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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000008364
Receipt No. R000009722
Scientific Title Chemotherapy with EGFR-tyrosine kinase inhibitor (EGFR-TKI) or chemotherapy alone in elderly patients with advanced NSCLC with acquired resistance to EGFR-TKI (NEJ017)
Date of disclosure of the study information 2012/07/06
Last modified on 2016/04/27

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Basic information
Public title Chemotherapy with EGFR-tyrosine kinase inhibitor (EGFR-TKI) or chemotherapy alone in elderly patients with advanced NSCLC with acquired resistance to EGFR-TKI (NEJ017)
Acronym NEJ017
Scientific Title Chemotherapy with EGFR-tyrosine kinase inhibitor (EGFR-TKI) or chemotherapy alone in elderly patients with advanced NSCLC with acquired resistance to EGFR-TKI (NEJ017)
Scientific Title:Acronym NEJ017
Region
Japan

Condition
Condition Non-small cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate the efficacy and safety of EGFR-TKI and chemotherapy or chemotherapy alone for elderly or PS 2 patients with advanced NSCLC with acquired resistance to EGFR tyrosine kinase inhibitors
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes progression-free survival
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Chemotherapy and EGFR-TKI
Interventions/Control_2 Chemotherapy
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)Patients with ECOG PS 0-2 and age 70 years or older or PS2 and age younger than 75 years
2)Pathologically or cytlogically confirmed non-small cell lung cancer
3)Patients with clinical stage IIIB unsuitable for radiotherapy, stage IV or recurrent post-operative NSCLC
4) Patients with sensitive EGFR mutation confirmed by sensitive methods such as PNA-LNA PCR clump method
5)Patients with advanced NSCLC and acquired resistance to EGFR-TKIs after achieving stable disease for 6 month or more
6)Patients who had been received EGFR-TKI within 6 weeks of registration of this trial
7)Patients who had received EGFR-TKI only as the previous chemotherapy
8)Patients with evaluable disease defined by RECIST 1.1
9)Patients with adequate organ functions
10)Patients with an estimated survival of at least 3 month
11)Patients with written informed concent
Key exclusion criteria 1)Patients with severe drug allergy
2)Patients with active infection
3)Patients who uses steroids or immunosuppressant drugs
4)Patients with uncontrollable disease
5)Patients with interstitial pneumonia or pulmonary fibrosis on chest CT
6)Patients with massive pleural effusion, ascites, pericardial effusion (drainage or pleurodesis with OK432 or minocylcine are permissive.)
7)Patients who received surgery within 3 weeks or radiotherapy within 2 weeks of registration
8)History of active double cancer within 5 years
9)Patients who have the possibility of pregnancy or in lactation period
10)Patients with symptomatic brain metastases
11)HBs antigen positive
12)Patients whose participation in the trial is judged to be inappropriate by the attending doctor
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Oizumi
Organization Hokkaido University
Division name First Department of Medicine
Zip code
Address N15, W7, Kita-Ku, Sapporo
TEL 011-706-5911
Email soizumi@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hajime Asahina
Organization Hokkaido University
Division name First Department of Medicine
Zip code
Address N15, W7, Kita-Ku, Sapporo
TEL 011-706-5911
Homepage URL
Email hajime.asahina@gmail.com

Sponsor
Institute North East Japan Study Group
Institute
Department

Funding Source
Organization North East Japan Study 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
2012 Year 07 Month 06 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
2012 Year 06 Month 20 Day
Date of IRB
Anticipated trial start date
2012 Year 07 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
2012 Year 07 Month 06 Day
Last modified on
2016 Year 04 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009722

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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