Unique ID issued by UMIN | UMIN000005468 |
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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 |
Efficacy of low-dose erlotinib as maintenance therapy in patients of lung adenocarcinoma with EGFR mutation
Efficacy of low-dose erlotinib as maintenance therapy
Efficacy of low-dose erlotinib as maintenance therapy in patients of lung adenocarcinoma with EGFR mutation
Efficacy of low-dose erlotinib as maintenance therapy
Japan |
lung adenocarcinoma
Pneumology | Hematology and clinical oncology |
Malignancy
YES
To study anti-tumor effect and adverse event in lung adenocarcinoma patinets with EGFR mutation administrated low-dose erlotinib (25mg/day)
Efficacy
Response rate (CR+PR)
Overall survival, progression-free survival, Disease control rate, frequency of adverse events, QOL
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
Low-dose erlotinib (25mg/day) is administrated after treatment of platinum based combination regimen
20 | years-old | <= |
85 | years-old | > |
Male and Female
(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
(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
40
1st name | |
Middle name | |
Last name | Satoshi Hirano |
National center for global health and medicine hospital
Respiratory medicine
Toyama, 1-21-1, Shinjuku-ku
+81-3-3202-7181
shirano@mmc.funabashi.chiba.jp
1st name | |
Middle name | |
Last name | Satoshi Hirano |
Funabashi municipal medical center
Medical oncology
Kanasugi 1-21-1, Funabashi city
+81-47-438-3321
shirano@mmc.funabashi.chiba.jp
National center for global health and medicine
The Grant of National Center for Global Health and Medicine
Funabashi Municipal Medical Center
NO
2011 | Year | 04 | Month | 19 | Day |
Unpublished
Terminated
2010 | Year | 12 | Month | 06 | Day |
2011 | Year | 04 | Month | 01 | Day |
2020 | Year | 04 | Month | 01 | Day |
2020 | Year | 04 | Month | 01 | Day |
2020 | Year | 04 | Month | 01 | Day |
2020 | Year | 04 | Month | 01 | Day |
2011 | Year | 04 | Month | 19 | Day |
2015 | Year | 04 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006484
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