UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005468 |
|---|---|
| Receipt number | R000006484 |
| Scientific Title | Efficacy of low-dose erlotinib as maintenance therapy in patients of lung adenocarcinoma with EGFR mutation |
| Date of disclosure of the study information | 2011/04/19 |
| Last modified on | 2015/04/24 12:39:06 |
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Basic information
Public title
Efficacy of low-dose erlotinib as maintenance therapy in patients of lung adenocarcinoma with EGFR mutation
Acronym
Efficacy of low-dose erlotinib as maintenance therapy
Scientific Title
Efficacy of low-dose erlotinib as maintenance therapy in patients of lung adenocarcinoma with EGFR mutation
Scientific Title:Acronym
Efficacy of low-dose erlotinib as maintenance therapy
Region
| Japan |
Condition
Condition
lung adenocarcinoma
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To study anti-tumor effect and adverse event in lung adenocarcinoma patinets with EGFR mutation administrated low-dose erlotinib (25mg/day)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Response rate (CR+PR)
Key secondary outcomes
Overall survival, progression-free survival, Disease control rate, frequency of adverse events, QOL
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
Low-dose erlotinib (25mg/day) is administrated after treatment of platinum based combination regimen
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Lung adenocarcinoma with EGFR mutation is obtained pathologically or cytologically.
(2)Patient with normal swallowing function to take erlotinib.
(3)WBC>3000
Platelet<100000
GOT, GPT<2xthe upper limit of the normal range
T-Bil<the upper limit of normal range
sCr<1.5xupper limit of normal range
(4)Patinet without interstitial pneumonitis and lung fibrosis
(5)patient without treatment history of EGFR-TKI
(6)Performance status;PS<4
(7)Age>19, age<85
(8)Informed consent is obtained from the patient
Key exclusion criteria
(1) Patient with severe complication
(2) Patient with symptomatic brain metastasis
(3) Patient with double cancer
(4) Pregnant, breast feeding patient. Patient with possibility of pregnant
(5) Patient with diarrhea
(6) History of myocardial infarction within 3 months
(7) Unsuitable patient for this study in opinion of doctor in charge
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Hirano |
Organization
National center for global health and medicine hospital
Division name
Respiratory medicine
Zip code
Address
Toyama, 1-21-1, Shinjuku-ku
TEL
+81-3-3202-7181
shirano@mmc.funabashi.chiba.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Hirano |
Organization
Funabashi municipal medical center
Division name
Medical oncology
Zip code
Address
Kanasugi 1-21-1, Funabashi city
TEL
+81-47-438-3321
Homepage URL
shirano@mmc.funabashi.chiba.jp
Sponsor or person
Institute
National center for global health and medicine
Institute
Department
Personal name
Funding Source
Organization
The Grant of National Center for Global Health and Medicine
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Funabashi Municipal Medical Center
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 | 04 | Month | 19 | 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
Terminated
Date of protocol fixation
| 2010 | Year | 12 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2020 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2020 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2020 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 04 | Month | 19 | Day |
Last modified on
| 2015 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006484
