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Recruitment status
Unique ID issued by UMIN UMIN000001032
Receipt No. R000001244
Scientific Title Phase II Study of Gemcitabine + S-1 in Elderly Patients With Non-Small Cell Lung Cancer
Date of disclosure of the study information 2008/04/01
Last modified on 2010/09/30

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Basic information
Public title Phase II Study of Gemcitabine + S-1 in Elderly Patients With Non-Small Cell Lung Cancer
Acronym Phase II Study of Gemcitabine + S-1 in Elderly Patients With Non-Small Cell Lung Cancer
Scientific Title Phase II Study of Gemcitabine + S-1 in Elderly Patients With Non-Small Cell Lung Cancer
Scientific Title:Acronym Phase II Study of Gemcitabine + S-1 in Elderly Patients With Non-Small Cell Lung Cancer
Region
Japan

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

Objectives
Narrative objectives1 To test the efficacy and tolerability of combination chemotherapy of gemcitabine plus S-1 as first-line chemotherapy in elderly patients with stage IIIB/IV non-small cell lung cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes progression-free survival
Key secondary outcomes compliance, safety, response rate, overall survival time

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 gemcitabine, S-1
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) Patients must have histologically or cytologically confirmed non-small cell lung cancer that is inoperable or unsuitable for radical radiotherapy Stage IIIB or Stage IV. Recurrence after surgery is allowed.
2) Patient has measurable disease.
3) Patient has no prior chemotherapy. Patients who had received previous radiotherapy are included if their assessable disease is outside of the radiation field.
4) Patients must be greater than or equal to 75 years of age.
5) ECOG performance status 0 or 1
6) Laboratory values must be as follows;
WBC count greater than or equal to 4,000/mm3,absolute neutrophil count greater than or equal to 2,000/mm3, platelet count greater than or equal to 100,000/mm3, hemoglobin greater than or equal to 9.0g/dL, AST and ALT within twice the upper limit of normal for the institution,bilirubine level less than or equal to 1.5 mg/dL, serum creatinine within the upper limit of normal, or creatinine clearance greater than or equal to 60 mL/min, PaO2 greater than or equal to 60 torr
7) Estimated life expectancy 3 months
8) Patients must sign an informed consent.
Key exclusion criteria 1)No interstitial pneumonia or pulmonary fibrosis, as determined by chest x-ray
2)A history of severe allergic reactions to drugs
3) Patients with concurrent serious infections or complications are excluded
4) Clinically significant pleural/pericardial effusion which requires drainage before study entry.
5) Patients with an unstable or serious heart disease
6) Inadequately controlled diabetes mellitus
7) Symptomatic brain metastases
8) The presence of other concomitant or metachronous cancers
9)Any concomitant pathology that would, in the investigator`s opinion, contraindicate the use of the drugs in the protocol
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaaki Kawahara
Organization National Hospital Organization Kinki-chuo Chest Medical Center
Division name Internal Medicine
Zip code
Address 1180 Nagasone, Kitaku, Sakai, Osaka, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shinji Atagi
Organization National Hospital Organization Kinki-chuo Chest Medical Center
Division name Internal Medicine
Zip code
Address
TEL 0722-52-3021
Homepage URL
Email

Sponsor
Institute National Hospital Organization Lung Cancer Study Group
Institute
Department

Funding Source
Organization National Hospital Organization Lung Cancer Study Group
Organization
Division
Category of Funding Organization
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
2008 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

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
Date of protocol fixation
2008 Year 01 Month 16 Day
Date of IRB
Anticipated trial start date
2008 Year 02 Month 01 Day
Last follow-up date
2010 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
2008 Year 02 Month 14 Day
Last modified on
2010 Year 09 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001244

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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