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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000035853 |
Receipt No. | R000040841 |
Official scientific title of the study | 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 | 2019/02/12 |
Basic information | ||
Official scientific title of the study | Retrospective study of alectinib on long-term prognosis in poor performance status patients with ALK positive, advanced/recurrent NSCLC | |
Title of the study (Brief title) | LOGIK1401-B | |
Region |
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Condition | |||
Condition | Non-Small Cell Lung Cancer | ||
Classification by specialty |
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Classification by malignancy | Malignancy | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | 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. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | 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 |
Key secondary outcomes |
Base | |
Study type | Observational |
Study design | |
Basic design | |
Randomization | |
Randomization unit | |
Blinding | |
Control | |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |
No. of arms | |
Purpose of intervention | |
Type of intervention | |
Interventions/Control_1 | |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1) 15 sites with participation to LOGIK1401 where patients were enrolled in LOGIK1401
2) Institutions approved by institutional ethics committee on this observational study. |
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Key exclusion criteria | Nothing particular | |||
Target sample size | 18 |
Research contact person | |
Name of lead principal investigator | Isamu Okamoto |
Organization | Kyushu University Hospital |
Division name | Research Institute for Disease of the Chest |
Address | 3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan |
TEL | 092-642-5378 |
okamotoi@kokyu.med.kyushu-u.ac.jp |
Public contact | |
Name of contact person | Eiji Iwama |
Organization | Kyushu University Hospital |
Division name | Research Institute for Disease of the Chest |
Address | 3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan |
TEL | 092-642-5378 |
Homepage URL | |
iwama@kokyu.med.kyushu-u.ac.jp |
Sponsor | |
Institute | Lung Oncology Group in Kyushu, Japan (LOGIK) |
Institute | |
Department |
Funding Source | |
Organization | Clinical Research Support Center Kyushu |
Organization | |
Division | |
Category of Funding Organization | Non profit foundation |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
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 | 九州大学病院(福岡県)、 |
Other administrative information | |||||||
Date of disclosure of the study information |
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Progress | |||||||
Recruitment status | No longer recruiting | ||||||
Date of protocol fixation |
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Anticipated trial start date |
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Last follow-up date | |||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
URL releasing results | |
Results | |
Other related information | 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. |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040841 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |