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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002014
Receipt No. R000002455
Scientific Title Phase III study of gefitinib versus erlotinib in patients with previously treated lung adeno carcinoma
Date of disclosure of the study information 2009/06/19
Last modified on 2016/03/31

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Basic information
Public title Phase III study of gefitinib versus erlotinib in patients with previously treated lung adeno carcinoma
Acronym gefitinib versus erlotinib in patients with previously treated lung adeno carcinoma (WJOG5108)
Scientific Title Phase III study of gefitinib versus erlotinib in patients with previously treated lung adeno carcinoma
Scientific Title:Acronym gefitinib versus erlotinib in patients with previously treated lung adeno carcinoma (WJOG5108)
Region
Japan

Condition
Condition Previously treated lung adeno carcinoma
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare the efficacy of gefitinib with erlotinib in previously treated lung adeno carcinoma.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Progression free survival
Key secondary outcomes Overall survival, Response rate, disease control rate, Toxicity, Time to treatment failure,

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 A: Reference arm
Erlotinib monotherapy
Interventions/Control_2 B: Experimental arm
Gefitinib monotherapy
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)Patients with lung cancer which was pathologically proven adenocarcinoma.
2)Patients with stage IIIb or IV who heve previously treated one or more chemotherapy.
*Adjuvant and neo-adjuvant chemotherapy
are not considered as one regimen of chemotherapy.
*Oral agents except for TS-1 are not considered as one regimen of chemotherapy.
3).Patients with evaluable disease (not necessarily to be measurable)
4)7.Age eligible for study: 20 years and above
5)ECOG PS 0-2
6)Sufficient organ function
WBC>=3000/mm3
Plt >=75000/mm3
GOT/GPT <=100IU/L
T-bil=<1.5mg/dl
Cr. =<1.2mg/dL
SpO2>=95% or PaO2>=60%
7)No prior drug therapy targeting EGFR (TKI, Abs) .
8)Patients are expected to live over 12 weeks.
9)Written informed consent
Key exclusion criteria 1)History of obvious and widely distributed interstitial pneumonia or pulmonary fibrosis detected by chest CT
2)History of drug induced interstitial pneumonia
3)History of severe drug allergy
4)History of radiation therapy for mediastinum or lung within 14 days at the time of entry. (Radiation therapy for other parts is not adapted for this exclusion cliteria.)
5)History of poorly controlled pleural effusion, pericardial effusion or ascites necessitating drainage
6)History of active infection
7)History of persistent watery diarrhea
8)History of ileus
9)Patients who are not take in drug orally
10)History of symptomatic brain metastases.
11)History of active double cancer
12)History of poorly controlled cardiac diseases.
13)History of active psychological disease.
14) History of pregnancy or lactation
15) Patients whose participation in the trial is judged to be inappropriate by the attending doctor
Target sample size 560

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiko Urata
Organization Hyogo Cancer Center
Division name Thoracic Oncology
Zip code
Address 13-70 Kitaoji &#8211;cho, Akasi-city, Hyogo.
TEL 078-929-1151
Email urata@hp.pref.hyogo.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinichiro Nakamura
Organization West Japan Oncology Group
Division name WJOG datacenter
Zip code
Address Namba Plaza Bldg.3F 1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN
TEL 06-6633-7400
Homepage URL
Email datacenter@wjog.jp

Sponsor
Institute West Japan Oncology Group
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 06 Month 19 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/27022112
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
2009 Year 05 Month 23 Day
Date of IRB
Anticipated trial start date
2009 Year 06 Month 01 Day
Last follow-up date
2013 Year 10 Month 12 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 05 Month 29 Day
Last modified on
2016 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=R000002455

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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