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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001746
Receipt No. R000002106
Scientific Title A phase II study of CBDCA and TS-1 in patients with advanced non-small cell lung cancer
Date of disclosure of the study information 2009/03/03
Last modified on 2014/03/06

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Basic information
Public title A phase II study of CBDCA and TS-1 in patients with advanced non-small cell lung cancer
Acronym A phase II study of CBDCA and TS-1
Scientific Title A phase II study of CBDCA and TS-1 in patients with advanced non-small cell lung cancer
Scientific Title:Acronym A phase II study of CBDCA and TS-1
Region
Japan

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

Objectives
Narrative objectives1 To assess the efficacy and safety of carboplatin and TS-1 in patients with advanced non-small cell lung cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Response rate
Key secondary outcomes To assess toxicity, overall survival and progression-free survival

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 Carboplatin and TS-1 chemotherapy
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 proven non-small cell lung cancer
2)Stage IIIB with no induction of radiation therapy, and Stage IV
3)Age range from 20 to 74 years
4)ECOG performance status of 0 or 1
5)a life expectancy of 12 weeks or more
6)Measurable by RECST criteria
7)no previous chemotherapy or radiotherapy
8)adequate bone marrow, liver, and renal functions
WBC > 4000 mm-3
Neutro > 2000 mm-3
Platlets > 100000 mm-3
Hb > 9 g dL-1
T-Bil< 1.5 mg dL-1
AST, ALT<100IU/L
s-Cr < 1.5 mg dL-1
CCr > 60 mL min-1
PaO2>70torr
9)Written informed consent
Key exclusion criteria 1)Pulmonary fibrosis detectable on chest X-ray films
2)Massive pleural effusion, ascites and pericardial effusion required drainage
3)Concomitant malignancy
4)Serious medical complications: uncontrolled angina pectoris, myocardial infarction within 3 months, heart failure. Uncontrolled diabetes mellitus, hypertension, infection (ileus, bleeding, superior vena cava syndrome
5)Symptomatic brain metastasis
6)Pregnant or milk-feeding female. Intention to be pregnant in the future
7)With severe allergy
8)Other clinical difficulties to this study
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noriaki Sunaga
Organization Gunma University Hospital
Division name Department of Respiratory Medicine
Zip code
Address 3-39-15 showa-machi, Maebashi, Gunma 371-0014, Japan
TEL 027-220-7111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Noriaki Sunaga
Organization Gunma University Hospital
Division name Department of Respiratory Medicine
Zip code
Address 3-39-15 showa-machi, Maebashi, Gunma 371-0014, Japan
TEL 027-220-7111
Homepage URL
Email nsunaga@showa.gunma-u.ac.jp

Sponsor
Institute Gunma University Hospital
Institute
Department

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
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 03 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
2007 Year 04 Month 14 Day
Date of IRB
Anticipated trial start date
2007 Year 06 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
2011 Year 10 Month 24 Day

Other
Other related information

Management information
Registered date
2009 Year 03 Month 02 Day
Last modified on
2014 Year 03 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002106

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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