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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000005468
Receipt No. R000006484
Scientific Title Efficacy of low-dose erlotinib as maintenance therapy in patients of lung adenocarcinoma with EGFR mutation
Date of disclosure of the study information 2011/04/19
Last modified on 2015/04/24

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Basic information
Public title Efficacy of low-dose erlotinib as maintenance therapy in patients of lung adenocarcinoma with EGFR mutation
Acronym Efficacy of low-dose erlotinib as maintenance therapy
Scientific Title Efficacy of low-dose erlotinib as maintenance therapy in patients of lung adenocarcinoma with EGFR mutation
Scientific Title:Acronym Efficacy of low-dose erlotinib as maintenance therapy
Region
Japan

Condition
Condition lung adenocarcinoma
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To study anti-tumor effect and adverse event in lung adenocarcinoma patinets with EGFR mutation administrated low-dose erlotinib (25mg/day)
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Response rate (CR+PR)
Key secondary outcomes Overall survival, progression-free survival, Disease control rate, frequency of adverse events, QOL

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 Low-dose erlotinib (25mg/day) is administrated after treatment of platinum based combination regimen
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
85 years-old >
Gender Male and Female
Key inclusion criteria (1)Lung adenocarcinoma with EGFR mutation is obtained pathologically or cytologically.
(2)Patient with normal swallowing function to take erlotinib.
(3)WBC>3000
Platelet<100000
GOT, GPT<2xthe upper limit of the normal range
T-Bil<the upper limit of normal range
sCr<1.5xupper limit of normal range
(4)Patinet without interstitial pneumonitis and lung fibrosis
(5)patient without treatment history of EGFR-TKI
(6)Performance status;PS<4
(7)Age>19, age<85
(8)Informed consent is obtained from the patient
Key exclusion criteria (1) Patient with severe complication
(2) Patient with symptomatic brain metastasis
(3) Patient with double cancer
(4) Pregnant, breast feeding patient. Patient with possibility of pregnant
(5) Patient with diarrhea
(6) History of myocardial infarction within 3 months
(7) Unsuitable patient for this study in opinion of doctor in charge
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Hirano
Organization National center for global health and medicine hospital
Division name Respiratory medicine
Zip code
Address Toyama, 1-21-1, Shinjuku-ku
TEL +81-3-3202-7181
Email shirano@mmc.funabashi.chiba.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Hirano
Organization Funabashi municipal medical center
Division name Medical oncology
Zip code
Address Kanasugi 1-21-1, Funabashi city
TEL +81-47-438-3321
Homepage URL
Email shirano@mmc.funabashi.chiba.jp

Sponsor
Institute National center for global health and medicine
Institute
Department

Funding Source
Organization The Grant of National Center for Global Health and Medicine
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Funabashi Municipal Medical Center
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
2011 Year 04 Month 19 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 12 Month 06 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 01 Day
Last follow-up date
2020 Year 04 Month 01 Day
Date of closure to data entry
2020 Year 04 Month 01 Day
Date trial data considered complete
2020 Year 04 Month 01 Day
Date analysis concluded
2020 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 04 Month 19 Day
Last modified on
2015 Year 04 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006484

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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