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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000184
Receipt No. R000000258
Scientific Title Phase II study of gefitinib in untreated advanced non-small cell lung cancer with EGF receptor mutations
Date of disclosure of the study information 2005/09/12
Last modified on 2006/03/31

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Basic information
Public title Phase II study of gefitinib in untreated advanced non-small cell lung cancer with EGF receptor mutations
Acronym Phase II study of gefitinib in untreated advanced non-small cell lung cancer with EGF receptor mutations
Scientific Title Phase II study of gefitinib in untreated advanced non-small cell lung cancer with EGF receptor mutations
Scientific Title:Acronym Phase II study of gefitinib in untreated advanced non-small cell lung cancer with EGF receptor mutations
Region
Japan

Condition
Condition non-small cell lung cancer
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine the efficacy and safety of gefitinib from the first line in patients with advanced non-small-cell lung cancer with EGF receptor mutations
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Response rate
Key secondary outcomes Toxicity
Survival

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 Gefitinib 250mg/day, until disease progression
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 proved NSCLC
2.EGFR mutation positive
3.No prior chemotherapy
4.Stage IIIB or IV disease
5.Measurable disease on RECIST criteria
6.ECOG PS 0 to 2
7.20 or more than 20 years of age
8.Normal organ functions
9.Anticipated survival at least 3 months
10.Written informed consent.
Key exclusion criteria 1.Serious concomitant systemic disorders
2.Uncontrollable angina, acute myocardial infarction or severe heart failure within 3 months
3.Uncontrollable diabetes mellitus or hypertension
4.Active infection
5.Interstitial pneumonia
6.Uncontrollable pleural effusion
7.Active ulcer
8.Active second malignancy
9.History of severe hypersensitivity
10.Severe SVC syndrome
11.Pregnancy
12.Other severe complication
Target sample size 16

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaharu Nishimura
Organization Hokkaido Lung Cancer Clinical Study Group
Division name First Department of Medicine, Hokkaido University School of Medicine
Zip code
Address North 15, West 7, Kitaku, Sapporo 060-8638, Japan
TEL 011-706-5911
Email

Public contact
Name of contact person
1st name
Middle name
Last name Koichi Yamazaki
Organization Hokkaido Lung Cancer Clinical Study Group
Division name First Department of Medicine, Hokkaido University School of Medicine
Zip code
Address North 15, West 7, Kitaku, Sapporo 060-8638, Japan
TEL 011-706-5911
Homepage URL
Email kyamazak@med.hokudai.ac.jp

Sponsor
Institute Hokkaido Lung Cancer Clinical Study Group
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 12 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
2004 Year 11 Month 22 Day
Date of IRB
Anticipated trial start date
2004 Year 11 Month 01 Day
Last follow-up date
2007 Year 01 Month 01 Day
Date of closure to data entry
2007 Year 01 Month 01 Day
Date trial data considered complete
2007 Year 01 Month 01 Day
Date analysis concluded
2007 Year 01 Month 01 Day

Other
Other related information

Management information
Registered date
2005 Year 09 Month 12 Day
Last modified on
2006 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000258

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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