UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001849 |
|---|---|
| Receipt number | R000002118 |
| Scientific Title | phase II study of Erlotinib for non-small cell lung cancer patients with EGFR mutation |
| Date of disclosure of the study information | 2009/04/04 |
| Last modified on | 2012/04/23 00:46:16 |
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Basic information
Public title
phase II study of Erlotinib for non-small cell lung cancer patients with EGFR mutation
Acronym
Erlotinib PII for EGFR mutation(+) NSCLC
Scientific Title
phase II study of Erlotinib for non-small cell lung cancer patients with EGFR mutation
Scientific Title:Acronym
Erlotinib PII for EGFR mutation(+) NSCLC
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To confirm efficacy and safty of elrotinib for non-samll cell lung cancer patiets with EGFR mutation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
response rate
Key secondary outcomes
progression free survival, overall survival, toxicity
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
To diagnosis non-small cell lung cancer by cytology or histology.To have EGFR mutation. To have a majarble tumor. Without active malignancies. Previously treated with chemotherpy.With adequate organ functions.PS of 0 to 2. To get I.C.
Key exclusion criteria
Pericardial effusion With subjective symptoms. Superior vena cava syndrome with necessary of emergecy radiation.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoichi Nakamura |
Organization
Nagasaki University Hospital of Medecine
Division name
Second department of Internal Medecine
Zip code
Address
Sakamoto1-7-1,Nagasaki city
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kohei Motoshima |
Organization
Second department of Internal Medecine
Division name
Nagasaki Thoracic Oncology Group
Zip code
Address
TEL
Homepage URL
preiland5461@yahoo.co.jp
Sponsor or person
Institute
Nagasaki Thoracic Oncology Group
Institute
Department
Personal name
Funding Source
Organization
Nagasaki Thoracic Oncology Group
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
| 2009 | Year | 04 | Month | 04 | 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
| 2008 | Year | 06 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 04 | Month | 04 | Day |
Last modified on
| 2012 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002118
