UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluating the safety of bevacizumab in non-squamous NSCLC patients -Observational study-
Title of the study (Brief title)	Evaluating the safety of bevacizumab in non-squamous NSCLC patients -Observational study-
Region	Japan

Condition
Condition	Patients with non-squamous non-small cell lung cancer
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate safety and efficacy of combination therapy with Bevacizumab in patients with non-squamous non-small cell lung cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Safety
Key secondary outcomes	PFS:Progression Free Survival DCR:Disease Control Rate ORR:Overall Response Rate TTF:Time to treatment failure OS:Overall Survival Safety and efficacy in patients with brain metastases

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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)Histological or cytological diagnosis of non-squamous NSCLC (2)Provided written consent in person for participation in this study (3)Age 20 years or older (4)ECOG Performance Status (PS) 0 to 2 (5)Have measurable lesions according to the Response Evaluation Criteria in Solid Tumors ver1.1 (6)Have adequate function of major organs (bone marrow, liver, kidneys) defined as follows: Neutrophils>=1,500 /mm3 Platelets>=100,000 /mm3 Hemoglobin>8.0 g/dl AST and ALT<=100IU/l Serum creatinine<=1.5 mg/dl
Key exclusion criteria	(1)Received transfusion or G-CSF within 14 days prior to enrollment (2)Urine protein>=2+ (3)History of drug allergy (4)Active multiple cancers (5)Severe infection (6)High fever (7)Abnormal cardiac function (8)Severe pulmonary disease; Interstitial pneumonia, severe COPD, pulmonary thromboembolism (9)Need for drainage of pleural effusion, acsites or pericardial effusion (10)History of hematoemesis, ileus and gastroduodenal ulcer (11)symptomatic CNS metastases (12)CNS or Psychological disorders (13)Medically uncontrolled hypertension or diabetes mellitus (14)Nonhealing wound and surgery within 4 weeks before treatment (15)History of hemoptysis; one-half teaspoon of bright red blood per event (16)Therapeutic anticoagulation(full-dose therapeutic anticoagulation current and recent use of aspirin (>=325 mg/day) (17)severe bone marrow suppression (18)Pregnancy or lactation
Target sample size	120

Research contact person
Name of lead principal investigator	Eiji Shimizu
Organization	Faculty of Medicine, Tottori University
Division name	Division of Medical Oncology
Address	36-1 Nishi-machi, Yonago-shi, Tottori-ken
TEL	0859-38-6537
Email	Eiji@med.tottori-u.ac.jp

Public contact
Name of contact person	Masahiro Kodani
Organization	Faculty of Medicine, Tottori University
Division name	Division of Medical Oncology
Address	36-1 Nishi-machi, Yonago-shi, Tottori-ken
TEL	0859-38-6537
Homepage URL
Email	kodani@med.tottori-u.ac.jp

Sponsor
Institute	Division of Medical Oncology and Molecular Respirology Department of Multidisciplinary Internal Medicine Faculty of Medicine, Tottori University
Institute
Department

Funding Source
Organization	Molecular Respirology Department of Multidisciplinary Internal Medicine Faculty of Medicine, Tottori University
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	鳥取大学医学部附属病院、鳥取県立中央病院、米子医療センター

Other administrative information
Date of disclosure of the study information	2013 Year 09 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 03 Month 28 Day
Anticipated trial start date	2012 Year 04 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	The aim of this observational study is to evaluate the safety and efficacy of bevacizumab in non-squamous NSCLC patients, especially with brain metastases.

Management information
Registered date	2013 Year 09 Month 30 Day
Last modified on	2018 Year 10 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013917