UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009828
Receipt number R000011483
Scientific Title Phase II Study of Bevacizumab in Combination with First-line Platinum-Doublet Chemotherapy in Non-squamous NSCLC Patients with Asymptomatic Untreated Brain Metastases.
Date of disclosure of the study information 2013/01/22
Last modified on 2019/01/27 22:34:18

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Basic information

Public title

Phase II Study of Bevacizumab in Combination with First-line Platinum-Doublet Chemotherapy in Non-squamous NSCLC Patients with Asymptomatic Untreated Brain Metastases.

Acronym

Phase II Study of Bevacizumab in Combination with First-line Platinum-Doublet Chemotherapy in Non-squamous NSCLC Patients with Asymptomatic Untreated Brain Metastases.

Scientific Title

Phase II Study of Bevacizumab in Combination with First-line Platinum-Doublet Chemotherapy in Non-squamous NSCLC Patients with Asymptomatic Untreated Brain Metastases.

Scientific Title:Acronym

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

1st name
Middle name
Last name Ichiro Kawase

Organization

Osaka Prefectural Medical Center for Respiratory and Allergic Diseases

Division name

Department of Thoracic Malignancy

Zip code


Address

3-7-1 Habikino Habikino city Osaka

TEL

072-957-2121

Email

moto19781205@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Motohiro Tamiya/Takayuki Shiroyama

Organization

Osaka Prefectural Medical Center for Respiratory and Allergic Diseases

Division name

Department of Thoracic Malignancy

Zip code


Address

3-7-1 Habikino Habikino City Osaka Japan

TEL

072-957-2121

Homepage URL


Email

moto19781205@yahoo.co.jp


Sponsor or person

Institute

Osaka Prefectural Medical Center for Respiratory and Allergic Diseases

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

National Hospital Organization Kinki-Chuo Chest Medical Center

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



Other administrative information

Date of disclosure of the study information

2013 Year 01 Month 22 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

Completed

Date of protocol fixation

2012 Year 12 Month 01 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011483


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name