UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032860 |
|---|---|
| Receipt number | R000037470 |
| Scientific Title | Palonosetron versus granisetron in combination with fosaprepitant and dexamethasone for TC therapy in patients with gynecologic gancer |
| Date of disclosure of the study information | 2018/06/10 |
| Last modified on | 2018/12/20 17:31:42 |
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Basic information
Public title
Palonosetron versus granisetron in combination with fosaprepitant and dexamethasone for TC therapy in patients with gynecologic gancer
Acronym
Antiemetic therapy for TC therapy, phase 3 study.
Scientific Title
Palonosetron versus granisetron in combination with fosaprepitant and dexamethasone for TC therapy in patients with gynecologic gancer
Scientific Title:Acronym
Antiemetic therapy for TC therapy, phase 3 study.
Region
| Japan |
Condition
Condition
gynecologic gancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety anf efficacy of palonosetron or granisetron in combination with fosaprepitant and dexamethasone for TC therapy in patients with gynecologic gancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The proportion of patients with no vomiting and no nausea
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
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
Palonosetron, fosaprepitant and dexamethasone
Interventions/Control_2
Granisetron, fosaprepitant and dexamethasone
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
Female
Key inclusion criteria
Female pstienst older than 20 y.o
Fistologically confirmed gynecological cancer
No history of administration with chemotherapy
Scheduled to receive TC regimen
Key exclusion criteria
Severe complicatoins or/and brain metastasis
History of convulsive disorder
Gastrointestinal obstruction
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Soshi Kusunoki |
Organization
Faculty of Medicine, Juntendo University
Division name
Department of Obstetrics and Gynecology
Zip code
Address
Bunkyoku, Tokyo, Japan
TEL
03-3823-3111
skusuno@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Soshi Kusunoki |
Organization
Faculty of Medicine, Juntendo University
Division name
Department of Obstetrics and Gynecology
Zip code
Address
Bunkyoku,Tokyo
TEL
03-3823-3111
Homepage URL
skusuno@juntendo.ac.jp
Sponsor or person
Institute
Department of Obstetrics and Gynecology, Faculty of Medicine, Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Department of Obstetrics and Gynecology, Faculty of Medicine, Juntendo University
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
| 2018 | Year | 06 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 05 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 06 | Month | 10 | 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
| 2018 | Year | 06 | Month | 04 | Day |
Last modified on
| 2018 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037470
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| Registered date | File name |
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