UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006322 |
|---|---|
| Receipt number | R000007381 |
| Scientific Title | A phase II study of Bevacizumab and Docetaxel for elderly patients advanced Non-Small Cell Lung Cancer |
| Date of disclosure of the study information | 2011/09/12 |
| Last modified on | 2011/09/10 12:14:22 |
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Basic information
Public title
A phase II study of Bevacizumab and Docetaxel for elderly patients advanced Non-Small Cell Lung Cancer
Acronym
A phase II study of Bevacizumab and Docetaxel for elderly patients with NSCLC
Scientific Title
A phase II study of Bevacizumab and Docetaxel for elderly patients advanced Non-Small Cell Lung Cancer
Scientific Title:Acronym
A phase II study of Bevacizumab and Docetaxel for elderly patients with NSCLC
Region
| Japan |
Condition
Condition
Non-squamous non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of Docetaxel with Bevacizumab in chemotherapy for elderly patients
with advanced non-squamous non-small-cell lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
RR: response rate
Key secondary outcomes
PFS: progression free survival
OS: overall survival
safety
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
DTX+BEV
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)Histologically or cytrologically confirmed diagnosis of NSCLC (Non squamous cell carcinima)
2)No prior systemic treatment advanced NSCLC
3)Tumors must have measurable disease
4)ECOG performance status 0 or 1
5)Patients aged 70- years
6)Written informed consent from the patients
7)No problem adequate organ function
Key exclusion criteria
1)Subjects with interstitial pneumonia or pulmonary fibrosis.
2)Uncontrolled systematic disease
3)Uncontrolled active infection
4)No other active malignancies
5)Concurrent use of steroid therapy
6)Subjects with brain metastases
7)Uncontrolled pleural effusion and ascites
8)have had or require continuous oral administration of hemostat/have had or require injectable administration of hemostat
9)Pregnant patients
10)Have a bleeding diathesis
11)Tumor invasion to major vessels
12)Cavity in tumor
13)History of uncontrolled gastroduodenal ulcer
14)Uncontrolled hypertension
15)Symptomatic heart failure,unstable angina, uncontrolled arrhythmia,
myocardial infarction within 1 year
16)Symptomatic cerebrovasucular disease
17)Any other reason that,in the opinion of the investugator precludes the subject from participating in the study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Morimoto |
Organization
University hospital, Hirosaki University School of Medicine
Division name
Cardiology,respiratory medicine and nephrology
Zip code
Address
5 Zaifu-cho, Hirosaki, 036-8562 Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hisashi Tanaka |
Organization
University hospital, Hirosaki University School of Medicine
Division name
Cardiology,respiratory medicine and nephrology
Zip code
Address
5 Zaifu-cho, Hirosaki, 036-8562 Japan
TEL
Homepage URL
Sponsor or person
Institute
University hospital, Hirosaki University School of Medicine
Cardiology,respiratory medicine and nephrology
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
Hirosaki Central Hospital
Natonal Hospital Orgnization Hirosaki Hospital
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 | 09 | Month | 12 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 08 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | 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
| 2011 | Year | 09 | Month | 10 | Day |
Last modified on
| 2011 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007381
