UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005763
Receipt number R000006702
Scientific Title A Phase II Study of Cisplatin, Pemetrexed and Bevacizumab for Advanced Non-Small Cell (Non squamous cell) Lung Cancer
Date of disclosure of the study information 2011/06/13
Last modified on 2018/06/14 12:45:46

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Basic information

Public title

A Phase II Study of Cisplatin, Pemetrexed and Bevacizumab for Advanced Non-Small Cell (Non squamous cell) Lung Cancer

Acronym

A Phase II Study of Cisplatin, Pemetrexed and Bevacizumab for Advanced Non-Small Cell (Non squamous cell) Lung Cancer

Scientific Title

A Phase II Study of Cisplatin, Pemetrexed and Bevacizumab for Advanced Non-Small Cell (Non squamous cell) Lung Cancer

Scientific Title:Acronym

A Phase II Study of Cisplatin, Pemetrexed and Bevacizumab for Advanced Non-Small Cell (Non squamous cell) Lung Cancer

Region

Japan


Condition

Condition

Advanced Non-Small Cell (Non squamous cell) Lung Cance

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To assess the safety and efficacy of Cisplatin Pemetrexed and Bevacizum in a phase II clinical study of patients with advanced non-small cell Lung cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

ORR

Key secondary outcomes



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

CDDP+PEM+BEV

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

75 years-old >

Gender

Male and Female

Key inclusion criteria

1)Histologically or cytrologically confirmed diagnosis of NSCLC with a adeno or large cell carcinoma
2)No prior systemic treatment advanced NSCLC with documented Stage IIIB or Stage IV or recurrent disease
3)Tumors must have measurable disease by RECIST version 1.1
4)20 years of age or older to 75 years exclusive
5))ECOG performance status 0 or 1
6)No problem adequate organ function

Key exclusion criteria

1)Subjects with interstitial pneumonia or pulmonary fibrosis.
2)Uncontrolled Active infection
3)No other active malignancies
4)Concurrent use of steroid therapy
5)Subjects with symptomatic brain metastases.
6)have had or require continuous oral administration of hemostat/have had or require injectable administration of hemostat
7)Uncontrolled pleural.
8)Have received radiation therapy to lesions of lung
9)Have a bleeding diathesis
10)Uncontrolled hypertension
11)Any other reason that,in the opinion of the investugator precludes the subject from participating in the study.

Target sample size

45


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Makoto Nishio

Organization

Japanese Foundation for Cancer Research, the Cancer Institute Hospital

Division name

Thoracic Oncology Center

Zip code


Address

3-8-31,Ariake, Koto-ku, Tokyo

TEL

03-3520-0111

Email

mnishio@jfcr.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Noriko Yanagitani

Organization

anese Foundation for Cancer Research, the Cancer Institute Hospital

Division name

Thoracic Oncology Center

Zip code


Address

3-8-31,Ariake, Koto-ku, Tokyo

TEL

03-3520-0111

Homepage URL


Email

noriko.yanagitani@jfcr.or.jp


Sponsor or person

Institute

Japanese Foundation for Cancer Research, the Cancer Institute Hospital

Institute

Department

Personal name



Funding Source

Organization

Japanese Foundation for Cancer Research, the Cancer Institute Hospital

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan


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



Other administrative information

Date of disclosure of the study information

2011 Year 06 Month 13 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

No longer recruiting

Date of protocol fixation

2011 Year 04 Month 05 Day

Date of IRB


Anticipated trial start date

2011 Year 06 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

2011 Year 06 Month 13 Day

Last modified on

2018 Year 06 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006702


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name