UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028424 |
|---|---|
| Receipt number | 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 12:51:50 |
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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
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
koichi-a@med.showa-u.ac.jp
Sponsor or person
Institute
Division of Respiratory Medicine and Allergology, Department of Medicine, Showa University, Hatanodai, 1-5-8, Shinagawa-ku, Tokyo, 142-8666, Japan
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032533
