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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028605
Receipt No. R000032727
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)
Date of disclosure of the study information 2017/08/09
Last modified on 2017/12/27

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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
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

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
Name of secondary funder(s)

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 Open public recruiting
Date of protocol fixation
2017 Year 08 Month 06 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 01 Day
Last follow-up date
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
2017 Year 12 Month 27 Day


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

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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