UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006079 |
|---|---|
| Receipt number | R000007195 |
| Scientific Title | A cohort study in patients with StageIIIB/IVnon-small cell lung cancer, who had treated as 1st-line Conbination therapy of Carboplatin/Paclitaxel/Bavacizumab, and 2nd-line by Erlotinib |
| Date of disclosure of the study information | 2011/07/30 |
| Last modified on | 2018/02/19 15:13:23 |
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Basic information
Public title
A cohort study in patients with StageIIIB/IVnon-small cell lung cancer, who had treated as 1st-line Conbination therapy of Carboplatin/Paclitaxel/Bavacizumab, and 2nd-line by Erlotinib
Acronym
A cohort study in patients with StageIIIB/IVnon-small cell lung cancer, who had treated as 1st-line Conbination therapy of Carboplatin/Paclitaxel/Bavacizumab, and 2nd-line by Erlotinib
Scientific Title
A cohort study in patients with StageIIIB/IVnon-small cell lung cancer, who had treated as 1st-line Conbination therapy of Carboplatin/Paclitaxel/Bavacizumab, and 2nd-line by Erlotinib
Scientific Title:Acronym
A cohort study in patients with StageIIIB/IVnon-small cell lung cancer, who had treated as 1st-line Conbination therapy of Carboplatin/Paclitaxel/Bavacizumab, and 2nd-line by Erlotinib
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Covering analysis including effectiveness and safety of treated as 1st-line Conbination therapy of Carboplatin/Paclitaxel/Bavacizumab, and as 2nd-line Erlotinib for patients with StageIIIB/IV non- squamous non-small cell lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time to Treatment Failure
Key secondary outcomes
2nd PFS, Adverse events, Overall survival,
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)histologically or cytologically confirmed non-squamous non-small-cell lung cancer
2) stage IIIB/IV or postoperative recurrence patients
3)chemotheraoy naive patients
4)Patients providing written informed consent
Key exclusion criteria
1)Inappropriate patients for this study judged by the physicians
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoko Shibata |
Organization
Yamagata University School of Medicine
Division name
Department of Cardiology, Pulmonology, and Nephrology
Zip code
Address
2-2-2 Iida-Nishi, Yamagata-shi,Yamagata 990-9585, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Yamagata University School of Medicine
Division name
Department of Cardiology, Pulmonology, and Nephrology
Zip code
Address
2-2-2 Iida-Nishi, Yamagata-shi,Yamagata 990-9585, Japan
TEL
023-628-5302
Homepage URL
Sponsor or person
Institute
Yamagata University School of Medicine
Institute
Department
Personal name
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
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 | 07 | Month | 30 | 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
| 2011 | Year | 05 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | 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
Covering analysis including effectiveness and safety of treated as 1st-line Conbination therapy of Carboplatin/Paclitaxel/Bavacizumab, and as 2nd-line Erlotinib for patients with StageIIIB/IV non- squamous non-small cell lung cancer
Management information
Registered date
| 2011 | Year | 07 | Month | 29 | Day |
Last modified on
| 2018 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007195
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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