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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000281
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute The Tokyo Cooperative Oncology Group
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000359

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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