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

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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 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


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

Value
https://center6.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