UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005267 |
|---|---|
| Receipt number | R000006264 |
| Scientific Title | Evaluating quality of life of non-small cell lung cancer in the elderly treated with chemotherapy or molecular targeted therapy |
| Date of disclosure of the study information | 2011/03/17 |
| Last modified on | 2013/10/17 18:48:07 |
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Basic information
Public title
Evaluating quality of life of non-small cell lung cancer in the elderly treated with chemotherapy or molecular targeted therapy
Acronym
Evaluating quality of life of non-small cell lung cancer in the elderly treated with chemotherapy or molecular targeted therapy
Scientific Title
Evaluating quality of life of non-small cell lung cancer in the elderly treated with chemotherapy or molecular targeted therapy
Scientific Title:Acronym
Evaluating quality of life of non-small cell lung cancer in the elderly treated with chemotherapy or molecular targeted therapy
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
1)To examine the QOL changes in the comparison with the injection anticancer agent and EGFR-TKI
2)To examine the QOL changes in the comparison with in-patient and out-patient chemotherapy
Basic objectives2
Others
Basic objectives -Others
observation study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
QOL evaluation (FACT-L)
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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Histology/cytology-proven non-small cell lung cancer, age of 70 years or over
2)ECOG performance status of 0-2
3)Acquisition of written informed consent
Key exclusion criteria
1)Patients with dementia
2)Those judged to be not suitable by the attending physician
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukari Tsubata |
Organization
Shimane University Faculty of Medicine
Division name
Division of Clinical Oncology and Respiratory Medicine
Zip code
Address
89-1, Enya-cho, Izumo, Shimane
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Shimane University Faculty of Medicine
Division name
Division of Clinical Oncology and Respiratory Medicine
Zip code
Address
89-1, Enya-cho, Izumo, Shimane
TEL
Homepage URL
Sponsor or person
Institute
Shimane University Faculty of Medicine, Division of Clinical Oncology and Respiratory Medicine
Institute
Department
Personal name
Funding Source
Organization
Shimane University Faculty of Medicine, Division of Clinical Oncology and Respiratory Medicine
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
| 2011 | Year | 03 | Month | 17 | 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
| 2009 | Year | 03 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 06 | Month | 01 | Day |
Other
Other related information
Prospective observation study
Management information
Registered date
| 2011 | Year | 03 | Month | 17 | Day |
Last modified on
| 2013 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006264
