UMIN-CTR Clinical Trial

Basic information
Public title	A randomized controlled Phase II study comparing TS-1 alone with CDDP+TS-1 as postoperative adjuvant chemotherapy in non-small-cell-lung-cancer ; translational research of the chemotherapy effect prediction factor
Acronym	WJOG4107
Scientific Title	A randomized controlled Phase II study comparing TS-1 alone with CDDP+TS-1 as postoperative adjuvant chemotherapy in non-small-cell-lung-cancer ; translational research of the chemotherapy effect prediction factor
Scientific Title:Acronym	WJOG4107
Region	Japan

Condition
Condition	Non Small Cell Lung Cancer
Classification by specialty	Pneumology Chest surgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To evaluate the clinical effectiveness of TS-1 alone compared with CDDP + TS-1 for postoperative Non Small Cell Lung Cancer. Moreover, it searches for the chemotherapy effect prediction factor.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Relapse-free survival of 2 years, to searches for the chemotherapy effect prediction factor.
Key secondary outcomes	Overall survival (OS), Rate of adverse events, Relative dose intensity, to searches for a prognosis prediction factor.

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 Gene
Interventions/Control_1	TS-1
Interventions/Control_2	CDDP,TS-1
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 confirmed Non Small Cell Lung Cancer 2)pStage II, IIIA (N2 Case is single station) 3)Case in which chemotherapy enforcement less than 8weeks after the operation is possible 4)Without prior chemotherapy nor use of chemotherapy, RT 5)Oral intake is possible 6)20<=,<75 years 7)Performance Status (ECOG) 0-1 8)Adequate organ functions 9)Written informed consent
Key exclusion criteria	1) clinically significant drug allergy 2) Under treatment with flucytosine, phenytoin, Warfarin Potassium, other trial drugs. 3) The infection which needs the medical treatment by antibiotics, and other serious complications 4) The case which has diarrhea continuously 5) The case which has clear interstitial pneumonia or a clear fibroid lung with a chest simple X ray 6) The case which has malignant tumors other than the lung cancer 7) The case which has the past of a malignant tumor 8) Not suitable for participating in the study for any other reason
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yasuo Iwamoto
Organization	Hiroshima city hospital
Division name	Dept of chemotherapy center
Zip code
Address	7-33.Moto-machi. Naka-ku. Hiroshima.shi.730-8518 Japan
TEL	082-221-2291
Email

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	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	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	2009 Year 01 Month 26 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	http://www.ncbi.nlm.nih.gov/pubmed/26253869
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	2007 Year 06 Month 23 Day
Date of IRB
Anticipated trial start date	2007 Year 09 Month 01 Day
Last follow-up date	2015 Year 08 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	2009 Year 01 Month 26 Day
Last modified on	2017 Year 05 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001999

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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