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
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
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
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
