UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019122 |
|---|---|
| Receipt number | R000022109 |
| Scientific Title | A phase II randomised study to evaluate the efficacy of aprepitant plus palonosetron for preventing delayed-phase CINV associated with TC therapy in gynaecological cancer |
| Date of disclosure of the study information | 2015/09/26 |
| Last modified on | 2021/03/22 17:24:41 |
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Basic information
Public title
A phase II randomised study to evaluate the efficacy of aprepitant plus palonosetron for preventing delayed-phase CINV associated with TC therapy in gynaecological cancer
Acronym
A phase II randomised study to evaluate the efficacy of aprepitant plus palonosetron for preventing delayed-phase CINV associated with TC therapy in gynaecological cancer
Scientific Title
A phase II randomised study to evaluate the efficacy of aprepitant plus palonosetron for preventing delayed-phase CINV associated with TC therapy in gynaecological cancer
Scientific Title:Acronym
A phase II randomised study to evaluate the efficacy of aprepitant plus palonosetron for preventing delayed-phase CINV associated with TC therapy in gynaecological cancer
Region
| Japan |
Condition
Condition
gynaecological cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
efficacy of aprepitant plus palonosetron against that of palonosetron for CINV in patient receiving moderately emetic cancer chemotherapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
complete response (CR, defined as complete absence of emetic events) in the delayed phase
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
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
control group (standard antiemetic therapy:0.75 mg palonosetron administered intravenously on day 1 and 6 mg dexamethasone administered intravenously on day 1 and 4 mg dexamethasone administered orally on days 2 and 3).
Interventions/Control_2
aprepitant group (oral administration of 125 mg aprepitant 90 minutes before administration of the chemotherapy drug on day 1 and of 80 mg on days 2 and 3 and 0.75 mg palonosetron administered intravenously on day 1 and 6 mg dexamethasone administered intravenously on day 1 and 4 mg dexamethasone administered orally on days 2 and 3)
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
20 years of age with gynaecological cancer who were scheduled to receive single-day chemotherapy with a carboplatin target area under the concentration curve of 5, and paclitaxel at 175 mg/m2. All patients had an Eastern Cooperative Oncology Group performance status of 0-2, adequate renal function, adequate hepatic function, and adequate marrow function.
All patients provided written informed consent for their participation in the study.
Key exclusion criteria
receipt of any agent that could affect the study results (such as an antiemetic, steroid, or pimozide) before the start of chemotherapy; symptomatic brain metastasis; gastro-intestinal obstruction or any other condition that could provoke nausea and vomiting; and a known allergy or severe reaction to any of the study drugs.
Target sample size
76
Research contact person
Name of lead principal investigator
| 1st name | Daiki |
| Middle name | |
| Last name | Ogishima |
Organization
Juntendo Nerima Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
177-8521
Address
Takanodai 3-1-10, Nerima-ku, Tokyo, Japan
TEL
03-5923-3111
daiki@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Yayoi |
| Middle name | |
| Last name | Sugimori |
Organization
Juntendo Nerima Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
177-8521
Address
Takanodai 3-1-10, Nerima-ku, Tokyo, Japan
TEL
03-5923-3111
Homepage URL
ysugi-junten@umin.ac.jp
Sponsor or person
Institute
Juntendo Nerima Hospital
Institute
Department
Personal name
Funding Source
Organization
Juntendo Nerima Hospital
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
Juntendo Nerima Hospital
Address
Takanodai 3-1-10, Nerima-ku, Tokyo, Japan
Tel
03-5923-3111
ysugi-junten@umin.ac.jp
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 | 09 | Month | 26 | 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
| 2010 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | 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 | 09 | Month | 26 | Day |
Last modified on
| 2021 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022109
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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