UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000133 |
|---|---|
| Receipt number | R000000195 |
| Scientific Title | Randomized phase II trial of S-1 plus docetaxel combination versus single-agent docetaxel in platinum-pretreated patients with non-small-cell lung cancer |
| Date of disclosure of the study information | 2005/09/12 |
| Last modified on | 2015/01/08 18:17:18 |
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Basic information
Public title
Randomized phase II trial of S-1 plus docetaxel combination versus single-agent docetaxel in platinum-pretreated patients with non-small-cell lung cancer
Acronym
Phase II of S-1 plus docetaxel versus docetaxel alone for relapsed non-small-cell lung cancer
Scientific Title
Randomized phase II trial of S-1 plus docetaxel combination versus single-agent docetaxel in platinum-pretreated patients with non-small-cell lung cancer
Scientific Title:Acronym
Phase II of S-1 plus docetaxel versus docetaxel alone for relapsed non-small-cell lung cancer
Region
| Japan |
Condition
Condition
platinum-pretreated patients with non-small-cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective is to compare the response rate of S-1/docetaxel therapy with that of single-agent docetaxel in platinum-pretreated patients with non-small cell lung cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
progression-free survival, overall survival, quality of life, adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
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
Combination chemotherapy of S-1 and docetaxel
Interventions/Control_2
Single-agent of docetaxel
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
| Not applicable |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Histologically and/or cytologically proven NSCLC
Progression after platinum-based chemotherapy in 1st line
Age ≤ 75
ECOG performance status 0 or 1
Measurable disease
adequate bone marrow, lung, hepatic, and renal function
No prior therapy within four weeks
Written informed consent
Key exclusion criteria
Active concomitant malignancy
Active Interstitial pneumonia
Massive effusions
Unstable angina, recent myocardial infarction
Uncontrolled diabetes
Severe active infection
Other severe complications
Pregnant or lactating women
Inappropriate condition for this study judged by physicians.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsune Tanimoto |
Organization
Okayama University Hospital
Division name
Hematology, Oncology, Respiratory Medicine
Zip code
Address
2-5-1 Shikata-cho, Okayama 700-8558
TEL
086-235-7227
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nagio Takigawa |
Organization
Okayama Lung Cancer Study Group Coordinating Office
Division name
Department of Respiratory Medicine, Okayama University Hospital
Zip code
Address
2-5-1 Shikata-cho, Okayama 700-8558
TEL
086-235-7227
Homepage URL
ntakigaw@md.okayama-u.ac.jp
Sponsor or person
Institute
Okayama Lung Cancer Study Group
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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
| 2005 | Year | 09 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2005 | Year | 08 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 12 | 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
| 2005 | Year | 09 | Month | 08 | Day |
Last modified on
| 2015 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000195
