UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005710 |
|---|---|
| Receipt number | 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 08:29:07 |
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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
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
thorimat@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006752
