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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010525
Receipt No. R000012306
Scientific Title Efficacy and safety of erlotinib in elderly patients with non-small-cell lung cancer harboring epidermal growth factor receptor mutations: A phase 2 study.
Date of disclosure of the study information 2013/04/17
Last modified on 2016/06/10

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Basic information
Public title Efficacy and safety of erlotinib in elderly patients with non-small-cell lung cancer harboring epidermal growth factor receptor mutations: A phase 2 study.
Acronym Efficacy and safety of erlotinib in elderly patients with EGFR-mutations-positive NSCLC.
Scientific Title Efficacy and safety of erlotinib in elderly patients with non-small-cell lung cancer harboring epidermal growth factor receptor mutations: A phase 2 study.
Scientific Title:Acronym Efficacy and safety of erlotinib in elderly patients with EGFR-mutations-positive NSCLC.
Region
Japan

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

Objectives
Narrative objectives1 The objective of this study is to assess the efficacy and safety of erlotinib in elderly patients aged 75 years or older with non-small-cell lung cancer harboring epidermal growth factor receptor mutations.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Response rate
Key secondary outcomes Progression free survival, overall survival, safety, QOL score

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 Elderly patients with EGFR-mutations-positive non-small-cell lung cancer receive elrotinib.
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
75 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria All participants must meet the following criteria.
1: Histologically or pathologically proven NSCLC; stage 3B, 4, or reccurence.
2: EGFR mutation positive.
3: Aged 75 years or older.
4: Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.
4: Stage 3B/4 NSCLC.
5: Chemotherapy naive or received 1 regimen chemotherapy.
6: Never administerd EGFR-TKI.
7: a. Hemoglobin: more than 9.0 g/dL.
b. Neutrophil count: more than 3,000/uL.
c. Platelet count: more than 100,000/uL.
d. Aspartate transaminase (AST), alanine transaminase(ALT): less than 2.5 times the upper limit of normal of the institutional reference range.
e. Total bilirubin: less than 1.5 times the upper limit of normal of the institutional reference range.
8: Life expectancy of more than 3 months.
9: Written informed consent.
Key exclusion criteria Exclusion criteria are as follows
1: History of severe allergic reactions to drugs.
2: Pregnancy or lactation.
3: Willing to get pregnant.
4: Interstitial lung disease.
5: Severe infection.
6; Severe and unstable medical comorbidities.
7: Difficulty in ingestion.
8: Uncontrolled brain metastases.
9: EGFR T790M mutation.
10: Judgment to attending physician.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takafumi Suda
Organization Hamamatsu University School of Medicine
Division name Second Division, Department of Internal Medicine
Zip code
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu-city, Japan
TEL 053-435-2263
Email suda@hama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yusuke Inoue
Organization Hamamatsu University School of Medicine
Division name Second Division, Department of Internal Medicine
Zip code
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu-city, Japan
TEL 053-435-2111
Homepage URL
Email y.inoue@hama-med.ac.jp

Sponsor
Institute Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization Other
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
2013 Year 04 Month 17 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
2013 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 17 Day
Last follow-up date
2015 Year 04 Month 08 Day
Date of closure to data entry
Date trial data considered complete
2015 Year 04 Month 08 Day
Date analysis concluded
2015 Year 04 Month 08 Day

Other
Other related information

Management information
Registered date
2013 Year 04 Month 17 Day
Last modified on
2016 Year 06 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012306

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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