UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective cohort study to explore predictive factors to TS-1 plus platinum-based drugs in patients with squamous cell lung cancer YCRG10
Title of the study (Brief title)	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	Takeshi Kaneko
Organization	Yokohama City University Medical Center
Division name	Respiratory Disease Center
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	Masaharu Shinkai
Organization	Yokohama City University Medical Center
Division name	Respiratory Disease Center
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 02 Month 27 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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-naïve 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/icdr_e/ctr_view.cgi?recptno=R000012357