UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028605 |
|---|---|
| Receipt number | 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 | 2021/10/08 17:09:59 |
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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
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
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032727
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| Registered date | File name |
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| Registered date | File name |
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