Unique ID issued by UMIN | UMIN000012056 |
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Receipt number | R000014095 |
Scientific Title | Efficacy and safety of erlotinib in elderly patients with non-small-cell lung cancer harboring epidermal growth factor receptor mutations |
Date of disclosure of the study information | 2013/10/31 |
Last modified on | 2013/10/16 22:44:39 |
Efficacy and safety of erlotinib in elderly patients with non-small-cell lung cancer harboring epidermal growth factor receptor mutations
Efficacy and safety of erlotinib in elderly patients with non-small-cell lung cancer harboring epidermal growth factor receptor mutations
Efficacy and safety of erlotinib in elderly patients with non-small-cell lung cancer harboring epidermal growth factor receptor mutations
Efficacy and safety of erlotinib in elderly patients with non-small-cell lung cancer harboring epidermal growth factor receptor mutations
Japan |
non-small-cell lung cancer
Pneumology |
Malignancy
NO
We examine the efficacy and safety of having to adjust the capacity of drug side effects and effects on the elderly patients with non-small-cell lung cancer harboring epidermal growth factor receptor mutations
Safety,Efficacy
Progression-free survival
Time to Treatment Failure, Disease Control Rate, Overall survival, Response Rate, Quality of life
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Erlotinib
75 | years-old | <= |
Not applicable |
Male and Female
1) Histologically or cytologically confirmed non-small-cell lung cancer
2) Unresectable or postoperative recurrence NSCLC
3) EGFR mutation positive
4) Prior EGFR-TKIs is not accepted
5) ECOG PS 0-3
6) Measurable lesions (RECIST)
7) Age>=75years
8) Adequate function of main organ
9) Provided written informed consent
1) EGFR mutation T790M positive
2) Active concomitant malignancy.
3) Interstitial pneumonia or pulmonary fibrosis on chest CT scans
4) Active concomitant malignancy
5) Pregnant or breast-feeding females
6) Inappropriate patients for this study judged by the physicians
38
1st name | |
Middle name | |
Last name | Sutani Akihisa |
Shimane university hospital
Clinical oncology and Respiratory medicine
89-1, Enya-cho, Izumo city, Shimane prefecture, Japan
0853-20-2580
sutani@med.shimane-u.ac.jp
1st name | |
Middle name | |
Last name | Sutani Akihisa |
Shimane university hospital
Clinical oncology and Respiratory medicine
89-1, Enya-cho, Izumo city, Shimane prefecture, Japan
0853-20-2580
sutani@med.shimane-u.ac.jp
Shimane university hospital
non
Self funding
NO
2013 | Year | 10 | Month | 31 | Day |
Unpublished
Open public recruiting
2013 | Year | 10 | Month | 08 | Day |
2013 | Year | 10 | Month | 08 | Day |
2013 | Year | 10 | Month | 16 | Day |
2013 | Year | 10 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014095
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