UMIN-CTR Clinical Trial

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	Obsterics 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
Email	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
Email	ysugi-junten@umin.ac.jp

Sponsor
Institute	Juntendo Nerima Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022109