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

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 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


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

Value
https://center6.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