UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007265 |
|---|---|
| Receipt number | 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 19:14:49 |
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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
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
hisashi7@kitasato-u.ac.jp
Sponsor or person
Institute
Gastroenterology, Department of Medicine Kitasato University, School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008571
