UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II Study of Bevacizumab in Combination with First-line Platinum-Doublet Chemotherapy in Non-squamous NSCLC Patients with Asymptomatic Untreated Brain Metastases.
Title of the study (Brief title)	Phase II Study of Bevacizumab in Combination with First-line Platinum-Doublet Chemotherapy in Non-squamous NSCLC Patients with Asymptomatic Untreated Brain Metastases.
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 bevacizumab in combination with first-line platinum doublet chemotherapy in Non-squamous NSCLC patients with asymptomatic untreated brain metastases.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Progression free Survival
Key secondary outcomes	Safety, Overall survival, Response Rate, Response Rate for intracranial metastases

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 Platinum-Doublet Chemotherapy
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-squamuous, non-small cell lung cancer (2)StageIV or recurrent non-small cell lung cancer without any chemotherapy (3)Age20=< (4)With one or more measurable disease based on RECIST (5)ECOG performance status of 0 to 2 (6)Adequate organ function, evaluated within 14 days before enrollment as WBC>=3,000/mm3 Neu>=1,500/mm3 Plt>=10.0x10000/mm3 hemoglobin >=9.0g/dL T-bil=<1.5mg/dL AST,ALT=<2.0xULN Cr>=1.5xULN SpO2>=90% Proteinuria<1+ (7) Interval -Immune therapy, Endocrine therapy >3wks -Palliative radiotherapy >2wks -Surgery >4wks -thoracic drainage >1wks -biopsy with dissection, indwelling port >2wks -Aspiration biopsy cytology >1wks (8) Expected to live over 3 months after administration days. (9) Written informed consent from the patients.
Key exclusion criteria	(1)Symptomatic brain metastasis (2)>=3cm Untreated brain metastasis (3)Have another active malignancy (4) Current or previous history of hemoptysis (5) Evidence of tumor invading large vessel on imaging (6) Have received radiation therapy to lesions of lung (7) Currently have or have a history of a Ascites ,Pleural effusion or pericardial effusion which requires treatment (8) Symptomatic Brain infarction within 1 year (9) Problematic infection (10) Patients receiving (oral or intravenous) administration of continuous systemic steroids. (11) Sever complications (12) Scheduled operation (13)Active radiation pneumonitis or esophagitis (14) Patients with a history of severe hypersensitivity to drugs used in this trial. (15) Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy (16) Psychotic disease judged should not to participate the trial (17) Decision of ineligibility by a physician.
Target sample size	25

Research contact person
Name of lead principal investigator	Ichiro Kawase
Organization	Osaka Prefectural Medical Center for Respiratory and Allergic Diseases
Division name	Department of Thoracic Malignancy
Address	3-7-1 Habikino Habikino city Osaka
TEL	072-957-2121
Email	moto19781205@yahoo.co.jp

Public contact
Name of contact person	Motohiro Tamiya/Takayuki Shiroyama
Organization	Osaka Prefectural Medical Center for Respiratory and Allergic Diseases
Division name	Department of Thoracic Malignancy
Address	3-7-1 Habikino Habikino City Osaka Japan
TEL	072-957-2121
Homepage URL
Email	moto19781205@yahoo.co.jp

Sponsor
Institute	Osaka Prefectural Medical Center for Respiratory and Allergic Diseases
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	National Hospital Organization Kinki-Chuo Chest Medical Center
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

Other administrative information
Date of disclosure of the study information	2013 Year 01 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 12 Month 01 Day
Anticipated trial start date	2013 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2013 Year 01 Month 21 Day
Last modified on	2019 Year 01 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011483