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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002452
Receipt No. R000003003
Scientific Title Phase II trial of Pemetrexed for elderly advanced non-squamous non-small cell lung cancer
Date of disclosure of the study information 2010/04/01
Last modified on 2013/03/05

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Basic information
Public title Phase II trial of Pemetrexed for elderly advanced non-squamous non-small cell lung cancer
Acronym Phase II trial of PEM for elderly non-sq NSCLC
Scientific Title Phase II trial of Pemetrexed for elderly advanced non-squamous non-small cell lung cancer
Scientific Title:Acronym Phase II trial of PEM for elderly non-sq NSCLC
Region
Japan

Condition
Condition non-sq NSCLC
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 to investigate the safety and efficacy of pemetrexed in patients with elderly non-sq NSCLC.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes response rate
Key secondary outcomes 1-year survival, overall survival, progression-free survival, safety

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 chemotherapy with 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
75 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)histologically or cytologically
proven non-sq NSCLC
2)Stage IIIb or IV
3)age: &#8805;75
4)ECOG PS 0-1
5)measurable lesion
6)chemo-naive
7)normal organ function
8)written informed consesnt
Key exclusion criteria 1)active concomitant malignancy
2)pregnant or lactating woman
3)psychiatry disease
4)interstitial pneumoia/active lung fibrosis on chest x-ray
5)symptomatic brain metastasis
6)massive or uncontrolable pleural effusion
7)uncontrolable diabetes mellitus
8)uncontrolable hypertension
9)unstable angina or myocardial infarction within 6 months
10)history of severe drug allergy
Target sample size 28

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Young Hak Kim
Organization Kyoto University Hospital
Division name Respiratory Medicine
Zip code
Address 54 Shogoin-Kawaharacho Sakyo-ku Kyoto
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kyoto University Hospital
Division name Respiratory Medicine
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Kyoto Thoracic Oncology Research Group
Institute
Department

Funding Source
Organization MinistryofEducation,Culture,Sports,
ScienceandTechnology
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

Other administrative information
Date of disclosure of the study information
2010 Year 04 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
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 21 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
2011 Year 09 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 05 Day
Last modified on
2013 Year 03 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003003

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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