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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032860
Receipt No. R000037470
Official scientific title of the study 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 2018/06/04

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Basic information
Official scientific title of the study Palonosetron versus granisetron in combination with fosaprepitant and dexamethasone for TC therapy in patients with gynecologic gancer
Title of the study (Brief title) Antiemetic therapy for TC therapy, phase 3 study.
Region
Japan

Condition
Condition gynecologic gancer
Classification by specialty
Obsterics 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 Soshi Kusunoki
Organization Faculty of Medicine, Juntendo University
Division name Department of Obstetrics and Gynecology
Address Bunkyoku, Tokyo, Japan
TEL 03-3823-3111
Email skusuno@juntendo.ac.jp

Public contact
Name of contact person Soshi Kusunoki
Organization Faculty of Medicine, Juntendo University
Division name Department of Obstetrics and Gynecology
Address Bunkyoku,Tokyo
TEL 03-3823-3111
Homepage URL
Email skusuno@juntendo.ac.jp

Sponsor
Institute Department of Obstetrics and Gynecology, Faculty of Medicine, Juntendo University
Institute
Department

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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 05 Month 31 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 06 Month 04 Day
Last modified on
2018 Year 06 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037470

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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