UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005733
Receipt number R000006778
Scientific Title Efficacy of palonosetron for prevention of chemotherapy-induced nausea and vomitting in patients with haematological malignancies
Date of disclosure of the study information 2011/06/17
Last modified on 2011/06/07 11:54:02

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Basic information

Public title

Efficacy of palonosetron for prevention of chemotherapy-induced nausea and vomitting in patients with haematological malignancies

Acronym

Efficacy of palonosetron for prevention of chemotherapy-induced nausea and vomitting in patients with haematological malignancies

Scientific Title

Efficacy of palonosetron for prevention of chemotherapy-induced nausea and vomitting in patients with haematological malignancies

Scientific Title:Acronym

Efficacy of palonosetron for prevention of chemotherapy-induced nausea and vomitting in patients with haematological malignancies

Region

Japan


Condition

Condition

haematological malignancies

Classification by specialty

Hematology and clinical oncology Adult

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effecacy of Palonosetron for prevention of Chemotherapy-induced nausea and vomitting in patients with haematological malignancies

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

CR rate in overall phase(6 daays after chemotherapy)

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Palonosetron on day 1

Interventions/Control_2

Granisetron on day 1 to 4

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)over 20 years old
2)determinded of haematological malignancies
3)recive over MEC chemotherapy until 4 days
4)able to fact-finding on the spot
5)oral administration
6)PS(ECOG):0-2
7)adequate organ function
8)first-line chemotherapy or over 12 month chemo-free
9)written informed concent

Key exclusion criteria

1)hypersensitivity for palonosetron or other 5-HT3 receptor antagonist
2)wiht naisea(CTCAE Grade2) at register
3)judge to be not suitable by the attending physycian

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shiro Fujii

Organization

Tokushima University Hospital

Division name

Divusion of Haematology

Zip code


Address

2-50-1 Kuramoto-cho,Tokushima,Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Tokushima University Hospital

Division name

Division of Haematology

Zip code


Address


TEL

088-633-7120

Homepage URL


Email



Sponsor or person

Institute

Tokushima University Hospital

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

2011 Year 06 Month 17 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

Preinitiation

Date of protocol fixation

2011 Year 05 Month 31 Day

Date of IRB


Anticipated trial start date

2011 Year 07 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

2011 Year 06 Month 07 Day

Last modified on

2011 Year 06 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006778


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name