UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001271 |
|---|---|
| Receipt number | 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 16:11:23 |
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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
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
okubok@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
JMTO
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001548
