UMIN-CTR Clinical Trial

Public title

Evaluating the safety of bevacizumab in non-squamous NSCLC patients -Observational study-

Acronym

Evaluating the safety of bevacizumab in non-squamous NSCLC patients -Observational study-

Scientific Title

Evaluating the safety of bevacizumab in non-squamous NSCLC patients -Observational study-

Scientific Title:Acronym

Evaluating the safety of bevacizumab in non-squamous NSCLC patients -Observational study-

Region

Japan

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

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Eiji Shimizu

Organization

Faculty of Medicine, Tottori University

Division name

Division of Medical Oncology

Zip code

Address

36-1 Nishi-machi, Yonago-shi, Tottori-ken

TEL

0859-38-6537

Email

Eiji@med.tottori-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Masahiro Kodani

Organization

Faculty of Medicine, Tottori University

Division name

Division of Medical Oncology

Zip code

Address

36-1 Nishi-machi, Yonago-shi, Tottori-ken

TEL

0859-38-6537

Homepage URL

Email

kodani@med.tottori-u.ac.jp

Institute

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

Institute

Department

Personal name

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

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Date of disclosure of the study information

2013

Year

09

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2012

Year

03

Month

28

Day

Date of IRB

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

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.

Registered date

2013

Year

09

Month

30

Day

Last modified on

2018

Year

10

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013917