UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013125
Receipt number 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 20:53:56

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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 or person

Institute

Department of Pulmonary Medicine, School of Medicine, Keio University, Tokyo, Japan

Institute

Department

Personal name



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

Value
https://center6.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