UMIN-CTR Clinical Trial

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	Japan

Condition
Condition	Non-Small Cell Lung Cancer
Classification by specialty	Pneumology Hematology and clinical oncology
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	20 years-old <=
Age-upper limit	Not applicable
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.
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
Email	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
Email	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	2019 Year 02 Month 12 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2018 Year 06 Month 28 Day
Anticipated trial start date	2018 Year 08 Month 15 Day
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	2019 Year 02 Month 12 Day
Last modified on	2019 Year 02 Month 12 Day

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

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