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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | colorectal cancer | |
Classification by specialty |
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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
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 30 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
miyahide@faculty.chiba-u.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
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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 |
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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 | |
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Results Delayed | |
Results Delay Reason | |
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Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |