UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009263 |
|---|---|
| Receipt number | 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 13:04:50 |
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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
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
rmorinaga@oita-u.ac.jp
Sponsor or person
Institute
Oita University Faculty of Medicine, Department of Medical Oncology & Hematology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010853
