UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Bevacizumab Combined With Cisplatin Plus Pemetrexed as Front-line Chemotherapy for Asymptomatic Brain Metastases in Non-squamous Non-small Cell Lung Cancer.
Title of the study (Brief title)	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	Nobuyuki Katakami
Organization	Institute of Biomedical Research and Innovation
Division name	Division of Integrated Oncology
Address	2-2, Minatojima-minamimachi, Chuo-ku, Kobe
TEL	078-304-5200
Email

Public contact
Name of contact person	Akito Hata
Organization	Institute of Biomedical Research and Innovation
Division name	Division of Integrated Oncology
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 08 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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