UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005268 |
|---|---|
| Receipt number | R000006265 |
| Scientific Title | Efficacy of palonosetoron compared with granisetron for prevention of chemotherapy-induced nausea and vomiting (CINV) using MASCC antiemetic tool |
| Date of disclosure of the study information | 2011/03/17 |
| Last modified on | 2013/10/17 18:49:09 |
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Basic information
Public title
Efficacy of palonosetoron compared with granisetron for prevention of chemotherapy-induced nausea and vomiting (CINV) using MASCC antiemetic tool
Acronym
Efficacy of palonosetoron compared with granisetron for prevention of CINV using MAT
Scientific Title
Efficacy of palonosetoron compared with granisetron for prevention of chemotherapy-induced nausea and vomiting (CINV) using MASCC antiemetic tool
Scientific Title:Acronym
Efficacy of palonosetoron compared with granisetron for prevention of CINV using MAT
Region
| Japan |
Condition
Condition
Lung cancer, Colon cancer, Breast cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology | Gastrointestinal surgery |
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate efficacy of Palonosetoron compared with granisetoron using MAT and FLIE in HEC or MEC.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Score of delayed CINV in MAT
Key secondary outcomes
1)Score of nausea in FLIE
2)Score of vomiting in FLIE
3)Number of delayed vomiting
4)Number of acute vomiting
5)Number of acute nausea
6)Number of acute vomiting
7)Plasma concentration of 5-HIAA, Substance P and ghrelin
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Paronosetoron 0.75mg d.i.v. 30 min prior to chemotherapy on Day1
Interventions/Control_2
Granisetoron 3mg d.i.v. 30 min prior to chemotherapy on Day1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patient receiving HEC or MEC defined by Japan Society of Clinical Oncology guideline 2010, ver 1
2)ECOG performance status of 0-2
3)Acquisition of written informed consent
Key exclusion criteria
1)Patient with dementia
2)Concurrent brain radiotherapy
3)Serious infections
4)Clinical brain metastasis
5)Massive pericardial, pleural effusion, or ascites
6)Vestibular disorder
7)Clinical hypercalcaemia or hyponatremia
8)Clinical uremia
9)Ireus or sub-ireus
10)Serious clinical probrems
11)Previous drug allergy
12)Hoped to be pregnant/ nursing
13)Those judged to be not suitable by the attending physician
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukari Tsubata |
Organization
Shimane University Faculty of Medicine
Division name
Division of Clinical Oncology and Respiratory Medicine
Zip code
Address
89-1, Enya-cho, Izumo, Shimane
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Shimane University Faculty of Medicine
Division name
Division of Clinical Oncology and Respiratory Medicine
Zip code
Address
89-1, Enya-cho, Izumo, Shimane
TEL
Homepage URL
Sponsor or person
Institute
Shimane University Faculty of Medicine
Division of Clinical Oncology and Respiratory Medicine
Institute
Department
Personal name
Funding Source
Organization
Shimane University Faculty of Medicine
Division of Clinical Oncology and Respiratory Medicine
Organization
Division
Category of Funding Organization
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 | 03 | Month | 17 | 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
| 2011 | Year | 07 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2013 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2013 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 03 | Month | 17 | Day |
Last modified on
| 2013 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006265
