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
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
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
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
