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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005284
Receipt No. R000006285
Scientific Title Phase2 study of Carboplatin / Paclitaxel + Bevacizumab to non-small-cell lung cancer (non-squamous cell carcinoma) with pleural efussion in stage4
Date of disclosure of the study information 2011/03/22
Last modified on 2013/03/18

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Basic information
Public title Phase2 study of Carboplatin / Paclitaxel + Bevacizumab to non-small-cell lung cancer (non-squamous cell carcinoma) with pleural efussion in stage4
Acronym Phase2 study of CBDCA / PTX + Bevacizumab to non-small-cell lung cancer with pleural efussion
Scientific Title Phase2 study of Carboplatin / Paclitaxel + Bevacizumab to non-small-cell lung cancer (non-squamous cell carcinoma) with pleural efussion in stage4
Scientific Title:Acronym Phase2 study of CBDCA / PTX + Bevacizumab to non-small-cell lung cancer with pleural efussion
Region
Japan

Condition
Condition non-small-cell lung cancer (non-squamous cell carcinoma) with pleural efussion in stage4
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 we rospectivelyexamine the efficacy and safety of Carboplatin / Paclitaxel + bevacizumab to non-small-cell lung cancer (non-squamous cell carcinoma) with pleural efussion in stage4
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes efficacy
Key secondary outcomes Density of chest underwater VEGF before and after, overall survival time, safety, 1-year survival rate, frequency of chest water drainage, progression free survival

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 Carboplatin/paclitaxel+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)Histologically or cytologically confirmed Stage IV Non-small-cell lung cancer
2)Non-Squamous Non-small-cell lung cancer
3)Pleural effusion requiring drainage
4)Adjuvant chemotherapy is permitted
5)At least one year has to be past since the last administration of adjuvant chemotherapy
6)Age : 20 years or older
7)At least one measurable lesion by RECIST
8)PS : 0-2
9)adequate major organ (hemoatologic hepatic, respiratory and renal function) function
white blood cell >=3000/mm3
hemoglobin >=9.0g/dl
platelet >=100000/mm3
total bilirubin <= 1.5
AST/ALT <=2.0 times upper limit of normal
SpO2 >=90%
Adequate organ function
10)Life expectancy more than three months
11)Adequate interval since the last radiation therapy or surgery
12)written informed consent
Key exclusion criteria 1)History of pleurodesis
2)Severe infection except for non-active hepatitis C
3)Fever more than 38 degree
4)Severe comorbidity (heart failure/kidney failure/hepatic failure/uncontrollable diabetes/uncontrollable hypertension, etc)
5)Active double cancer
6)Symptomatic brain metastasis
7)History of hemoptysis with 2.5mL or more
8)Pericardial effusion requiring drainage
9)Interstitial pneumonia or pulmonary fibrosis detectable on X ray
10)History of drug sensitivity
11)Pregnant or lactating women
12)Psychiatric disease or mental trouble
13)Continuing administration of steroid
14)Evaluated to be ineligible by a physician for other reasons
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomonori Hirashima
Organization Osaka Prefectural Medical Center for Respiratory and Allergic diseases
Division name Thoracic Malignancy
Zip code
Address 3-7-1 Habikino Habikino city Osaka
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Motohiro Tamiya
Organization Osaka Prefectural Medical Center for Respiratory and Allergic diseases
Division name Thoracic Malignancy
Zip code
Address 3-7-1 Habikino Habikino city Osaka
TEL 072-957-2121
Homepage URL
Email

Sponsor
Institute Osaka Prefectural Medical Center for Respiratory and Allergic diseases
Institute
Department

Funding Source
Organization none
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
2011 Year 03 Month 22 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 Completed
Date of protocol fixation
2010 Year 08 Month 02 Day
Date of IRB
Anticipated trial start date
2010 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
2013 Year 03 Month 14 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 03 Month 21 Day
Last modified on
2013 Year 03 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006285

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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