UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030121
Receipt No. R000034391
Scientific Title A comparative analysis of the mechanisms of resistance to EGFR-TKI in clinical practice: Retrospective study.
Date of disclosure of the study information 2017/12/01
Last modified on 2019/03/14

* 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 comparative analysis of the mechanisms of resistance to EGFR-TKI in clinical practice: Retrospective study.
Acronym Retrospective study of EGFR-TKI in clinical practice.
Scientific Title A comparative analysis of the mechanisms of resistance to EGFR-TKI in clinical practice: Retrospective study.
Scientific Title:Acronym Retrospective study of EGFR-TKI in clinical practice.
Region
Japan

Condition
Condition Non-small cell lung cancer harboring EGFR mutation.
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 The aim of this study is to analyze the mechanisms of resistance to EGFR-TKI and evaluate the efficacy of sequential therapy after each EGFR-TKI failure.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Overall survival(restospective research)
Key secondary outcomes Progression-free survival(retrospective research)
Response rate (retrospective research)

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1)Non-small cell lung cancer harboring EGFR mutation.
(2)Experienced to recieve EGFR tyrosine kinase inhibitor
Key exclusion criteria Nothing
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name Hida
Middle name
Last name Toyoaki
Organization Aichi Cancer Center
Division name Department of Thoracic Oncology
Zip code 4648681
Address 1-1, Kanokoden, Chikusa-ku, Nagoya city, Aichi, Japan
TEL +81-52-762-6111
Email 107974@aichi-cc.jp

Public contact
Name of contact person
1st name Kentaro
Middle name
Last name Ito
Organization Matsusaka Municipal Hospital
Division name Respiratory Centor
Zip code 5158544
Address 1550, Tonomachi, Matsusaka city, Mie, Japan
TEL +81-598-23-1515
Homepage URL
Email kentarou_i_0214@yahoo.co.jp

Sponsor
Institute Aichi Cancer Center
Institute
Department

Funding Source
Organization Nippon Boehringer Ingelheim Co ., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Aichi Cancer Center
Address 1-1, Kanokoden, Chikusa-ku, Nagoya city, Aichi, Japan
Tel +81-52-762-6111
Email 107974@aichi-cc.jp

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 愛知県がんセンター中央病院(愛知県)
松阪市民病院(三重県)

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 01 Day

Related information
URL releasing protocol https://upload.umin.ac.jp/cgi-bin/ctr/ctr_up_reg_f5.cgi
Publication of results Unpublished

Result
URL related to results and publications https://oncologypro.esmo.org/Meeting-Resources/ESMO-2018-Congress/Comparative-analysis-of-overall-su
Number of participants that the trial has enrolled 1467
Results
A total of 1400 pts from 11 institutions were enrolled in this study, and the data from the 1354 pts who received EGFR-TKI alone was analyzed   Median OS (months [95%CI]) were 30.9 [27.7-33.9] in 1G (gefitinib, 32.2 [28.4-36.4]; erlotinib, 28.1 [24.9-33.4]), and 38.6 [32.2-NR] in 2G (afatinib), respectively. The trend of longer OS for afatinib against first-generation EGFR-TKIs remained even after adjusted by propensity score. 
Results date posted
2019 Year 03 Month 14 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
All patients with EGFR-mutated NSCLC who received EGFR-TKI therapy between Jan 2008 and Aug 2017, using the electronic medical records from 11 institutions in Japan. 
Participant flow
No (Retrospective study)
Adverse events
No (Retrospective study)
Outcome measures
Overall survival
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2016 Year 04 Month 20 Day
Date of IRB
2016 Year 09 Month 28 Day
Anticipated trial start date
2017 Year 12 Month 01 Day
Last follow-up date
2018 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information (1)An accompanying research of "Liquid biopsy of acquired resistance to afatinib"(UMIN000025112).
(2)Study design: Retrospective observational study.
(3)The analysis is planned to be conducted according to the statistical plan.

Management information
Registered date
2017 Year 11 Month 26 Day
Last modified on
2019 Year 03 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034391

Research Plan
Registered date File name
2019/03/14 AFA耐性化研究 研究計画書 ver.2.1_Final.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.