UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002468
Receipt number R000003006
Scientific Title A Phase 2 Study of Pemetrexed in Elderly Patients with Previously Untreated Non-Squamous Non-Small-Cell Lung Cancer
Date of disclosure of the study information 2009/09/09
Last modified on 2013/02/27 18:54:54

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Basic information

Public title

A Phase 2 Study of Pemetrexed in Elderly Patients with Previously Untreated Non-Squamous Non-Small-Cell Lung Cancer

Acronym

A Phase 2 Study of Pemetrexed in Elderly Patients with Previously Untreated Non-Squamous Non-Small-Cell Lung Cancer

Scientific Title

A Phase 2 Study of Pemetrexed in Elderly Patients with Previously Untreated Non-Squamous Non-Small-Cell Lung Cancer

Scientific Title:Acronym

A Phase 2 Study of Pemetrexed in Elderly Patients with Previously Untreated Non-Squamous Non-Small-Cell Lung Cancer

Region

Japan


Condition

Condition

Elderly patients with previously untreated 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 for elderly patients with previously untreated non-squamous non-small cell lung cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Response rate

Key secondary outcomes

Progression free survival
Overall survival
Disease control rate
Safety


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(500mg/m2) day 1,q3w until 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

75 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
(without large cell neuroendocrine carcinoma)
2)Non-squamous non-small cell cancer patients with stage IIIB(with pleural dissemination or malignant pleural effusion),stage IV or recurrent disease after surgery,who have no prior chemoterapy
3)With measurable lesion
4)If the patient underwent radiotherapy, there should be the following interval between the radiotherapy and the registration
i)Radiotherapy including pulmonary field ->3 months
ii)Radiotherapy other than thoracic radiation ->1 month
5)75 years or older
6)ECOG PS 0-1
7)Adequate organ function
8)Life expectancy more than 3 months
9)Written informed consent

Key exclusion criteria

1)Interstitial pneumonia or pulmonary fibrosis detectable on CT scan
2)History of drug induced interstitial pneumonia
3)History of severe drug allergy
4)History of active infection or other serious disease condition
(GI bleeding,etc.)
5)History of poorly controlled pleural effusion,pericardial effusion and ascites
6)History of severe heart disease(uncontrollable arrythmia,uncontrollable angina pectoris,herat failure,etc.)
7)Uncontrollable diabetes mellitus
8)History of symptomatic brain metastases
9)Hystory of active double cancer
10)History of active psychological disease
11)Patients whose participation in the trial is judged to be inappropriate by the attending doctor

Target sample size

45


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshikazu Kotani

Organization

Kobe University Hospital

Division name

Department of Respiratory Medicine

Zip code


Address

7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo 650-0017, Japan

TEL

078-382-5846

Email



Public contact

Name of contact person

1st name
Middle name
Last name Yoshiiro Hattori

Organization

Hyogo Cancer Center

Division name

Department of Thoracic Oncology

Zip code


Address

13-70, Kitaouji-cho, Akashi, Hyogo 673-8558, Japan

TEL

078-929-1151

Homepage URL


Email

hattori@hp.pref.hyogo.jp


Sponsor or person

Institute

Kobe Lung Cancer Study Group

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


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

神戸大学医学部附属病院(兵庫県)
先端医療センター(兵庫県)
兵庫県立がんセンター(兵庫県)


Other administrative information

Date of disclosure of the study information

2009 Year 09 Month 09 Day


Related information

URL releasing protocol


Publication of results

Partially 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 08 Month 10 Day

Date of IRB


Anticipated trial start date

2009 Year 08 Month 01 Day

Last follow-up date

2012 Year 06 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 07 Day

Last modified on

2013 Year 02 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003006


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name