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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004018
Receipt No. R000004830
Scientific Title Phase II study of pemetrexed for advanced or relapsed non-squamous non-small-cell lung cancer in elderly patients
Date of disclosure of the study information 2010/08/10
Last modified on 2010/08/09

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Basic information
Public title Phase II study of pemetrexed for advanced or relapsed non-squamous non-small-cell lung cancer in elderly patients
Acronym Phase II study of pemetrexed for advanced or relapsed non-squamous non-small-cell lung cancer in elderly patients
Scientific Title Phase II study of pemetrexed for advanced or relapsed non-squamous non-small-cell lung cancer in elderly patients
Scientific Title:Acronym Phase II study of pemetrexed for advanced or relapsed non-squamous non-small-cell lung cancer in elderly patients
Region
Japan

Condition
Condition Non-squamous non-small cell lung cancer in elderly chemo-naive patients
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy and safety of pemetrexed for chemo-naive non-squamous non-small cell lung cancer in elderly patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Response rate
Key secondary outcomes Overall survival
Progression free survival
Safety
Quality of life

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)Chemo-naive clinical stage IIIB/IV or relapsed patients (no indication of surgery or radiotherapy)
3)Age of 70 years or older
4)Performance status(PS) of 0-1 in ECOG criteria
5)Adequate organ functions
6)With measurable lesion
7)Life expectancy more than 3 months
8)Written informed consent
Key exclusion criteria 1)Patients with brain metastasis in need of steroid or anticonvulsant
2)Previous radiation therapy to primary lesion
3)History of active double cancer
4)Patients with superior vena cava syndrome
5)Uncontrollable pleural effusion, pericardial effusion or ascites
6)History of uncontrollable hypertention, diabetes mellitus, active angina pectoris, active gastrointestinal hemorrhage, recent cardiac incompetence, recent myocardial infarction, and active virus infection(except viral hepatitis)
7)Interstitial pneumonia or pulmonary fibrosis obviously detectable on chest X-ray
8)History of severe drug allergy
9)History of severe psychiatric disease
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 Kazuhisa Takahashi
Organization Juntendo University, School of Medicine
Division name Department of Respiratory Medicine
Zip code
Address 2-1-1 Hongo,Bunkyo-Ku,Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Keiko Muraki
Organization Juntendo University, School of Medicine
Division name Department of Respiratory Medicine
Zip code
Address 2-1-1 Hongo,Bunkyo-Ku,Tokyo
TEL 03-5802-1063
Homepage URL
Email

Sponsor
Institute Juntendo University
Institute
Department

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

Other administrative information
Date of disclosure of the study information
2010 Year 08 Month 10 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
2010 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2010 Year 04 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
2010 Year 08 Month 09 Day
Last modified on
2010 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004830

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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