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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002994
Receipt No. R000003630
Scientific Title Phase I/II study of first line chemotherapy with TS-1 in elderly patients with advanced non-small cell lung cancer
Date of disclosure of the study information 2010/01/07
Last modified on 2010/01/07

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Basic information
Public title Phase I/II study of first line chemotherapy with TS-1 in elderly patients with advanced non-small cell lung cancer
Acronym Phase I/II study of first line chemotherapy with TS-1 in elderly patients with advanced non-small cell lung cancer
Scientific Title Phase I/II study of first line chemotherapy with TS-1 in elderly patients with advanced non-small cell lung cancer
Scientific Title:Acronym Phase I/II study of first line chemotherapy with TS-1 in elderly patients with advanced non-small cell lung cancer
Region
Japan

Condition
Condition Non-small cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the efficacy and safety of TS-1 in elderly non-small cell lung cancer patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Response rate
Key secondary outcomes

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 TS-1:65mg/m2/day-80mg/m2/day
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
75 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Histologically or cytologically Proven non-small cell lung cancer
2)Stage IIIB with no induction radiation therapy,or Stage IV
3)Age range older than 75
4)No previous chemotherapy surgery or radiotherapy
5)Measurable by RECIST criteria
6)Adequate bone narrow,liver, and renal functions
Hb:over9.0g/dl
WBC:4000-12000mm3
Neutro:over2000mm3
PLT:over100000/mm3
T-Bil:underNUMx1.5
AST,ALT:under100IU
Ccr:over30ml/min
PaO2:over60mmHg
7)ECOG Performance status of 0-2
8)Life expectancy of 12 weeks or more
9)Nomal EKG
10)Written informed concent
Key exclusion criteria 1)Serious medical complications
2)Patients with active lung disease such as interstitial pneumonia, pulmonary fibrosis
3)Massive pleural effusion,ascites and penicardial effusion requires drainage
4)Symptomatic brain metastasis
5)History of severe allergy
6)Received radiotherapy to primary region
7)Concomitant malignancy
8)Other clinical difficulties to this study
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasufumi Yamaji
Organization Mitoyo General Hospital
Division name Chest Physician
Zip code
Address 708 Himehama Toyohama Kan-onji Kagawa 769-1695 JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kagawa University School of Medicine
Division name First Department of Medicine
Zip code
Address
TEL 087-891-2145
Homepage URL
Email

Sponsor
Institute Kagawa TGO Study Group
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
2010 Year 01 Month 07 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 10 Month 20 Day
Date of IRB
Anticipated trial start date
2005 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 01 Month 07 Day
Last modified on
2010 Year 01 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003630

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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