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 |
* 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
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
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
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
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
