UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024219
Receipt number 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 14:09:06

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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