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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003691
Receipt No. R000004451
Scientific Title A Phase II Study of Pemetrexed in Elderly Patients with Previously Untreated Non-Squamous Non-Small-Cell Lung Cancer
Date of disclosure of the study information 2010/06/01
Last modified on 2014/12/04

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Basic information
Public title A Phase II Study of Pemetrexed in Elderly Patients with Previously Untreated Non-Squamous Non-Small-Cell Lung Cancer
Acronym A Phase II Study of Pemetrexed in Elderly Patients with Previously Untreated Non-Squamous Non-Small-Cell Lung Cancer
Scientific Title A Phase II Study of Pemetrexed in Elderly Patients with Previously Untreated Non-Squamous Non-Small-Cell Lung Cancer
Scientific Title:Acronym A Phase II 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
1 year survival rate
Safety
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 (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
70 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)70 years or older
3)Previously untreated stage III/IV patients (no indication of surgery or radiotherapy)
4)ECOG PS 0-2
5)With measurable lesion
6)Adequate organ function
7)Life expectancy more than 2 months
8)Eligible in case of controlled pleural effusion
9)Eligible in case of controlled brain metastases
10)Written informed consent
Key exclusion criteria 1)Interstitial pneumonia or pulmonary fibrosis detectable on chest X-ray
2)Patients with superior vena cava syndrome
3)History of uncontrollable diabetes mellitus, active angina pectoris, recent myocardial infaction, and recent brain infarction
4)History of active infection
5)History of severe psychological disease
6)Hystory of active double cancer
7)History of severe drug allergy
8)History of severe heart disease
9)Patients with immunotherapy or vaccine therapy
10)Patients whose participation in the trial is judged to be inappropriate by the attending doctor
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenji Eguchi
Organization Teikyo University Hospital
Division name Division of Medical Oncology
Zip code
Address 2-11-1, Kaga, Itabashi-ku, Tokyo 173-8606, Japan
TEL 03-3964-1211
Email keguchi@med.teikyo-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nobuhiko Seki
Organization Teikyo University Hospital
Division name Division of Medical Oncology
Zip code
Address 2-11-1, Kaga, Itabashi-ku, Tokyo 173-8606, Japan
TEL 03-3964-1211
Homepage URL
Email nseki@med.teikyo-u.ac.jp

Sponsor
Institute Lung Cancer Experts Network
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

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
2010 Year 06 Month 01 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 PR 20.0%(95%Cl:7.7-38.6)
PFS 89.0days(95%Cl:71.0-217.0)
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
2010 Year 03 Month 03 Day
Date of IRB
Anticipated trial start date
2010 Year 05 Month 01 Day
Last follow-up date
2012 Year 07 Month 25 Day
Date of closure to data entry
Date trial data considered complete
2012 Year 07 Month 26 Day
Date analysis concluded
2012 Year 10 Month 24 Day

Other
Other related information none

Management information
Registered date
2010 Year 06 Month 01 Day
Last modified on
2014 Year 12 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004451

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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