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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000608
Receipt No. 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

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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
Institute The Tokyo cooperative oncology group
Institute
Department

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
URL(English) https://upload.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


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