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Name:
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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000005764
Receipt No. R000006511
Scientific Title A Phase2 Study of Platinum Doublet and Bevacizumab followed by Bevacizumab and Pemetrexed maintenance for Non-squarmous Non Small Cell Lung Cancer Patients
Date of disclosure of the study information 2011/06/16
Last modified on 2014/06/13

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Basic information
Public title A Phase2 Study of Platinum Doublet and Bevacizumab followed by Bevacizumab and Pemetrexed maintenance for Non-squarmous Non Small Cell Lung Cancer Patients
Acronym Platinum Doublet and Bevacizumab followed by Bevacizumab and Pemetrexed maintenance for Non-squarmous Non Small Cell Lung Cancer Patients
Scientific Title A Phase2 Study of Platinum Doublet and Bevacizumab followed by Bevacizumab and Pemetrexed maintenance for Non-squarmous Non Small Cell Lung Cancer Patients
Scientific Title:Acronym Platinum Doublet and Bevacizumab followed by Bevacizumab and Pemetrexed maintenance for Non-squarmous Non Small Cell Lung Cancer Patients
Region
Japan

Condition
Condition Non-squarmous Non Small Cell Lung Cancer(non-pretreated patient)
Classification by specialty
Pneumology Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To access the efficacy and safety of maintenance Bevacizumab+Pemetrexed following Platinum Doublet+Bevacizumab
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Progression Free Survival
Key secondary outcomes Safety
Overall Survival
Rate of shift to maintenance

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 Pulatinum doublet and Bevacizumab followed by maintenance Bevacizumab and Pemetrexed until Clinical disease progression
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
75 years-old >
Gender Male and Female
Key inclusion criteria 1)Histologically or cytologically proven non small cell lung cancer(non-squarmous cell lung cancer)
2)Stage 3B/4
3)With evaluated and measured lesion according to RECIST(Ver.1.1)
4)Age 20-75
5)ECOG PS0-1
6)Adequate functions of major organs
7)Written informed concent
Key exclusion criteria 1)Previous hemopotysis (2.5ml)
2)Brain metastasis.
3)Any operation, biopsy associated with section, or any saturation of wounds within 4 weeks before enrollment.
4)Untreated traumatic bone fracture.
5)Consolidated or history of gastric perforation within 1 year before enrollment.
6)Uncontrollable peptic ulcer.
7)Tendency to bleed, or coagulation defect.
8)Treated with antithrombotic drugs within 10 days before enrollment.
9)Chronic inflammatory disease requiring anti-platelet agent.
10)History of interstitial lung disease.
11)Uncontrollable pleural effusion or ascites.
12)Uncontrollable heart disease and/or hypertension.
13)Cardiac infraction or cerebral infraction within 6 months before enrollment.
14)Have another active malignancy.
15)Severe infection or malnutrition.
16)Severe drug allergy.
17)In pregnancy, during breast feeding, or possibility of pregnancy.
18)Invasion to major vessel.
19)Cavitation of tumor.
20)History of chest irradiation (excluding if radiation field does not cover the primary tumor).
21)Any patient who is judged to be inappropriate for participation.
Target sample size 48

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshinobu Iwasaki
Organization Kyoto Prefectural University of Medicine
Division name Pulmonary Medicine
Zip code
Address 465 Kajii-cho, Kamigyoku, Kyoto city 602-8566
TEL 075-251-5513
Email yiwasaki@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshinobu Iwasaki
Organization Kyoto Prefectural University of Medicine
Division name Pulmonary Medicine
Zip code
Address Hirokoji, Kawaramachi, Kamigyo-ku, Kyoto
TEL 075-251-5513
Homepage URL
Email yiwasaki@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization Kyoto Prefectural University of Medicine
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 京都府立医科大学附属病院(京都府)

Other administrative information
Date of disclosure of the study information
2011 Year 06 Month 16 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
2011 Year 03 Month 15 Day
Date of IRB
Anticipated trial start date
2011 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
2011 Year 06 Month 13 Day
Last modified on
2014 Year 06 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006511

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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