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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007265
Receipt No. R000008571
Scientific Title Phase II trial of palonosetron, aprepitant plus dexamethasone in the prevention of nausea and vomiting induced by hepatic arterial injection chemotherapy with cisplatin for Hepatocellular carcinoma
Date of disclosure of the study information 2012/02/10
Last modified on 2017/08/16

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Basic information
Public title Phase II trial of palonosetron, aprepitant plus dexamethasone in the prevention of nausea and vomiting induced by hepatic arterial injection chemotherapy with cisplatin for Hepatocellular carcinoma
Acronym Phase II trial of palonosetron, aprepitant plus dexamethasone in the prevention of nausea and vomiting induced by hepatic arterial injection chemotherapy with cisplatin for Hepatocellular carcinoma
Scientific Title Phase II trial of palonosetron, aprepitant plus dexamethasone in the prevention of nausea and vomiting induced by hepatic arterial injection chemotherapy with cisplatin for Hepatocellular carcinoma
Scientific Title:Acronym Phase II trial of palonosetron, aprepitant plus dexamethasone in the prevention of nausea and vomiting induced by hepatic arterial injection chemotherapy with cisplatin for Hepatocellular carcinoma
Region
Japan

Condition
Condition Hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine Hematology and clinical oncology
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 hepatic arterial injection chemotherapy with cisplatin for Hepatocellular carcinoma
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.), 2-4 8mg (p.o.)
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 are scheduled to receive hepatic arterial injection chemotherapy with cisplatin for Hepatocellular carcinoma
2) No prior chemotherapy
3) Aged 20 years or older
4) Adequate organ function
5) ECOG performance status of 0 or 1
6) Written informed consent
Key exclusion criteria 1) Receiving pimozide
2) With other sever diseases
3) Clinical suspicion or history of metastasis to brain or meninges
4) Patients who need anticonvulsants therapy
5) Ascites and/or pleural effusion to need treatment
6) Pyloric stenosis and/or intestinal obstruction
7) Vomiting, or grade 2 or higher nausea according to CTCAE ver4.0
8) History of drug allergy
9) Pregnant or lactating women or women of childbearing potential, and no birth-control
10) Patient who doesn't have ability or intention that cooperates for procedure of the study
11) Not appropriate for the study at the physician's assessment
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisashi Hidaka
Organization Department of Medicine Kitasato University, School of Medicine
Division name Gastroenterology
Zip code
Address 2-1-1 Asamizodai, Minami-ku, Sagamihara, Kanagawa, 252-0380, Japan
TEL 042-778-8111
Email hisashi7@kitasato-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hisashi Hidaka
Organization Department of Medicine Kitasato University, School of Medicine
Division name Gastroenterology
Zip code
Address 2-1-1 Asamizodai, Minami-ku, Sagamihara, Kanagawa, 252-0380, Japan
TEL 042-778-8111
Homepage URL
Email hisashi7@kitasato-u.ac.jp

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

Funding Source
Organization none
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
2012 Year 02 Month 10 Day

Related information
URL releasing protocol
Publication of results Published

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
2011 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 11 Month 16 Day
Last follow-up date
2013 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2017 Year 08 Month 16 Day

Other
Other related information

Management information
Registered date
2012 Year 02 Month 10 Day
Last modified on
2017 Year 08 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008571

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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