UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002510
Receipt number R000003059
Scientific Title phase 2 study of pemetrexed in the first-line treatment of advanced non-small cell lung cancer patients with PS2
Date of disclosure of the study information 2009/09/16
Last modified on 2012/04/09 13:28:56

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Basic information

Public title

phase 2 study of pemetrexed in the first-line treatment of advanced non-small cell lung cancer patients with PS2

Acronym

phase 2 study of pemetrexed in the first-line treatment of advanced non-small cell lung cancer patients with PS2

Scientific Title

phase 2 study of pemetrexed in the first-line treatment of advanced non-small cell lung cancer patients with PS2

Scientific Title:Acronym

phase 2 study of pemetrexed in the first-line treatment of advanced non-small cell lung cancer patients with PS2

Region

Japan


Condition

Condition

non-squamous,non-small cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

to evaluate efficacy and safety of pemetrexed in the first line treatment of advanced non-small cell lung cancer with PS2

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Response rate

Key secondary outcomes

Progression-free survival,Overall survival,QOL


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

pemetrexed

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)patients with stage IIIB or stage IV, who is impossible of radical irradiation
3)Non prior chemotherapy and irradiation for any other carcinomas.But we can permit picibani and minocycline for a pleurodesis.
4)With measurable lesion
5)20 years or older
6)ECOG PS 2
7)Adequate organ function
8)Life expectancy more than 12 weeks
9)Written informed consent

Key exclusion criteria

1)Interstitial pneumonia or pulmonary fibrosis detectable on Xray
2)History of severe drug allergy
3)History of poorly controlled pleural effusion,pericardial effusion and ascites.When that is controlled,we can permit.
4)History of symptomatic brain metastases
5)Hystory of active double cancer
6)History of severe comorbidity disease
i)uncontrollable angina pectoris,herat failure)
ii)active infection
7)History of active psychological disease
8)Pregnancy,breast feeding or wish of
future bearing
9)with systemic continuous steroid therapy
10)Other conditions not suitable for this
study

Target sample size

31


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Young Hak Kim

Organization

Graduate School of Medicine, Kyoto University

Division name

Department of Respiratory Medicine

Zip code


Address

54 Shogoin-Kawaharacho, Sakyo-Ku, Kyoto 606-8507, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name yuichi sakamori

Organization

Graduate School of Medicine, Kyoto University

Division name

Department of Respiratory Medicine

Zip code


Address

54 Shogoin-Kawaharacho, Sakyo-Ku, Kyoto 606-8507, Japan

TEL

075-751-3830

Homepage URL


Email



Sponsor or person

Institute

Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Science and Culture (19689018, and 17790524) of the Japanese government

Organization

Division

Category of Funding Organization

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

京都大学医学部付属病院


Other administrative information

Date of disclosure of the study information

2009 Year 09 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

2009 Year 09 Month 16 Day

Date of IRB


Anticipated trial start date

2009 Year 12 Month 01 Day

Last follow-up date

2014 Year 12 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2009 Year 09 Month 16 Day

Last modified on

2012 Year 04 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003059


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name