UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003397
Receipt No. R000004061
Scientific Title Feasibility study of Docetaxel plus Bevacizumab in selected patient with previously treated advanced NSCLS(non-squamous).
Date of disclosure of the study information 2010/03/29
Last modified on 2013/09/30

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Feasibility study of Docetaxel plus Bevacizumab in selected patient with previously treated advanced NSCLS(non-squamous).
Acronym Feasibility study of Docetaxel plus Bevacizumab in selected patient with previously treated advanced NSCLS(non-squamous).
Scientific Title Feasibility study of Docetaxel plus Bevacizumab in selected patient with previously treated advanced NSCLS(non-squamous).
Scientific Title:Acronym Feasibility study of Docetaxel plus Bevacizumab in selected patient with previously treated advanced NSCLS(non-squamous).
Region
Japan

Condition
Condition Previously treated advanced NSCLC(non-squamous)
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Safety/Efficacy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes frequency DLT
Key secondary outcomes

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 Bevacizumab plus Docetaxel
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients recived one previus platinum-bsed chemotherapy rejimen for NSCLC.

Patients with histologically or cytologically confirmed NSCLC were eligible.

An ECOG performance status of 0 to 2




Key exclusion criteria Patients with Brain metastasis.
Patinets with symptomatic congestive heart failure,unstable angina pectoris,cardiac arrhythmias,thorombotic events,a history of gross hemoptysis.

Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Nishio
Organization Cancer Institute Hospital,Japanese Foundation for Cancer Reseach
Division name Thoracic Oncology
Zip code
Address 3-8-31 Ariake Koto-ku ,Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Cancer Institute Hospital,Japanese Foundation for Cancer Reseach
Division name Thoracic Oncology
Zip code
Address
TEL 03-3520-0111
Homepage URL
Email

Sponsor
Institute Cancer Institute Hospital
Japanese Foundation for Cancer Research
Institute
Department

Funding Source
Organization Cancer Institute Hospital
Japanese Foundation for Cancer Research
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

Other administrative information
Date of disclosure of the study information
2010 Year 03 Month 29 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Completed
Date of protocol fixation
2010 Year 03 Month 03 Day
Date of IRB
Anticipated trial start date
2010 Year 04 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
2010 Year 03 Month 29 Day
Last modified on
2013 Year 09 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004061

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.