UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001658 |
|---|---|
| Receipt number | 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 13:21:52 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001999
