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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033374
Receipt No. R000038048
Official scientific title of the study Efficacy of S-1 after Pemetrexed in patient with non-squamous non-small cell carcinoma: a retrospective multi-institutional analysis
Date of disclosure of the study information 2018/07/12
Last modified on 2018/07/12

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Basic information
Official scientific title of the study Efficacy of S-1 after Pemetrexed in patient with
non-squamous non-small cell carcinoma:
a retrospective multi-institutional analysis
Title of the study (Brief title) Efficacy of S-1 after Pemetrexed in patient with
non-squamous non-small cell carcinoma:
a retrospective multi-institutional analysis
Region
Japan

Condition
Condition Non small-cell lung cancer patients receiving both PEM and S-1
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To verify the effect of S-1 after PEM
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Response Rate of S-1
Key secondary outcomes

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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Non small-cell lung cancer patients recieving PEM and S-1 between April 1, 2012 to March 31, 2017
Key exclusion criteria Nothing
Target sample size 80

Research contact person
Name of lead principal investigator Takemoto Shinnosuke
Organization National Hospital Organization, Nagasaki Medical Center
Division name Respiratoey of Medicine
Address Kubara 2-1001-1,Omura, Nagasaki, japan
TEL 0957-52-3121
Email shinnosuke-takemoto@umin.ac.jp

Public contact
Name of contact person Takemoto Shinnosuke
Organization National Hospital Organization, Nagasaki Medical Center
Division name Respiratoey of Medicine
Address Kubara 2-1001-1,Omura, Nagasaki, japan
TEL 0957-52-3121
Homepage URL
Email shinnosuke-takemoto@umin.ac.jp

Sponsor
Institute National Hospital Organization, Nagasaki Medical Center
Institute
Department

Funding Source
Organization No research fund
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

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
2018 Year 07 Month 12 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 06 Month 10 Day
Anticipated trial start date
2018 Year 06 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information Nothing

Management information
Registered date
2018 Year 07 Month 12 Day
Last modified on
2018 Year 07 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038048

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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