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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000010564
Receipt No. R000012357
Scientific Title A prospective cohort study to explore predictive factors to TS-1 plus platinum-based drugs in patients with squamous cell lung cancer YCRG10
Date of disclosure of the study information 2013/04/23
Last modified on 2018/10/29

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Basic information
Public title A prospective cohort study to
explore predictive factors to TS-1 plus platinum-based drugs in patients with squamous cell lung cancer
YCRG10
Acronym A prospective cohort study to
explore predictive factors to TS-1 plus platinum-based drugs in patients with squamous cell lung cancer
YCRG10
Scientific Title A prospective cohort study to
explore predictive factors to TS-1 plus platinum-based drugs in patients with squamous cell lung cancer
YCRG10
Scientific Title:Acronym A prospective cohort study to
explore predictive factors to TS-1 plus platinum-based drugs in patients with squamous cell lung cancer
YCRG10
Region
Japan

Condition
Condition squamous cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 The purpose of this study is to explore predictive factors whom treated with TS-1 plus platinum-based drugs(such as TS-1 plus Cisplatin or TS-1 plus Carboplatin) in chemotherapy-naïve patients with advanced squamous cell lung cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes To evaluate correlation between tumor response and gene expression and protein levels in serum,whole blood and tissue
Key secondary outcomes To evaluate correlation between PFS, OS, adverse events, relative dose intensity and gene expression and protein levels in serum,whole blood and tissue

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

Not applicable
Gender Male and Female
Key inclusion criteria 1)Advanced squamous cell lung cancer patients(no prior chemotherapy) who is planned to receive TS-1 plus platinum-based drugs
2)Patients age is older than 20 when registration
3)Patients whoes blood samples(
serum and whole blood) are available before treatment
4)Target lesion is evaluable
5)Written infomed consent from the patients
Key exclusion criteria Patients whose participation in this study is judged to be inappropriate by the physicians
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Kaneko
Organization Yokohama City University Medical Center
Division name Respiratory Disease Center
Zip code
Address 4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL 045-261-5656
Email takeshi@med.yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masaharu Shinkai
Organization Yokohama City University Medical Center
Division name Respiratory Disease Center
Zip code
Address 4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL 045-261-5656
Homepage URL
Email shinkai@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Medical Center
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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 横浜市立大学附属市民総合医療センター(神奈川県)
横浜市立大学附属病院(神奈川県)
藤沢市民病院(神奈川県)
横浜船員保険病院(神奈川県)
横浜南共済病院(神奈川県)
国立病院横浜医療センター(神奈川県)
大和市立病院(神奈川県)
茅ヶ崎市立病院(神奈川県)
関東労災病院(神奈川県)
横浜栄共済病院(神奈川県)
神奈川県立がんセンター(神奈川県)
済生会横浜市南部病院(神奈川県)
横須賀市民病院(神奈川県)


Other administrative information
Date of disclosure of the study information
2013 Year 04 Month 23 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 Terminated
Date of protocol fixation
2013 Year 02 Month 27 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 24 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study is designed to be prospective cohort study.
The purpose of this study is to explore predictive factors whom treated with TS-1 plus platinum-based drugs (such as TS-1 plus Cisplatin or TS-1 plus Carboplatin) in chemotherapy-na&iuml;ve patients with advanced squamous cell lung cancer.
To evaluate correlation between response and gene expression, we could estimate the population of sensitive patients to TS-1 plus platinum-based treatment.
50 patients is planned to be registered.(TS-1+CBDCA:25patients,TS-1+CDDP:25patients)
Continue until progression disease or unfeasible adverse events.

Management information
Registered date
2013 Year 04 Month 23 Day
Last modified on
2018 Year 10 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012357

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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