UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000281 |
|---|---|
| Receipt number | R000000359 |
| Scientific Title | Phase I/II Study of Docetaxel and S-1 Combination Therapy for Advanced Non-small Cell Lung Cancer |
| Date of disclosure of the study information | 2005/11/14 |
| Last modified on | 2012/02/06 13:46:12 |
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Basic information
Public title
Phase I/II Study of Docetaxel and S-1 Combination Therapy for Advanced Non-small Cell Lung Cancer
Acronym
Phase I/II Study of Docetaxel and S-1 Combination Therapy for Advanced Non-small Cell Lung Cancer
Scientific Title
Phase I/II Study of Docetaxel and S-1 Combination Therapy for Advanced Non-small Cell Lung Cancer
Scientific Title:Acronym
Phase I/II Study of Docetaxel and S-1 Combination Therapy for Advanced Non-small Cell Lung Cancer
Region
| Japan |
Condition
Condition
Advanced Non-small Cell Lung Cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The study on 1st-line is carried out to determine safety and efficacy in combination with docetaxel and S-1 for advanced non-small cell lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
Phase 1 study:to establish MTD and to determine the RD
Phase 2 study:Response rate
Key secondary outcomes
Phase 1 study:Safety,S-1compliance
Phase 2 study:Safety,Survival,Progression free-survival,S-1compliance
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Docetaxel is intravenously from 40 mg/m2 and step up to 50,60 mg/m2 on day1, and oral administration, of S-1 is given from 80mg/day and is invented to 100, 120 mg/day from day1 to 14 every 3weeks.
Interventions/Control_2
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)Measurable lesions (RECIST)
3)Stage IIIB or IV patients excluding applying radiotherapy
4)No prior therapy including operation radiation chemotherapy or BRM
5)P.S.(ECOG) 0-2
6)Age ranging from 20-74 years
7)Sufficient organ functions
8)Expected survival over 3 months
9)Provided written informed consent.
Key exclusion criteria
1)Serious infectious disease
2)Patient receiving flucytosine
3)Apparent ineterstitial pneumonia or pulmonary fibrosis
4)Medical history of allergy or hypersensitivity reactions to S-1 or any drug containing polysorbate 80
5)Edema need for treatment
6)Pleural or pericardial effusion requiring treatment
7)Patient intermittent oxygen supply
8)Serious concomitant disease
9)Cardiac infarction within 6 month
10)Supra vena cava syndrome patient
11)Pregnant or lactation women, or women with known or suspected pregnancy.
12)Man who wont let to pregnancy
13)Clinical symptom of brain metastases
14)Medical history of serious allergy reactions to any drug
15)Inappropriate patients for this study judged by the physicians.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiichi Nagao |
Organization
Chiba University
Division name
Safety and Health Organization
Zip code
Address
1-33 Yayoi-cho Inage-ku Chiba-shi Chiba 263-0022 Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Nippon Medical School
Division name
Department of Internal Medicine/Infection and Oncology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
The Tokyo Cooperative Oncology Group
Institute
Department
Personal name
Funding Source
Organization
The Tokyo Cooperative Oncology Group
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 | 11 | Month | 14 | 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 | 03 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 06 | 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 | 11 | Month | 14 | Day |
Last modified on
| 2012 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000359
