UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000008811
Receipt No. R000010315
Scientific Title Bevacizumab Combined With Cisplatin Plus Pemetrexed as Front-line Chemotherapy for Asymptomatic Brain Metastases in Non-squamous Non-small Cell Lung Cancer.
Date of disclosure of the study information 2013/09/01
Last modified on 2017/12/24

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Bevacizumab Combined With Cisplatin Plus Pemetrexed as Front-line Chemotherapy for Asymptomatic Brain Metastases in Non-squamous Non-small Cell Lung Cancer.
Acronym Bevacizumab With Cisplatin Plus Pemetrexed for Asymptomatic Brain Metastases in Non-Sq NSCLC
Scientific Title Bevacizumab Combined With Cisplatin Plus Pemetrexed as Front-line Chemotherapy for Asymptomatic Brain Metastases in Non-squamous Non-small Cell Lung Cancer.
Scientific Title:Acronym Bevacizumab With Cisplatin Plus Pemetrexed for Asymptomatic Brain Metastases in Non-Sq NSCLC
Region
Japan

Condition
Condition Non-squamous Non-small Cell Lung Cancer
Classification by specialty
Medicine in general Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy and safety of bevacizumab with cisplatin plus pemetrexed as front-line chemotherapyin non-squamous non-small cell lung cancer patients with asymptomatic brain metastases
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Progression-free survival
Key secondary outcomes 1. Overall survival
2. Response rate
3. Disease control rate
4. Progression free survival, response rate, and disease control rate
of brain metastases
5. Safety

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 Bevacizumab (15mg/kg, day 1) with cisplatin (75mg/m2, day 1) plus pemetrexed (500mg/m2, day 1) is administered every three weeks until four cycles. After the completion of four cycles, bevacizumab (15mg/kg, day 1) plus pemetrexed (500mg/m2, day 1) is administered every three weeks as a maintenance therapy.
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 proven non-squamous non-small cell lung cancer
2)Stage IIIB, stage IV or recurrent disease after surgery
3)Asymptomatic brain metastases less than 2 cm diameter without urgent local therapy. Extra brain lesion: With measurable or inmeasurable lesion
4)If the patient underwent radiotherapy, there should be the following interval between the radiotherapy and the registration
i)Radiotherapy including pulmonary field: not permissible ii)Radiotherapy other than thoracic radiation ->1 week
5)Over 20 years old
6)ECOG PS 0-1
7)Adequate organ function
8)Life expectancy more than 3 months
9)Written informed consent
Key exclusion criteria 1)Interstitial pneumonia or pulmonary fibrosis detectable on CT scan
2)History of severe drug allergy
3)History of active infection or other serious disease condition
(GI bleeding,etc.)
4)History of poorly controlled pleural effusion,pericardial effusion and ascites
5)History of severe heart disease(uncontrollable arrythmia,uncontrollable angina pectoris,herat failure,etc.)
6)Uncontrollable hypertension
7)Uncontrollable diabetes mellitus
8)Hystory of active double cancer
9)Invasion to main blood vessels
10)History of active psychological disease
11)Severe hemoptysis or blood sputum
12)History of gastrointestinal perforation
13)Symptomatic or more than 2 cm diameter brain metastases
14)Uncured bone fracture (excluding compression fracture due to osteoporosis)
15)Planned surgery
16)Obvious cavity on pulmonary lesions.
17)Bleeding tendency
18)Uncontrolled thromboembolizm
19)Pregnancy
20)Participation in the trial is judged to be inappropriate by the attending doctor
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuyuki Katakami
Organization Institute of Biomedical Research and Innovation
Division name Division of Integrated Oncology
Zip code
Address 2-2, Minatojima-minamimachi, Chuo-ku, Kobe
TEL 078-304-5200
Email

Public contact
Name of contact person
1st name
Middle name
Last name Akito Hata
Organization Institute of Biomedical Research and Innovation
Division name Division of Integrated Oncology
Zip code
Address 2-2, Minatojima-minamimachi, Chuo-ku, Kobe
TEL 078-304-5200
Homepage URL
Email a-hata@fbri.org

Sponsor
Institute Hanshin Oncology Group
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
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 大阪府立成人病センター(大阪府)
京都桂病院(京都府)
倉敷中央病院(岡山県)
神戸市立医療センター中央市民病院(兵庫県)
神戸市立医療センター西市民病院(兵庫県)
神戸大学医学部附属病院(兵庫県)
刀根山病院(大阪府)
先端医療センター(兵庫県)
兵庫県立がんセンター(兵庫県)

Other administrative information
Date of disclosure of the study information
2013 Year 09 Month 01 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 Terminated
Date of protocol fixation
2012 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 09 Month 01 Day
Last follow-up date
2017 Year 12 Month 01 Day
Date of closure to data entry
2017 Year 12 Month 01 Day
Date trial data considered complete
2017 Year 12 Month 01 Day
Date analysis concluded
2017 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 08 Month 30 Day
Last modified on
2017 Year 12 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010315

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.