UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005764
Receipt number R000006511
Scientific Title A Phase2 Study of Platinum Doublet and Bevacizumab followed by Bevacizumab and Pemetrexed maintenance for Non-squarmous Non Small Cell Lung Cancer Patients
Date of disclosure of the study information 2011/06/16
Last modified on 2014/06/13 09:10:45

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Basic information

Public title

A Phase2 Study of Platinum Doublet and Bevacizumab followed by Bevacizumab and Pemetrexed maintenance for Non-squarmous Non Small Cell Lung Cancer Patients

Acronym

Platinum Doublet and Bevacizumab followed by Bevacizumab and Pemetrexed maintenance for Non-squarmous Non Small Cell Lung Cancer Patients

Scientific Title

A Phase2 Study of Platinum Doublet and Bevacizumab followed by Bevacizumab and Pemetrexed maintenance for Non-squarmous Non Small Cell Lung Cancer Patients

Scientific Title:Acronym

Platinum Doublet and Bevacizumab followed by Bevacizumab and Pemetrexed maintenance for Non-squarmous Non Small Cell Lung Cancer Patients

Region

Japan


Condition

Condition

Non-squarmous Non Small Cell Lung Cancer(non-pretreated patient)

Classification by specialty

Pneumology Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To access the efficacy and safety of maintenance Bevacizumab+Pemetrexed following Platinum Doublet+Bevacizumab

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
Rate of shift to maintenance


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

Pulatinum doublet and Bevacizumab followed by maintenance Bevacizumab and Pemetrexed until Clinical disease progression

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 cytologically proven non small cell lung cancer(non-squarmous cell lung cancer)
2)Stage 3B/4
3)With evaluated and measured lesion according to RECIST(Ver.1.1)
4)Age 20-75
5)ECOG PS0-1
6)Adequate functions of major organs
7)Written informed concent

Key exclusion criteria

1)Previous hemopotysis (2.5ml)
2)Brain metastasis.
3)Any operation, biopsy associated with section, or any saturation of wounds within 4 weeks before enrollment.
4)Untreated traumatic bone fracture.
5)Consolidated or history of gastric perforation within 1 year before enrollment.
6)Uncontrollable peptic ulcer.
7)Tendency to bleed, or coagulation defect.
8)Treated with antithrombotic drugs within 10 days before enrollment.
9)Chronic inflammatory disease requiring anti-platelet agent.
10)History of interstitial lung disease.
11)Uncontrollable pleural effusion or ascites.
12)Uncontrollable heart disease and/or hypertension.
13)Cardiac infraction or cerebral infraction within 6 months before enrollment.
14)Have another active malignancy.
15)Severe infection or malnutrition.
16)Severe drug allergy.
17)In pregnancy, during breast feeding, or possibility of pregnancy.
18)Invasion to major vessel.
19)Cavitation of tumor.
20)History of chest irradiation (excluding if radiation field does not cover the primary tumor).
21)Any patient who is judged to be inappropriate for participation.

Target sample size

48


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshinobu Iwasaki

Organization

Kyoto Prefectural University of Medicine

Division name

Pulmonary Medicine

Zip code


Address

465 Kajii-cho, Kamigyoku, Kyoto city 602-8566

TEL

075-251-5513

Email

yiwasaki@koto.kpu-m.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yoshinobu Iwasaki

Organization

Kyoto Prefectural University of Medicine

Division name

Pulmonary Medicine

Zip code


Address

Hirokoji, Kawaramachi, Kamigyo-ku, Kyoto

TEL

075-251-5513

Homepage URL


Email

yiwasaki@koto.kpu-m.ac.jp


Sponsor or person

Institute

Kyoto Prefectural University of Medicine

Institute

Department

Personal name



Funding Source

Organization

Kyoto Prefectural University of Medicine

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

京都府立医科大学附属病院(京都府)


Other administrative information

Date of disclosure of the study information

2011 Year 06 Month 16 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

Open public recruiting

Date of protocol fixation

2011 Year 03 Month 15 Day

Date of IRB


Anticipated trial start date

2011 Year 04 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

2014 Year 06 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006511


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name