UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024219
Receipt No. R000027379
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
Date of disclosure of the study information 2016/10/01
Last modified on 2016/09/29

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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


Contact us.