UMIN-CTR Clinical Trial

Basic information
Public title	A retrospective study for ALK positive Lung Cancer - The Clinical Benefits of Sequential Therapy using Crizotinib followed by Alectinib in Clinical Practice: A Multicenter Retrospective Study. - (WJOG9516L)
Acronym	A retrospective study for ALK positive Lung Cancer
Scientific Title	A retrospective study for ALK positive Lung Cancer - The Clinical Benefits of Sequential Therapy using Crizotinib followed by Alectinib in Clinical Practice: A Multicenter Retrospective Study. - (WJOG9516L)
Scientific Title:Acronym	A retrospective study for ALK positive Lung Cancer
Region	Japan

Condition
Condition	Non-small-cell lung cancer (NSCLC)
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to clarify the background of ALK rearrangement NSCLC patients, treatment and outcome, efficacy and safety of ALK inhibitors, and prognosis in clinical practice.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Others
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Combined time-treatment-failure (TTF) of crizotinib and alectinib
Key secondary outcomes	Overall survival (OS) Time to treatment failure (TTF) Progression-free survival (PFS) Combined PFS Objective response rate (ORR) TTF of chemotherapy

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
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Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Confirmed diagnosis with NSCLC pathologically. 2) Confirmed diagnosis with ALK rearranged by molecular analysis. 3) Received crizotinib and/or alectinib therapy between May 1, 2012 and Dec 31, 2016.
Key exclusion criteria	No prior exposure of ceritinib before crizotinib or alectinib, regardless of clinical trial or practice.
Target sample size	700

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kentaro Ito
Organization	Matsusaka Municipal Hospital
Division name	Department of Respiratory Medicine
Zip code
Address	1550, Tonomachi, Matsusaka city, Mie, Japan
TEL	0598-23-1515
Email	kentarou_i_0214@yahoo.co.jp

Public contact
Name of contact person	1st name Middle name Last name Shinichiro Nakamura
Organization	West Japan Oncology Group
Division name	WJOG datacenter
Zip code
Address	Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka 556-0016 JAPAN
TEL	06-6633-7400
Homepage URL
Email	datacenter@wjog.jp

Sponsor
Institute	West Japan Oncology Group
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information	2017 Year 08 Month 09 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 08 Month 06 Day
Date of IRB	2017 Year 08 Month 06 Day
Anticipated trial start date	2017 Year 09 Month 01 Day
Last follow-up date	2019 Year 03 Month 09 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	TTF, OS, and PFS will be calculated and compared retrospectively between treatment groups with using Cox hazard model or propensity scoring.

Management information
Registered date	2017 Year 08 Month 09 Day
Last modified on	2021 Year 10 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032727