UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002452 |
|---|---|
| Receipt number | 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 13:08:43 |
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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: ≥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
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
Sponsor or person
Institute
Kyoto Thoracic Oncology Research Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003003
