UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008041 |
|---|---|
| Receipt number | R000009470 |
| Scientific Title | Evaluation of combinational effect of Aprepitant on nausea and vomiting induced by chemotherapy (moderate risk) in patients with Gastric Cancer or Colorectal Cancer |
| Date of disclosure of the study information | 2012/05/28 |
| Last modified on | 2017/06/05 10:36:17 |
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Basic information
Public title
Evaluation of combinational effect of Aprepitant on nausea and vomiting induced by chemotherapy (moderate risk) in patients with Gastric Cancer or Colorectal Cancer
Acronym
Emend
Scientific Title
Evaluation of combinational effect of Aprepitant on nausea and vomiting induced by chemotherapy (moderate risk) in patients with Gastric Cancer or Colorectal Cancer
Scientific Title:Acronym
Emend
Region
| Japan |
Condition
Condition
Inoperable advanced/recurrence Gastric Cancer or Colorectal Cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate combinational effect of Aprepitant on nausea and vomiting induced by chemotherapy (moderate risk) in patients with Gastric Cancer or Colorectal Cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
* Frequency of vomiting
* Severity of nausea
Key secondary outcomes
* Grading of appetite
* Used amount of per-request medication
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group A:
* 1st course : Conventional therapy (Palonosetron 0.75 mg i.v. on 1st day + Dexamathasone 9.9 mg i.v. on 1st day, 8 mg p.o. on 2nd day and 3rd day)
* 2nd course : Conventional therapy (Palonosetron 0.75 mg i.v. on 1st day + Dexamathasone 4.95 mg i.v. on 1st day, 4 mg p.o. on 2nd day and 3rd day) plus Aprepitant (125 mg p.o. on 1st day, 80 mg p.o. on 2nd day and 3rd day)
Interventions/Control_2
Group B:
* 1st course: Conventional therapy (Palonosetron 0.75 mg i.v. on 1st day + Dexamathasone 4.95 mg i.v. on 1st day, 4 mg p.o. on 2nd day and 3rd day) plus Aprepitant (125 mg p.o. on 1st day, 80 mg p.o. on 2nd day and 3rd day)
* 2nd course : Conventional therapy (Palonosetron 0.75 mg i.v. on 1st day + Dexamathasone 9.9 mg i.v. on 1st day, 8 mg p.o. on 2nd day and 3rd day)
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) Patient who has Gastric Cancer or Colorectal Cancer receiving FOLFILI, CPT-11 monotherapy, FOLFOX or XELOX regimen
(2) Performance Status (ECOG)=0-2
Key exclusion criteria
(1) Patient who has severe liver failure or renal failure
(2) Patient who has vomited or provoked nausea in the 24 hours prior to start of chemotherapy
(3) Patient who has a factor that induces nausea or vomitting except chemotherapy (brain tumor, obstruction of gastrointestinal tract, active peptic ulcer, brain metastasis et al)
(4) Patient who is considered inappropriate as a target patient by a physician-in-charge
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masashiro Goto |
Organization
Osaka Medical College Hospital
Division name
Chemotherapy Center
Zip code
Address
2-7 Daigaku-machi, Takatsuki City, Osaka, JAPAN
TEL
072-683-1221
in2030@poh.osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiro Goto |
Organization
Osaka Medical College Hospital
Division name
Chemotherapy Cancter
Zip code
Address
2-7 Daigaku-machi, Takatsuki City, Osaka, JAPAN
TEL
072-683-1221
Homepage URL
in2030@poh.osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College Hospital
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical College Hospital
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
大阪医科大学付属病院（Osaka Medical College Hospital)
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 05 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2012 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 05 | Month | 28 | Day |
Last modified on
| 2017 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009470
