UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003691 |
|---|---|
| Receipt number | 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 18:46:17 |
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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
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
nseki@med.teikyo-u.ac.jp
Sponsor or person
Institute
Lung Cancer Experts Network
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
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Address
Tel
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004451
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
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