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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000503
Receipt No. R000000607
Scientific Title Lung Cancer Evaluation of TS-1 Study
Date of disclosure of the study information 2006/10/18
Last modified on 2015/08/31

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Basic information
Public title Lung Cancer Evaluation of TS-1 Study
Acronym LETS study
Scientific Title Lung Cancer Evaluation of TS-1 Study
Scientific Title:Acronym LETS study
Region
Japan

Condition
Condition Previously untreated stageIIIB/IV NSCLC
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of Carboplatin and TS-1 combination therapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Overall survival
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 CBDCA+TS-1 chemotherapy
Interventions/Control_2 CBDCA+Paclitaxel chemotherapy
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
20 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria 1)Histologically or cytologically confirned non-small cell lung cancer (NSCLC)
2)Stage IIIB without any indications for radiotherapy or Stage IV
3)No prior treatment
4)Measurable disease
5)ECOG performance status of 0 or 1
6)More than 20 years old
7)Adequate organ functions
8)Estimated life expectancy of at least 12 weeks
9)Signed informed consent
Key exclusion criteria 1)SVC syndrome
2)Pregnant female or sexually active males/females unwilling to use contraception during the protocol treatment
3)Concomitant serious disease
4)Symptomatic brain metastases
5)Active concomitant malignancy
6)Pleural effusion, cardiac effusion, or cardiac effusion necessiating treatment
7)Uncontrolled diabetes
Target sample size 560

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiko Nakagawa
Organization Kinki University School of Medicine
Division name Department of Medical Oncology
Zip code
Address 377-2 Ohno-higashi, Osaka-Sayama, Osaka
TEL 072-366-0221
Email datacenter@wjog.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinichiro Nakamura
Organization West Japan Oncology Group
Division name WJOG datacenter
Zip code
Address Namba Plaza Bldg.3F 1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN
TEL 06-6633-7400
Homepage URL
Email datacenter@wjog.jp

Sponsor
Institute West Japan Oncology Group
Institute
Department

Funding Source
Organization TAIHO PHARMACEUTICAL CO.,LTD
Organization
Division
Category of Funding Organization Profit organization
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 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
2006 Year 10 Month 18 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed?term=23277482
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
2006 Year 06 Month 17 Day
Date of IRB
Anticipated trial start date
2006 Year 08 Month 01 Day
Last follow-up date
2011 Year 02 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2006 Year 10 Month 18 Day
Last modified on
2015 Year 08 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000607

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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