Unique ID issued by UMIN | UMIN000035853 |
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Receipt number | R000040841 |
Scientific Title | Retrospective study of alectinib on long-term prognosis in poor performance status patients with ALK positive, advanced/recurrent NSCLC |
Date of disclosure of the study information | 2019/02/12 |
Last modified on | 2020/02/13 17:56:14 |
Retrospective study of alectinib on long-term prognosis in poor performance status patients with ALK positive, advanced/recurrent NSCLC
LOGIK1401-B
Retrospective study of alectinib on long-term prognosis in poor performance status patients with ALK positive, advanced/recurrent NSCLC
LOGIK1401-B
Japan |
Non-Small Cell Lung Cancer
Pneumology | Hematology and clinical oncology |
Malignancy
NO
The observation period of "PhaseII safety and efficacy study of alectinib in poor performance status patients with ALK positive, advanced NSCLC (LOGIK1401)" was finished at 1.5 years after the completion of enrollment of 18 patients. The aim of this study is to follow-up the examination on progression free survival (PFS) and overall survival (OS) as well as 1-year and 2-year overall survival, pattern of progression (e.g. presence or absence of progression of brain metastasis) and post-treatment is performed in this study, and we also clarify.
Efficacy
Exploratory
Not applicable
Progression free survival (PFS)
Overall survival (OS)
One-year overall survival
Two-year overall survival
Presence or absence of progression
Pattern of progression (Presence or absence of progression of brain metastasis)
Post-treatment: 2nd treatment after the failure of alectinib treatment
Observational
20 | years-old | <= |
Not applicable |
Male and Female
1) 15 sites with participation to LOGIK1401 where patients were enrolled in LOGIK1401
2) Institutions approved by institutional ethics committee on this observational study.
Nothing particular
18
1st name | Isamu |
Middle name | |
Last name | Okamoto |
Kyushu University Hospital
Research Institute for Disease of the Chest
812-8582
3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
092-642-5378
okamotoi@kokyu.med.kyushu-u.ac.jp
1st name | Eiji |
Middle name | |
Last name | Iwama |
Kyushu University Hospital
Research Institute for Disease of the Chest
812-8582
3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
092-642-5378
iwama@kokyu.med.kyushu-u.ac.jp
Lung Oncology Group in Kyushu, Japan (LOGIK)
Clinical Research Support Center Kyushu
Non profit foundation
Clinical Research Network Fukuoka Certified Review Board
3-1-1 Maidashi, Higashi-ku, Fukuoka
092-643-7171
mail@crnfukuoka.jp
NO
九州大学病院(福岡県)、
2019 | Year | 02 | Month | 12 | Day |
Unpublished
18
No longer recruiting
2018 | Year | 06 | Month | 28 | Day |
2018 | Year | 08 | Month | 15 | Day |
2018 | Year | 08 | Month | 15 | Day |
2019 | Year | 09 | Month | 30 | Day |
Data collection
> Outcome (final survival date)
> Progression
Presence or absence of progression, pattern of progression (presence or absence of progression of brain metastasis): presence or absence of exacerbation or new emergence of brain metastases
> Post-treatment: next treatment after the failure of alectinib treatment, treatment period and detail.
2019 | Year | 02 | Month | 12 | Day |
2020 | Year | 02 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040841
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