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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017804
Receipt No. R000020622
Scientific Title The study of fosaprepitant in the prevention of chemotherapy induced nausea and vomiting in patients with gynecologic cancer undergoing the combination therapy of Taxens and carboplatin.
Date of disclosure of the study information 2015/06/05
Last modified on 2015/06/04

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Basic information
Public title The study of fosaprepitant in the prevention of chemotherapy induced nausea and vomiting in patients with gynecologic cancer undergoing the combination therapy of Taxens and carboplatin.
Acronym The study of fosaprepitant in the prevention of chemotherapy induced nausea and vomiting in patients with gynecologic cancer undergoing the combination therapy of Taxens and carboplatin.
Scientific Title The study of fosaprepitant in the prevention of chemotherapy induced nausea and vomiting in patients with gynecologic cancer undergoing the combination therapy of Taxens and carboplatin.
Scientific Title:Acronym The study of fosaprepitant in the prevention of chemotherapy induced nausea and vomiting in patients with gynecologic cancer undergoing the combination therapy of Taxens and carboplatin.
Region
Japan

Condition
Condition Cervical cancer, Endometrial cancer, Ovarian cancer, Fallopian tube cancer, and peritoneal cancer
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 to examine the safety and the efficacy of fosaprepitant for the patients who were not fully prevented from CINV with the combination of palonosetron and dexamethasone.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes the proportion of the patients with a complete response (CR, which was defined as no episodes of vomiting and no rescue therapy for nausea).
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 fosaprepitant for the patients who were not fully prevented from CINV with the combination of palonosetron and dexamethasone.
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 Female
Key inclusion criteria 1)Gynecological cancer patients who underwent the combination therapy of carboplatin and Taxens.
2)The patients who can list her symptom diary appropriately.
3)The patients who agreed participation of this study by written documents.
Key exclusion criteria 1)The patient who is complicated with a serious liver damage or a renal damage.
2)A pregnant woman and the patient who may be pregnant now.
3)A patient with past hypersensitivity of fosaprepitant and/or ingredient of aprepitant.
4)A patient using Pimozide.
5)A patient using steroids.
6)Patients who were determined unsuitable for this study by medical doctors.

Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Kurosaki
Organization Saitama Medical University International Medical Center
Division name Gynecologic Oncology
Zip code
Address 1397-1 Yamane, Hidaka-city, Saitama, Japan
TEL +81-42-984-4111
Email akirak@saitama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akira Kurosaki
Organization Saitama Medical University International Medical Center
Division name Gynecologic Oncology
Zip code
Address 1397-1 Yamane, Hidaka-city, Saitama, Japan
TEL +81-42-984-4111
Homepage URL
Email akirak@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University International Medical Center
Institute
Department

Funding Source
Organization Saitama Medical University International Medical Center
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
Email

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
2015 Year 06 Month 05 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
2013 Year 07 Month 03 Day
Date of IRB
Anticipated trial start date
2013 Year 07 Month 03 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
2015 Year 06 Month 04 Day
Last modified on
2015 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=R000020622

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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