UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003397 |
|---|---|
| Receipt number | R000004061 |
| Scientific Title | Feasibility study of Docetaxel plus Bevacizumab in selected patient with previously treated advanced NSCLS(non-squamous). |
| Date of disclosure of the study information | 2010/03/29 |
| Last modified on | 2013/09/30 15:52:29 |
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Basic information
Public title
Feasibility study of Docetaxel plus Bevacizumab in selected patient with previously treated advanced NSCLS(non-squamous).
Acronym
Feasibility study of Docetaxel plus Bevacizumab in selected patient with previously treated advanced NSCLS(non-squamous).
Scientific Title
Feasibility study of Docetaxel plus Bevacizumab in selected patient with previously treated advanced NSCLS(non-squamous).
Scientific Title:Acronym
Feasibility study of Docetaxel plus Bevacizumab in selected patient with previously treated advanced NSCLS(non-squamous).
Region
| Japan |
Condition
Condition
Previously treated advanced NSCLC(non-squamous)
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Safety/Efficacy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
frequency DLT
Key secondary outcomes
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
Bevacizumab plus Docetaxel
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
Patients recived one previus platinum-bsed chemotherapy rejimen for NSCLC.
Patients with histologically or cytologically confirmed NSCLC were eligible.
An ECOG performance status of 0 to 2
Key exclusion criteria
Patients with Brain metastasis.
Patinets with symptomatic congestive heart failure,unstable angina pectoris,cardiac arrhythmias,thorombotic events,a history of gross hemoptysis.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Nishio |
Organization
Cancer Institute Hospital,Japanese Foundation for Cancer Reseach
Division name
Thoracic Oncology
Zip code
Address
3-8-31 Ariake Koto-ku ,Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Cancer Institute Hospital,Japanese Foundation for Cancer Reseach
Division name
Thoracic Oncology
Zip code
Address
TEL
03-3520-0111
Homepage URL
Sponsor or person
Institute
Cancer Institute Hospital
Japanese Foundation for Cancer Research
Institute
Department
Personal name
Funding Source
Organization
Cancer Institute Hospital
Japanese Foundation for Cancer Research
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
| 2010 | Year | 03 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
| 2010 | Year | 03 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | 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
Management information
Registered date
| 2010 | Year | 03 | Month | 29 | Day |
Last modified on
| 2013 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004061
