UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000001826
Receipt No. R000002205
Scientific Title Randomized phase III trial of Docetaxel versus docetaxel plus S-1 for second-line treatment of non-small cell lung cancer (NSCLC)
Date of disclosure of the study information 2009/03/31
Last modified on 2010/09/30

* 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 Randomized phase III trial of Docetaxel versus docetaxel plus S-1 for second-line treatment of non-small cell lung cancer (NSCLC)
Acronym Randomized phase III trial of Docetaxel versus docetaxel plus S-1 for second-line treatment of non-small cell lung cancer (NSCLC)
Scientific Title Randomized phase III trial of Docetaxel versus docetaxel plus S-1 for second-line treatment of non-small cell lung cancer (NSCLC)
Scientific Title:Acronym Randomized phase III trial of Docetaxel versus docetaxel plus S-1 for second-line treatment of non-small cell lung cancer (NSCLC)
Region
Japan

Condition
Condition Advanced non-small cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare the efficacy and safety between the combination regimen of Docetaxel puls S-1 and Docetaxel alone regimen in patients with previously treated NSCLC
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Overall survival
Key secondary outcomes Progression free survival
Adverse events
Response rate

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Docetaxel alone
Interventions/Control_2 Docetaxel and S-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
Key inclusion criteria 1) Histologically confirmed Non Small Cell Lung Cancer
2) Advanced Stage (IV or IIIB)
3) With measurable lesion
4) One more prior platinum-based chemotherapy
5) Performance Status (ECOG) 0-1
6) )20<=,<75 years
7) Adequate organ functions
8) Patients who have estimated life expectancy longer than 3 month
9) Oral intake is possible
10) Written informed consent
Key exclusion criteria 1) Patients with serious infections or suspected infections with fever.
2) Pregnant or lactating women
3) Active concomitant malignancy
4) sever allergy
5) Active ineterstitial pneumonitis
6) The prior treatment is a case only of the molecular-targeted agent.
7) Symptomatic brain metastasis
8) History of using 5-FU or docetaxel
9) Inappropriate patients for this study judged by the physicians.
Target sample size 860

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaaki Kawahara
Organization National Hospital Organization Kinki-chuo Chest Medical Center
Division name Internal Medicine
Zip code
Address 1180 Nagasone, Kitaku, Sakai, Osaka, Japan
TEL 06-6972-1181
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization The Japan-multinational Trial Organization
Division name The Japan-multinational Trial Organization
Zip code
Address
TEL 075-241-4894
Homepage URL http://www.jmto.org
Email

Sponsor
Institute The Japan-multinational Trial Organization
Institute
Department

Funding Source
Organization The Japan-multinational Trial Organization
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 03 Month 31 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
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
Date of protocol fixation
2008 Year 12 Month 03 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
2014 Year 04 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 03 Month 31 Day
Last modified on
2010 Year 09 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002205

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.