UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002783 |
|---|---|
| Receipt number | R000003384 |
| Scientific Title | A phase II study of gefitinib as first-line treatment for elderly patients with advanced lung adenocarcinoma who have active EGFR mutations |
| Date of disclosure of the study information | 2009/11/19 |
| Last modified on | 2012/05/28 13:14:34 |
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Basic information
Public title
A phase II study of gefitinib as first-line treatment for elderly patients with advanced lung adenocarcinoma who have active EGFR mutations
Acronym
A phase II study of gefitinib as first-line treatment for elderly patients with advanced lung adenocarcinoma who have active EGFR mutations
Scientific Title
A phase II study of gefitinib as first-line treatment for elderly patients with advanced lung adenocarcinoma who have active EGFR mutations
Scientific Title:Acronym
A phase II study of gefitinib as first-line treatment for elderly patients with advanced lung adenocarcinoma who have active EGFR mutations
Region
| Japan |
Condition
Condition
lung adenocarcinoma
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
evaluate the efficacy and feasibility of gefitinib as first-line treatment for elderly advanced lung adenocarcinoma patients with EGFR mutations
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Response rate
Key secondary outcomes
safety, disease control rate, progression free survival overall survival, 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
gefitinib
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)histopathologically diagnosed as
primary lung adenocarcinoma
2)including the mutation in exon 19 or
21
3)confirmed advanced stage 3B or 4 lung
adenocarcinoma
4)75 years or older
5)ECOG PS 0-2
6)measurable lesion
7)adequate organ function
8)predicted 12 weeks or more survival
9)informed consent
Key exclusion criteria
1)interstitial pneumonia on computed
tomography scan
2)liver cirrhosis, uncontrolled diabetes
mellitus, cardiac infarciton and
cereral apoplexy onset within three
months
3)othere active cancer
4)symptomatic brain metastases
5)need to plan the radiotherapy included
in the lung field
6)history of sever drug allegy
7)judged to be inappropriate by the
attending doctor
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomonobu Koizumi |
Organization
Shinshu University School of Medicine
Division name
The first department of internal medicine
Zip code
Address
3-1-1 Asahi, Matsumoto, Nagano, JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Shinshu University School of Medicine
Division name
The first department of internal medicine
Zip code
Address
TEL
0263-37-2631
Homepage URL
Sponsor or person
Institute
Nagano lung cancer study meeting
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
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 | 11 | Month | 19 | 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
| 2007 | Year | 08 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 11 | 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 | 11 | Month | 19 | Day |
Last modified on
| 2012 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003384
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
