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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004865
Receipt No. 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

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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
Institute Niigata Lung Cancer Treatment Group
Institute
Department

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
URL(English) https://upload.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


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