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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000006498
Receipt No. R000007685
Scientific Title Palonosetoron+Aprepitant+Dexamethasone Therapy in patients receiving moderately emetogenic anticancer drugs (EJCG-1001)
Date of disclosure of the study information 2011/10/07
Last modified on 2011/10/07

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Basic information
Public title Palonosetoron+Aprepitant+Dexamethasone Therapy in patients receiving moderately emetogenic anticancer drugs (EJCG-1001)
Acronym Palonosetoron+Aprepitant+Dexamethasone Therapy in patients receiving moderately emetogenic anticancer drugs (EJCG-1001)
Scientific Title Palonosetoron+Aprepitant+Dexamethasone Therapy in patients receiving moderately emetogenic anticancer drugs (EJCG-1001)
Scientific Title:Acronym Palonosetoron+Aprepitant+Dexamethasone Therapy in patients receiving moderately emetogenic anticancer drugs (EJCG-1001)
Region
Japan

Condition
Condition Lung cancer
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate efficacy and safety of PaIonosetron+ Aprepitant + Dexamethasone in moderately emetic CINV in lung cancer.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Complete response rate in chemotherapy of CBDCA
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 1)Aprepitant:
125mg po. 1-1.5 hr. prior to chemotherapy on Day1
80mg po. on Day 2-3.

(2)Palonosetron
0.75mg iv. prior to chemotherapy on Day1

(3)Dexamethasone: 4.95mg iv. 30 min. prior to chemotherapy on Day 1
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)No prior chemotherapy
2)Patient receiving in CBDCA and Histologically or cytologically proven Lung cancer
3)ECOG performance status of 0 to 2
4)>=Age 20
6) Ability to ingestion intake and drug administration orally
7)Written IC.
Key exclusion criteria 1)Severe complications
2)Symptomatic brain meta
4) Massive pleural or abdominal effusion
5) Intestinal paralysis or ileus
7)Hypersensitivity for PaIonosetron, Aprepitant, Dexamethasone
9) Pregnant or lactating
10) Other patients who are unfit for the study as determined by the attending physician.
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshimichi Miya
Organization Nippom Medical School Tamanagayama Hospital
Division name Department of Pulmonary Medicine
Zip code
Address 1-7-1, Nagayama, Tama-city, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Toshimichi Miya
Organization Nippom Medical School Tamanagayama Hospital
Division name Department of Pulmonary Medicine
Zip code
Address
TEL
Homepage URL
Email tmiya@nms.ac.jp

Sponsor
Institute East Japan Chesters Group (EJCG)
Institute
Department

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 10 Month 07 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
2010 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 12 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 10 Month 07 Day
Last modified on
2011 Year 10 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007685

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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