
Name of contact person	1st name Middle name Last name Kaori Yamazaki
Organization	Chiba University Hospital
Division name	Division of Pharmacy
Zip code
Address	1-8-1 Inohana, Chuo-Ku, Chiba 260-8670
TEL	043-222-7171
Homepage URL
Email	yamazakika@chiba-u.jp

Sponsor
Institute	Chiba University, Graduate School of Medicine, Department of Frontier Surgery
Institute
Department

Funding Source
Organization	Japan science and technology agency
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	千葉大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 01 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	2008 Year 09 Month 03 Day
Date of IRB
Anticipated trial start date	2008 Year 11 Month 01 Day
Last follow-up date	2013 Year 10 Month 28 Day
Date of closure to data entry	2014 Year 03 Month 31 Day
Date trial data considered complete	2014 Year 05 Month 31 Day
Date analysis concluded	2015 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2016 Year 09 Month 29 Day
Last modified on	2016 Year 09 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027379

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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