UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008811
Receipt number R000010315
Scientific Title Bevacizumab Combined With Cisplatin Plus Pemetrexed as Front-line Chemotherapy for Asymptomatic Brain Metastases in Non-squamous Non-small Cell Lung Cancer.
Date of disclosure of the study information 2013/09/01
Last modified on 2017/12/24 16:09:22

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Basic information

Public title

Bevacizumab Combined With Cisplatin Plus Pemetrexed as Front-line Chemotherapy for Asymptomatic Brain Metastases in Non-squamous Non-small Cell Lung Cancer.

Acronym

Bevacizumab With Cisplatin Plus Pemetrexed for Asymptomatic Brain Metastases in Non-Sq NSCLC

Scientific Title

Bevacizumab Combined With Cisplatin Plus Pemetrexed as Front-line Chemotherapy for Asymptomatic Brain Metastases in Non-squamous Non-small Cell Lung Cancer.

Scientific Title:Acronym

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

1st name
Middle name
Last name Nobuyuki Katakami

Organization

Institute of Biomedical Research and Innovation

Division name

Division of Integrated Oncology

Zip code


Address

2-2, Minatojima-minamimachi, Chuo-ku, Kobe

TEL

078-304-5200

Email



Public contact

Name of contact person

1st name
Middle name
Last name Akito Hata

Organization

Institute of Biomedical Research and Innovation

Division name

Division of Integrated Oncology

Zip code


Address

2-2, Minatojima-minamimachi, Chuo-ku, Kobe

TEL

078-304-5200

Homepage URL


Email

a-hata@fbri.org


Sponsor or person

Institute

Hanshin Oncology Group

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

Recruitment status

Terminated

Date of protocol fixation

2012 Year 08 Month 01 Day

Date of IRB


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


Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010315


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name