UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002847
Receipt number R000003452
Scientific Title A Phase II study of Cisplatin and Pemetrexed for Advanced Non-Small(Non squamous cell)Lung Cancer
Date of disclosure of the study information 2009/12/04
Last modified on 2014/09/24 19:00:10

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Basic information

Public title

A Phase II study of Cisplatin and Pemetrexed for Advanced Non-Small(Non squamous cell)Lung Cancer

Acronym

A Phase II study of Cisplatin and Pemetrexed for Advanced Non-Small(Non squamous cell)Lung Cancer

Scientific Title

A Phase II study of Cisplatin and Pemetrexed for Advanced Non-Small(Non squamous cell)Lung Cancer

Scientific Title:Acronym

A Phase II study of Cisplatin and Pemetrexed for Advanced Non-Small(Non squamous cell)Lung Cancer

Region

Japan


Condition

Condition

Advanced Non-Small Cell (Non squamous cell)lung Cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Aim of study is to evaluate efficacy and safety of Cisplatin plus pemetrexed for patients with untreated advanced non-small-cell lung cancer(NSCLC)

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

ORR

Key secondary outcomes

toxicity,PFS,OS


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

Cisplatin 75mg/m2 iv
pemetrexed 500mg/m2 iv

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

74 years-old >=

Gender

Male and Female

Key inclusion criteria

Histologically or Cytologoically confirmed NSCLC (non squamous cell).


Key exclusion criteria

A recognized ILD or pulmonary fibrosis on X-rays.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Makoto Nishio

Organization

Cancer Institute Hospital
Japanese Foundation for cancer research

Division name

Thoracic Medical oncology ,Thoracic Center

Zip code


Address

3-10-6 Ariake,Koto-ku,Tokyo

TEL

03-3520-0111

Email



Public contact

Name of contact person

1st name
Middle name
Last name Fumiyoshi Ohyanagi

Organization

Japanese Foundation for cancer research

Division name

Thoracic Medical oncology , Thoracic Center

Zip code


Address


TEL

03-3520-0111

Homepage URL


Email



Sponsor or person

Institute

Thoracic Medical oncology
Thoracic center
Cancer Institute Hospital
Japanese Foundation for cancer research

Institute

Department

Personal name



Funding Source

Organization

Thoracic Medical oncology
Thoracic Center
Cancer Institute Hospital
Japanese Foundation for cancer research

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



Other administrative information

Date of disclosure of the study information

2009 Year 12 Month 04 Day


Related information

URL releasing protocol


Publication of results

Published


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

2009 Year 11 Month 21 Day

Date of IRB


Anticipated trial start date

2009 Year 11 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

2009 Year 12 Month 04 Day

Last modified on

2014 Year 09 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003452


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name