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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000009263
Receipt No. R000010853
Scientific Title Prospective study of Docetaxel combined with Bevacizumab in advanced or recurrent non-squamous non-small cell lung cancer patients unfit for platinum-doublet chemotherapy and exploratory biomarker analysis for predicting the effect with antiangiogenic therapy.(OLCAS-001)
Date of disclosure of the study information 2012/11/05
Last modified on 2014/08/05

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Basic information
Public title Prospective study of Docetaxel combined with Bevacizumab in advanced or recurrent non-squamous non-small cell lung cancer patients unfit for platinum-doublet chemotherapy and exploratory biomarker analysis for predicting the effect with antiangiogenic therapy.(OLCAS-001)
Acronym Phase II study of Docetaxel plus Bevacizumab in non-squamous NSCLC patients unfit for platinum-doublet chemotherapy
Scientific Title Prospective study of Docetaxel combined with Bevacizumab in advanced or recurrent non-squamous non-small cell lung cancer patients unfit for platinum-doublet chemotherapy and exploratory biomarker analysis for predicting the effect with antiangiogenic therapy.(OLCAS-001)
Scientific Title:Acronym Phase II study of Docetaxel plus Bevacizumab in non-squamous NSCLC patients unfit for platinum-doublet chemotherapy
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 evaluate the efficacy and safety of docetaxel plus bevacizumab for advanced or recurrent non-squamous NSCLC patients unfit for platinum-doublet chemotherapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Progression free survival
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 docetaxel plus bevacizumab
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 1)pathologically or cytologically confirmed non-squamous non-small lung cancer
2)patients with clinical stage IIIb/IV or recurrent post-operative status, unsuitable for curative therapy or recurrent
3)no prior chemotherapy
4)patients who have the measurable disease defined by RECIST v1.1
5)patients with ECOG PS 0-2
6)age 20 years or older
7)medically unfit for platinum-doublet chemotherapy
8)adequate organ functions
9)estimated survival of at least 3 months
10)with written informed consent
Key exclusion criteria 1) with uncontrollable co-morbidities
2)with episode of hemoptysis
3)clinically unfit for bevacizumab containing chemotherapy
4)with severe allergy of the medication
5)with ineligible conditions judged by the attending physician
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shirao Kuniaki
Organization Oita University Hospital
Division name Department of Medical Oncology
Zip code
Address 1-1, Idaigaoka, Hasama-machi, Yufu-city, Oita
TEL 097-586-6275
Email kshirao@oita-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Morinaga Ryotaro
Organization Oita University Hospital
Division name Department of Medical Oncology
Zip code
Address 1-1, Idaigaoka, Hasama-machi, Yufu-city, Oita
TEL 097-586-6275
Homepage URL
Email rmorinaga@oita-u.ac.jp

Sponsor
Institute Oita University Faculty of Medicine, Department of Medical Oncology & Hematology
Institute
Department

Funding Source
Organization Infection Control Oita Network
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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
2012 Year 11 Month 05 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 Terminated
Date of protocol fixation
2012 Year 09 Month 05 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 05 Day
Last follow-up date
2016 Year 11 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 11 Month 05 Day
Last modified on
2014 Year 08 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010853

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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