UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005800
Receipt number R000006864
Scientific Title A feasibility study of chemotherapy with vinorelbine plus bevacizumab in elderly patients with non-small lung cancer
Date of disclosure of the study information 2011/06/20
Last modified on 2014/12/19 23:16:27

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Basic information

Public title

A feasibility study of chemotherapy
with vinorelbine plus bevacizumab in
elderly patients with non-small lung cancer

Acronym

A feasibility study of chemotherapy
with vinorelbine plus bevacizumab in
elderly patients with non-small lung cancer

Scientific Title

A feasibility study of chemotherapy
with vinorelbine plus bevacizumab in
elderly patients with non-small lung cancer

Scientific Title:Acronym

A feasibility study of chemotherapy
with vinorelbine plus bevacizumab in
elderly patients with non-small lung cancer

Region

Japan


Condition

Condition

Non-small cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Objective of the study is to investigate feasibility of bevacizumab in combination with vinorelbine for elderly patients with non-small cell lung cancer.

Basic objectives2

Others

Basic objectives -Others

Treatment completion

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Treatment completion

Key secondary outcomes

Safety
Efficacy
QOL
OS
PFS


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

Vinorelbine 25mg/m2Day1,8
Bevacizumab 15mg/m2 Day1
3-6 cycle
21days as one cycle

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)StageIIIB/IV non-small-cell lung cancer(non-squamous cell carcinoma)
2)Age>=70
3)ECOG performance status 0-1
4) With one or more measurable disease
5)Patients who have previously treated chemotherapy, radiotherapy, immunotherapy regimen (without bevacizumab and vinorelbine).
6) No problem adequate organ function.
7)A life expectancy of more than 3 months.
8)All patients provided written informed consent before initiation of study-related procedures.

Key exclusion criteria

1) Receiving a blood transfusion, hematopoietic factor, anticoagulant drug 2 weeks prior to enrollment.
2) Severe renal function disorder
2+ or higher proteinuria within 2 weeks prior to enrollment.
3) Serious drug allergy.
4) Active synchronous malignancies.
5) Uncontrolled Active infection.
6) Uncontrollable hypertension, uncontrollable diabetes.
7) Clinically significant heart disease.
8)Thromboembolism, interstitial pneumonia, pulmonary fibrosis and severe emphysema within the past one year.
9)Traumatic fracture of unrecovery
10) Mental disorder, central nervous system disorders, cerebrovascular disorders.
11) Permeation of the neoplastic cell in large vessels.
12) Hollowing out of the tumor.
13) Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.

Target sample size

15


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazutoshi Isobe

Organization

Toho University Omori Medical Center

Division name

Department of Respiratory Medicine

Zip code


Address

6-11-1, Omori-Nishi, Ota-ku, Tokyo, Japan

TEL

03-3762-4151

Email

kazutoshiisobe@aol.com


Public contact

Name of contact person

1st name
Middle name
Last name Kazutoshi Isobe

Organization

Toho University Omori Medical Center

Division name

Department of Respiratory Medicine

Zip code


Address

6-11-1, Omori-Nishi, Ota-ku, Tokyo

TEL

03-3762-4151

Homepage URL


Email

kazutoshiisobe@aol.com


Sponsor or person

Institute

Toho University Omori Medical Center

Institute

Department

Personal name



Funding Source

Organization

Non

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


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

東邦大学医療センター大森病院(東京都)


Other administrative information

Date of disclosure of the study information

2011 Year 06 Month 20 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 05 Month 20 Day

Date of IRB


Anticipated trial start date

2011 Year 06 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 06 Month 19 Day

Last modified on

2014 Year 12 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006864


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name