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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000001271
Receipt No. R000001548
Scientific Title Outcome study of complete resections for p-N2 non-small cell lung cancer
Date of disclosure of the study information 2008/07/28
Last modified on 2008/07/28

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Basic information
Public title Outcome study of complete resections for p-N2 non-small cell lung cancer
Acronym p-N2 outcome study
Scientific Title Outcome study of complete resections for p-N2 non-small cell lung cancer
Scientific Title:Acronym p-N2 outcome study
Region
Japan

Condition
Condition non-small cell lung cancer
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 outcome study
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes overall survival
Key secondary outcomes relapse-free survival

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) during 2000/1 - 2004/12/31
2) non-small cell lung cancer
3) pT1-3N2M0, pathologically proven
4) completely resected
5) 20 years of age or more
6) ECOG PS 0-1
7) with written informed consent for surgery
Key exclusion criteria 1) active double cancer
2) preoperatively treated with chemotherapy, radiotherapy, and/or bronchial artery infusion of chemotherapy, or intraoperatively treated with anticancer drug in the thorax or pericardium
3) serious infection, cardiac disease, arrythmia, pshycological disease, or others
4) otherwise unsuitable judged by investigators
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi adate
Organization Kyoto University
Division name Thoracic Surgery
Zip code
Address 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL 075-751-4975
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kenichi Okubo
Organization Kyoto University
Division name Thoracic Surgery
Zip code
Address
TEL 075-751-4975
Homepage URL
Email okubok@kuhp.kyoto-u.ac.jp

Sponsor
Institute JMTO
Institute
Department

Funding Source
Organization JMTO
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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
2008 Year 07 Month 28 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
Date of protocol fixation
2008 Year 05 Month 26 Day
Date of IRB
Anticipated trial start date
2008 Year 06 Month 01 Day
Last follow-up date
2009 Year 06 Month 01 Day
Date of closure to data entry
2009 Year 06 Month 01 Day
Date trial data considered complete
2009 Year 06 Month 01 Day
Date analysis concluded
2009 Year 12 Month 01 Day

Other
Other related information under investigation

Management information
Registered date
2008 Year 07 Month 28 Day
Last modified on
2008 Year 07 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001548

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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