Unique ID issued by UMIN | UMIN000010525 |
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Receipt number | R000012306 |
Scientific Title | Efficacy and safety of erlotinib in elderly patients with non-small-cell lung cancer harboring epidermal growth factor receptor mutations: A phase 2 study. |
Date of disclosure of the study information | 2013/04/17 |
Last modified on | 2016/06/10 09:31:25 |
Efficacy and safety of erlotinib in elderly patients with non-small-cell lung cancer harboring epidermal growth factor receptor mutations: A phase 2 study.
Efficacy and safety of erlotinib in elderly patients with EGFR-mutations-positive NSCLC.
Efficacy and safety of erlotinib in elderly patients with non-small-cell lung cancer harboring epidermal growth factor receptor mutations: A phase 2 study.
Efficacy and safety of erlotinib in elderly patients with EGFR-mutations-positive NSCLC.
Japan |
non-small-cell lung cancer
Pneumology |
Malignancy
NO
The objective of this study is to assess the efficacy and safety of erlotinib in elderly patients aged 75 years or older with non-small-cell lung cancer harboring epidermal growth factor receptor mutations.
Safety,Efficacy
Response rate
Progression free survival, overall survival, safety, QOL score
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Elderly patients with EGFR-mutations-positive non-small-cell lung cancer receive elrotinib.
75 | years-old | <= |
Not applicable |
Male and Female
All participants must meet the following criteria.
1: Histologically or pathologically proven NSCLC; stage 3B, 4, or reccurence.
2: EGFR mutation positive.
3: Aged 75 years or older.
4: Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.
4: Stage 3B/4 NSCLC.
5: Chemotherapy naive or received 1 regimen chemotherapy.
6: Never administerd EGFR-TKI.
7: a. Hemoglobin: more than 9.0 g/dL.
b. Neutrophil count: more than 3,000/uL.
c. Platelet count: more than 100,000/uL.
d. Aspartate transaminase (AST), alanine transaminase(ALT): less than 2.5 times the upper limit of normal of the institutional reference range.
e. Total bilirubin: less than 1.5 times the upper limit of normal of the institutional reference range.
8: Life expectancy of more than 3 months.
9: Written informed consent.
Exclusion criteria are as follows
1: History of severe allergic reactions to drugs.
2: Pregnancy or lactation.
3: Willing to get pregnant.
4: Interstitial lung disease.
5: Severe infection.
6; Severe and unstable medical comorbidities.
7: Difficulty in ingestion.
8: Uncontrolled brain metastases.
9: EGFR T790M mutation.
10: Judgment to attending physician.
30
1st name | |
Middle name | |
Last name | Takafumi Suda |
Hamamatsu University School of Medicine
Second Division, Department of Internal Medicine
1-20-1 Handayama, Higashi-ku, Hamamatsu-city, Japan
053-435-2263
suda@hama-med.ac.jp
1st name | |
Middle name | |
Last name | Yusuke Inoue |
Hamamatsu University School of Medicine
Second Division, Department of Internal Medicine
1-20-1 Handayama, Higashi-ku, Hamamatsu-city, Japan
053-435-2111
y.inoue@hama-med.ac.jp
Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine
Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine
Other
NO
2013 | Year | 04 | Month | 17 | Day |
Unpublished
Completed
2013 | Year | 04 | Month | 01 | Day |
2013 | Year | 04 | Month | 17 | Day |
2015 | Year | 04 | Month | 08 | Day |
2015 | Year | 04 | Month | 08 | Day |
2015 | Year | 04 | Month | 08 | Day |
2013 | Year | 04 | Month | 17 | Day |
2016 | Year | 06 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012306
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