UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010538 |
|---|---|
| Receipt number | 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 17:41:35 |
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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
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/
info@csp.or.jp
Sponsor or person
Institute
LC-02 Executive committee
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012236
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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