UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II trial of palonosetron, aprepitant plus dexamethasone in the prevention of nausea and vomiting induced by chemotherapy for urothelial cancer.
Title of the study (Brief title)	Phase II trial of palonosetron, aprepitant plus dexamethasone in the prevention of nausea and vomiting induced by chemotherapy for urothelial cancer.
Region	Japan

Condition
Condition	Urothelial cancer
Classification by specialty	Hematology and clinical oncology Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of palonosetron, aprepitant plus dexamethasone in the prevention of nausea and vomiting induced by chemotherapy for urotherial cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	Complete Response Rate in overall phase(0-120 hours after chemotherapy)
Key secondary outcomes	Complete Response Rate in acute and delayed phase Complete Control Rate in overall, acute and delayed phase The proportion of patients without nausea in overall, acute and delayed phase Safety

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	Palonosetron: day1 0.75mg (i.v.) Aprepitant: day1 125mg, 2-3 80mg (p.o.) Dexamethasone: day1 9.9mg (i.v.)
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	Male and Female
Key inclusion criteria	1) Patients who need anticonvulsants therapy 2) Vomiting, or CTCAE grade 2 or higher nausea 3) History of hypersensitivity for Palonosetron and/or Aprepitant and/or Dexamethasone 4) Pregnant or lactating women or women of childbearing potential 5) Receiving medicine that has antiemetic activity 6) Patient who doesn't have ability or intention that cooperates for procedure of the study 7) Not appropriate for the study at the physician's assessment
Key exclusion criteria	1) Patients who need anticonvulsants therapy 2) Vomiting, or CTCAE grade 2 or higher nausea 3) History of hypersensitivity for Palonosetron and/or Aprepitant and/or Dexamethasone 4) Pregnant or lactating women or women of childbearing potential 5) Receiving medicine that has antiemetic activity 6) Patient who doesn't have ability or intention that cooperates for procedure of the study 7) Not appropriate for the study at the physician's assessment
Target sample size	45

Research contact person
Name of lead principal investigator	Kazumasa Matsumoto
Organization	Department of Medicine Kitasato University, School of Medicine
Division name	Urology
Address	1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, 252-0374, Japan
TEL
Email

Public contact
Name of contact person	Kazumasa Matsumoto
Organization	Department of Medicine Kitasato University, School of Medicine
Division name	Urology
Address
TEL
Homepage URL
Email	kazumasa@cd5.so-net.ne.jp

Sponsor
Institute	Urology, Department of Medicine Kitasato University, School of Medicine
Institute
Department

Funding Source
Organization	non
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	2012 Year 08 Month 06 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2011 Year 06 Month 14 Day
Anticipated trial start date	2011 Year 06 Month 14 Day
Last follow-up date	2014 Year 05 Month 01 Day
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	2012 Year 08 Month 06 Day
Last modified on	2018 Year 11 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010140