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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000010538
Receipt No. R000012236
Scientific Title Observational study of treatment of epidermal growth factor receptor activating mutation positive(EGFRm+)advanced or recurrent non-small-cell lung cancer
Date of disclosure of the study information 2013/04/19
Last modified on 2014/01/30

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Basic information
Public title Observational study of treatment of epidermal growth factor receptor activating mutation positive(EGFRm+)advanced or recurrent non-small-cell lung cancer

Acronym CSPOR-LC02
Scientific Title Observational study of treatment of epidermal growth factor receptor activating mutation positive(EGFRm+)advanced or recurrent non-small-cell lung cancer

Scientific Title:Acronym CSPOR-LC02
Region
Japan

Condition
Condition Advanced lung cancer
Classification by specialty
Pneumology Hematology and clinical oncology Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 he objective of this study is to survey the clinical course and the actual pattern of care after radiological progressive disease to the first-line therapy with EGFR-tyrosine kinase inhibitor (EGFR-TKI) in patients with EGFR activating mutation-positive (EGFRm+) advanced or recurrent non-small-cell lung cancer (NSCLC).
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The time from RECIST-based PD to clinical PD with EGFR-TKI.
Key secondary outcomes 1.Proportion of patients to whom EGFR-TKI was continued after radiological PD was judged according to RECIST to EGFR-TKI
1)with or without concomitant therapy
2)with concomitantly administered radiotherapy, surgery or chemotherapy
2.Propotion of patients in which flare developed after discontinuation of EGFR-TKI
3.Pattern of failure at the time of judgment as RECIST-based PD
4.Whole duration of treatment with EGFR-TKI
5.Survival after discontinuation of treatment with EGFR-TKI
6.Survival after RECIST-based PD to EGFR-TKI therapy was judged
7.Survival after clinical PD to EGFR-TKI therapy was judged
8.Reason of discontinuation of EGFR-TKI
9.Overall survival time

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.Patients with advanced or recurrent NSCLC
2.Patients with activating EGRF mutation-positive (EGFRm+)tumor
3.Patients for whom treatment with EGFR-TKI (iressa or tarceva)was started as first-line systemic treatment from January1, 2009 to December 2011
Key exclusion criteria 1.History of platinum-based adjuvant chemotherapy
2.Presence of other active malignancy
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideo Kunitoh
Organization Japanese Red Crose Medical Center
Division name department of chemotherapy
Zip code
Address 4-1-22 Hiroo, Shibuyaku. Tokyo, 150-8935 , Japan
TEL 03-3400-1311
Email no@mail

Public contact
Name of contact person
1st name
Middle name
Last name Akira Yamao
Organization Public Health Research Foundation
Division name Comprehensive Support Project for Oncology Research
Zip code
Address 1-1-7, Nishiwaseda, Shinjuku-ku, Tokyo, 169-0051, Japan
TEL 03-5287-2633
Homepage URL http://www.csp.or.jp/
Email info@csp.or.jp

Sponsor
Institute LC-02 Executive committee
Institute
Department

Funding Source
Organization Public Health Research Foundation
Organization
Division
Category of Funding Organization Other
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
2013 Year 04 Month 19 Day

Related information
URL releasing protocol http://www.csp.or.jp
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 No longer recruiting
Date of protocol fixation
2013 Year 02 Month 06 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 19 Day
Last follow-up date
2014 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information RECIST version1.1
Clinical PD
CTCAE version4

Management information
Registered date
2013 Year 04 Month 18 Day
Last modified on
2014 Year 01 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012236

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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