UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004541 |
|---|---|
| Receipt number | 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 15:44:44 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005215
