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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN C000000118
Receipt No. R000000173
Scientific Title A Phase II Trial of Gefitinib Monotherapy in Elderly Chemo-naïve Patients with Advanced Non–Small Cell Lung Cancer
Date of disclosure of the study information 2005/09/06
Last modified on 2005/09/06

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Basic information
Public title A Phase II Trial of Gefitinib Monotherapy in Elderly Chemo-naïve Patients with Advanced Non–Small Cell Lung Cancer
Acronym A Phase II Trial of Gefitinib Monotherapy in Elderly Chemo-naïve Patients with Advanced Non–Small Cell Lung Cancer
Scientific Title A Phase II Trial of Gefitinib Monotherapy in Elderly Chemo-naïve Patients with Advanced Non–Small Cell Lung Cancer
Scientific Title:Acronym A Phase II Trial of Gefitinib Monotherapy in Elderly Chemo-naïve Patients with Advanced Non–Small Cell Lung Cancer
Region
Japan

Condition
Condition Non small cell lung cancer
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate the safety and efficacy of gefitinib monotherapy in elderly chemo-naïve patients with advanced non-small cell lung cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes response rate
Key secondary outcomes

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 Gefinitib daily administration
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
100 years-old >=
Gender Male and Female
Key inclusion criteria Histologically or cytologically confirmed NSCLC
Stage IIIB/IV
No prior treatment
Measurable disease
ECOG PS 0-2
Adequate organ function
Age ≥75
Written informed consent
Key exclusion criteria Past history of drug hypersensitivity
SVC syndrome
Pleural or pericardial effusion that required drainage
Active infection
Interstitial pneumonia or active lung fibrosis
Symptomatic brain metastasis
Active concomitant malignancy
Uncontrolled diabetes
Uncontrolled heart disease.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noriyuki Ebi
Organization Iizuka Hospital
Division name Department of Respiratory Medicine
Zip code
Address 3-83 Yoshio-machi, Iizuka city, Fukuoka, Japan Zip-code 820-8505
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization LOGIK
Division name LOGIK
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute LOGIK
Institute
Department

Funding Source
Organization LOGIK
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
2005 Year 09 Month 06 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
Date of protocol fixation
2004 Year 05 Month 07 Day
Date of IRB
Anticipated trial start date
2004 Year 05 Month 01 Day
Last follow-up date
2006 Year 05 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
2005 Year 09 Month 06 Day
Last modified on
2005 Year 09 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000173

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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