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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000004046
Receipt No. R000004878
Scientific Title A phase II study of erlotinib for gefitinib-resistant non-small cell lung cancer without T790M mutation analyzed in the circulating tumor cell
Date of disclosure of the study information 2010/10/01
Last modified on 2013/04/04

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Basic information
Public title A phase II study of erlotinib for gefitinib-resistant non-small cell lung cancer without T790M mutation analyzed in the circulating tumor cell
Acronym Erlotinib for gefitinib-resistant NSCLC without T790M in CTC
Scientific Title A phase II study of erlotinib for gefitinib-resistant non-small cell lung cancer without T790M mutation analyzed in the circulating tumor cell
Scientific Title:Acronym Erlotinib for gefitinib-resistant NSCLC without T790M in CTC
Region
Japan

Condition
Condition Non-small cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The efficacy and safety of erlotinib for gefitinib-resistant non-small cell lung cancer without T790M in circulating tumor cell
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Objective response rate
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are 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
20 years-old <
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Advanced non-small cell lung cancer harboring EGFR sensitive mutation
2. Pretreated with gefitinib and re-growth was detected
3. Without T790M in the analysis of circulation tumor cell
4. Adequate organ functions, PS0-2
5. Written informed concent
Key exclusion criteria 1. Clinical symptomatic brain metastasis
2. With severe co-morbidities
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Inoue
Organization Tohoku University Hospital
Division name Department of respiratory medicine
Zip code
Address 1-1, Seiryo-machi, Aobaku, Sendai
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Tohoku University Hospital
Division name Department of respiratory medicine
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute North-East Japan Study Group
Institute
Department

Funding Source
Organization Grant from MEXT in Japan
Organization
Division
Category of Funding Organization
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
2010 Year 10 Month 01 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
2010 Year 08 Month 23 Day
Date of IRB
Anticipated trial start date
2010 Year 10 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

Management information
Registered date
2010 Year 08 Month 16 Day
Last modified on
2013 Year 04 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004878

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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