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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000004541
Receipt No. R000005215
Scientific Title Feasibility study of maintenance therapy of TS-1 for stage IV non-small cell lung cancer
Date of disclosure of the study information 2010/11/11
Last modified on 2013/09/18

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Basic information
Public title Feasibility study of maintenance therapy of TS-1 for stage IV non-small cell lung cancer
Acronym Feasibility study of maintenance TS-1 for non-small cell lung cancer
Scientific Title Feasibility study of maintenance therapy of TS-1 for stage IV non-small cell lung cancer
Scientific Title:Acronym Feasibility study of maintenance TS-1 for 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 evaluate the efficacy and toxicity of maintenance chemotherapy (TS-1)
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To evaluate the feasibility of maintenance chemotherapy (TS-1)
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Histologically or cytologically proven stageIV non-small cell lung cancer.
Patients previously treated with platinum- based chemotherapy and except PD cases by RECIST.
Patients aged above 20 years.
ECOG performance status (PS): 0-2
Patients having sufficient function of main organ and bone marrow.

Written informed consent.
Key exclusion criteria Patients with active interstitial pneumonia or pulmonary fibrosis recognized by chest X-ray.
Patients with massive uncontrolled pleural effusion , ascites, or pericardial effusion.
Patients having active other cancers.
a serious or uncontrolled concomitant systematic disorder (ileus, interstitial pneumonia, pulmonary fibrosis, COPD, uncontrolled diabetes mellitus, cardiac infarction or unstable angina within 6 months.)
Patients with active concomitant pregnancy.
HIV or HBV-positive patients
Inappropriate patients for this study judged by the physicians
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noboru Hattori
Organization Hiroshima University Hospital
Division name Department of Respiratory Medicine
Zip code
Address 1-2-3,Kasumi,Minami-ku, Hiroshima,Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Hiroshima University Hospital
Division name Department of Respiratory Medicine
Zip code
Address 1-2-3,Kasumi,Minami-ku, Hiroshima,Japan
TEL
Homepage URL
Email

Sponsor
Institute Hiroshima University
Institute
Department

Funding Source
Organization Hiroshima University
Organization
Division
Category of Funding Organization Other
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 11 Month 11 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 Terminated
Date of protocol fixation
2010 Year 11 Month 08 Day
Date of IRB
Anticipated trial start date
2010 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 To evaluate the feasibility of maintenance chemotherapy (TS-1)

Management information
Registered date
2010 Year 11 Month 11 Day
Last modified on
2013 Year 09 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005215

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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