UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000000503
Receipt number R000000607
Scientific Title Lung Cancer Evaluation of TS-1 Study
Date of disclosure of the study information 2006/10/18
Last modified on 2015/08/31 15:57:39

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Basic information

Public title

Lung Cancer Evaluation of TS-1 Study

Acronym

LETS study

Scientific Title

Lung Cancer Evaluation of TS-1 Study

Scientific Title:Acronym

LETS study

Region

Japan


Condition

Condition

Previously untreated stageIIIB/IV NSCLC

Classification by specialty

Pneumology Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of Carboplatin and TS-1 combination therapy

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase III


Assessment

Primary outcomes

Overall survival

Key secondary outcomes



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

Interventions/Control_1

CBDCA+TS-1 chemotherapy

Interventions/Control_2

CBDCA+Paclitaxel chemotherapy

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 or cytologically confirned non-small cell lung cancer (NSCLC)
2)Stage IIIB without any indications for radiotherapy or Stage IV
3)No prior treatment
4)Measurable disease
5)ECOG performance status of 0 or 1
6)More than 20 years old
7)Adequate organ functions
8)Estimated life expectancy of at least 12 weeks
9)Signed informed consent

Key exclusion criteria

1)SVC syndrome
2)Pregnant female or sexually active males/females unwilling to use contraception during the protocol treatment
3)Concomitant serious disease
4)Symptomatic brain metastases
5)Active concomitant malignancy
6)Pleural effusion, cardiac effusion, or cardiac effusion necessiating treatment
7)Uncontrolled diabetes

Target sample size

560


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuhiko Nakagawa

Organization

Kinki University School of Medicine

Division name

Department of Medical Oncology

Zip code


Address

377-2 Ohno-higashi, Osaka-Sayama, Osaka

TEL

072-366-0221

Email

datacenter@wjog.jp


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

TAIHO PHARMACEUTICAL CO.,LTD

Organization

Division

Category of Funding Organization

Profit organization

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

2006 Year 10 Month 18 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed?term=23277482

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

2006 Year 06 Month 17 Day

Date of IRB


Anticipated trial start date

2006 Year 08 Month 01 Day

Last follow-up date

2011 Year 02 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

2006 Year 10 Month 18 Day

Last modified on

2015 Year 08 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000607


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name