UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002468
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Institute Kobe Lung Cancer Study Group
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 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
URL(English) https://upload.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


Contact us.