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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000006322
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute University hospital, Hirosaki University School of Medicine
Cardiology,respiratory medicine and nephrology
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007381

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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