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


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 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


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

Value
https://center6.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