UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000000608
Receipt number R000000733
Scientific Title Phase III randomized comparative study of combination therapy with CDDP and TS-1 vs. combination therapy with CDDP and Docetaxel in stage IIIB/IV non-small cell lung cancer
Date of disclosure of the study information 2007/04/01
Last modified on 2015/06/18 13:16:24

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Basic information

Public title

Phase III randomized comparative study of combination therapy with CDDP and TS-1 vs. combination therapy with CDDP and Docetaxel in stage IIIB/IV non-small cell lung cancer

Acronym

Phase III randomized comparative study of combination therapy with CDDP and TS-1 vs. combination therapy with CDDP and Docetaxel in stage IIIB/IV non-small cell lung cancer (CATS Trial)
(CATS Trial)

Scientific Title

Phase III randomized comparative study of combination therapy with CDDP and TS-1 vs. combination therapy with CDDP and Docetaxel in stage IIIB/IV non-small cell lung cancer

Scientific Title:Acronym

Phase III randomized comparative study of combination therapy with CDDP and TS-1 vs. combination therapy with CDDP and Docetaxel in stage IIIB/IV non-small cell lung cancer (CATS Trial)
(CATS Trial)

Region

Japan


Condition

Condition

Stage IIIB/IV or ppstoperative recurrent non-small sell lung cancer

Classification by specialty

Pneumology Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To verify the non-inferiority of combination therapy with CDDP and TS-1 to combination therapy with CDDP plus Docetaxel, standard therapy used as the control, in terms of the efficacy in a randomized comparative study in patients with stage IIIB/IV or postoperative recurrent non-small sell lung cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

overall survival

Key secondary outcomes

PFS
TTF
Response rate
Adverse event
QOL


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

CDDP: 80mg/m2 day1
Docetaxel: 60mg/m2 day1
q3-4weeks

Interventions/Control_2

Doc(60mg/m2) day8
TS-1(800mg/m2) day1-21
q4-5weeks

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 confirmed NSCLC
2.Oral intake is possible
3.Stage IIIB or IV and recurrence after operation
4.With measurable or assessable legion(s)
5.Age of 20 to 74-year old
6.PS(ECOG)0 or 1
7.Without prior anti-tumor therapy
8.Preserved organ functions
8.Adequate bone marrow,hepatic and renal function
9.Written IC
10.Life expectancy longer than 12 weeks

Key exclusion criteria

1.With adjuvant chemotherapy
2.History of serious drug allergy
3.Active concomitant malignancy
4.Serious complications
5.Proven or suspected infections diseases
6.Symptomatic brain metastasis
7.Watery diarrhea or Chronic constipation
8.Pleural effusion,peritoneal fluid,and pericardial fluid
9.Concomitant therapy with another anticancer drug or flucytocine
10.Pregnancy,breast feeding or wish of future bearing
11.Mental disease or psychotic manifestation
12.It participated in the development clinical trial of and others within 1 month
13.Other conditions not suitable for this study

Target sample size

600


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shoji Kudo

Organization

Fukujuji Hospital

Division name

Director

Zip code


Address

3-1-24 Matsuyama Kiyose-City Tokyo,Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

The Tokyo cooperative oncology group

Division name

Clinical Study Promotion Agency

Zip code


Address


TEL


Homepage URL


Email



Sponsor or person

Institute

The Tokyo cooperative oncology group

Institute

Department

Personal name



Funding Source

Organization

TAIHO Fharmaceutical 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

2007 Year 04 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://annonc.oxfordjournals.org/content/early/2015/05/22/annonc.mdv190.abstract

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 01 Month 25 Day

Date of IRB


Anticipated trial start date

2007 Year 04 Month 01 Day

Last follow-up date

2011 Year 10 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

2007 Year 02 Month 13 Day

Last modified on

2015 Year 06 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000733


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name