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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000018322
Receipt No. R000021197
Scientific Title Phase II study of carboplatin, weekly paclitaxel and bevacizumab for advanced non-squamous cell, non-small-cell lung cancer with idiopathic interstitial pneumonia
Date of disclosure of the study information 2015/07/15
Last modified on 2018/01/24

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Basic information
Public title Phase II study of carboplatin, weekly paclitaxel and bevacizumab for advanced non-squamous cell, non-small-cell lung cancer with idiopathic interstitial pneumonia
Acronym Phase II study of carboplatin, weekly paclitaxel and bevacizumab for advanced non-squamous cell, non-small-cell lung cancer with idiopathic interstitial pneumonia
Scientific Title Phase II study of carboplatin, weekly paclitaxel and bevacizumab for advanced non-squamous cell, non-small-cell lung cancer with idiopathic interstitial pneumonia
Scientific Title:Acronym Phase II study of carboplatin, weekly paclitaxel and bevacizumab for advanced non-squamous cell, non-small-cell lung cancer with idiopathic interstitial pneumonia
Region
Japan

Condition
Condition advanced non-squamous cell, non-small-cell lung cancer with idiopathic interstitial pneumonia
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the safety and efficacy of carboplatin, weekly paclitaxel and bevacizumab for advanced non-squamous cell, non-small cell lung cancer with idiopathic interstitial pneumonia.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes response rate
Key secondary outcomes OS: overall survival
PFS: progression free survival
TTF: time to treatment failure
toxicity

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 AUC = 5, day1
paclitaxel 70mg/m2, day1 ,8 ,15
bevacizumab 15mg/kg, day1
every 4 weeks, 4-6 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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) non-squamous, non-small cell lung cancer
2) Age over twenty
3) Idiopathic interstitial pneumonia
4) Measurable lesion
5) expected treatment date to be 4 weeks over surgury, 2 weeks over drainage of pleural effusion, 2 weeks over biopsy requiring incision, 1 week over bronchoscopic procedure or implantation of central venous port
6) ECOG performance status 0 or 1
7) Adequate organ function
WBC>=3000/mm3 and neutrophil count >=2000/mm3
Hgb>=10.0 g/dL, Plt>=100,000/mm3, T-bil=<1.5mg/dL, AST=<100 IU/L, ALT=<100 IU/L, CRN=<1.5mg/dL, urine protein<= 1+
8) PaO2>=60.0 torr or SpO2>=92.0 %( room air)
9) Life expectancy > 3 months
10) Written informed consent
Key exclusion criteria 1) Secondary interstitial pneumonia.
2) History of acute exacerbation of interstitial pneumonia within 3 months.
3) Subacute progression of interstitial pneumonia within 3 months.
4) Using prednisolone or immune-suppressive agent.
5) In need of home oxygen therapy.
6) Past history of severe drug allergy.
7) Active infectious disease.
8) Severe complications
9) brain metastasis.
10) Uncontrollable effusion.
11) history of hemosputum
12) tumor invasion into thoracic large vessels or tumor with cavity
13)active gastrointestinal ulcer
14)bleeding tendency
15)operation wound not cured
16)thrombosis in need with treatment
17) Active combined malignancy
18) Any ineligible case judged by physician.
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuyuki Katakami
Organization Kobe City Medical Center General Hospital
Division name Department of Medical Oncology
Zip code
Address 2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, Japan 650-0047
TEL 078-302-4321
Email nkatakami@kcho.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kojiro Otsuka
Organization Kobe City Medical Center General Hospital
Division name Department of Respiratory Medicine
Zip code
Address 2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, Japan 650-0047
TEL 078-302-4321
Homepage URL
Email kotsuka@kcho.jp

Sponsor
Institute IP lung cancer study group
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
2015 Year 07 Month 15 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
2012 Year 11 Month 21 Day
Date of IRB
Anticipated trial start date
2012 Year 12 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
2015 Year 07 Month 15 Day
Last modified on
2018 Year 01 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021197

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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