UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006122 |
|---|---|
| Receipt number | R000007243 |
| Scientific Title | Phase3 trial comparing oral S-1 plus carboplatin with paclitaxel plus carboplatin in chemotherapy-naive patients with advanced non-small-cell lung cancer LETS Biomarker study |
| Date of disclosure of the study information | 2011/08/05 |
| Last modified on | 2017/01/30 11:37:07 |
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Basic information
Public title
Phase3 trial comparing oral S-1 plus carboplatin with paclitaxel plus carboplatin in chemotherapy-naive patients with advanced non-small-cell lung cancer
LETS Biomarker study
Acronym
LETS Biomarker study
Scientific Title
Phase3 trial comparing oral S-1 plus carboplatin with paclitaxel plus carboplatin in chemotherapy-naive patients with advanced non-small-cell lung cancer
LETS Biomarker study
Scientific Title:Acronym
LETS Biomarker study
Region
| Japan |
Condition
Condition
Previously untreated stage IIIB/IV NSCLC
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To explore biomarkers associated with the sensitivity to TS-1 or paclitaxel.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Protein and gene expression analysis
Somatic mutation analysis
Gene amplification analysis
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients enrolled onto LETS study who had available tumor tissue specimens
Key exclusion criteria
Nothing particular
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuto Nishio |
Organization
Kinki University Faculty of Medicine
Division name
Dept. of Genome Biology
Zip code
Address
377-2 Ohnohigashi, Osakasayama, Osaka 589-8511 Japan
TEL
072-366-0221
knishio@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichiro Nakamura |
Organization
West Japan Oncology Group
Division name
datacenter
Zip code
Address
Namba Plaza Bldg.3F 1-5-7,Motomachi Naniwa-ku,Osaka 556-0016 JAPAN
TEL
06-6633-7400
Homepage URL
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
Institute
Department
Personal name
Funding Source
Organization
TAIHO PHARMACEUTICAL CO.,LTD
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kinki University Faculty of Medicine, Dept. of Genome Biology
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
| 2011 | Year | 08 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/24810493
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 | 18 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To explore biomarkers associated with the sensitivity to TS-1 or paclitaxel.
Management information
Registered date
| 2011 | Year | 08 | Month | 05 | Day |
Last modified on
| 2017 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007243
