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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030082
Receipt No. R000034345
Scientific Title Follow up analysis of phase III study of gefitinib versus erlotinib in patients with advanced lung adenocarcinoma.
Date of disclosure of the study information 2017/11/22
Last modified on 2018/02/05

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Basic information
Public title Follow up analysis of phase III study of gefitinib versus erlotinib
in patients with advanced lung adenocarcinoma.
Acronym Long term follow-up study of gefitinib vs erlotinib for lung adenocarcinoma
Scientific Title Follow up analysis of phase III study of gefitinib versus erlotinib
in patients with advanced lung adenocarcinoma.
Scientific Title:Acronym Long term follow-up study of gefitinib vs erlotinib for lung adenocarcinoma
Region
Japan

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

Objectives
Narrative objectives1 To confirm final overall survival of patients harboring EGFR mutation treated with gefitinib or erlotinib who were enrolled into WJOG5108L study.
To investigate the efficacy of EGFR-TKI for patients with brain metastasis according to treatment arm who were enrolled into WJOG5108L study.
Basic objectives2 Others
Basic objectives -Others 1.Final overall survival
1)All eligible patients
2)Patients harboring activating mutation
3)Patients with brain metasitasis
4)Patients with brain metastasis and activating mutation
2. Final progression free survival
1)All eligible patients
2)Patients harboring activating mutation
3)Patients with brain metasitasis
4)Patients with brain metastasis and activating mutation
3. Response rate
1)Response rate of brain metastasis according to treatment arm
2)Response rate of brain metastasis in patients with activating mutation accord to treatment arm
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Overall survival of patients with activating mutation according to treatment arm
Key secondary outcomes Efficacy of brain metastasis in patients with brain metastasis according to treatment arm

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 Patients expressing informed consents with WJOG5108LFS study who were enrolled into original WJOG5108L study
Key exclusion criteria none
Target sample size 561

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuyuki Katakami
Organization Kobe City Medical Center General Hospital
Division name Medical Oncology
Zip code
Address 2-1-1 Minatojima Minamimachi Cyuo-ku Kobe City, Hyogo.
TEL +81-78-302-432
Email nkatakami@kcho.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. 304-1-5-7, Motomachi Naniwa-ku, Osaka 556-0016 JAPAN
TEL 06-6633-7400
Homepage URL
Email datacenter@wjog.jp

Sponsor
Institute West Japan Oncology Group
Institute
Department

Funding Source
Organization Fund of Nonprofit Foundation Institute of Biomedical Research and Innovation
Organization
Division
Category of Funding Organization Non profit foundation
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
2017 Year 11 Month 22 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 Enrolling by invitation
Date of protocol fixation
2017 Year 10 Month 06 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Analysis of OS and PFS according to treatment arms were performed for the following cases;
1) all eligible cases
2) case harboring activating mutation
3) case harboring L858R
4) case harboring exon 19 del
5) case with brain metastasis
6) case with brain metastasis and activating mutation.

Survival curves (PFS and OS) were analyzed by the Kaplan Meier method and were compared between groups by the Cox regression model and log-rank test. The 95% CIs for median PFS and OS were calculated using the Brookmeyer and Crowley method. Subgroup analyses for PFS and OS were performed to examine the interaction effect of treatment arm with each of the following factors: gender, age (<65 years old vs >65 years old, stage (stage IIIB, IV, postoperative recurrence), smoking status (never smoker or light smoker, ever-smoker), treatment line (2nd line, 3rd line or later), brain metastasis (yes, no), EGFR status (EGFR mutation positive, EGFR wild type)

Tumor response for brain metastasis of the following cases was compared between the two treatment arms using the x2 test;
1) case with brain metastasis at the time of treatment
2) case with brain metastasis and EGFR mutation at the time of treatment

Management information
Registered date
2017 Year 11 Month 22 Day
Last modified on
2018 Year 02 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034345

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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