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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004822
Receipt No. R000005742
Scientific Title A phase II study of first-line gefitinib for advanced and recurrent EGFR mutation positivenon-small cell lung cancerwith high-risk factors
Date of disclosure of the study information 2011/01/05
Last modified on 2017/07/11

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Basic information
Public title A phase II study of first-line gefitinib for advanced and recurrent EGFR mutation positivenon-small cell lung cancerwith high-risk factors
Acronym A phase II study of first-line gefitinib for advanced and recurrent EGFR mutation positivenon-small cell lung cancerwith high-risk factors
Scientific Title A phase II study of first-line gefitinib for advanced and recurrent EGFR mutation positivenon-small cell lung cancerwith high-risk factors
Scientific Title:Acronym A phase II study of first-line gefitinib for advanced and recurrent EGFR mutation positivenon-small cell lung cancerwith high-risk factors
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 efficacy and safety of first-line gefitinib for advanced and recurrent EGFR mutation positivenon-small cell lung cancer with high-risk factors
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 safety, progression-free survival, overall survival

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 Gefitinib(250mg), oral daily
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)histologically or cytologically confirmed non-small cell lung cancer
2)unresectable, stage III or IV disease and radical radiotherapy unable
3)possess measurable lesion
4)EGFR mutation positive
5)20 years old or over
6)naive to chemotherapy for lung cancer
7)naive to radiotherapy for primally lung cancer
8)preserved organ's function
WBC>=2,000/mm3
Hemoglobin>= 7.0g/dl
Platelet count>=75,000/mm3
Total serum bilirubin <=1.5 mg/dl
GOT/GPT <100 IU/l
Serum creatinine <=1.5mg/dl
9)written informed consent
and applicable to 1 or 2 risk factors below
10)ECOG Perfomance status 2 -3
11)75 years old or over
12)evident pleural effusion
13)symptomatic brain or osseous metastasis
14)metastasis in more than two organs
Key exclusion criteria 1)ECOG Perfomance Status 4
2)white blood cell count; less than 2,000/mm3
3)bsolute neutrophil count; less than 1,000/mm3
4)hemoglobin; less than 7.0 g/dL
5)platelet count; less than 75,000/mm3
6)serum total bilirubin; 1.5 mg/dL or over
7)AST/ALT; 100 IU/L or over
8)serum creatinine; 1.5 mg/dL or over
9)serious complications below
I)uncontrollable angina pectoris, myocardial infarction within 6 months or heart failure
II)serious heart dosease
III)uncontrollable diabetes or hypertension
IV)infection
10)pulmonary fibrosis or interstitial pneumonitis evident on chest X ray
11)now pregnant or lactation, or possible pregnancy or refusal of contraception
12)difficult to perform or continue of this study
Target sample size 37

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kozo Yamada
Organization Kanagawa Cancer Center
Division name Department of Thoracic Oncolog
Zip code
Address 2-3-2, Nakao, Asahi-ku, Yokohama, Japan
TEL 045-520-2222
Email yamadak@kcch.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shuji Murakami
Organization Kanagawa Cancer Center
Division name Department of Thoracic Oncology
Zip code
Address 2-3-2, Nakao, Asahi-ku, Yokohama, Japan
TEL 045-520-2222
Homepage URL
Email murakamis@kcch.jp

Sponsor
Institute Kanagawa Cancer Center
Institute
Department

Funding Source
Organization none
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
2011 Year 01 Month 05 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
2010 Year 09 Month 17 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
2011 Year 01 Month 05 Day
Last modified on
2017 Year 07 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005742

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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