UMIN-CTR Clinical Trial

Public title

A clinical study of bevacizumab to analyze a correlation of efficacy and the VEGF-related gene cluster for Patients with Advanced Non- Squamous Non-Small Cell Lung Cancer -KTOSG1003-

Acronym

KTOSG1003 study

Scientific Title

A clinical study of bevacizumab to analyze a correlation of efficacy and the VEGF-related gene cluster for Patients with Advanced Non- Squamous Non-Small Cell Lung Cancer -KTOSG1003-

Scientific Title:Acronym

KTOSG1003 study

Region

Japan

Condition

Non-small-cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

To explore the efficacy and positive predictive biomarkers of bevacizumab in patients with advanced Non-squamous non-small-cell lung cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

Explore the positive predictive biomarkers of bevacizumab

Key secondary outcomes

Response rate, Prgression free survival, safety

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Bevacizumab treatment

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)Writtened informed consent
(2)Age of 20 years or older
(3)Performance Status (ECOG) 0-1.
(4)Life expectancy of at least 3 months
(5)Histologically or cytrologically confirmed diagnosis of NSCLC without squamus cell carcinoma
(6)Tumors must have measurable disease by RECIST ver1.1.
(7)adequate organ function.

Key exclusion criteria

(1)CNS metastasis.
(2)History of treatment for brain metastasis.
(3)History of active double cancer.
(4)History of hemoptysis or hemosputum.
(5)Evidence of bleeding diathesis or coagulopathy.
(6)With great vessel invasion or cavity in tumor.
(7)Radiotherapy for thoracic lesions.
(8)History of severe heart disease.
(9)Superior vena cava syndrome.
(10)Spinal cord compression
(11)Current or previous history (within the last 1 year) of symptomatic cerebrovascular disease.
(12)Non-healing bone fracture and wound.
(13)Active infectious disease in need of intravenous administration of anti-bacterial, anti-fungal, or anti-viral drugs.
(14)Plan of the operation.
(15)Uncontrollable thrombosis.
(16)Uncontrollable gastrointestinal ulceration.
(17)Current or previous(within the last 1 year)history of GI perforation.
(18)Uncontrollable systemic disease (hyper tension or diabetes mellitus).
(19)Severe cardiac disease.
(20)Interstitial pneumonia or pulmonary fibrosis detectable on X-ray.
(21)Peripheral neuropathy > Grade2.
(22)With a history of drug sensitivity.
(23)History of bevacizumab treatment in the past.
(24)History of pregnancy or lactation.
(25)No intention to practice birth control.
(26)Registration to other trial.
(27)Patients whose participation in the trial is judged to be inappropriate by the attending doctor.

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Ji-ichirou Sasaki

Organization

Kitasato University Hospital

Division name

Department of Respiratory Medicine

Zip code

Address

1-15-1 kitasato, Minami-ku, Sagamihara-shi, Kanagawa, Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name	Sho Saeki

Organization

Kumamoto University Hospital

Division name

Department of Respiratory Medicine

Zip code

Address

TEL

Homepage URL

Email

saeshow@wg7.so-net.ne.jp

Institute

Department of Respiratory Medicine,
Kumamoto University Hospital

Institute

Department

Personal name

Organization

None

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

熊本大学医学部附属病院（熊本県）

Date of disclosure of the study information

2012

Year

03

Month

31

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

Enrolling by invitation

Date of protocol fixation

2010

Year

09

Month

15

Day

Date of IRB

Anticipated trial start date

2010

Year

11

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Multicenter prospective cohort study

Registered date

2012

Year

03

Month

31

Day

Last modified on

2012

Year

10

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008862