UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004865
Receipt number R000005792
Scientific Title Palonosetron+Aprepitant+Dexamethasone for highly emetic chemotherapy induced nausea and voimiting
Date of disclosure of the study information 2011/01/13
Last modified on 2015/05/29 14:00:22

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Basic information

Public title

Palonosetron+Aprepitant+Dexamethasone for highly emetic chemotherapy induced nausea and voimiting

Acronym

Palonosetron+Aprepitant+Dexamethasone for highly emetic chemotherapy induced nausea and voimiting

Scientific Title

Palonosetron+Aprepitant+Dexamethasone for highly emetic chemotherapy induced nausea and voimiting

Scientific Title:Acronym

Palonosetron+Aprepitant+Dexamethasone for highly emetic chemotherapy induced nausea and voimiting

Region

Japan


Condition

Condition

Lung cancer

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate efficacy and safety of PaIonosetron+ Aprepitant + Dexamethasone in highly emetic CINV in lung cancer.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Primary end point: Complete control rate

Key secondary outcomes

Secondary end point: Complete control rate, Time to treatment failure, QOL assessment.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Aprepitant: 125mg po. 1-1.5 hr. prior to chemotherapy on Day1
PaIonosetron:0.75mg iv. prior to chemotherapy on Day1
Dexamethasone: 9.9mg iv. 30 min. prior to chemotherapy on Day 1, 8mg po. on Day 2-4.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Histologically or cytologically proven Lung cancer
2)No prior chemotherapy
3)Patient receiving highly emetic chemotherapy defined by NCCN guideline 2009, ver 1.
3) Written IC.

Key exclusion criteria

1) Vomiting prior to chemotherapy
2)HEC administration except Day 1.
3)Radiation therapy
4)Contraindication of Dexamethasone
5)Symptomatic brain meta
6)Hypersensitivity for PaIonosetron, Aprepitant, Dexamethasone

Target sample size

95


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hirohisa Yoshizawa

Organization

Niigata University Medical and Dental Hospital

Division name

Bioscience Medical Research Center

Zip code


Address

1-754 Asahimachi-Dori,Niigata City, Niigata 951-8520

TEL

025-227-2517

Email

hy0522@med.niigata-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hirohisa Yoshizawa

Organization

Niigata University Medical and Dental Hospital

Division name

Bioscience Medical Research Center

Zip code


Address

1-754 Asahimachi-Dori,Niigata City, Niigata 951-8520

TEL

025-227-2517

Homepage URL


Email

hy0522@med.niigata-u.ac.jp


Sponsor or person

Institute

Niigata Lung Cancer Treatment Group

Institute

Department

Personal name



Funding Source

Organization

Niigata Foundation for the Promotion of Medicine

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan


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

新潟肺癌治療研究会参加施設
新潟大学医歯学総合病院
新潟県立がんセンター新潟病院
鶴岡市立荘内病院
新潟市民病院
新潟県立新発田病院
佐渡総合病院
南部郷総合病院
厚生連長岡中央綜合病院
厚生連三条総合病院
厚生連刈羽郡総合病院
長岡赤十字病院
厚生連豊栄病院
済生会新潟第二病院
国立病院機構西新潟中央病院
新潟県立中央病院
新潟県立柿崎病院
燕労災病院
上越総合病院
新潟県立吉田病院


Other administrative information

Date of disclosure of the study information

2011 Year 01 Month 13 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed/23644992

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

2010 Year 07 Month 01 Day

Date of IRB


Anticipated trial start date

2010 Year 12 Month 01 Day

Last follow-up date

2012 Year 07 Month 01 Day

Date of closure to data entry

2012 Year 07 Month 07 Day

Date trial data considered complete

2012 Year 07 Month 10 Day

Date analysis concluded

2012 Year 07 Month 14 Day


Other

Other related information



Management information

Registered date

2011 Year 01 Month 13 Day

Last modified on

2015 Year 05 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005792


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name