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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000005800
Receipt No. 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

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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
Institute Toho University Omori Medical Center
Institute
Department

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
URL(English) https://upload.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


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