UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase II study of first-line gefitinib for advanced and recurrent EGFR mutation positivenon-small cell lung cancerwith high-risk factors
Title of the study (Brief title)	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	Kozo Yamada
Organization	Kanagawa Cancer Center
Division name	Department of Thoracic Oncolog
Address	2-3-2, Nakao, Asahi-ku, Yokohama, Japan
TEL	045-520-2222
Email	yamadak@kcch.jp

Public contact
Name of contact person	Shuji Murakami
Organization	Kanagawa Cancer Center
Division name	Department of Thoracic Oncology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 09 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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