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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000008318
Receipt No. R000006107
Scientific Title Effect of additional aprepitant on palonosetron and dexamethasone for prevention of moderately emetogenic chemotherapy-induced nausea and vomiting in patients with lung cancer: clinical phase II study
Date of disclosure of the study information 2012/07/02
Last modified on 2012/07/02

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Basic information
Public title Effect of additional aprepitant on palonosetron and dexamethasone for prevention of moderately emetogenic chemotherapy-induced nausea and vomiting in patients with lung cancer: clinical phase II study
Acronym Effect of additional aprepitant on palonosetron and dexamethasone for prevention of moderately emetogenic chemotherapy-induced nausea and vomiting in patients with lung cancer: clinical phase II study
Scientific Title Effect of additional aprepitant on palonosetron and dexamethasone for prevention of moderately emetogenic chemotherapy-induced nausea and vomiting in patients with lung cancer: clinical phase II study
Scientific Title:Acronym Effect of additional aprepitant on palonosetron and dexamethasone for prevention of moderately emetogenic chemotherapy-induced nausea and vomiting in patients with lung cancer: clinical phase II study
Region
Japan

Condition
Condition lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To examine the effect of additional apreptant to palonosetron and dexamethasone for prevention of moderately emetogenic chemotherapy-induced nausea and vomiting in patients with lung cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Complete Response (CR) rate
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Palonosetoron+Dexamethasone
Interventions/Control_2 Palonosetoron+Aprepitant+Dexamethasone
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1)No prior chemotherapy
2)Patient receiving combination chemotherapy with CBDCA and moderately emetogenic anticancer drugs
7)Written IC.
Key exclusion criteria 1)vomiting within 24h before first chemotherapy
2)continuatory use of severely or moderately emetogenic anticancer drugs after Day 2
3)concurrent radiotherapy
4) Severe complications
5)Symptomatic brain meta
6)Hypersensitivity for PaIonosetron, Aprepitant, Dexamethasone
7) Other patients who are unfit for the study as determined by the attending physician.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiki Ishii
Organization Dokkyo Medical University
Division name Department of Pulmonary Medicine and Clinical Immunology
Zip code
Address 880 Kitakobayashi, Mibu, Tochigi, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiki Ishii
Organization Dokkyo Medical University
Division name Department of Pulmonary Medicine and Clinical Immunology
Zip code
Address
TEL
Homepage URL
Email ishiiysk@dokkyomed.ac.jp

Sponsor
Institute Dokkyo Medical University
Institute
Department

Funding Source
Organization Dokkyo Medical University
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 07 Month 02 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 Open public recruiting
Date of protocol fixation
2011 Year 02 Month 10 Day
Date of IRB
Anticipated trial start date
2012 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
2012 Year 07 Month 02 Day
Last modified on
2012 Year 07 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006107

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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