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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005710
Receipt No. R000006752
Scientific Title Efficacy of preventive treatment of nausea and vomiting induced by chemotherapy of Colorectal Cancer
Date of disclosure of the study information 2011/06/02
Last modified on 2014/05/25

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Basic information
Public title Efficacy of preventive treatment of nausea and vomiting induced by chemotherapy of Colorectal Cancer
Acronym Efficacy of preventive treatment of nausea and vomiting induced by chemotherapy of Colorectal Cancer
Scientific Title Efficacy of preventive treatment of nausea and vomiting induced by chemotherapy of Colorectal Cancer
Scientific Title:Acronym Efficacy of preventive treatment of nausea and vomiting induced by chemotherapy of Colorectal Cancer
Region
Japan

Condition
Condition Colorectal cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of Palonosetron/Dexamethasone plus aprepitant therapy with prevention of CINV according to chemotherapy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Complete Response Rate
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Palonosetron/Dexamethasone
Interventions/Control_2 Palonosetron/Dexamethasone plus aprepitant
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

Not applicable
Gender Male and Female
Key inclusion criteria 1 Chemotherapy including Oxaliplatin or Irinotecan (FOLFOX,FOLFIRI,XELOX)
2 Age 20< or =
3 Performance status of 0,1
4 Written informed consent
Key exclusion criteria 1 Severe renal dysfunction or liver dysfunction
2 History of nausea or vomiting within 24 hours
3 History of GI dysfunction
4 Uncontrollable diabetes mellitus
5 Pregnant or lactating woman
6 Allergy of aprepitant
7 Pimozide administration
8 Not appropriate for the study at the physician's assessment
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Manabu Muto
Organization Graduate School of Medicine, Kyoto University
Division name Department of Gastroenterology and Hepatology
Zip code
Address Kawahara-cho, 54, Shogoin, Sakyo-ku, Kyoto
TEL 075-751-4592
Email mmuto@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takahiro Horimatsu
Organization Graduate School of Medicine, Kyoto University
Division name Department of Gastroenterology and Hepatology
Zip code
Address Kawahara-cho, 54, Shogoin, Sakyo-ku, Kyoto
TEL 075-751-3518
Homepage URL
Email thorimat@kuhp.kyoto-u.ac.jp

Sponsor
Institute Graduate School of Medicine, Kyoto University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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

Other administrative information
Date of disclosure of the study information
2011 Year 06 Month 02 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
2011 Year 05 Month 20 Day
Date of IRB
Anticipated trial start date
2011 Year 07 Month 01 Day
Last follow-up date
2013 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
2013 Year 05 Month 25 Day
Date analysis concluded
2013 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date
2011 Year 06 Month 02 Day
Last modified on
2014 Year 05 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006752

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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