UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013055 |
|---|---|
| Receipt number | R000015231 |
| Scientific Title | Erlotinib in non- or light-smoker patients with NSCLC harvoring wild type EGFR and wild type ALK |
| Date of disclosure of the study information | 2014/02/03 |
| Last modified on | 2016/11/28 10:48:26 |
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Basic information
Public title
Erlotinib in non- or light-smoker patients with NSCLC harvoring wild type EGFR and wild type ALK
Acronym
Erlotinib in light-smoking lung adenocarcinoma with wild EGFR and ALK
Scientific Title
Erlotinib in non- or light-smoker patients with NSCLC harvoring wild type EGFR and wild type ALK
Scientific Title:Acronym
Erlotinib in light-smoking lung adenocarcinoma with wild EGFR and ALK
Region
| Japan |
Condition
Condition
Lung adenocarcinoma
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Efficacy of erlitinib
Basic objectives2
Others
Basic objectives -Others
false negative rate of EGFR testing
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Response rate
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Erlotinib
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
Lung adnocarcinoma
Negative in the 1st EGFR and ALK test
At least one cytotixic chemotherapy
No EGFR-TKI treatment
Eligible for erlotinib
PS0-2
Sufficient organ function
Key exclusion criteria
Concomitant interstitial pneumonotis
Concomitant other advanced cancer
Smoing index > 100
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumio |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Department
Zip code
Address
1-3-3 Nakamichi Higashinari-ku, Osaka 537-8511, Japan
TEL
0669721181
imamura-fu@mc.pref.osaka.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | F |
Organization
Osaka
Division name
Department of Thoracic Oncology
Zip code
Address
1-3-3 Nakamichi Higashinari-ku, Osaka 537-8511, Japan
TEL
0669721181
Homepage URL
imamura-fu@mc.pref.osaka.jp
Sponsor or person
Institute
Department of Thoracic Oncology
Institute
Department
Personal name
Funding Source
Organization
Department of Thoracic Oncology
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
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
| 2014 | Year | 02 | Month | 03 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 04 | 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
| 2014 | Year | 02 | Month | 03 | Day |
Last modified on
| 2016 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015231
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
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