UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017804 |
|---|---|
| Receipt number | 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 09:31:26 |
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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
| Obstetrics 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
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
akirak@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University International Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020622
