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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001849
Receipt No. 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

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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
Email

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
Email preiland5461@yahoo.co.jp

Sponsor
Institute Nagasaki Thoracic Oncology Group
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002118

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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