UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002783
Receipt No. R000003384
Scientific Title A phase II study of gefitinib as first-line treatment for elderly patients with advanced lung adenocarcinoma who have active EGFR mutations
Date of disclosure of the study information 2009/11/19
Last modified on 2012/05/28

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A phase II study of gefitinib as first-line treatment for elderly patients with advanced lung adenocarcinoma who have active EGFR mutations
Acronym A phase II study of gefitinib as first-line treatment for elderly patients with advanced lung adenocarcinoma who have active EGFR mutations
Scientific Title A phase II study of gefitinib as first-line treatment for elderly patients with advanced lung adenocarcinoma who have active EGFR mutations
Scientific Title:Acronym A phase II study of gefitinib as first-line treatment for elderly patients with advanced lung adenocarcinoma who have active EGFR mutations
Region
Japan

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

Objectives
Narrative objectives1 evaluate the efficacy and feasibility of gefitinib as first-line treatment for elderly advanced lung adenocarcinoma patients with EGFR mutations
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Response rate
Key secondary outcomes safety, disease control rate, progression free survival overall survival, quality of life

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
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 1)histopathologically diagnosed as
primary lung adenocarcinoma
2)including the mutation in exon 19 or
21
3)confirmed advanced stage 3B or 4 lung
adenocarcinoma
4)75 years or older
5)ECOG PS 0-2
6)measurable lesion
7)adequate organ function
8)predicted 12 weeks or more survival
9)informed consent
Key exclusion criteria 1)interstitial pneumonia on computed
tomography scan
2)liver cirrhosis, uncontrolled diabetes
mellitus, cardiac infarciton and
cereral apoplexy onset within three
months
3)othere active cancer
4)symptomatic brain metastases
5)need to plan the radiotherapy included
in the lung field
6)history of sever drug allegy
7)judged to be inappropriate by the
attending doctor

Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomonobu Koizumi
Organization Shinshu University School of Medicine
Division name The first department of internal medicine
Zip code
Address 3-1-1 Asahi, Matsumoto, Nagano, JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Shinshu University School of Medicine
Division name The first department of internal medicine
Zip code
Address
TEL 0263-37-2631
Homepage URL
Email

Sponsor
Institute Nagano lung cancer study meeting
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
2009 Year 11 Month 19 Day

Related information
URL releasing protocol
Publication of results Published

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
2007 Year 08 Month 16 Day
Date of IRB
Anticipated trial start date
2007 Year 09 Month 01 Day
Last follow-up date
2011 Year 11 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 11 Month 19 Day
Last modified on
2012 Year 05 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003384

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.