UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001826 |
|---|---|
| Receipt number | 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 12:03:52 |
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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
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
Sponsor or person
Institute
The Japan-multinational Trial Organization
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002205
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
