Unique ID issued by UMIN | UMIN000024219 |
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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 |
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
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
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
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
Japan |
colorectal cancer
Gastrointestinal surgery |
Malignancy
NO
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).
Efficacy
Exploratory
Pragmatic
Phase II
the incidence of all grade of a late-onset diarrhea during the treatment period
-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
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
YES
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
Hangeshashinto(TJ-14)
Oral alkalization
20 | years-old | <= |
80 | years-old | >= |
Male and Female
-Eastern Cooperative Oncology Group performance status (PS)0-1
-Patients who have treated with FOLFORI-3 regimen
-Patients with written informed consent
-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
30
1st name | |
Middle name | |
Last name | Hideaki Miyauchi |
Graduate School of Medicine, Chiba University
Department of Frontier Surgery
1-8-1 Inohana, Chuo-Ku, Chiba 260-8670
043-222-7171
miyahide@faculty.chiba-u.jp
1st name | |
Middle name | |
Last name | Kaori Yamazaki |
Chiba University Hospital
Division of Pharmacy
1-8-1 Inohana, Chuo-Ku, Chiba 260-8670
043-222-7171
yamazakika@chiba-u.jp
Chiba University, Graduate School of Medicine, Department of Frontier Surgery
Japan science and technology agency
Japanese Governmental office
NO
千葉大学医学部附属病院
2016 | Year | 10 | Month | 01 | Day |
Unpublished
Completed
2008 | Year | 09 | Month | 03 | Day |
2008 | Year | 11 | Month | 01 | Day |
2013 | Year | 10 | Month | 28 | Day |
2014 | Year | 03 | Month | 31 | Day |
2014 | Year | 05 | Month | 31 | Day |
2015 | Year | 03 | Month | 31 | Day |
2016 | Year | 09 | Month | 29 | Day |
2016 | Year | 09 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027379
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