UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012514 |
|---|---|
| Receipt number | R000014648 |
| Scientific Title | A phase II study of Erlotinib Plus Bevacizumab in patients with advanced Non-squamous Non- Small Cell Lung Cancer with brain metastasis and Harboring Epidermal Growth Factor Receptor Mutations. |
| Date of disclosure of the study information | 2013/12/09 |
| Last modified on | 2017/06/10 13:53:01 |
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Basic information
Public title
A phase II study of Erlotinib Plus Bevacizumab in patients with advanced Non-squamous Non- Small Cell Lung Cancer with brain metastasis and Harboring Epidermal Growth Factor Receptor Mutations.
Acronym
A phase II study of Erlotinib Plus Bevacizumab in patients with advanced Non-squamous Non- Small Cell Lung Cancer with brain metastasis and Harboring Epidermal Growth Factor Receptor Mutations.
Scientific Title
A phase II study of Erlotinib Plus Bevacizumab in patients with advanced Non-squamous Non- Small Cell Lung Cancer with brain metastasis and Harboring Epidermal Growth Factor Receptor Mutations.
Scientific Title:Acronym
A phase II study of Erlotinib Plus Bevacizumab in patients with advanced Non-squamous Non- Small Cell Lung Cancer with brain metastasis and Harboring Epidermal Growth Factor Receptor Mutations.
Region
| Japan |
Condition
Condition
Non-Small-Cell Lung Cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of Erlotinib and Bevacizumab in patients with advanced Non-squamous Non-Small Cell Lung Cancer with brain metastasis harboring EGFR mutation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
time to treatment failure
Key secondary outcomes
Toxicity
Response Rate for extracranial metastases
Response Rate for intracranial metastases
Overall survival
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
Erlotinib 150mg/day, oral daily
Bevacizumab 15mg/kg, intravenous q3w
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)Histologically or cytologically confirmed non-squamous NSCLC
2)brain metastasis
3)StageIVor postoperative recurrence NSCLC
4)EGFR mutation(exon18,19,21) positive
5)Age>=20years
6)Patients without previous treatment for lung cancer
A patient who has received postoperative chemotherapy is eligible if the last administration of the prior adjuvant regimen occurred at least 12 month
7)ECOG PS 0-2
8)Adequate function of main organ evaluated within enrollment as
WBC=3,000~12000/mm3
Neu>=1,500/mm3
Plt>=10.0x10000/mm3
hemoglobin >=8.5g/dL
AST,ALT=<2.5xULN
T-bil=<2.0mg/dL
Cr>=2.0xULN
Proteinuria<1+
SpO2>=90%
9)Written informed consent from the patients.
Key exclusion criteria
1)Squamous cell carcinoma
2)Interstitial pneumonia or pulmonary fibrosis on chest CT scans
3)History of EGFR-TKI, VEGF antibody allergic reaction.
4)Brain metastasis expected bleeding
5)Radiotherapy enforcement example for the brain
6)Active severe comorbidity disease.
7)History of hemoptysis
8)Uncontrollable hypertension
9)History of gastrointenstinal perforation or diverticulitis or fistula
10)Scheduled operation
11)Active concomitant malignancy
12)Pregnant or breast-feeding females
13)Inappropriate patients for this study judged by the physicians
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sho Saeki |
Organization
Kumamoto University Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
Honjo,Chuo-ku,Kumamoto city,Kumamoto,Japan
TEL
096-373-5012
saeshow@wg7.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sho Saeki |
Organization
Kumamoto University Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
Honjo,Chuo-ku,Kumamoto city,Kumamoto,Japan
TEL
096-373-5012
Homepage URL
saeshow@wg7.so-net.ne.jp
Sponsor or person
Institute
Department of Respiratory Medicine, Kumamoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kumamoto University Hospital
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
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
| 2013 | Year | 12 | Month | 09 | 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
Preinitiation
Date of protocol fixation
| 2013 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | 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
| 2013 | Year | 12 | Month | 07 | Day |
Last modified on
| 2017 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014648
