UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004133 |
|---|---|
| Receipt number | R000004963 |
| Scientific Title | A Clinical study to which Anti-emetic effect of change of 5-HT3RA is evaluated by using MAT in MEC for gastrointestinal cancer. |
| Date of disclosure of the study information | 2010/09/02 |
| Last modified on | 2013/10/04 09:21:41 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Clinical study to which Anti-emetic effect of change of 5-HT3RA is evaluated by using MAT in MEC for gastrointestinal cancer.
Acronym
A Clinical study to which Anti-emetic effect of change of 5-HT3RA is evaluated by using MAT in MEC for gastrointestinal cancer.
Scientific Title
A Clinical study to which Anti-emetic effect of change of 5-HT3RA is evaluated by using MAT in MEC for gastrointestinal cancer.
Scientific Title:Acronym
A Clinical study to which Anti-emetic effect of change of 5-HT3RA is evaluated by using MAT in MEC for gastrointestinal cancer.
Region
| Japan |
Condition
Condition
Gastric and Colorectal Cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Collection of information concerning improvement of effectiveness of aloxi by medicine change
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The level of each observation point of the nausea and vomiting before and after 5- HT3RA change is evaluated by MAT.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The aloxi 0.75mg is administered before the anti-cancer drug of day1 is administered.
Interventions/Control_2
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) Gastric or Colorectal Cancer
2) Patient of administering schedule when 5- HT3RA is being administered for MEC.
3) 20 years old or more
4) Performance Status(ECOG scale):0-2
5) Adequate organ function for enrollment.
6) Necessary data can be accumulated.
7) Written informed consent.
Key exclusion criteria
1) The change (The change of Dose is included) in the chemotherapeutic regimen is scheduled before and after the change of 5- HT3RA.
2) Hypersensitivity or severe drug allergy for Aloxi or other 5-HT3RA.
3) Hypersensitivity or severe drug allergy for dexamethasone.
4) Any other patient whom the physician in charge of the study judges to be not eligible
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihito Tsuji |
Organization
Kochi Health Sciences Center
Division name
Medical Oncology
Zip code
Address
Ike 2125-1, Kochi city, Kochi prefecture, 781-8555, JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kochi Health Sciences Center
Division name
Medical Oncology
Zip code
Address
Ike 2125-1, Kochi city, Kochi prefecture, 781-8555, JAPAN
TEL
Homepage URL
Sponsor or person
Institute
Kochi Health Sciences Center
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
高知医療センター
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 09 | 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
| 2010 | Year | 08 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 08 | Month | 31 | Day |
Last modified on
| 2013 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004963
