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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001658
Receipt No. R000001999
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
Date of disclosure of the study information 2009/01/26
Last modified on 2017/05/15

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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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