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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000013125
Receipt No. R000015308
Scientific Title A efficacy of maintenance intensification therapy by(Bevacizumab)/Pemetrexed/Carboplatin or Cisplatin after induction therapy by Erlotinib for EGFR mutation positive non -spuamous non-small cell lung cancer.
Date of disclosure of the study information 2014/02/10
Last modified on 2019/08/21

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Basic information
Public title A efficacy of maintenance intensification therapy by(Bevacizumab)/Pemetrexed/Carboplatin or Cisplatin after induction therapy by Erlotinib for EGFR mutation positive non -spuamous non-small cell lung cancer.
Acronym A efficacy of maintenance intensification therapy by(Bevacizumab)/Pemetrexed/Carboplatin or Cisplatin after induction therapy by Erlotinib for EGFR mutation positive non -spuamous non-small cell lung cancer.
Scientific Title A efficacy of maintenance intensification therapy by(Bevacizumab)/Pemetrexed/Carboplatin or Cisplatin after induction therapy by Erlotinib for EGFR mutation positive non -spuamous non-small cell lung cancer.
Scientific Title:Acronym A efficacy of maintenance intensification therapy by(Bevacizumab)/Pemetrexed/Carboplatin or Cisplatin after induction therapy by Erlotinib for EGFR mutation positive non -spuamous non-small cell lung cancer.
Region
Japan

Condition
Condition non-small non-squamous cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluate efficacy and safety of the Bevacizumab)/Pemetrexed/Platinum-Doublet ce-therapy in patients with EGFR mutation positive non-squamous and non-small cell lung cancer after the Erlotinib-induction therapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1-year Progression Free Survival rate
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 Pemetrexed
Platinum-Doublet
Erlotinib
(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
80 years-old >
Gender Male and Female
Key inclusion criteria 1)Histologically or cytologically proven non-squamous non-small cell lung cancer
2)at least one measurable leision (RECIST)
3)stageIII/IV or recurrent post-operative non-squamous and non-small cell lung cancer
4)EGFR mutaion positive
5)1. PS:0-2 (ECOG) (before Erlotinib),2. PS:0-1 (ECOG) (before Chemotherapy),
6)Patients aged 20 or over, 80 under
7)adequate bone marrow,liver,and renal functions
8)written informed consent
Key exclusion criteria 1)Patients with active infection
2)Patients with interstitial pneumonia by X ray or CT scan
3)severe complication
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Kenzo
Middle name
Last name Soejima
Organization School of Medicine, Keio University, Tokyo, Japan
Division name Department of Pulmonary Medicine
Zip code 1608582
Address shinamomachi 35, shinjyuku-ku, Tokyo
TEL 0333531211
Email ksoejima@cpnet.med.keio.ac.jp

Public contact
Name of contact person
1st name Tetsuo
Middle name
Last name Tani
Organization School of Medicine, Keio University, Tokyo, Japan
Division name Department of Pulmonary Medicine
Zip code 1608582
Address shinamomachi 35, shinjyuku-ku, Tokyo
TEL 0333531211
Homepage URL
Email t.tani@z3.keio.jp

Sponsor
Institute Department of Pulmonary Medicine, School of Medicine, Keio University, Tokyo, Japan
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 Ethics Committee, School of Medicine, Keio University
Address shinamomachi 35, shinjyuku-ku, Tokyo
Tel 03335312111
Email med-rinri-jimu@adst.keio.ac.jp

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
2014 Year 02 Month 10 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 20
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 Main results already published
Date of protocol fixation
2009 Year 02 Month 18 Day
Date of IRB
2010 Year 07 Month 26 Day
Anticipated trial start date
2010 Year 08 Month 01 Day
Last follow-up date
2019 Year 08 Month 02 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 02 Month 10 Day
Last modified on
2019 Year 08 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015308

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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