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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006749
Receipt No. R000007978
Scientific Title A comparison of the two scheduling of chemotherapy using carboplatin and paclitaxel for advanced non-small cell lung cancer.
Date of disclosure of the study information 2011/11/22
Last modified on 2013/03/10

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Basic information
Public title A comparison of the two scheduling of chemotherapy using carboplatin and paclitaxel for advanced non-small cell lung cancer.
Acronym A comparison of the two scheduling of chemotherapy using carboplatin and paclitaxel for advanced non-small cell lung cancer.
Scientific Title A comparison of the two scheduling of chemotherapy using carboplatin and paclitaxel for advanced non-small cell lung cancer.
Scientific Title:Acronym A comparison of the two scheduling of chemotherapy using carboplatin and paclitaxel for advanced non-small cell lung cancer.
Region
Japan

Condition
Condition Non small cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare a survival benefit between two scheduling.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Overall survival time
Key secondary outcomes Feasibility
Progression free survival time
Objective response rate

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 Histologicaly or cytologicaly diagnosed NSCLC.
Stage-IIIb or IV according to sixth edition of TNM classification.
Patients of NSCLC who were treated with carboplatin and paclitaxel at Kansai Medical University Takii Hospital from January 1999 to December 2010.
Key exclusion criteria Patients who were received thoracic irradiation with curative intention.
Patients who were diagnosed as Large Cell Neuroendocine Carcinoma (LC-NEC).
Crossover cases of two studying arms.
Patients with double active cancer.
Target sample size 167

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiki Shimizu
Organization Kansai Medical University
Division name 1st department of internal medicine
Zip code
Address Fumizono-cho 10-15, Moriguchi-city, Osaka.
TEL 06-6992-1001
Email

Public contact
Name of contact person
1st name
Middle name
Last name Toshiki Shimizu
Organization Kansai Medical University
Division name 1st department of internal medicine
Zip code
Address Fumizono-cho 10-15, Moriguchi-city, Osaka.
TEL 06-6992-1001
Homepage URL
Email shimizto@takii.kmu.ac.jp

Sponsor
Institute Kansai Medical University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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 YES
Study ID_1 23-6
Org. issuing International ID_1 The Clinical Research Board of Kansai Medical University Takii Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 関西医科大学附属滝井病院(大阪府)Kansai Medical University Takii Hospital (Osaka)

Other administrative information
Date of disclosure of the study information
2011 Year 11 Month 22 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3576211/
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 Completed
Date of protocol fixation
2011 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 11 Month 01 Day
Last follow-up date
2011 Year 12 Month 01 Day
Date of closure to data entry
2012 Year 01 Month 01 Day
Date trial data considered complete
2012 Year 01 Month 01 Day
Date analysis concluded
2012 Year 02 Month 01 Day

Other
Other related information Compare the survival benefit of scheduling of the administration of paclitaxel.

Management information
Registered date
2011 Year 11 Month 20 Day
Last modified on
2013 Year 03 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007978

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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