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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028424
Receipt No. R000032533
Scientific Title EGFR-TKI versus chemotherapy for Asians with previously untreated advanced non-small cell lung cancer: a meta-analysis
Date of disclosure of the study information 2017/07/31
Last modified on 2017/07/28

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Basic information
Public title EGFR-TKI versus chemotherapy for Asians with previously untreated advanced non-small cell lung cancer: a meta-analysis
Acronym EGFR-TKIs versus chemotherapy
Scientific Title EGFR-TKI versus chemotherapy for Asians with previously untreated advanced non-small cell lung cancer: a meta-analysis
Scientific Title:Acronym EGFR-TKIs versus chemotherapy
Region
Japan

Condition
Condition EGFR mutation-positive previously untreated non-small cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 to compare overall survival between EGFR-TKI and conventional platinum based chemotherapies by performing a meta-analysis of phase 3 randomized trials or their follow up analyses.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Overall survival
Key secondary outcomes progression free survival

Base
Study type Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_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
75 years-old >
Gender Male and Female
Key inclusion criteria a meta-analysis of phase 3 randomized trials or their follow up analyses.
Key exclusion criteria case-control, cohort, and non-blind clinical trials
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichi Ando
Organization Showa University
Division name Division of Respiratory Medicine and Allergology, Department of Medicine
Zip code
Address Hatanodai, 1-5-8, Shinagawa-ku, Tokyo, 142-8666, Japan
TEL +81-3-3784-8532
Email koichi-a@med.showa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koichi Ando
Organization Showa University
Division name Division of Respiratory Medicine and Allergology, Department of Medicine
Zip code
Address Hatanodai, 1-5-8, Shinagawa-ku, Tokyo, 142-8666, Japan
TEL +81-3-3784-8532
Homepage URL
Email koichi-a@med.showa-u.ac.jp

Sponsor
Institute Division of Respiratory Medicine and Allergology, Department of Medicine, Showa University, Hatanodai, 1-5-8, Shinagawa-ku, Tokyo, 142-8666, Japan

Institute
Department

Funding Source
Organization Division of Respiratory Medicine and Allergology, Department of Medicine, Showa University, Hatanodai, 1-5-8, Shinagawa-ku, Tokyo, 142-8666, Japan

Organization
Division
Category of Funding Organization Other
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
2017 Year 07 Month 31 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 Completed
Date of protocol fixation
2017 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 04 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 We could not demonstrate the overall efficacy for OS of EGFR-TKIs versus chemotherapy.

Management information
Registered date
2017 Year 07 Month 28 Day
Last modified on
2017 Year 07 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032533

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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