UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004822 |
|---|---|
| Receipt number | R000005742 |
| Scientific Title | A phase II study of first-line gefitinib for advanced and recurrent EGFR mutation positivenon-small cell lung cancerwith high-risk factors |
| Date of disclosure of the study information | 2011/01/05 |
| Last modified on | 2017/07/11 09:38:37 |
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Basic information
Public title
A phase II study of first-line gefitinib for advanced and recurrent EGFR mutation positivenon-small cell lung cancerwith high-risk factors
Acronym
A phase II study of first-line gefitinib for advanced and recurrent EGFR mutation positivenon-small cell lung cancerwith high-risk factors
Scientific Title
A phase II study of first-line gefitinib for advanced and recurrent EGFR mutation positivenon-small cell lung cancerwith high-risk factors
Scientific Title:Acronym
A phase II study of first-line gefitinib for advanced and recurrent EGFR mutation positivenon-small cell lung cancerwith high-risk factors
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate efficacy and safety of first-line gefitinib for advanced and recurrent EGFR mutation positivenon-small cell lung cancer with high-risk factors
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
safety, progression-free survival, overall survival
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(250mg), oral daily
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)histologically or cytologically confirmed non-small cell lung cancer
2)unresectable, stage III or IV disease and radical radiotherapy unable
3)possess measurable lesion
4)EGFR mutation positive
5)20 years old or over
6)naive to chemotherapy for lung cancer
7)naive to radiotherapy for primally lung cancer
8)preserved organ's function
WBC>=2,000/mm3
Hemoglobin>= 7.0g/dl
Platelet count>=75,000/mm3
Total serum bilirubin <=1.5 mg/dl
GOT/GPT <100 IU/l
Serum creatinine <=1.5mg/dl
9)written informed consent
and applicable to 1 or 2 risk factors below
10)ECOG Perfomance status 2 -3
11)75 years old or over
12)evident pleural effusion
13)symptomatic brain or osseous metastasis
14)metastasis in more than two organs
Key exclusion criteria
1)ECOG Perfomance Status 4
2)white blood cell count; less than 2,000/mm3
3)bsolute neutrophil count; less than 1,000/mm3
4)hemoglobin; less than 7.0 g/dL
5)platelet count; less than 75,000/mm3
6)serum total bilirubin; 1.5 mg/dL or over
7)AST/ALT; 100 IU/L or over
8)serum creatinine; 1.5 mg/dL or over
9)serious complications below
I)uncontrollable angina pectoris, myocardial infarction within 6 months or heart failure
II)serious heart dosease
III)uncontrollable diabetes or hypertension
IV)infection
10)pulmonary fibrosis or interstitial pneumonitis evident on chest X ray
11)now pregnant or lactation, or possible pregnancy or refusal of contraception
12)difficult to perform or continue of this study
Target sample size
37
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kozo Yamada |
Organization
Kanagawa Cancer Center
Division name
Department of Thoracic Oncolog
Zip code
Address
2-3-2, Nakao, Asahi-ku, Yokohama, Japan
TEL
045-520-2222
yamadak@kcch.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shuji Murakami |
Organization
Kanagawa Cancer Center
Division name
Department of Thoracic Oncology
Zip code
Address
2-3-2, Nakao, Asahi-ku, Yokohama, Japan
TEL
045-520-2222
Homepage URL
murakamis@kcch.jp
Sponsor or person
Institute
Kanagawa Cancer Center
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
| 2011 | Year | 01 | Month | 05 | 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
| 2010 | Year | 09 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | 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
| 2011 | Year | 01 | Month | 05 | Day |
Last modified on
| 2017 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005742
