UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002847 |
|---|---|
| Receipt number | R000003452 |
| Scientific Title | A Phase II study of Cisplatin and Pemetrexed for Advanced Non-Small(Non squamous cell)Lung Cancer |
| Date of disclosure of the study information | 2009/12/04 |
| Last modified on | 2014/09/24 19:00:10 |
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Basic information
Public title
A Phase II study of Cisplatin and Pemetrexed for Advanced Non-Small(Non squamous cell)Lung Cancer
Acronym
A Phase II study of Cisplatin and Pemetrexed for Advanced Non-Small(Non squamous cell)Lung Cancer
Scientific Title
A Phase II study of Cisplatin and Pemetrexed for Advanced Non-Small(Non squamous cell)Lung Cancer
Scientific Title:Acronym
A Phase II study of Cisplatin and Pemetrexed for Advanced Non-Small(Non squamous cell)Lung Cancer
Region
| Japan |
Condition
Condition
Advanced Non-Small Cell (Non squamous cell)lung Cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Aim of study is to evaluate efficacy and safety of Cisplatin plus pemetrexed for patients with untreated advanced non-small-cell lung cancer(NSCLC)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
ORR
Key secondary outcomes
toxicity,PFS,OS
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
Cisplatin 75mg/m2 iv
pemetrexed 500mg/m2 iv
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
| 20 | years-old | <= |
Age-upper limit
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Histologically or Cytologoically confirmed NSCLC (non squamous cell).
Key exclusion criteria
A recognized ILD or pulmonary fibrosis on X-rays.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Nishio |
Organization
Cancer Institute Hospital
Japanese Foundation for cancer research
Division name
Thoracic Medical oncology ,Thoracic Center
Zip code
Address
3-10-6 Ariake,Koto-ku,Tokyo
TEL
03-3520-0111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fumiyoshi Ohyanagi |
Organization
Japanese Foundation for cancer research
Division name
Thoracic Medical oncology , Thoracic Center
Zip code
Address
TEL
03-3520-0111
Homepage URL
Sponsor or person
Institute
Thoracic Medical oncology
Thoracic center
Cancer Institute Hospital
Japanese Foundation for cancer research
Institute
Department
Personal name
Funding Source
Organization
Thoracic Medical oncology
Thoracic Center
Cancer Institute Hospital
Japanese Foundation for cancer research
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
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
| 2009 | Year | 12 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
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 | 11 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 11 | 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
| 2009 | Year | 12 | Month | 04 | Day |
Last modified on
| 2014 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003452
