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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036255
Receipt No. R000024872
Scientific Title The Efficacy and Safety of Alectinib in Clinical Practice ; Comparision to Crizotinib, in A Multicenter Retrospective Study.
Date of disclosure of the study information 2019/03/19
Last modified on 2019/03/27

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Basic information
Public title The Efficacy and Safety of Alectinib in Clinical Practice ; Comparision to Crizotinib, in A Multicenter Retrospective Study.
Acronym The efficacy of alectinib in a multicenter retrospective study
Scientific Title The Efficacy and Safety of Alectinib in Clinical Practice ; Comparision to Crizotinib, in A Multicenter Retrospective Study.
Scientific Title:Acronym The efficacy of alectinib in a multicenter retrospective study
Region
Japan

Condition
Condition ALK rearranged non-small-cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 to evaluate the efficacy and safety of alectinib in clinical settings.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Time to treatment failure
Key secondary outcomes Progression-free survival
Overall survival

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 All patients who had ALK rearrangement positive results for sensitive immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), or reverse-transcriptase polymerase-chain-reaction (RT-PCR), and all patients with positive results for FISH had more than 15% split signals.
Key exclusion criteria Nothing
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Kentaro
Middle name
Last name Ito
Organization Matsusaka Municipal Hospital
Division name Respiratory Centor
Zip code 5150073
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 Kentaro
Middle name
Last name Ito
Organization Matsusaka Municipal Hospital
Division name Respiratory centor
Zip code 5150073
Address 1550, Tonomachi, Matsusaka city, Mie, Japan
TEL 0598-23-1515
Homepage URL
Email kentarou_i_0214@yahoo.co.jp

Sponsor
Institute Respiratory Centor, Matsusaka Municipal Hospital
Institute
Department

Funding Source
Organization Matsusaka Municipal Hospital
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 Matsusaka Municipal Hospital
Address 1550, Tonomachi, Matsusaka city, Mie
Tel 0598-23-1515
Email mchyanag@city-hosp.matsusaka.mie.jp

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
2019 Year 03 Month 19 Day

Related information
URL releasing protocol Nothing
Publication of results Published

Result
URL related to results and publications https://www.jto.org/article/S1556-0864(16)30701-8/fulltext
Number of participants that the trial has enrolled 61
Results
Sixty-one patients were enrolled. Forty-six patients were treated with ALK inhibitors (31 with crizotinib, 28 with alectinib, and 13 with both ALK inhibitors). The response rate was 66.7% for the crizotinib-treated group and 80.8% for the alectinib-treated group. Among all patients, TTF and PFS were significantly prolonged in the alectinib-treated group compared with in the crizotinib-treated group. OS was significantly longer in the alectinib-treated group than in the crizotinib-treated group. 
Results date posted
2019 Year 03 Month 19 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients who recieved ALK tyrosine kinase inhibitor (TKI) at six institutions from May 2012 through December 2015 were enrolled in the present study.
Participant flow
Enrollment retrospectively
Adverse events
Nothing (Retrospective study)
Outcome measures
Overall survival
Time to treatment failure
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 08 Month 10 Day
Date of IRB
2015 Year 08 Month 13 Day
Anticipated trial start date
2016 Year 03 Month 23 Day
Last follow-up date
2016 Year 03 Month 23 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We reviewed the backgrounds of all patients who were diagnosed with ALK rearranged NSCLC, and assessed the efficacy of ALK inhibitors in clinical practice, using time to treatment failure (TTF), progression-free survival (PFS), and overall survival (OS). We investigated the reasons for discontinuation of ALK inhibitors, patterns of progressive, and adverse events in detail. Electronic medical records were used to obtain patient-specific information. The treating physicians and radiologists in each institution assessed tumor response and toxicities.

Management information
Registered date
2019 Year 03 Month 19 Day
Last modified on
2019 Year 03 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024872

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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